NEWSLETTER - CiteSeerX

Inside: President’s Report ..................................................................................................................Page 62Grant Awards for 2006............................................................................................................Page 68Dear SIRS - Absorbent Wrapper Design ............................................................................Page 70Officers, Directors, Committees - 2006 ..............................................................................Page 72Donors ........................................................................................................................................Page 732006 APSF Grant Application Guidelines..........................................................................Page 74ASA Abstracts ..........................................................................................................................Page 76Scientific/Technical ASA Exhibits ......................................................................................Page 78Labeling History ......................................................................................................................Page 86

NEWSLETTERVolume 20, No. 4, 61-88 Circulation 76,548 Winter 2005-2006

www.apsf.org The Official Journal of the Anesthesia Patient Safety Foundation

by John H. Eichhorn, MD

Three intensely personal presentations of tragicanesthesia events were the nucleus of the APSFBoard of Directors (BOD) workshop, “The Role ofPatients in the Mission of the APSF,” at the APSFAnnual Meeting October 21, 2005, in Atlanta. Thesurvivor of an anesthesia-related cardiac arrest, themother of an 11-year-old boy who suffered massivepermanent brain damage from an anesthesia acci-dent, and the wife of a 33-year-old marathon runnerwho eventually was allowed to die after an anesthe-sia mishap, all told their stories to an empathicaudience that was appalled, entranced, and galva-nized, in an effort to determine what the APSF cando to help heal their wounds and prevent othersfrom experiencing such trauma.

While the APSF has sought patient input formany years, this was the first time the foundationwas able to organize a program reflecting the per-spective of patients or “victims” of injuries fromaccidents solely related to anesthesia care. As thebroader concept of patient safety and the efforts atblame-free full disclosure and discussion followingmedical accidents have been more widely publi-cized in the U.S., survivors of medical catastrophes(including families of patients who die) appear morewilling to publicly share their experiences. As areflection of this, several survivor support/advo-cacy groups were recognized at the National PatientSafety Foundation Annual Meeting in May 2005.

inaugurate a new perspective for the APSF that willbe driven by the power of patients and the power ofstories. Dr. Cooper noted that this program was anattempt to “open up the filters” that physiciansoften automatically apply to patients’ views andavoid the reflex response of “that’s not how it’sdone”/“that can’t be done” so often applied to ideasfrom patients or their survivors. Further, he com-mented that one of the reasons it had been difficultto assemble a program of this nature was that (for-tunately) anesthesia care catastrophes are exceed-ingly rare, and also that open public discussion canbe inhibited by medical-legal exigencies (there wereno pending claims or proceedings involving any ofthe workshop presenters). One inspiration for Dr.Cooper was the open discussion by both the sur-vivor of an anesthesia-induced cardiac arrest andthe involved anesthesiologist of an event thatoccurred within the Harvard system (Dr. Cooper’sacademic affiliation), and that was the basis of thefirst story. [NOTE: Following are brief summaries ofthe presentations. First-person detailed accountsauthored by the workshop presenters themselvesare planned for an upcoming issue of the APSFNewsletter.]

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See “Patients,” Page 63

The following report highlights patient and family perspectives of adverse events that were presented at the APSF Board ofDirectors Workshop on October 21, 2005. These unique and important accounts give clinicians a glimpse into how anesthesiacomplications affect our patients and their families and demonstrate the importance of good communication and disclosure.

Because the October APSF workshop wasfocused on the profound impact on patients and sur-viving families of incidents perceived to representadverse outcomes specifically from anesthesia care,and how the APSF can learn from these stories, thepresentations were accepted as offered by the non-medical survivors. There were no “M and M” typereviews, no questioning to search for precise detailsof the anesthesia care and possible mechanisms ofinjuries. The outcomes were what they were, even ifthe presenters in some circumstances may not havefully appreciated relevant aspects of physiology,pharmacology, or anesthesia protocols. Rather, theAPSF Board of Directors was primarily interested inthe experiences, perceptions, and emotions of thepresenters. The goal was to gain new insight from anew source to help establish a role for patients in theAPSF and also to guide and energize anesthesia careand patient safety efforts for the future. The statedultimate objectives were to provoke action that willmake the APSF better understand the needs and con-cerns of patients/families who experience an adverseanesthesia event and to develop methods forpatients/families to be more involved in helpinginsure patient safety.

The workshop was organized and moderated byJeffrey B. Cooper, PhD, Executive Vice President ofthe APSF. He stressed that this is the “human side”of the equation of anesthesia care—a balance to theremarkable technologic and behavioral progress inpatient safety. A key goal of the program was to

Patient Perspectives Personalize Patient Safety

(Left to Right): Sue Stratman, Dr. Jeffrey Cooper, Dr.Julianne Chase, Dr. Frederick van Pelt, and Linda Kenneypresent Patient and Family Perspectives at the 2005APSF Board of Directors Workshop.

The Anesthesia Patient Safety FoundationNewsletter is the official publication of the nonprofitAnesthesia Patient Safety Foundation and ispublished quarterly at Wilmington, Delaware.Annual contributor status: Individual - $100.00,Corporate - $500.00. This and any additional contri-butions to the Foundation are tax deductible. © Copyright, Anesthesia Patient Safety Foundation, 2005.

The opinions expressed in this Newsletter are notnecessarily those of the Anesthesia Patient SafetyFoundation or its members or board of directors.Validity of opinions presented, drug dosages,accuracy, and completeness of content are notguaranteed by the APSF.APSF Executive Committee:

Robert K. Stoelting, MD, President; Jeffrey B.Cooper, PhD, Executive Vice President; George A.Schapiro, Executive Vice President; David M. Gaba,MD, Secretary; Casey D. Blitt, MD, Treasurer; Sorin J.Brull, MD; Robert A. Caplan, MD; Nassib G.Chamoun; Robert C. Morell, MD; Michael A.Olympio, MD; Richard C. Prielipp, MD.Newsletter Editorial Board:

Robert C. Morell, MD, Editor; Sorin J. Brull, MD;Joan Christie, MD; Jan Ehrenwerth, MD; John H.Eichhorn, MD; Regina King; Lorri A. Lee, MD ;Rodney C. Lester, PhD, CRNA; Glenn S. Murphy,MD; Denise O’Brien, BSN, RN; Karen Posner, PhD;Keith Ruskin, MD; Wilson Somerville, PhD; JefferyVender, MD.

Address all general, contributor, and subscriptioncorrespondence to:Administrator, Deanna WalkerAnesthesia Patient Safety FoundationBuilding One, Suite Two8007 South Meridian StreetIndianapolis, IN 46217-2922e-mail address: [email protected]: (317) 888-1482

Address Newsletter editorial comments, questions, letters, and suggestions to:Robert C. Morell, MDEditor, APSF Newsletterc/o Addie Larimore, Editorial AssistantDepartment of AnesthesiologyWake Forest University School of Medicine9th Floor CSBMedical Center BoulevardWinston-Salem, NC 27157-1009e-mail: [email protected]

APSF NEWSLETTER Winter 2005-2006 PAGE 62

Inside:

Performance Enhancing Drugs............................

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Ventilator Failure (Dear Sirs) ............................

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Cure for the Dopey Doc?............................

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Managing Fatigue............................

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Britain & Ireland’s Approach to Fatigue ............................

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Costs of Fatigue ............................

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age 15

Donors ............................

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Report on Long-Term Outcome Workshop............................

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ACS Collaborates With APSF ............................

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NEWSLETTER

Volume 20, No. 1, 1-24

Circulation 75,648

Spring 2005

www.apsf.orgThe Official Journal of the Anesthesia Patient Safety Foundation

Fatigue and Safety

Fatigue has played a causal or contributory role

in some famous accidents.1 In 1986, the Presidential

Commission found that faulty decision-making by

sleep-deprived managers contributed to the unto-

ward launch of the space shuttle Challenger. The

nuclear accidents at Three Mile Island and Cher-

nobyl both occurred during the early morning

hours when our bodies are craving sleep. The

grounding of the Exxon Valdez was a monumental

environmental catastrophe. The National Trans-

portation Safety Board found that the probable

cause of this accident was the fatigue of the person

sailing the ship. The National Highway Traffic

Safety Administrations estimates that over 100,000

people are killed or injured each year in crashes

attributed to drivers who fell asleep at the wheel or

were impaired by severe drowsiness. These exam-

ples and many others reveal that fatigue is a prob-

lem that extends beyond health care and is deeply

embedded within our society.

Studies have shown a correlation between the

performance effects of sleep deprivation and

ethanol intoxication.2 At 24 hours of continuous

wakefulness, psychomotor function was equivalent

to a blood alcohol concentration of 0.1%. This is at

or above the legal limit for driving in most states.

Think of the professional and personal liability of

coming to work intoxicated!

Anesthesia providers, like all health care

providers, are required to care for patients when

they present for care—anytime of the day or night.

This is often in opposition to what our physiology

demands. An irrefutable fact is that fatigue and

sleep deprivation negatively impact performance

and mood (see Table 1). In fact, the anesthesiolo-

gist’s role of monitoring the patient in a vigilant

manner may be particularly vulnerable to the effects

of fatigue.3 Vigilance is defined as the act of being

alertly watchful, especially to avoid danger. The

word “vigilance” is at the center of the seal and is

the motto of the American Society of Anesthesiolo-

gists. If we become disengaged from our environ-

ment (such as the “microsleeps” that happen when

we are sleep-deprived), all vigilance is lost.

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Everyone has seen it. For example, watching a colleague fall

asleep at a meeting or watching an intern struggle to remain alert while

holding a surgical retractor. Everyone has felt it. Eyelids get heavy and the

environment starts to “grey out.” Ask yourself if you desire to be cared for by

health care workers who look and feel this way. This clearly is a dangerous

situation for our patients. It is also unsafe for the practitioner when you

consider the possibility of harm due to occupational injury (e.g.,

needlesticks) and the increased risk of driving while sleepy.

This edition of the APSF Newsletter will focus on fatigue and the anesthesia care

provider. There is renewed interest in this topic, and we have gathered a cadre of

individuals who will present important new information on this topic. Anesthesiol-

ogy has been very forward-looking regarding many aspects of safety, and there is again

an opportunity to be at the “cutting edge” in dealing with this pervasive problem. We

hope that the material in this issue will encourage others in our field to join with us to

change the manner in which we practice and care for patients.

See “Fatigue,” Page 3

Fatigue & the Practice of Anesthesiology

by Steve Howard, MD, Guest Editor

by Robert K. Stoelting, MD

As President of the Anesthesia Patient SafetyFoundation (APSF), it is my privilege to report annu-ally on the activities of the foundation during the pastcalendar year. I am pleased to report that 2005 hasbeen a rewarding and successful year including advo-cacy of safety initiatives intended to fulfill our missionthat no patient shall be harmed by anesthesia.

Audible Information SignalsI am most pleased to report that the APSF “audible

alarms” initiative has reached a successful outcomethat can only be viewed as the “right thing to do forour patients.” As a result of your foundation’sefforts, both the American Association of NurseAnesthetists and the American Society of Anesthesi-ologists have added audible alarms from pulseoximetry and capnography to their monitoring stan-dards. The evidence was compelling that this newmonitoring requirement (standard) will save livesand improve patient safety. Without the APSF advo-cating this change, it is unlikely that audible alarmswould have been added to the monitoring stan-dards. I doubt if any one of us would knowingly flyon an airplane on which the pilot silenced the audi-ble alarms; our patients deserve no less.

Carbon Dioxide AbsorbentDesiccation Conference

The report of the “Carbon Dioxide DesiccationSafety Conference” convened by the APSF in April2005 was published in the Summer 2005 APSFNewsletter. This conference was attended by repre-sentatives of industry (carbon dioxide absorbentmanufacturers, machine manufacturers, producersof volatile anesthetics) along with clinicians, withthe single goal of creating a consensus statement fordissemination to all anesthesia professionals. Therecommendations of the conference demonstratethe APSF’s role in providing safety information tothe anesthesia professional responsible for care ofpatients during anesthesia and surgery.

A unique value of the APSF is its ability to bringtogether members of industry, nursing, and medi-cine under a neutral umbrella without the issue ofrestraint of trade or conflict of interests that wouldbe present in other environments. The carbon diox-ide absorbent conference was a rewarding exampleof this unique aspect of the APSF.

Long-Term OutcomesAn evolution of the APSF Long-Term Outcome

conference in September 2004 is the APSF TaskForce chaired by Marcel E. Durieux, MD. He and themembers of his task force are evaluating the scien-tific basis of possible factors (inflammation, auto-nomic nervous system activity, genetic profile, druginterventions [beta-blockers, alpha-agonists, statins],anesthetic depth, body temperature) on long-termoutcome following anesthesia and surgery. In addi-tion, a future issue of the Anesthesiology Clinics ofNorth America edited by Steffen E. Meiler, MD, willbe devoted to issues discussed at this conference.

Data Dictionary Task ForceThe APSF Data Dictionary Task Force chaired by

Terri G. Monk, MD, has been successful in creatingcommon anesthesia terms that have been adopted bythe Systematized Nomenclature of Medicine andlicensed by the National Library of Medicine. Dr.Monk and her colleagues (again reflecting the coop-erative efforts of industry and clinicians under thesponsorship of the APSF) have now entered the nextphase of the process in developing a schema of stan-dardized terms (minimum data elements) for use onanesthesia records as part of automated informationmanagement systems. This is the next essential stepto collect comparative data, from millions of anes-thetics, to determine best practices leading toimproved anesthesia patient safety.

Board of Directors WorkshopThe APSF Board of Directors workshop in Octo-

ber 2005 was organized by Jeffrey B. Cooper, PhD,APSF Executive Vice President, and reflected thefoundation’s initiative to include patients in the mis-sion of APSF. The topic of the workshop was “fulldisclosure” to patients when an adverse anesthesiaevent occurs. Participants included 3 families (a par-ent, a patient, a spouse) and 1 anesthesiologist whocared for the patient participant. Their poignant sto-ries of how adverse events during anesthesiachanged their lives was a moving and memorableexperience for the attendees. The common messagefrom all the participants was the compelling humanneed for explanations (as soon as possible) and ulti-mately some recognition that what happened tothem or their family member would become a learn-ing experience to reduce the likelihood of a similarexperience occurring to someone else in the future.

Research GrantsThe APSF has awarded more than $2 million

dollars since 1987 for support of investigators pur-suing patient safety research. Two grants for$75,000 were awarded for 2006, and 1 of these

APSF President PresentsState of Foundation Report

See “President’s Report,” Page 67

NEWSLETTERwww.apsf.org

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ASA and AANA agree withAPSF initiative and addaudible alarms for pulse

oximetry and capnography totheir monitoring standards.

The Official Journal of the Anesthesia Patient Safety Foundation

Incredible Save Followed by Poor Communication


See “Patients,” Next Page

Ms. Kenney knew she was lucky to be alive andknew if she had been at a different hospital, shelikely would have died. Against advice, Dr. van Peltwrote her a letter about 10 days after her dischargeacknowledging the suffering she and her family hadexperienced, apologizing for what he had done, andexpressing a desire for open and honest communi-cation. He stated in his presentation that if the letterprovoked her to sue, “so be it.” He did not believehe made an error, but he did feel responsible. Ms.Kenney at the time believed this letter was just“damage control” and ignored it. She experienced“survivor guilt” and eventually devolved into sig-nificant post-traumatic stress disorder. The eventwas reviewed in the hospital QA system and in thedebate over whether this was a reportable “sentinelevent,” Dr. van Pelt felt “hung out to dry.” For anumber of reasons, he left that hospital and relo-cated to Seattle 4 months later. Ms. Kenney wasdepressed. Her multiple calls to the hospital for helpand support yielded nothing but uncompassionateform letters. She asked for the names of the peopleon the team that had saved her life so she couldthank them and was refused. She grew very tired ofbeing asked by everyone she knew whether or notshe was going to sue, and if she saw the white light.She ultimately decided not to sue because she sawthe incident as a complication, not an error, and alsobecause she wanted to move on with her life. Shedecided there would be benefit from finallyresponding to Dr. van Pelt’s letter. Six months afterthe event she contacted him in Seattle and they hadan uplifting phone conversation that was the start ofhealing for them both. He told her all the clinicaldetails, and she had understanding and forgiveness.Dr. van Pelt eventually returned to his former hos-pital in Boston, and 2 years following the event, theymet in a coffee shop to talk further.

Constructive interaction between the survivor ofan anesthesia catastrophe and the involved anesthe-siologist yielded a resolve to “do something” aboutthe appalling lack of support and care revealed bythe aftermath of this event. Ms. Kenney foundedthe Medically-Induced Trauma Support Services(MITSS - website), an organization dedicated tohelping patients, families, and care providersinvolved in adverse medical events. MITSS focuseson the need for 1) full disclosure in real time; 2) anapology or acknowledgment of responsibility andrecognition of the traumatic impact; 3) concreteefforts to prevent similar occurrences in the future;and 4) support that is flexible and patientdirected—emotional, logistical, financial, or what-ever is needed (excepting legal). To its credit, thehospital that just wanted Ms. Kenney to go awayafter her event, now 6 years later, embraces MITSSin its efforts to correct the glaring deficienciesexposed by her experiences. Dr. van Pelt reiteratedthat the “wall of silence” operative in his case justpushes patients and their families to sue. It alsotakes a huge toll on the involved caregivers. He wasnot supported at all by his colleagues after theevent (even though he felt some wanted to reachout to him, but they did not). He had no way toexpress and deal with his feelings, which, he stated,is typical in the medical care system. Even thoughthe idea that this case “was a phenomenal save”was universally discussed, no one really consideredthe enormous impact it had on him. Consequently,Dr. van Pelt has assembled a task force at his hospi-tal to develop an OR pilot program to implementafter an event that will provide flexible peer-based,emotional support (including group and individualstress debriefing), and access to other resources. He

“Incredible Save”The patient who survived a life-threatening

anesthesia complication and her anesthesiologiststood shoulder to shoulder at the lectern to recounttheir perspectives of an anesthesia nightmare. Theassembled APSF Board was spellbound by the gut-wrenching story.

Ms. Linda Kenney, at age 37, was scheduled forone in a long series of foot/ankle surgeries andagreed to a popliteal nerve block as part of the anes-thetic. Frederick (Rick) van Pelt, MD, had extensiveexperience with such blocks. Using a nerve stimula-tor, he injected 30 ml of bupivacaine in a routineincremental manner, employing classic safeguards.However, subsequent evolving signs of bupiva-caine toxicity were followed by grand-mal seizureand cardiac arrest. After 10 minutes of ACLS proto-col without any impact, a fortuitous set of coinci-dences led to the resuscitation of the patient.Directly across the hall from the OR in which thearrest occurred was an open-heart surgery OR, car-diopulmonary bypass (CPB) pump primed andready, waiting for a patient to arrive. CPR inprogress, Ms. Kenney was wheeled across the halland “crashed” on to CPB via an emergency ster-notomy. Within a few minutes and approximately30 minutes after the injection, sinus rhythmreturned. After an hour on CPB, she was weaned.The incision was closed and she was taken to ICU,where she recovered without neurological damageover the following days.

The parallel perspectives on the events follow-ing the arrest and resuscitation were fascinating.Dr. van Pelt was told that he had done the blockcorrectly, that even the best physicians get sued,and not to talk to anyone about the event. Ms. Ken-ney’s husband was called to the hospital,sequestered alone in a small conference room for anextended period, and was offered no immediate orlong-term support for his distress, panic, and anger.Ms. Kenney recalls awakening in the ICU and laterbeing told she had “an allergic reaction to the anes-thesia,” which she found hard to believe, and thatmade her distrustful. There was no other discussionof the cause of the incident with her. She was mostconcerned about the emotional well-being of her 3young children. After experiencing some minor butannoying complications, she was discharged 10days after the arrest with wound care instructionsfor her chest and a follow-up appointment for that,but no counseling of any type. Dr. van Pelt wantedvery much to speak with the patient while she wasin the hospital, but was strongly discouraged fromdoing so by the hospital administration and, fearingthe negative emotional impact to the patient, alsoby her caregivers. He was expected to go back towork the next morning as if nothing had happened,even though he was very emotional and distracted.

“Patients,” From Page 61

Small group participants explore Board of Directors Workshop issues involving patient perspectives on adverse events.


set to cycle at intervals, and the single initial bloodpressure value was recorded 3 times on the recordover nearly 15 minutes; an LMA was in place, butspontaneous breathing slowed so there was hand-assisted bag ventilation; the surgeon remarked ondark-colored blood upon incision; cycling the NIBPrevealed profound hypotension and heart block,then arrest followed.

There was little communication to the familyimmediately after the event, and there was a delayin allowing them to see Daniel in the PACU, wherehe was intubated, ventilated, having seizures, andposturing. Beyond the panic, Ms. Stratman wascrushed because she had promised Daniel no tubesor ventilator this time. After a week of littleimprovement and essentially no communication tothe family, there was mention of the possibility ofdiscontinuing life support. Daniel’s cardiologistdemanded an investigation at the hospital. Theattending anesthesiologist visited daily and wasemotionally distressed, including about events inher own family, which she discussed with Daniel’sfamily. Ms. Stratman stated that the attending anes-thesiologist communicated to her that she never

really understood what had happened. Mrs. Strat-man came to believe that the anesthesiologist didknow what happened but did not disclose this.

Ms. Stratman stated that they were kept com-pletely in the dark about the incident, and shelearned that the hospital staff had been instructednot to talk with anyone (family, friends, coworkers,or other hospital personnel) while the investigation(initiated by the cardiologist) was conducted. Shestated they were stunned to learn the truth about theevent but, painful as that was, it was critical to knoweverything. The family did receive an out-of-courtfinancial settlement. They did receive an acknowl-edgment from the hospital that mistakes had beenmade, but no acknowledgment from the anesthesiol-ogist. Neither the hospital nor the anesthesiologistever admitted that the records had been altered. Ms.Stratman stated that, even 9 years later, she wouldlike the opportunity to talk with the anesthesiologistto help bring closure because she suspects that theanesthesiologist is not doing well with the burden ofthe situation.

Ms. Stratman clearly outlined what she believesshould happen with the anesthetic for a surgerysuch as Daniel’s: 1) take it seriously—as if it is themost complex major surgery imaginable, eventhough it’s a “minor case”; 2) the attending shouldnever leave the patient [although it appeared thatthe function of anesthesia trainees in academic med-ical centers was not fully appreciated]; 3) be sure theequipment works and is used correctly; and 4) tellthe truth. As seen in the previous presentation, therewas a profound desire by this family to “do some-thing” to help prevent tragedies such as this. Thefamily has started the Daniel Stratman Foundationto help educate about patient safety. They are mem-bers of a medical malpractice survivors’ supportgroup. Ms. Stratman stated they had served on ahospital “parents board,” but abandoned that whenit was clear to them the hospital was not really inter-ested in discussing substantive patient safety issueswith families.

Again, the APSF Board was moved. Note wasagain taken of the potential disconnect betweenpatient/family understanding of events duringmedical care, prospectively, and especially retro-spectively, and the providers’ realities. The damag-ing impact of failure of disclosure after the eventand overall failure of communication was unmistak-able. Finally, as before, the drive by the survivors to“do something,” to “make a difference” so similarcatastrophes would not afflict other families in thefuture, was heartfelt and strong, which is preciselythe element sought by the APSF Board in these pre-sentations and, more importantly, as stimulus forfuture follow-up efforts by the foundation.

believes the core concept of “integrity and compas-sion” will have a major beneficial impact.

Uncharacteristically, the APSF Board was virtu-ally speechless after this presentation. There wasunanimous acknowledgment that there is a greatdeal the APSF specifically, and the medical careestablishment in general, can learn from thoughtfulpatient input. An obvious key element was the “dis-connect” of the starkly different perspectives andpriorities of the patient/family versus the medicalcare establishment, and the potential damage thisdisconnect can cause. Overcoming this clearly canhave helpful risk management implications, but theemphasis is on promoting healing for all involved.Likewise, the final note of the presentation was posi-tive in that it was recognized that everything wasdone exactly wrong regarding communication andsupport, but that this fact led to awareness and con-structive changes that should help all those involvedin any future anesthesia care catastrophe.

“A Parent’s Nightmare”Ms. Sue Stratman opened with the observation

that she had seen both the best and worst of the med-ical care system. She is the mother of Daniel, who wasborn with congenital heart disease but had donespectacularly well with 3 open-heart surgeries overthe course of his first 11 years and in 1996 was welland vigorously active, successfully playing competi-tive soccer. He was found to have an inguinal herniaand the repair under general anesthesia was sched-uled at the same very well-known large academicmedical center where he had his heart repaired. Therewas a thorough discussion of Daniel’s history, cardiacstatus, and the anesthesia plan with the attendinganesthesiologist prior to what was planned for aquick outpatient procedure. During the anesthetic,Daniel arrested and his heart was resuscitated, but hesuffered permanent brain damage such that he todayis blind, cannot use his arms, can walk only with theassistance of 2 people, can barely speak, and needstotal 24-hour care.

Ms. Stratman stated that she was not aware pre-operatively that a student nurse anesthetist wouldbe involved in the anesthetic and would be leftalone with Daniel during the case by the attendingwho was also supervising another room. The anes-thesiologist was also distracted due to her ownongoing family issues. Ms. Stratman stated that therecords had been altered “to make it look like hisheart had given out,” but that eventual analysis ofthe original records and the printout from the moni-tor values suggested this scenario: Daniel climbedup on the table himself and was given an inhalationinduction with 5% halothane; this induction dosewas continued and not reduced to maintenance lev-els when the attending left the room; the non-inva-sive blood pressure machine (NIBP) had not been

Halothane Overdose Results in Cardiac Arrest


“Patients,” From Preceding Page

In the top photo, Dr. Julianne Chase recounts her expe-riences, and in the bottom photo, Linda Kenney and Dr.Frederick Van Pelt discuss Ms. Kenney’s adverse event.All participants agreed that poor post-event communi-cation was a major problem.


the surgeon was later asked why he accepted thispersonnel change, he replied that he thought it didnot matter. In the one conversation Dr. Chase hadwith the involved anesthesiologist, he had no expla-nation for the cause of the event, was defensive, andoffered no expression of remorse or regret. She neversaw or spoke to him again. The surgeon expresseddeep regret and sorrow, particularly after Danny’sdeath, and this revealed to Dr. Chase the profoundimpact medical misadventure can have on theinvolved practitioners, recalling some of the pointsmade by Dr. Van Pelt.

Dr. Chase was told that the involved anesthesi-ologist retired soon after the event under pressurefrom the hospital. Her malpractice suit was settledout of court.

She, at times, still feels guilty about not havingbeen more insistent on the morning of surgeryabout being certain that her husband was gettingthe “good anesthesiologist,” but that revelation pro-voked her to share persistent questions about theinternal regulation of the quality of practice withinthe medical profession, and the obvious patientsafety implications. Why were there anesthesiolo-gists practicing who should be avoided—particu-larly when other doctors at the hospital knew oftheir lapses? How does one stop doctors from prac-ticing when they are incompetent? Why is it so dif-ficult for physicians to monitor each other?[Following Dr. Chase’s presentation, intense discus-sions ensued regarding these questions.]

Again, as with the others, Dr. Chase expressed astrong desire to help implement measures that willprevent similar catastrophes from striking otherpatients and families. She suggested a monitoringprogram to detect “near-misses” and physicianswho are “slipping repeatedly,” and then a remedia-tion program for them and also alternatives todivert physicians into jobs they could safely per-form. The APSF Board continued the thorny andcomplex discussion of the issues of measuringphysician competence, setting criteria for action,and implementing enforcement when a qualityproblem is documented. Finally, the relatedextended patient safety concept that injuries wouldbe prevented by implementing such a program wasraised but, predictably, there was no agreement.

So Now What?The high-impact and thought-provoking nature

of the 3 presentations was dramatically evident bythe length, breadth, and intensity of the discussionamong members of the APSF Board and also thepresenters. Consistent with the goal of outliningpossible action for the APSF, several themes andsuggestions emerged. One important item thatcould immediately and directly help prevent ormitigate patient injuries was again broadcasting areminder that “Administrative Guidelines for

Response to an Adverse Anesthesia Event” havebeen published and are available on the APSF web-site: www.apsf.org, “Resource Center,” “ClinicalSafety Tools,” then “Adverse Events Protocol.”Another suggestion was the simple idea of survey-ing patients/families to help determine what typeand how much information and communicationthey really want, both in general and specificallyconcerning an adverse medical event.

A primary specific initiative is to continue tocollect (possibly including through a “hotline” tothe APSF) and publicize these potent “stories” ofpatients/families who have experienced an adverseanesthesia event. Not only will this raise the aware-ness of all those who read those accounts, it willform a database that can be organized and minedfor common elements, much like the model of theASA Closed Claims study that identified clinicaltrends (preventable hypoventilation as a cause ofinjury) and even specific syndromes (cardiac arrestduring spinal anesthesia). A related initiative willbe the use of the great power of the telling of thesestories to develop a curriculum in “the patient sideof anesthesia patient safety” for distribution to allanesthesiology residency and nurse anesthesiatraining programs, as well as to medical schools forincorporation into their clinical teaching. Closelytied would be additions to modules used in anes-thesia simulator training that add experience inpost-event management of both the patient/familyand the involved anesthesia provider. This intenserole-playing likely would evoke strong emotionsand would be videotaped for the debriefing of theparticipants in the specific simulation and also forpotential inclusion in curriculum modules for anes-thesia trainees and medical students. Having thesemodules available on the web for all anesthesiaproviders through their respective national profes-sional organizations also would have a significantimpact because their direct relevance and inherentdrama would provoke widespread interest andattention.

One major recurrent theme was the failure ofcommunication with the patient/family at the timeof the catastrophic event and thereafter. The overallconcept of trying to shift from a “culture of blame”to a “culture of learning” certainly applies. It wasagreed that, in the spirit of “the patient’s bill ofrights,” there should be an expectation by thepatient/family of open communication and full dis-closure (even to the point that the surgical/anesthe-sia consent forms should specify that after anyevent, prompt full disclosure will be made). Theexpected concerns about risk management and thepotential legal liability implications of apologies andfull disclosure were expressed, but reference wasthen made to the study from the VA system demon-strating a significant reduction in liability costs asso-ciated with prompt full disclosure after an event.

“A Question of Competence”Dr. Julianne Chase, Senior Assistant Dean for

Medical Education at NYU School of Medicine,revealed to the APSF Board that this was the firsttime she had discussed with a professional group ofphysicians the event her husband experienced inthe OR since it happened, in 1986. She then told thepowerful story of Danny Delio, 33, an exercisephysiologist in superb physical condition as anactive marathon runner. He had had previous hem-orrhoid surgery and the same surgeon suggestedsurgical treatment of an anal fistula after drainingan abscess in the office. Over Dr. Chase’s objection,Danny scheduled his surgery at a local communityhospital rather than an available teaching hospital.An internist friend of theirs told them there were 2anesthesiologists at that hospital to avoid becauseof prior complications and incidents, and that hewould speak with the surgeon to advise him whichanesthesiologists to request and which to avoid.Danny had confusion on the day of the procedureabout which was which, but did not want to botherhis internist friend early that morning to check. Hedid ask his surgeon if the procedure could be donewithout general anesthesia and was advised thatwas not a good idea. The anesthesiologist who didthe preoperative evaluation was not the one whowould be administering the anesthetic, and Dr.Chase did not believe this was proper, but Dannywas prepared to go ahead and did so. Both believedthe internist friend had arranged for one of the“good anesthesiologists” to do the case.

Precise events in the OR were never clear to Dr.Chase. Near the end of the case, with Danny breath-ing spontaneously, reportedly “with very littleassistance,” the anesthesiologist announced thatthere was a cardiac arrest. Danny’s heart was resus-citated in 5 minutes, but he then suffered intractablegrand mal seizures reflecting hypoxic brain dam-age. After intubation and ventilation in the OR,Danny’s pCO2 was more than 80, and the pH was7.0, suggesting that there had been unrecognizedhypoventilation and consequent respiratory acido-sis. He was transferred out of the hospital wherethe event occurred to the ICU in the larger localcounty hospital in a persistent vegetative state,where he became the subject of a court case regard-ing withdrawal of nutrition and hydration. DannyDelio died 13 months after his anesthetic for repairof an anal fistula, and following a landmark courtcase supporting his right to refuse medical treat-ment if he were ever in a persistent vegetative state.

Following the catastrophe, the family’s internistfriend confirmed that the anesthesiologist involvedwas one of the two he had said to avoid. Appar-ently the anesthesiologist requested had been work-ing all weekend and had transferred this case to hissenior colleague on the morning of surgery. When

Question of Competence Raised After Unrecognized Hypoventilation“Patients,” From Preceding Page



how precisely this translates into documentableimpact on patient safety prompted calls for furtherdiscussion and research. A survey of anesthesiaproviders regarding how they would suggest eval-uating practice competency was proposed. Imple-mentation of carefully crafted true “360evaluations” for anesthesia clinicians was recog-nized as potentially very valuable, but cumbersometo implement. Soliciting APSF Research Grantapplications regarding this specific technique andeven a small pilot study conducted by the APSFitself were considered. The APSF Executive Com-mittee will address these ideas in January. Likewise,offered for consideration was possible APSF spon-sorship of a larger study that would start with anattempt to define baseline anesthesia competency.

Overall, the APSF Board of Directors Workshopon “The Role of Patients in the Mission of APSF”was a remarkably rich and stimulating experiencethat appeared to have more impact on the partici-pants than could have been imagined. The APSFhas resolved to have more awareness of and inputfrom patients and families, both in general andspecifically related to the aftermath of anesthesiacatastrophes. Optimum utilization of this untappedresource can only enhance and encourage efforts tofurther the APSF stated mission that “no patientshall be harmed by anesthesia.”

Dr. Eichhorn, Professor of Anesthesiology at theUniversity of Kentucky, founded the APSF Newsletterin 1985 and was its Editor until 2002. He remains on theEditorial Board and serves as a senior consultant to theAPSF Executive Committee.

Letter to the Editor

Full DisclosureRecommendedTo the Editor:

The Fall 2005 issue of the Anesthesia PatientSafety Foundation (APSF) Newsletter includes thearticle “DepoDur™: A New Drug FormulationWith Unique Safety Considerations.” It is disclosedthat the author is a paid scientific advisor for EndoPharmaceuticals, the U.S. marketer of DepoDur™,and has also received research support from Endo.Most of the article describes the putative benefits ofDepoDur™. A smaller portion deals with safetyissues and presents generic advice common tointravenous and neuraxial opioids. The opposingviews of an unbiased author are not presented.Given the tone of the article, one could mistake it asmarketing literature. This cynical but realistic viewcould be avoided if APSF would select authors whoare not influenced by such conflicts of interest.

It is more concerning that the article does notclearly state that Endo is a financial supporter of theAPSF. The financial relationship between APSF andEndo Pharmaceuticals should have been clearlyrevealed in the article. It is reasonable to ask ifEndo’s financial support played a role in the APSFdecision-making and editorial process, especiallysince that support was not clearly disclosed.

The specific concern expressed in this lettershould not be generalized to other APSF activitiesor publications. However, since APSF’s credibilityand reputation could be seriously damaged withonly one mistake or ethical lapse, any indiscretion isimportant. It is also relevant that the AmericanSociety of Anesthesiologists (ASA) is a long-timeprovider of significant financial support to theAPSF. Since many APSF Newsletter readers are alsothe dues-paying ASA members providing that sup-port, the APSF has an important obligation to main-tain editorial objectivity and avoid even theperception of bias or inappropriate influence.

Jeff Mueller, MDScottsdale, AZ

Editor’s Response:Dr. Mueller raises points to which the APSF and the

Newsletter Editorial Board are sensitive. We believe wecarefully attempt to avoid commercial bias in safety arti-cles that are written by our invited authors. However, ifinformed readers such as Dr. Mueller conclude other-wise, we will reexamine our approach. As Dr. Muellerpoints out, the article in question disclosed that theauthor has received investigative grant support from,and has been compensated as a scientific advisor by,Endo Pharmaceuticals. In the future, the APSF Newslet-ter will also include, as appropriate, a statement that theAPSF receives financial support from an industry spon-sor who could be perceived to benefit from a given article.This statement will be in addition to our current practiceof listing all corporate sponsors on the donor page. TheAPSF thanks Dr. Mueller for his interest and letter.

Related was the favorably-received suggestion thatpatient care facilities where anesthetics are adminis-tered should have an ombudsman or “patient advo-cate” always immediately available or on call sothat this advocate can immediately interpret, facili-tate communications, and organize support of alltypes for the involved patient/family in the eventof an anesthesia accident, or any acute medicaladverse event for that matter. This tied in to theprojected goal that perioperative services should be“high-empathy organizations” as well as high-relia-bility organizations. The proposal that patient/fam-ily representatives be included on the committee forthe peer-review analysis after an adverse event pro-voked significant discussion, but did not yield aconsensus. However, the suggestion that the insti-tution and the practice group involved with ananesthesia accident share with the affectedpatient/family the details of changes made follow-ing the event (whether policy, procedure, behavior,equipment, or organizational) intended to preventany recurrence of that type of accident met withwidespread approval.

Promoting thoughtful, compassionate, and opensupport for anesthesia providers who have beeninvolved in a catastrophic anesthesia accident (evenone with an eventual good outcome) is anotherunanimously accepted proposal resulting from theAPSF Board workshop. Clearly the front line andthe bulk of this effort should be at the local level,within the institution and immediate group of theinvolved anesthesia provider(s). Prospective con-crete plans that are widely disseminated to allinvolved should be in place in order to avoid a con-fusing scramble of disparate resources at the time ofan event. Group leaders and facility administratorsshould immediately activate the pre-plannedresponse to provide support and counseling, aswell as specific advice and encouragement aboutdisclosure to the involved anesthesia personnel.Further, it was suggested that the APSF couldestablish another type of “hotline” to offer situa-tion-specific suggestions to assist and support thepersonal needs and concerns of anesthesiaproviders finding themselves under stress follow-ing involvement in an adverse event. The more gen-eral question of anesthesia providers under somuch personal stress as to be dangerously dis-tracted and a safety risk was also broached.Enhanced vigilance and sympathetic support fromcoworkers, promoted by articles such as this one,was seen as the best immediate strategy.

Finally, possibly the thorniest issue closed outthe discussion. The question of measuring practi-tioner competence and quality of practice and, then,

Workshop Identifies Needto Tap Patient Resources“Patients,” From Preceding Page

See Page 74 for APSF

Grant ApplicationGuidelines

Award Limit Has Been Increased

to $150,000Per Application

Funded

President Welcomes Inputas APSF Enters 20th Year

APSF Selects NewVice PresidentAt its October 2005 annual meeting, the APSF waspleased to announce the appointment of PaulBaumgart as its new Vice President. Paul Baumgartis General Manager of Respiratory Care for GEHealthcare Clinical Systems, based in Madison,Wisconsin, with responsibility for GE’s globalrespiratory care business. Previously he heldmarketing roles at GE covering perioperativemonitoring products and OR information systems.Prior to joining GE in December 2000, he spentnearly 20 years at Ohmeda in a variety of marketingpositions related to the company’s anesthesiasystem business, including Director of Marketing forthe Americas.

Paul’s active involvement in the AnesthesiaPatient Safety Foundation dates to 1987 when hejoined the committee on Education at the suggestionof W. Dekle Rountree, then President of Ohmeda,who at that time was serving in the role of the firstVice President of the APSF. Since then Paul hasserved on both the Committee on Education and onthe Committee on Technology. During the 2004meeting of the ASA, Paul was elected to serve on theBoard of Directors of the APSF and will serve on theCommittee on Scientific Evaluation in 2006.

Paul has been a recognized speaker at anesthesi-ologist, nurse anesthetist, anesthesia technologist,and biomedical engineering meetings throughoutNorth America and Europe on topics that includeanesthesia safety, operating room information man-agement, anesthesia gas delivery, and monitoringsystem design and evolution. He holds an MBAdegree from the University of Wyoming and is anadjunct faculty member in the University of Wis-consin Executive Education program. He and hiswife Lynn reside in Madison, Wisconsin.

Financial support to the APSF from individuals,specialty and component societies, and corporatepartners in 2005 has been most gratifying. Theincreased level of support in 2005 will make newinitiatives possible and provide for ongoing initia-tives, as well as increase research funding. In partic-ular, the APSF wishes to recognize AnesthesiaHealthcare Partners for their generous contributionin 2005 making possible the co-sponsorship withthe APSF of a research grant awarded in 2006.Equally important, the October 2005 House of Dele-gates of the American Society of Anesthesiologistsapproved increasing the funding of the APSF from$400,000 annually to $500,000 beginning in 2006.Anesthesia is unique in American medicine in hav-ing a foundation dedicated to anesthesia patientsafety, and this is reflected by the vision and sup-port of the American Society of Anesthesiologistssince the formation of the APSF in 1985.

As in the previous annual report, I wish to reit-erate the desire of the APSF Executive Committeeto provide a broad-based consensus on anesthesiapatient safety issues. We welcome comments andsuggestions from all those who participate in thecommon goal of making anesthesia a safe experi-ence. There remains much to still accomplish, andeveryone’s participation is important and valued as“your foundation” enters its 20th year.

Best wishes for a prosperous and rewardingyear 2006.

Robert K. Stoelting, MDPresident, APSF


grants received an additional $5,000 as the EllisonC. Pierce, Jr., MD, Education Award. The othergrant is designated the APSF/AHP ResearchAward in recognition of the contribution fromAnesthesia Healthcare Partners for support of thisgrant plus an additional amount for administrativesupport to the APSF.

Beginning in 2007, the APSF Research Grantswill be increased from the current level of $75,000to $150,000. This increased level of funding isintended to reflect the quality of the research appli-cations and the importance of the grant process inthe mission of the APSF.

APSF NewsletterThe APSF Newsletter, as the official journal of

the APSF with Robert C. Morell, MD, as editor, con-tinues to provide the most rapid dissemination ofanesthesia patient safety information possible. Thecurrent circulation exceeds 76,000 recipients andreflects the fact that every anesthesia professional inthe United States receives the Newsletter and bene-fits from the information it provides. I am person-ally committed to doing everything possible toinsure that all anesthesia professionals continue toreceive the APSF Newsletter as patient safety infor-mation is valuable and important to everyone whocares for patients in the operating room.

A highly successful part of the APSF Newsletterhas been the “Dear SIRS” (Safety InformationResponse System) column that is coordinated byMichael A. Olympio, MD, Chair of the APSF Com-mittee on Technology. Dr. Olympio and his com-mittee members provide timely responses toquestions including equipment design and functionthat are submitted by recipients of the Newsletter.These responses also include the comments fromcolleagues representing industry and often themanufacturers of the equipment in question.

Wall Street Journal ArticleOn June 21, 2005, a front page article in the Wall

Street Journal entitled, “Heal Thyself—Once Seen asRisky, One Group of Doctors Changes its Ways”described the success of the anesthesia patientsafety movement in reducing professional liabilityinsurance premiums by virtue of making anesthesiasafer. The article was complimentary to the APSFand its role over the years in anesthesia safety. AsPresident of the APSF, I recognize and salute thecontribution of all anesthesia professionals for theirrole in making possible the safety successesdescribed in this highly visible article.

Financial Support

“President’s Report,” From Page 62

Dr. Robert Stoelting (left), APSF President, welcomes new APSF Vice President, Paul Baumgart.

by Sorin J. Brull, MD

The Anesthesia Patient Safety Foundation (APSF)is pleased to report that it continues to attract out-standing applications for funding. The educationalfocus of APSF includes innovative methods ofeducation and training to improve patient safety,development of educational content with applicationto patient safety, and development of testing ofeducational content to measure and improve safedelivery of perioperative anesthetic care.

The application process continues with an elec-tronic, online submission format introduced lastyear. The applications, as well as all the requiredattachments, are uploaded to the newly redesignedAPSF website (www.apsf.org), a process thatfacilitates the application review by members of theScientific Evaluation Committee, improves thetimeliness of response, and facilitates transmissionof reviewer feedback to the applicants. The Scien-tific Evaluation Committee members continue tomodify and perfect the electronic application andreview process.

Also of significance for the APSF grant applica-tion process was the increase in funding to $75,000per accepted application introduced in 2004. Inaddition to the Clinical Research and Education andTraining content that is the major focus of the fund-ing program, the APSF continues to recognize thepatriarch of what has become a patient safety cul-ture in the United States and internationally, andone of the founding members of the foundation—Ellison C. “Jeep” Pierce Jr., MD. The APSF ScientificEvaluation Committee continues to designate 1 ofthe funded proposals each year as the recipient ofthis prestigious nomination, the Ellison C. Pierce,Jr., MD, Research Award. The award carries with itan additional, unrestricted prize of $5,000. New thisfunding cycle is the addition of the APSF/Anesthe-sia Healthcare Partners Research Award, madepossible by an unrestricted grant from AnesthesiaHealthcare Partners (AHP).

For the year 2005 (projects to be funded startingJanuary 1, 2006), two grants were selected for fund-ing by the APSF Scientific Evaluation Committee(for names of committee members, please refer tothe list in this issue). The APSF Scientific EvaluationCommittee members were pleased to note that theyreviewed 21 applications in the first round, 8 ofwhich were selected for final review at the Ameri-can Society of Anesthesiologists (ASA) AnnualMeeting in Atlanta, Georgia. As in previous years,the grant submissions addressed areas of high pri-ority in clinical anesthesia. The major objective ofthe APSF is to stimulate the performance of studiesthat lead to prevention of mortality and morbidityfrom anesthesia mishaps. A particular priority con-tinues to be given to studies that address anestheticproblems in healthy patients, and to those studies

that are broadly applicable and promise improvedmethods of patient safety with a defined and directpath to implementation into clinical care. Addition-ally, the APSF is encouraging the study of innova-tive methods of education and training to improvepatient safety.

The applications that the Scientific Evaluation Com-mittee received this year covered a variety of topics:

• The cost-effectiveness of reducing the incidenceof retained surgical sponges.

• The investigation of a neuromuscular blockeradvisory system utilizing adaptive processcontrol technology.

• Improving patient safety during epidural needleinsertion by creating an educational outline andobjective assessment of skills and judgment.

• Prediction of respiratory compromise duringpatient-controlled analgesia by heuristicmodeling of continuous oximetry andcapnography.

• An investigation of the use of electronic patientrecords to determine independent intraoperativepredictors of perioperative mortality.

• The detection of anaerobic metabolism duringanesthesia using indirect calorimetry.

• Evaluation of lingual tonsil hyperplasia duringthe preoperative endoscopic exam.

• Assessment of resident performance duringobstetric anesthesia using the human patientsimulator.

• The effects of depth of sedation on long-termfunctional outcome and postoperative deliriumin elderly orthopedic patients.

• An evaluation of the severity of illness as apredictive model of outcomes.

• The evaluation of an interdisciplinary OR teamin a malignant hyperthermia simulation scenarioto promote improved outcome.

• The analysis of anti-coagulant effects of threetimes daily (TID) low-dose heparin regimen onremoval of epidural catheters in surgical patients.

• The investigation of phenotyping thesusceptibility to malignant hyperthermia using amicrodialysis technique.

• The evaluation of vocal cord immobility due torecurrent laryngeal nerve paresis during anteriorcervical spine surgery.

• An investigation of the association betweenanesthesiologist age and incidence of malpracticelitigation.

• The development of a perioperative dental riskrecognition and prevention program.

• The evaluation of the acceptance of a novelsyringe-catheter connector system for spinal andepidural administration of medication.

• The effectiveness of perioperative beta-blockadein morbidly obese patients in reducingintraoperative anesthetic requirements.

• The investigation of the prolonged QT syndromein the perioperative period.

• The development of digital video technology toimprove the education, proficiency, and safety ofanesthesia residents performing invasive clinicalprocedures.

The APSF Scientific Evaluation Committee metduring the ASA annual meeting on October 22,2005, in Atlanta for final evaluation of the propos-als. Of the 8 finalists, the members of the APSF Sci-entific Evaluation Committee selected 2 awardees:

Melanie C. Wright, PhD – Assistant Professor,Department of Anesthesiology, and Human Simu-lation and Patient Safety Center, Duke University,Durham, NC. Her grant submission is entitled,“Objective Measures of Performance in Simulated Anes-thesia: A Comparison of Novices and Experts.”

The use of human patient simulators in anesthe-siology training and assessment has been limited bythe lack of objective, validated measures of humanperformance. Such measures are necessary if simu-lators are to be used to evaluate the skills and train-ing of anesthesia providers and teams, or toevaluate the impact of new processes or equipmentdesign on overall system performance. There are 2main goals of this project: the first is to quantita-tively compare objective measures of anesthesiaprovider performance with regard to their sensitiv-ity to both provider experience and simulated anes-thesia case difficulty. The authors plan to comparepreviously validated measures of anesthesiaprovider performance to 2 objective measures thatare relatively novel to the environment of anesthe-sia care: an objective measure of provider situationawareness, and a measure of providers’ eye scan


See “Grants,” Next Page

APSF Awards Two Grants for 2006

Melanie C. Wright, PhD


determine associations with the primary (perioper-ative mortality and outcomes) and secondary (1-year mortality and hospital length of stay)outcomes. This pilot study will facilitate a greaterunderstanding of current practices in a high-risksurgical population, and will lay the groundworkfor larger scale funding from federal agencies. Thisproject has a particular application to patient safety,as it will better delineate specific areas in whichfocused, randomized controlled trials of particulardrugs may be logistically practical and economi-cally feasible. The collaborators listed in Dr. Lon-don’s proposal are William G. Henderson, PhD,Co-Director of the NSQIP from the Denver DataAnalysis Center, and Francesca Cunningham,PharmD, research coordinator.

In addition to receiving the requested fundingof $75,000 for his project, Dr. London is the recipi-ent of the inaugural APSF/Anesthesia HealthcarePartners Research Award.

On behalf of APSF, the members of the ScientificEvaluation Committee wish to congratulate all ofthe investigators who submitted their work toAPSF, whether or not their proposals were funded.We hope that the high quality of the proposals andthe important findings that will undoubtedly resultfrom completion of these projects will serve as astimulus for other investigators to submit researchgrants that will benefit all patients and our spe-cialty.

Sorin J. Brull, MD, is Chair of the APSF ScientificEvaluation Committee and Professor of Anesthesiologyat the Mayo Clinic College of Medicine, Jacksonville, FL.

Martin J. London, MD — Professor of ClinicalAnesthesia, Department of Anesthesiology, Univer-sity of California, San Francisco, San Francisco, CA.His grant proposal is entitled, “Perioperative Pharma-cologic Prophylaxis for Cardiovascular Events in theDepartment of Veterans Affairs: A Pharmacoepidemio-logic Pilot Project.”

The objective of this proposal is to develop apharmacoepidemiologic study of the association ofcardiovascular pharmacologic prophylaxis withperioperative and 1-year outcomes after major non-cardiac surgery in the Department of VeteransAffairs (DVA) population. Outpatient and inpatientprescription data from the system-wide PharmacyBenefits Management–Strategic Healthcare Groupfor beta-blockers, statins, calcium channel blockers,alpha-2 agonists, and antiplatelet agents will bematched with risk factors, surgical details, and peri-operative outcomes (myocardial infarction, cardiacarrest, pulmonary edema, stroke, all cause mortal-ity, and length of stay) for patients undergoingmajor general, vascular, thoracic, urologic, neuro-surgical, and orthopedic procedures in 4 fiscal years(2002–2006) collected by the National Surgical Qual-ity Improvement Program (NSQIP). One-year all-cause mortality will be determined using the DVA’sadministrative death benefits database (BIRLS). Theauthors will study approximately 100,000 majorsurgical cases performed at approximately 123 hos-pitals. Propensity scoring will be used to adjust formedication prescribing biases, followed by riskadjustment using validated NSQIP methodology.Logistic regression models will be developed usingpatient and hospital covariates along with drug use(considering duration of therapy, dose, and class) to

patterns. The second goal of this project is to quali-tatively evaluate the situation awareness and eyetracking data to identify key determinants of exper-tise in anesthesia providers. These determinants ofexpertise may then be used to further enhanceobjective measures of performance as assessmenttools, and to improve training of anesthesiaproviders.

The results of this study are directly applicableto the assessment of anesthesia providers’ abilityand to training, and will ultimately lead toimproved patient care and safety. This study pro-poses to validate 2 objective measures of perfor-mance that may provide better scalability withrespect to assessing multiple performers. In addi-tion, situation awareness and eye tracking measuresmay provide improved means for assessing theunderlying dynamic knowledge of care providersand their performance with respect to accessing rel-evant information. The validation of these measuresmay also serve to support efforts in the design andevaluation of anesthesia displays for their safe andeffective use by care providers.

Perhaps more importantly, this study provides abasis for identifying specific determinants of exper-tise in anesthesia. Through qualitative evaluation ofsituation awareness query responses and eye track-ing data, the authors propose to identify specificindicators that are reflective of skill acquisition inanesthesia. Such information will be useful inenhancing training of anesthesia providers.

Investigators listed in Dr. Wright’s research pro-posal include Jeffrey M. Teakman, MD, Jonathan B.Mark, MD, and Mark Stafford-Smith, MD. Otherpersonnel include Eugene W. Hobbs, LaboratoryTechnician; Bryan Andregg, Analyst Programmer;and Barbara G. Phillips-Bute, Statistician.

In addition to receiving the requested fundingof $74,959 for this project, Dr. Wright is also therecipient of the Ellison C. Pierce, Jr., MD, ResearchAward, which consists of an additional, unre-stricted grant of $5,000.

Martin J. London, MD

The APSF wishes to expressits sincere appreciation to Abbott Laboratories

for Abbott’s continued commitment to anesthesia patient safety and

their generous support of this issue of theAPSF Newsletter.

www.abbott.com

Drs. Wright and London Each Receive Awards“Grants,” From Preceding Page


Dear SIRS refers to the Safety Information

Response System. The purpose of this column is

to expeditiously communicate technology-related

safety concerns raised by our readers, with input

and responses from manufacturers and industry

representatives. This process was developed by

Drs. Michael Olympio, Chair of the Committee on

Technology, and Robert Morell, Editor of this

newsletter. Dr. Olympio is overseeing the column

and coordinating the readers’ inquiries and the

responses from industry. Dear SIRS made its

debut in the Spring 2003 issue.

Editor’s Note: Although Dr. Wright may have laterdetermined the manufacturer of the product in question,the Editors subsequently located at least 2 additionalreports of circuit obstruction by unwrapped absorbentcanisters, apparently manufactured by other companies.Our focus, then, is not to implicate any particularbrands, but to allow manufacturers to address the issueof safety. ~ Drs. Morell and Olympio

Dear SIRS:

I am aware of 2 instances where the plasticwrapper on the soda lime was not removed priorto installation into the machine. Both instancesoccurred late in the day and were accompaniedby unexpected ventilation problems. Bothinstances were “solved” before a catastropheoccurred, but there was much “running around”during the trouble-shooting.

I am concerned that this will result in a patientdeath.

This could all be avoided if we always checkedour machines before induction, but I know thatmy colleagues don't always do that once the dayis underway. Also, we instituted a protocolwhereby the anesthesia “aide” who changes thelime is to write a note and set it on the gasmachine warning the anesthetist that the lime hasbeen changed. This was not done in the mostrecent case. That case was also accompanied by achange in nursing personnel at 3:00 pm. The newnurse was not informed that the lime had beenchanged, nor was I.

The problem here is that the line of communica-tion can always be broken.

If, however, the canister could not be closedwith a properly designed wrapper on it, then itwould be impossible to close the cage over anunwrapped canister. The wrapper on these canis-ters is clear plastic with some fenestrations (whichallowed some airflow through them) and printedon that plastic in red letters is the following: “THISWRAPPER MUST BE REMOVED PRIOR TO USE.”It is repeated numerous times on each canister, andis hard to miss.

I would appreciate your thoughts. Thanks forlistening, and thanks for the APSF.

Tom Wright, MDMinneapolis, MN

Responses

Dear SIRS,

Grace has taken several steps to ensure that endusers are aware of the wrapping around our pre-pak cartridges and that said wrapping should beremoved prior to use. The first step is a clear, writ-ten statement printed on the wrap stating clearly"STOP!!! - remove this shrink wrap before use." Sec-ond, we have a red "easy open" tear strip aroundthe top of the package that has clearly written on it"STOP - remove before use.” Third, and even moreimportant, Grace does not tighten the wrapping tothe point at which it fully adheres to the sides of thecontainer. We purposefully "blouse" the wrappingso it protrudes from the sides of the container, mak-ing the wrapping not only more evident, but alsomaking it more difficult for the end user to put thecartridge into the delivery unit. I have attached aphoto as a visual aid to show you what I mean.

I would very much like to get further detailsfrom Dr. Wright to determine whether it was aSodasorb brand cartridge that was put into useprior to the wrapping being removed, and if so, toget additional details so we can enter this incidentinto our formal quality follow-up process.

Jeff MackGlobal Sales & Marketing Manager, SodasorbGrace Performance ChemicalsW.R. Grace & Co.-Conn

Dear SIRS,

Carbolime is shipped with a shrink wrapper thatincorporates a label within the wrapper materialitself. The label clearly states that the wrapper mustbe removed before use. Additionally, when thewrapper is shrunk onto the canister, the “corners” ofthe wrapper protrude from the circumference of thecanister making it difficult to insert the canister intoan anesthesia machine without removing the wrap-per. Despite these factors, there have been—albeitextremely infrequent—reports of users placing Car-bolime canisters in anesthesia machines withoutremoving the wrapper from the canister. Alliedencourages users of its Carbolime product to readand heed all labels associated with the product.

Eldon P. RosentraterVP AdministrationAllied Healthcare Products, Inc.

Michael Olympio, MD, Chair of the APSF Committee on Technologyand Co-Founder of the Dear SIRS Initiative.

S AFETY

I NFORMATION

R ESPONSE

S YSTEM

Absorbent Wrapper Design QuestionedDear SIRS

See “Wrapper,” Next Page


An apparently “simple” solution is not always“simple” and, without extensive field research,does not always have the expected or desired effect.

David BainesSales and Marketing DirectorMolecular Products Limited

Dear SIRS:

The letter from Tom Wright, MD, to the APSFNewsletter describes what may most likely be seen byany anesthesia provider as an immediate high-prior-ity problem, the unexpected inability to ventilate apatient (the lack of visibility of the root cause, theabsorbent wrapper, complicated this event). Typicaltechniques may ultimately find the problem but, asthe author states, “there was much ‘running around’during the trouble-shooting.”

The author further suggests possible solutionsthat may help prevent this event from occurring inthe future and, while some solutions may beexplored, the preoperative checkout procedurerequired by the FDA1 provides users with anappropriate method to help avoid these events

Dear SIRS:

We are committed to working together with ourdistributors, equipment manufacturers, and design-ers, as well as the end users to ensure ease andproper use of our products and to participate inproper training.

Sofnolime is shipped to this end with safety fea-tures in mind.

1) Clear markings are placed in the outer wrapperof cartridges to enable user-friendly remindersand facilitate training in the preparation and useof “one shot” cartridges.

2) Cartridges are shrink-wrapped with clearmarkings and instructions.

We believe that the concept of “better bydesign” in combination with these 2 principles canmake a difference.

Molecular Products encourages all distributors andcustomers to spread the “good practice” of reading alllabels and instructions before use of consumables.Continuous training and re-enforcement programs arean integral part of these good practice regimes.

Our carton and product markings are underconstant review, and we welcome suggestions as tomore effective, internationally recognizable, andattention-seeking labels that would reduce furtherany instance that threatens patient safety.

“Designed for purpose” is the ultimate goal ofevery product and this incident has provokeddebate about removable packaging that could aid inavoiding repeat instances.

The “better by design” approach can have someunexpected consequences. It is quite easy to intro-duce a safety feature that, while preventing oneform of misuse, inadvertently introduces an unex-pected effect.

These effects can include both safety and com-mercial issues. Introducing a tear off safety tag thatprevents insertion of the absorber can lead to peo-ple forcing the disposable cartridge into place,which causes damage to the ventilator equipmentand in turn potentially leads to an even larger haz-ard to the patient than the original issue. It may alsoprevent insertion of further cartridges.

There is also the issue of increased cost. Forinstance, apart from the extra cost of the safetydevice itself, there can also be manufacturingprocess costs or packing density effects, which canalter the shipping costs and storage efficiency.

Design Changes May Have Unexpected Consequences

today. The FDA procedure provides both an accu-rate and reliable method to detect an anesthesiamachine that is not functioning properly. The FDAprocedure is designed to be conducted at the begin-ning of the work day and, in an abbreviated form,prior to each subsequent anesthetic.

The FDA checkout procedure is currently beingreviewed2 and recommendations for changes maybe presented shortly. In the meantime, this check-out procedure should remain a crucial portion ofevery safe anesthetic.

Michael MittonDirector of Clinical AffairsGE Healthcare, Life Support Solution

References

1. Anesthesia Apparatus Checkout Recommendations,1993. Available at: http://www.fda.gov/cdrh/hum-fac/anesckot.html. Accessed November 28, 2005.

2. Feldman J. Efforts under way to revise the preuse check-out recommendations. ASA Newsletter 2005;69(10):Available at http://www.asahq.org/Newslet-ters/2005/10-05/feldman10_05.html. Accessed Novem-ber 28, 2005.

“Wrapper,” From Preceding Page

This photograph is an example of one manufacturer’s reminders to remove the wrapper on an absorbent canister beforeinstallation into the anesthesia machine.


Peter J. Davis, MDPittsburgh, PA

David B. Goodale, PhD, DDSJeana E. Havidich, MDBarry A. Harrison, MD

Jacksonville, FLAlfred Lupien, PhD, CRNA

Augusta, GAChristopher O’Connor, MD

Chicago, ILDavid Paulus, MD

Gainesville, FLIra Rampill, MD

Stony Brook, NYKaren J. Souter, MB

Seattle, WASally T. Trombly, RN, JDRobert A. ViragMatthew B. Weinger, MDCommittee on TechnologyMichael A. Olympio, MD, Chair

Winston-Salem, NCAbe AbramovichThomas W. Barford

Datascope Nassib G. ChamounRobert Clark

Dräger MedicalMichael P. Dosch, CRNA

Pontiac, MIJames D. Eisenkraft, MD

New York, NYPatrick Foster, MD

Hershey, PAJulian M. Goldman, MD

Boston, MABill Jonnalee, CertAT

Lebanon, NHSiegfried Kastle

Philips Medical SystemsMichael Mitton, CRNA

GE HealthcareErvin Moss, MDFrancis R. Narbone, CRNA

Chicago, ILJohn M. O’Donnell, CRNAA. William Paulson, PhD

Savannah, GAKenneth C. Plitt, CRNA

Newton, MAPatty Reilly, CRNA

Tyco Healthcare NellcorBonnie Reinke

GE HealthcareChet I. Wyman, MD

Baltimore, MDCorporate Advisory CouncilGeorge A. Schapiro, Chair

APSF Executive Vice PresidentRobert K. Stoelting, MD

APSF PresidentCorporate MembersAbbott Laboratories (Elizabeth F.

Holland)Anesthesia Healthcare Partners

(Sean Lynch)

Burton A. Dole, Jr.Pauma Valley, CA

Marcel E. Durieux, PhD, MDUniversity of VirginiaCharlottesville, VA

Jan Ehrenwerth, MDYale UniversityNew Haven, CT

Norig Ellison, MDUniversity of PennsylvaniaArdmore, PA

David M. Gaba, MDDavid B. Goodale, PhD, DDS,

AstraZenecaWilmington, DE

Alexander A. Hannenberg, MDNewton-Wellesley HospitalNewton, MA

Elizabeth F. HollandAbbott LaboratoriesAbbott Park, IL

Walter HuehnPhilips Medical SystemsBoeblingen, Germany

R. Scott Jones, MDUniversity of VirginiaCharlottesville, VA

Rodney C. Lester, PhD, CRNAHouston, TX

Edward C. MillsPreferred Physicians MedicalRiskMission, KS

Terri G. Monk, MDDuke UniversityDurham, NC

Robert C. Morell, MDErvin Moss, MD

New Jersey Society ofAnesthesiologistsVerona, NJ

Denise O’Brien, MSN, RNASPANYpsilanti, MI

John M. O’Donnell, CRNAUniversity of PittsburghPittsburgh, PA

Richard C. Prielipp, MD, FCCMKeith J. Ruskin, MD

Yale UniversityNew Haven, CT

George A. SchapiroRobert K. Stoelting, MDRaul A. Trillo, MD

Baxter HealthcareNew Providence, NJ

Sally T. Trombly, RN, JDDartmouth-Hitchcock MedicalCenterLebanon, NH

Rebecca S. Twersky, MDLawrence, NY

Robert A. ViragTrifid Medical Group, LLCChesterfield, MO

Mark A. Warner, MDMayo ClinicRochester, MN

Matthew B. Weinger, MDRobert Wise

JCAHOOakbrook Terrace, IL

Consultants to ExecutiveCommitteeJohn H. Eichhorn, MD

University of KentuckyLexington, KY

APSF CommitteesNewsletter Editorial BoardRobert C. Morell, MD, EditorAddie Larimore, Editorial Assistant

Winston-Salem, NCSorin J. Brull, M.D.Joan M. Christie, MDJan Ehrenwerth, MDJohn H. Eichhorn, MDLorri A. Lee, MD

Seattle, WARodney C. Lester, PhD, CRNAGlenn S. Murphy, MD

Chicago, ILDenise O’Brien, MSN, RNKaren L. Posner, PhD

Seattle, WAKeith J. Ruskin, MDWilson Somerville, PhD

Winston-Salem, NCJeffery S. Vender, MD

Evanston, ILCommittee on Education andTrainingRichard C. Prielipp, MD, ChairKenneth J. Abrams, MD

Montville, NJKevin J. Cardinal, CRNA

Minneapolis, MNJoan M. Christie, MDAlan M. Harvey, MD

Springfield, MATimothy N. Harwood, MD

Winston-Salem, NCJeana E. Havidich, MD

Charleston, SCR. Scott Jones, MDDeborah Lawson, AA

Solon, OHSamsun (Sem) Lampotang, PhD

Gainesville, FLThomas J. Mancuso, MD

Atlanta, GATricia A. Meyer, PharmD

Temple, TXSusan L. Polk, MD

Chicago, ILKeith J. Ruskin, MDArthur J. C. Schneider, MD

Hershey, PAMichael Smith, MD

Cleveland, OHN. Ty Smith, MD

San Diego, CAMatthew B. Weinger, MDDavid Wharton, RN

Ada, OKCommittee on Scientific EvaluationSorin J. Brull, MD, ChairKaren L. Posner, PhD, Vice Chair

Executive Committee (Officers)Robert K. Stoelting, MD

APSF PresidentIndianapolis, IN

Jeffrey B. Cooper, PhDAPSF Executive Vice PresidentMassachusetts General HospitalBoston, MA

George A. SchapiroAPSF Executive Vice PresidentHillsborough, CA

Paul A. BaumgartAPSF Vice PresidentGE HealthcareMadison, WI

David M. Gaba, MDAPSF SecretaryStanford UniversityPalo Alto, CA

Casey D. Blitt, MDAPSF TreasurerTucson, AZ

Executive Committee (Members at Large)Robert A. Caplan, MD

Virginia Mason Medical CenterSeattle, WA

Nassib G. ChamounAspect Medical SystemsNewton, MA

Matthew B. Weinger, MDVanderbilt UniversityNashville, TN

Executive Committee (Committee Chairs)Sorin J. Brull, MD

Mayo ClinicJacksonville, FL

Robert C. Morell, MDNiceville, FL

Michael A. OlympioWake Forest UniversityWinston-Salem, NC

Richard C. Prielipp, MDUniversity of MinnesotaMinneapolis, MN

Board of DirectorsJames F. Arens, MD

University of TexasHouston, TX

Paul A. BaumgartCasey D. Blitt, MDSorin J. Brull, M.DRobert A. Caplan, MDNassib G. ChamounFrederick W. Cheney, Jr., MD

University of WashingtonSeattle, WA

Joan M. Christie, MDTampa, FL

Robert ClarkDräger MedicalTelford, PA

Jeffrey B. Cooper, PhDWilliam T. Denman, MD

Tyco Healthcare NellcorBoston, MA

Albert L. deRichemondECRIPlymouth Meeting, PA

Anesthesia Patient Safety Foundation Officers, Directors, and Committees, 2006Arrow International (Philip Croxford)

Aspect Medical Systems (NassibG. Chamoun)

AstraZeneca (David B. Goodale,PhD, DDS)

Bayer Pharmaceuticals (StanleyHorton, PhD)

Baxter Healthcare (Raul A. Trillo,MD)

Becton Dickinson (Michael S. Fer-rara)

Cardinal Healthcare (Tim Van-derveen)

Datascope (Thomas W. Barford)

Dräger Medical (Robert Clark)

Endo Pharmaceuticals (Brian Mul-nix)

FPIC (Robert White)

GE Healthcare (Paul A. Baumgart)

Hospira (Tim Hagerty)

Kimberly Clark (Judson Boothe)

LMA North American (Steven C.Mendell)

Philips (Walter Huehn)

Preferred Physicians Medical RiskRetention Group (Edward C.Mills)

ResMed (Ron Richard)

Smiths Medical (Andrew Rose)

Spacelabs Medical (Joseph Davin)

The Doctors Company (Ann S.Lofsky, MD)

Tyco Healthcare (William T. Den-man, MD)

Vital Signs (Terry Wall)

Data Dictionary Task ForceTerri G. Monk, MD, Chair

Clinical Advisory Group

David L. Reich, MD

Ronald A. Gabel, MD

Dr. Martin Hurrell

Robert S. Lagasse, MD

Dr. Anthony P. Madden

Dr. Andrew C. Norton

Dr. Roger Tackley

Homer Wang, MD

David Wax, MD

Technical Group (Corporate Participants)

Cerner

DocuSys

Dräger Medical

Eko systems

GE Healthcare

iMDsoft

Informatics

Philips Medical Systems

Picis


Corporate DonorsFounding Patron ($400,000 and higher)American Society of Anesthesiologists (asahq.org)

Sustaining Patron ($100,000 to $199,999)Anesthesia Healthcare Partners, Inc. (AHP) (ahphealthcare.com)

Sponsoring Patron ($75,000 to $99,999)GE Healthcare (gemedical.com)

Foundation Patron ($50,000 to $74,999) Abbott Laboratories (abbott.com)

Benefactor Patron ($25,000 to $49,999)

Aspect Medical Systems (aspectms.com)

AstraZeneca Pharmaceuticals, LP (astrazeneca.com)

Hospira (hospira.com)

Organon (organon.com)

Philips Medical Systems (medical.philips.com)

Tyco Healthcare (tycohealthcare.com)

Grand Patron ($15,000 to $24,999)Baxter Anesthesia and Critical Care (baxter.com)Dräger Medical (nad.com)Preferred Physicians Medical Risk Retention Group (ppmrrg.com)

Patrons ($10,000 to $14,999)DocuSys (docusys.net)Endo Pharmaceuticals (endo.com)Ethicon Endo-Surgery (ethiconendo.com)iMDsoft (imd-soft.com) Spacelabs Medical (spacelabs.com)

Sustaining Members ($5,000 to $9,999)Anesthesiologists Professional Assurance CompanyArrow International (arrowintl.com)Bayer Pharmaceuticals Corporation (bayer.com)Becton Dickinson (bd.com)Cardinal Health, Alaris Products (alarismed.com)Datascope Corporation (datascope.com)GlaxoSmithKline (gsk.com)Kimberly-Clark (kimberly-clark.com) LMA of North America (lmana.com)ResMed (resmed.com)Smiths Medical (smiths-medical.com)The Doctors Company (thedoctors.com)Vance Wall FoundationVital Signs(vital-signs.com)

Sponsoring Members ($1,000 to $4,999)Anesthesia Business Consultants (anesthesiallc.com)Allied Healthcare (alliedhpi.com)Armstrong Medical (armstrongmedical.net)Cerner Corporation (cerner.com)Cook Critical Care (cookgroup.com)Intersurgical Ltd. (intersurgical.com)King Systems Corporation (kingsystems.com)Masimo Corporation (masimo.com)Medical Education Technologies, Inc. (meti.com)Molecular Products Ltd. (molecularproducts.co.uk)Oridion (oridion.com)TRIFID Medical Group LLC (trifidmedical.com)W.R. Grace (wrgrace.com)

Corporate Level Members ($500 to $999)Belmont Instrument Corporation (belmontinstrument.com)Lippincott Williams and Wilkins

Participating AssociationsAmerican Association of Nurse Anesthetists (aana.com)

Subscribing SocietiesAmerican Society of Anesthesia Technologists and Technicians

(asatt.org)American Academy of Anesthesiologist Assistants (anesthetist.org)

Anesthesia Patient Safety Foundation

Community Donors (includes Anesthesia Groups, Individuals, Specialty Organizations, and State Societies)

Grand Sponsor ($5,000 and higher)American Association of Nurse AnesthetistsAmerican Medical FoundationAsheville Anesthesia AssociatesFlorida Society of AnesthesiologistsIndiana Society of AnesthesiologistsIowa Society of AnesthesiologistsRobert K. Stoelting, MD

Sustaining Sponsor ($2,000 to $4,999)Alabama State Society of AnesthesiologistsAnesthesia Associates of MassachusettsAnesthesia Consultants Medical GroupAnesthesia Resources ManagementArizona Society of AnesthesiologistsNassib G. ChamounGeorgia Society of AnesthesiologistsGlenn P. Gravlee, MDMassachusetts Society of AnesthesiologistsMichigan Society of AnesthesiologistsMinnesota Society of AnesthesiologistsOhio Society of AnesthesiologistsOld Pueblo Anesthesia GroupPennsylvania Society of AnesthesiologistsSanford Schaps, MDSociety of Cardiovascular Anesthesiologists

Contributing Sponsor ($750 to $1,999)Academy of AnesthesiologyAffiliated Anesthesiologists, Inc.American Society of Critical Care AnesthesiologistsJ. Jeffrey Andrews, MDAnesthesia Associates of Northwest Dayton, Inc.Anesthesia Services of BirminghamArkansas Society of AnesthesiologistsAssociation of Anesthesia Program DirectorsSorin J. Brull, MDCapital Anesthesiology AssociationFrederick W. Cheney, MDConnecticut State Society of AnesthesiologistsJeffrey B. Cooper, PhD

Steven F. Croy, MDDavid M. Gaba, MDJohn H. Eichhorn, MDIllinois Society of AnesthesiologistsKentucky Society of AnesthesiologistsJohn W. Kinsinger, MDThomas J. Kunkel, MDRodney C. Lester, CRNAEdward R. Molina-Lamas, MDMadison Anesthesiology ConsultantsMaine Society of AnesthesiologistsMaryland Society of AnesthesiologistsMembers of the Academy of AnesthesiologyMichiana Anesthesia CareMissouri Society of AnesthesiologistsRobert C. Morell, MDNebraska Society of AnesthesiologistsJohn B. Neeld, MDNevada State Society of AnesthesiologistsNew Mexico Anesthesia ConsultantsNorthwest Anesthesia PhysiciansNeshan Ohanian, MDOklahoma Society of AnesthesiologistsOregon Anesthesiology GroupOregon Society of AnesthesiologistsPhysician Anesthesia ServicePittsburgh Anesthesia AssociatesSociety of Academic Anesthesia ChairsSociety for Ambulatory Anesthesia Society of Neurosurgical Anesthesia and Critical CareSociety for Pediatric AnesthesiaSouth Carolina Society of AnesthesiologistsSouth Dakota Society of AnesthesiologistsStockham-Hill FoundationTennessee Society of AnesthesiologistsTexas Society of AnesthesiologistsDrs. Mary Ellen and Mark WarnerWashington State Society of AnesthesiologistsWest Jersey Anesthesia Associates, PAWisconsin Society of Anesthesiologists

Sponsor ($100 to $749)Anesthesia Associates of BoiseAnesthesia Associates of Chester County

Anesthesia Associates of St. CloudRobert Barth, MDSusan Bender, CRNAPaul E. Burke, MDDouglas Caceres, MDCalifornia Society of AnesthesiologistsRobert A. Caplan, MDCardiovascular Anesthesia, LLCCHMC Anesthesia FoundationMelvin A. Cohen, MDStuart M. Cohen, MDColorado Society of AnesthesiologistsCommonwealth Anesthesia AssociatesPaula A. Craigo, MDGlenn E. DeBoerJohn DesMarteau, MDWalter C. Dunwiddie, MDNorig Ellison, MDJan Ehrenwerth, MDJoseph Gartner, MDGeorgia Anesthesia AssociatesBarry M. Glazer, MDGriffin Anesthesia AssociatesPeter Hendricks, MDJames S. Hicks, MDDr. and Mrs. Glen E. HolleyVictor J. Hough, MDHoward E. Hudson, Jr., MDIdaho Society of AnesthesiologistsIndependence Anesthesia, Inc.Indianapolis Society of AnesthesiologistsRobert E. Johnstone, MDDaniel J. Klemmedson, DDS, MDKansas Society of AnesthesiologistsScott D. Kelley, MDRoger W. Litwiller, MDAlan P. Marco, MDJohn P. McGee, MDMedical Anesthesiology Consultants CorporationMississippi Society of AnesthesiologistsRoger A. Moore, MDErvin Moss, MDJoseph J. Naples, MD

New Hampshire Society of AnesthesiologistsNew Jersey State Society of AnesthesiologistsNew Mexico Society of AnesthesiologistsBeverly K. Nichols, CRNAL. Charles Novak, MDMark S. Noguchi, CRNADenise O’Brien, RNJill Oftebro, CRNAMichael A. Olympio, MDNewton E. PalmerPennsylvania Association of Nurse AnesthetistsPhysician’s Accounts ReceivableMukesh K. Patel, MDGaylon K. Peterson, MDPhysician Specialists in AnesthesiaRichard C. Prielipp, MDDebra D. Pulley, MDRhode Island Society of AnesthesiologistsMuthia Shanmugham, MDSociety for Technology in AnesthesiaSouthern Tier Anesthesiologists, PCSouth County Anesthesia AssociationDavid W. Todd, DMD, MDThe Woodlands Anesthesia AssociationUniversity of Maryland Anesthesiology AssociatesUtah Society of AnesthesiologistsVermont Society of AnesthesiologistsVirginia Society of AnesthesiologistsPamela K. Webb, PhDMatthew B. Weinger, MDWest Virginia Association of Nurse AnesthetistsWest Virginia Society of AnesthesiologistsDr. and Mrs. WetchlerLawrence Wobbrock, JDWaterville Anesthesia AssociatesWest River Anesthesiology Consultants

In MemoriamIn memory of Gale E. Dryden, MD (friends of the

Dryden family)In memory of Margie Frola, CRNA (Sharon R.

Johnson, MD)

Note: Donations are always welcome. Send to APSF; c/o 520 N. Northwest Highway, Park Ridge, IL 60068-2573 (Donor list current through December 27, 2005)


• Adequacy of assurances detailing thesafeguarding of human or animal subjects;

• Uniqueness of scientific, educational, ortechnological approach of proposed research;

• Applicability of the proposed research andpotential for broad healthcare adoption;

• Clinical significance of the area of research andlikelihood of the studies to produce quantifiableimprovements in patient outcome such asincreased life-span, physical functionality, orability to function independently, potential forreductions in procedural risks such as mortalityor morbidity, or significant improvements inrecovery time;

• Ability of research proposals to maximize benefitswhile minimizing risks to individual humanresearch participants. Each proposal shouldproscriptively enunciate the criteria for institutingrescue therapy whenever there is the remotestpossibility of an untoward adverse event to ahuman research volunteer. In some instances, therescue therapy may be triggered by more than 1variable (e.g., duration of apnea [in seconds],oxygen saturation <90%, etc.). Additionally, theprotocol should specify the nature of the rescueprocedure(s), including the rescue therapy anddosages, and the responsible personnel. If otherdepartments are involved in the rescue process,the application should specify if such departmentsare to be informed when a new volunteer isparticipating in the trial.

• Priority will be given to topics that do not haveother available sources for funding.

• Proposals to create patient safety educationcontent or methods that do not include a rigorousevaluation of content validity and/or benefit willbe unlikely to attain sufficient priority forfunding.

NOTE: Innovative ideas and creativity arestrongly encouraged. New applicants are advised toseek guidance from an advisor/mentor skilled inexperimental design and preparation of grant appli-cations. Poorly conceived ideas, failure to have aclear hypothesis or research plan, or failure to

demonstrate clearly the relationship of the work topatient safety are the most frequent reasons forapplications being disapproved or receiving a lowpriority score.

BUDGETThe budget request must not exceed $150,000

(including a maximum of 15% institutional over-head). Projects may be for up to 2 years in duration,although shorter anticipated time to completion isencouraged.

ELIGIBILITYAwards are made to a sponsoring institution, not

to individuals or to departments. Any qualifiedmember of a sponsoring institution in the UnitedStates or Canada may apply. Only 1 person may belisted as the principal investigator. All co-investiga-tors, collaborators, and consultants should be listed.Applications will not be accepted from a principalinvestigator currently funded by the APSF. Re-appli-cations from investigators who were funded byAPSF in previous years, however, will be acceptedwithout prejudice.

Previous applicants are strongly encouraged torespond to the reviewers’ comments in a letter indi-cating point-by-point how the comments and sug-gestions were addressed.

Applications that fail to meet these basic criteriawill be eliminated from detailed review andreturned with only minimal comment. A summaryof reviewers’ comments and recommendations willbe provided to applicants only if requested from theScientific Evaluation Committee Vice-Chair.

AWARDSAwards for projects to begin January 1, 2007, will

be announced at the meeting of the APSF Board ofDirectors on October 14, 2006 (2006 ASA AnnualMeeting, Chicago, IL).

NOTE: No award will be made unless the state-ment of institutional human or animal studies'committee approval is received by the committeeprior to October 1, 2006.

PRIORITIESThe APSF accepts applications in 1 of 2 categories

of identified need: CLINICAL RESEARCH andEDUCATION AND TRAINING. Highest priority isgiven to

• Studies that address peri-anesthetic problems forrelatively healthy patients; or

• Studies that are broadly applicable AND thatpromise improved methods of patient safety witha defined and direct path to implementation intoclinical care; or

• Innovative methods of education and training toimprove patient safety.

AREAS OF RESEARCHAreas of research interest include, but are not

limited to

• New clinical methods for prevention and/or earlydiagnosis of mishaps;

• Evaluation of new and/or re-evaluation of oldtechnologies for prevention and diagnosis ofmishaps;

• Identification of predictors of negative patientoutcomes and/or anesthesiologist/anesthetistclinical errors;

• Development of innovative methods for the studyof low-frequency events;

• Measurement of the cost effectiveness oftechniques designed to increase patient safety;

• Development or testing of educational content tomeasure, develop, and improve safe delivery ofanesthetic care during the perioperative period; and

• Development, implementation, and validation ofeducational content or methods of relevance topatient safety (NOTE: both patient and careprovider educational projects qualify).

SCORINGStudies will be scored on

• Soundness and technical merit of proposedresearch with a clear hypothesis and research plan;

The Anesthesia Patient Safety Foundation (APSF) Grant Program supports research directed toward enhancing anesthesia patient safety. Its major objectiveis to stimulate studies leading to prevention of mortality and morbidity resulting from anesthesia mishaps.

NOTE: The grant award limit has increased to $150,000 per project (including up to 15% institutional overhead). Additionally, there havebeen changes in areas of designated priority, in requirements for materials, and specific areas of research. For the current funding cycle, theAPSF is placing a specific emphasis on PATIENT SAFETY EDUCATION.

To recognize the patriarch of what has become a model patient safety culture in the United States and internationally, the APSF inaugurated in2002 the Ellison C. Pierce, Jr., MD, Research Award. The APSF Scientific Evaluation Committee will designate one of the funded proposals as therecipient of this nomination that carries with it an additional, unrestricted award of $5,000. The APSF is also proud to announce the inauguration ofthe APSF/Anesthesia Healthcare Partners (AHP) Research Award, made possible by a generous, unrestricted grant from AHP.

Anesthesia Patient Safety Foundation (APSF)

2006 GRANT PROGRAMGuidelines for Grant Applications Scheduled to Be Funded January 1, 2007

See “Application,” Next Page


3. Specific aims: what questions will be answeredby the investigation? If applicable, whathypothesis will be tested? For an educationalproject, what are the specific learning objec-tives or objectives of the methodology beingdeveloped?

4. Significance and applicability: briefly describethe historical prevalence and severity of themorbidity and mortality of the studied anesthe-sia mishaps. Quantify the potential improve-ments in patient outcome or recovery time andidentify how the proposed work can bebroadly applied to reduce procedural risks inhealth care.

5. If the application is a resubmission, describechanges from prior application, and specificallyaddress the reviewers' comments.

B. Methods to be employed

1. Describe data collection procedure, specifictechniques, and number of observations orexperiments. For educational projects, describehow the effects of the intervention programwill be assessed. Qualitative methodologies areacceptable.

2. Describe types of data to be obtained and theirtreatment, including statistical and/or poweranalyses, if indicated.

3. Point out and discuss potential problems andlimitations of the project.

4. If appropriate, include a statement of approvalof this proposal by the institutional committeereviewing human or animal investigations, or astatement that approval has been requested.

IV. Budget - include all proposed expenditures.Indicate under each category the amountrequested or provided from other sources.

A. Personnel (limit salaries of individuals to NIHGuidelines)

B. Consultant costs

C. Equipment

D. Supplies

E. Patient costs

F. Other costs

G. Total funds requested (no indirect costs)

H. Budget justification - CLEARLY andcompletely justify each item, including the roleof each person involved in the project. Ifcomputer equipment is requested, explain whysuch resources are not already available fromthe sponsoring department/institution. NOTE:Failure to adequately justify any item may leadto reduction in an approved budget.

I. List all current or pending research support(federal, foundation, industrial, departmental)available for the proposed project to theprincipal investigator, his collaborators, or hismentor. List all other research support for theprincipal investigator, stating percentage ofeffort devoted to current projects, and percenteffort expected for pending projects.

J. List the facilities, equipment, supplies, andservices essential for this project and indicatetheir availability.

V. Abbreviated CV (maximum of 3 pages) of theprincipal investigator only.

VI. Letter from the departmental chairpersonindicating

A. The number of working days per weekavailable to the applicant for the proposedresearch, the degree of involvement of theapplicant in other research projects, and thechair's degree of enthusiasm for the proposedproject.

B. The availability of facilities essential to thecompletion of the proposed research.

C. An agreement to return unused funds if theapplicant fails to complete the project.

VII. Sign and date the Acceptance of Conditions ofthe Grant form and upload this form as anAdobe PDF file to the website along with theapplication.

VIII. Starting with the 2004 funding cycle, ONLYELECTRONIC APPLICATIONS (MicrosoftWord or Excel format and Adobe PDF formatfor figures or drawings) will be accepted.

GUIDELINES FOR PREPARATION OF APPLI-CATIONS AND ELIGIBILITY REQUIREMENTSCAN BE OBTAINED FROM THE APSF WEB PAGE:http://www.apsf.org

The original application must be submitted elec-tronically to the website no later than Monday, June19, 2006. Once the completed application isuploaded, an automatic confirmatory e-mail will begenerated and sent to the Chair of the ScientificEvaluation Committee:

Sorin J. Brull, MD Chair, APSF Scientific Evaluation CommitteeProfessor of Anesthesiology Mayo Clinic College of Medicine 4500 San Pablo Road, JAB-4035 Jacksonville, FL 32224 Telephone: (904) 296-5688 Facsimile: (904) 296-3877 E-mail: [email protected]

PAPERLESS APPLICATIONSAll applications and accompanying documents

MUST INCLUDE

• application

• applicant's curriculum vitae

• applicant's acceptance form

• departmental chair letter of support

• budget justification

• Institutional Review Board approval orsubmission letter.

These documents will be accepted in ELECTRONICformat only. Electronic files in Microsoft Word,Excel, or Adobe Acrobat PDF format are acceptablefor all text, charts, and graphics, and must beuploaded to the APSF website:

http://apsf.org/grants/application/applicant/

Please follow the Application Format instruc-tions carefully; applications not conforming to therequirements may be disallowed.

APPLICATION FORMATI. Cover Page

A. Title of research project

B. Designation of proposal as "Clinical Research"or "Education and Training"

C. Name of applicant with academic degrees,office address, phone number, fax number, ande-mail address

D. Name, office address, and phone number ofdepartmental chairperson

E. Sponsoring institution and name, officeaddress, phone number, and e-mail address ofthe responsible institutional financial officer

F. Amount of funding requested

G. Start and end dates of proposed project.

II. Research Summary - a 1-paragraph description ofthe project.

III. Research Plan (limited to 10 pages, typed,double-spaced, excluding references; appendicesare discouraged):

A. Introduction

1. Objectives of the proposed clinical research oreducation and training project.

2. Background: reference work of other authorsleading to this proposal and the rationale of theproposed investigation or project. Describe therelationship to the priorities highlighted in thefirst paragraph of the APSF guidelines. Includecopies of in-press manuscripts containing pilotdata, if available.

Grant Application Submission Date — June 19, 2006“Application, ” From Preceding Page


by Glenn S. Murphy, MD, and Jeffery S. Vender, MD

Nearly 1,500 scientific papers were presented atthe 2005 American Society of AnesthesiologistsAnnual Meeting in Atlanta, Georgia. Importantstudies relating to patient safety were discussed inmany of the 94 separate sessions. This review willhighlight a few of these important presentations.

Intraoperative AwarenessSeveral abstracts examined the incidences and

consequences of intraoperative awareness. The ThaiAnesthesia Incidence Study (A-1283) prospectivelycollected data from 20 hospitals over a 1-yearperiod. Details of intraoperative awareness wererecorded and analyzed to identify contributing fac-tors and preventive strategies. Among over 150,000anesthetics, 99 cases of awareness were observed.Awareness was noted more frequently in certainpatient populations (female gender, ASA I and IIpatients, patients undergoing cardiac, obstetric, andlower abdominal surgery). Although 50% ofpatients reported experiencing pain during theawareness episode, only 13% described postopera-tive emotional stress or anxiety. Pollard and col-leagues (A-8) conducted a modified Brice interviewin postoperative patients (within 24-48 hours) todetermine the incidence of intraoperative aware-ness. A total of 161,824 general anesthesia patientswere interviewed over a 4-year period. Only 12cases of intraoperative awareness (0.007% inci-dence) were identified in this investigation, whichsuggests that the risk of awareness may be lower incertain practice settings. Researchers in Sweden (A-7) examined the severity of immediate and delayedsuffering due to intraoperative awareness. Afterinterviewing 2,681 consecutive patients scheduledfor general anesthesia, 98 patients were identifiedwho considered themselves to have experiencedawareness. Detailed interviews were conducted inthe 46 patients who appeared to have actually beenaware during a general anesthetic. Thirty patientsdescribed an acute emotional reaction, and 15patients experienced late symptoms with a medianseverity score of 4 (on a scale of 12). Four patientscontacted medical personnel due to mental symp-toms relating to awareness. However, only 1 patientwas diagnosed with post-traumatic stress disorder.Leslie et al. (A-9) presented details of awarenesscases in the B-Aware Trial. Patients with confirmedawareness in this trial were more likely to have pre-operative impaired cardiovascular status and intra-operative hypotension requiring vasopressortreatment than patients without awareness. In addi-tion, these patients received lower concentrations ofinhaled volatile anesthetics (MAC equivalent of0.3%). Six of 13 patients reported adverse conse-quences resulting from the awareness episode.These findings clearly demonstrate that hemody-namically unstable patients are at greatest risk ofawareness, and measures to reduce the risk of this

complication in this high-risk population must beconsidered.

PediatricsThree abstracts from the Pediatric Sedation

Research Consortium (PSRC) were presented (A-1312, A-1312, A-1314). The PSRC is a collaborativegroup of 24 institutions organized to examine thesafety of pediatric sedation practices and practition-ers. A web-based data collection tool was used tocollect data on all sedation procedures performed ateach institution. Data were received on 10,552 pro-cedures. Complications were defined as any of thefollowing; apnea, desaturation, unplanned maskventilation or intubation, prolonged sedation orunplanned deep sedation, emesis, use of reversalagents, or change in vital signs >30%. The incidenceof complications was lowest when sedation wasprovided by an anesthesiologist (2.6%) when com-pared to other clinicians (nurse/physician assistant4.7%; ER physician 7.0%; intensivist 7.0%; pediatri-cian 8.7%; radiologist 5.7%). Adjusting complicationrates for age, ASA status, and emergency statusincreased these differences further. The results fromthe PSRC suggest that serious complications relatedto pediatric sedation are rare, and that the risk ofcomplications may be influenced by the type ofprovider administering sedative agents.

The Pediatric Perioperative Cardiac Arrest(POCA) Registry was formed in 1994 to investigatecauses and outcomes associated with perioperativecardiac arrest in children. Researchers from theUniversity of Washington School of Medicineexamined the causes of cardiac arrest in pediatricpatients over 2 time periods: 1994-1997 and 1998-2003 (A-1310). There was a decrease in the propor-tion of infants and an increase in the proportion ofolder children (6-18 years) suffering a perioperativecardiac arrest over time. The severity of injury dur-ing the 2 time periods did not differ, with morethan one-quarter of cardiac arrests resulting indeath. The proportion of medication-related deathswas significantly lower in the 1998-2003 period(20%) compared to the 1994-1997 interval (32%).The authors attribute this difference to the declin-ing use of halothane in favor of sevoflurane inpediatric patients.

Jimenez and colleagues analyzed 525 pediatricclaims from the ASA Closed Claims database toidentify trends in types of patient injury and out-comes over the last 3 decades (A-1309). The propor-tion of claims relating to respiratory eventsdecreased over time (1970s - 57%; 1990-2000 - 25%;P < 0.001), as well as the proportion of claims fordeath or permanent brain damage (1970s - 78%;1990-2000 - 61%; P=0.03). Although the reasons forthese changes in pediatric claims over time are notestablished, the authors hypothesize that improve-ments in monitoring, drugs, or training (subspecial-ization) may have influenced patient outcomes.

AirwayThe incidence and predictors of difficult mask

ventilation have been poorly understood. Kheterpalet al. (A-1415) examined the level of ease or diffi-culty of mask ventilation during 15,923 generalanesthetics over a 1-year period. The ability to maskventilate was graded on a 4-point scale (1: ventila-tion without the need for an oral airway, 2: ventila-tion requiring an oral airway, 3: ventilation that wasdifficult, inadequate, or required 2 providers, or 4:impossible ventilation). Grade 3 ventilation wasobserved in 214 (1.3%) patients and Grade 4occurred in 24 (0.16%) cases. Independent predic-tors of Grade 3 ventilation included a history ofsnoring, a BMI >25, limited jaw protrusion, thepresence of a beard, and an ASA status of 3-5. Pre-dictors of Grade 4 ventilation were the presence of aneck mass or sleep apnea. These data suggest thepredictors for difficult intubation and ventilationmay differ.

Two studies by Mort and colleagues investi-gated emergency airway management of the obesepatient outside the operating room setting. Anemergency intubation database was reviewed toexamine the incidence of difficult intubation (A-1145), and the role of the LMA as a rescue device(A-288), in this patient population. When comparedto a cohort of patients with a BMI <25, morbidlyobese (MO) patients (BMI >40) had a higher inci-dence of poor glottic visualization (Lehane-Cor-mack grade 4: 28%-MO vs. 8%), unsuccessfulintubation on first attempt (48%-MO vs. 28%), andrequiring more than 3 intubation attempts (18% vs.10%). The incidence of hypoxemia was also higherin the MO group. The authors also reported on theuse of the LMA as a rescue device in obese patients(BMI >30) outside the OR. A total of 97% of obesepatients were successfully ventilated with the LMAwithin 3 attempts at placement. Overall, 91% ofpatients were successfully intubated via the LMA.The authors note that obese patients pose chal-lenges to the airway manager outside the OR, andthat the LMA may be a useful device to establishboth ventilation and intubation in these situations.

MiscellaneousThe impact of type of anesthesia (inhalational

vs. intravenous) on outcomes remains controver-sial. Investigators from the Netherlands studied theassociation between method of general anesthesia(propofol or volatile agents) and 1-year mortality(A-1271). Adult patients (n = 1,508) undergoinggeneral or vascular surgery were examined. Multi-variate logistic regression analysis was used toadjust for potential confounding variables. Overall1-year mortality was 5.2%. Mortality was associatedwith comorbidities, age, and surgical procedure,but not with type of anesthesia. The authors note

2005 Abstracts Include Many Safety Topics

See “Abstracts,” Next Page


that inhalational agents were more frequently usedin older patients with comorbidities, which mayexplain previous observations of higher mortalitiesin patients administered volatile agents.

Ischemic optic neuropathy (ION) is the mostcommon cause of postoperative visual loss (POVL)after spine surgery. Lee and colleagues examinedthe ASA POVL Registry to identify potential riskfactors for POVL (A-1). Seventy-one cases of IONfollowing spine surgery were reviewed and com-pared to 9 cases of central retinal artery occlusion.Of the 71 ION cases, the median age was 50, meananesthesia duration was 10 hours, the mean esti-mated blood loss was 3.8 liters, and 79% of caseshad ≥15 minutes of a systolic blood pressure <100mmHg. Cases of central retinal artery occlusionwere associated with a shorter anesthesia dura-tion (6.4 hours) and a lower estimated blood losscompared to ION cases. Although ION may occurduring prolonged spine surgery with significantblood loss and hypotension, the wide ranges inthese reported variables suggest a multi-factorialetiology of ION.

This brief review summarized only a smallnumber of the important abstracts on patient safetypresented at the 2005 Annual Meeting. To viewother abstracts on patient safety, or to obtain furtherinformation on the abstracts discussed in thisreview, please visit the Anesthesiology website atwww.anesthesiology.org.

Dr. Murphy is Director of Cardiac Anesthesia forEvanston Northwestern Healthcare and an AssociateProfessor at Northwestern University Medical Schoolin Chicago. Dr. Vender is Chairman of the Departmentof Anesthesia at Evanston Northwestern Healthcareand Professor at Northwestern University MedicalSchool in Chicago.

during labor. Pain management should be providedwhenever medically indicated.”1 While this docu-ment goes on to note, “that of the various pharmaco-logic methods used for pain relief during labor anddelivery, regional analgesia techniques—epidural,spinal, and combined spinal epidural—are the mostflexible, effective, and least depressing to the centralnervous system, allowing for an alert, participatingmother and an alert neonate,” there is no require-ment to use regional analgesia. Individual hospitalsand anesthesia groups must determine what theycan practically and safely provide. This mightinclude single shot-spinal opioids with additional IVopioids as needed, as some smaller centers do, orsimply IV opioids if regional analgesia is not feasi-ble. We would further note that this document takesa strong stance on appropriate reimbursement.

Dr. Parker does raise issues of serious concern.These issues deserve ongoing, careful considerationand discussion among the leadership of our profes-sional societies. However, it is not in keeping withthe spirit of professionalism that we expect fromour anesthesia colleagues to belittle, insult, and dis-parage women in labor for their entirely appropri-ate requests for pain relief. These issues need to befaced by our obstetric colleagues as well as hospitaladministrators, in consultation with the anesthesiol-ogist. Together, we can find solutions and provideadequate pain relief for women in labor, and insuresafe, healthy deliveries for the children in ourrespective communities.

William Camann, MDBoston, MA

Samuel Hughes, MDSan Francisco, CA

David Birnbach, MDMiami, FL

Reference

1. ACOG Committee Opinion, # 231," Pain Relief DuringLabor," February 2000. This opinion replaces # 118, Jan-uary 1993. (It is a joint statement from the ACOG Com-mittee on Obstetric Practice and the ASA Committee onObstetric Anesthesia.)

To the Editor:

We read with interest, and much dismay, theletter by Dr. Thomas Parker, Jr., regarding laborepidurals in the summer 2005 issue of the APSFNewsletter. Dr. Parker raises some issues that areimportant and of very real concern to the specialtyof anesthesiology. Daytime fatigue and patient-safety concerns owing to night-time work is anobvious and important problem. Provision of com-prehensive, 24-hour-per-day anesthetic services insmall, rural hospitals is a particular challenge. Lim-ited anesthetic manpower and resources are asource of stress for many practitioners in a varietyof settings, both large and small. Appropriate reim-bursement for our services is an essential matter offairness and important to all practitioners.

However, Dr. Parker's letter was a virtual diatribeagainst labor epidurals, and more specifically,against the women requesting them. We feel this ismisdirected and inappropriate. Dr. Parker refers towomen requesting pain relief with labor epiduralsas “incessant,” “entitled,” “demanding,” and “priv-ileged,” and to labor epidurals themselves as “non-essential.” Labor pain is one of the most severepains a woman will ever experience in her lifetime,and relief of this pain is no less important than thesurgical anesthesia we provide in the operatingroom. The provision of obstetric analgesia or anes-thesia, either at night or during daylight hours, isone of the most important services that we as anes-thesiologists can provide. The women who receivethese services are no more or less deserving of painrelief than any other patient in the surgical suite.

What, according to Dr. Parker, renders epiduralanalgesia in labor a “privilege”? What other ser-vices provided by Dr. Parker are considered “privi-leges,” and who among his patients are “entitled”to receive these services? What is an “incessantdemand”? Is the sound of a woman in excruciatingpain, pleading for relief, an “incessant demand”?Does the “request” for pain relief become a“demand” when made by a patient without privatehealth insurance? Is labor pain somehow moreamenable and appropriate to relieve by regionalanalgesia at 2 o’clock in the afternoon than at 2o’clock in the morning? When does a group ofpatients experiencing severe pain become “overlydemanding”? Perhaps when they cannot pay forthe services that would provide relief?

The American Society of Anesthesiologists andthe American College of Obstetricians and Gynecol-ogists have issued a joint statement that, “In theabsence of a medical contraindication, maternalrequest is sufficient medical indication for pain relief

The Anesthesia Patient Safety Foundation

wishes to recognize and thank

Asheville AnesthesiaAssociates

Asheville, NC

for their generous support of APSF in 2005

“Abstracts,” From Preceding Page

Lee PresentsPOVL Data


Labor Analgesia Needs to Be AvailableSolution to Challenge Deserves Careful Consideration

Editor’s Note: The APSF Newsletter wishesto thank Drs. Camann, Hughes, and Birnbachfor their thoughtful input on this importantissue.

by John H. Eichhorn, MD

Patient safety again was a prominent theme inthe exhibit hall at the American Society of Anesthe-siologists Annual Meeting October 22-26, even withthe hurried translocation from hurricane-ravagedNew Orleans to Atlanta. Both the Scientific/Educa-tional Exhibits and also the Technical Exhibits fromvendors of anesthesia-related equipment and sup-plies contained a few fresh concepts related topatient safety as well as many familiar themes withsome new refinements.

In the Scientific/Educational Exhibits, 9 of the48 exhibits in some way related to airway concerns.This simply reinforces the intriguing suggestionthat airway management remains likely the greatesttechnical/mechanical challenge for anesthesia pro-fessionals. Indeed, it is the one central componentof practice that has changed the least in the “mod-ern era” of anesthesia, as defined by the wide-spread adoption nearly 20 years ago of electronicmonitors such as oximeters and capnographs toextend the power of human senses and allow muchearlier detection of dangerous intraoperative situa-tions. The fact remains that general anesthesia con-tinues to include induction of unconsciousness andthen paralysis of a patient’s ventilatory musculaturewhen there is no specific guarantee that intubationof the trachea or even positive pressure ventilationwill be possible. Accordingly, virtually all anesthe-sia professionals still today experience “difficult air-way” situations with a frequency that depends ontheir type of patients and practice. Thus, airwaytools of a wide variety, airway models, airway sim-ulators, airway educational efforts and the associ-ated Scientific/Educational Exhibits, as well asairway-related products for sale in the TechnicalExhibits continue to constitute a significant fractionof the displays. Frustratingly, there was no exhibitthis year of any type of future “Star-Trek”-like com-puterized scanner that would fit over the patient’shead at the bedside or in an office setting and inseconds generate a detailed 3-D map of the airwayand also a highly educated “smart algorithm” opin-ion of precisely how to manipulate and/or instru-ment the airway to facilitate successful airwaymanagement. Invention, testing, approval, andimplementation of such devices or their (realistic)functional equivalent would revolutionize anesthe-sia care in somewhat the same manner as the intro-duction of electronic monitoring did in themid-1980s.

In any case, a comprehensive plan for a depart-mental airway workshop was outlined by sponsorsfrom the Medical College of Wisconsin, withreports of enhanced confidence in airway manage-ment gained by participants. Likewise, computer-ized video of airway management situations werepresented from Rhode Island Hospital with theadded intention of creating a detailed video archiveof the difficult airways of specific patients for future

pre-op reference by subsequent anesthesia person-nel. Another related exhibit from the ClevelandClinic featured a website for airway teaching mater-ial, particularly video. [Such a website could be apotential archive of actual difficult airways—withvideo of how to manage them—that could beaccessed by any anesthesia provider anywherewhen provided with the unlocking security code ofthe subject difficult airway patient who needs addi-tional anesthesia care.] Specific airway managementstrategies for pregnant patients and for pediatricpatients were featured in extensive exhibits. Strate-gies for topical anesthetization of the airway werefeatured as well as another exhibit devoted specifi-cally to tools useful when extubating a patient (upto and including transtracheal jet ventilation andcricothyrotomy). An exhibit from Yale featuredvideo through the LMA “C-Trach” device that isdesigned specifically to allow the anesthesiaprovider to see via a fiberoptic bundle down intothe airway and guide placement of an endotrachealtube via the LMA under “direct vision” in circum-stances where traditional views of the larynx areimpossible. Further, the new concept of specificself-customization of the widely accepted “difficultairway algorithm” by different individual practi-tioners was recommended in an exhibit from Mon-tefiore Medical Center in New York. Finally, theimportance of these and all the airway relatedissues was specifically emphasized by the fact that“The Society for Airway Management” (founded in1995 and pointedly billed as “apolitical”) had abooth in the exhibits and highlighted its promotionof airway education and research as well as its liai-son with other anesthesia-related professionalgroups.

Other Scientific/Educational Exhibits withsafety themes included one from the University ofCalifornia at San Francisco with the intriguing title“How to Avoid Death for a Dollar,” which featuredthe implementation of (inexpensive) perioperativecardiac risk-reduction strategies employing provenbeneficial medication: beta blockers and clonidine.A literature review as well as implementation pro-tocols for medication administration were available.The American Sleep Apnea Association had a boothpromoting its “A.W.A.K.E. Network” of apnea sup-port groups. The use of ultrasound guidance forplacement of arterial, central, and peripheralvenous vascular catheters as well as for assistingwith peripheral nerve blocks was again presentedin 2 exhibits, but with more emphasis on the safetystrategies of preventing errors and untowardpatient outcomes. Finally, the evolution of molecu-lar genetic testing for susceptibility to malignanthyperthermia and its obvious anesthesia patientsafety implications was outlined in an exhibit pre-sented by Henry Rosenberg, MD, from New Jersey.Note also that there was an exhibit from the Univer-sity of Minnesota regarding “surgical errors” and asystems-based approach to help avoid them. The

presentation cited the distribution of major errorsas: wrong site (76%), wrong patient (13%), andwrong procedure (11%). While patient safety, notlegal liability, was the exhibit’s emphasis, the impli-cations were clear for anesthesia providers involvedin such “surgical errors.”

The Technical Exhibits at the ASA meeting werenearly as numerous and elaborate as in a normalyear, albeit rearranged from the original printedfloor plan. The ASA-associated foundations wereprominently located directly by the main entrancedoor with the APSF booth directly in the entry path.Attendee interest in the APSF patient safety exhibitswas significantly increased this year.

In the large exhibit hall, continuing the themefrom the Scientific/Educational Exhibits, therewere no fewer than 29 technical/commercialexhibits exclusively or largely devoted to equip-ment and supplies for airway management, againdramatically emphasizing the major role ofimproving airway handling as an ongoing compo-nent of the evolution of anesthesia patient safety.Several very large displays exhibited a panoply ofall manner of airway tools and equipment, possiblyraising the question that there may be too manycompeting technologies and varieties of equipmentavailable for there to be adequate investigation oftheir applications, risks, and benefits. As is fre-quently characteristic of the commercial market-place in medical equipment, it appears that severalmanufacturers have rushed into production of newtools or technologies that have only been “tested”by their inventor and have never been the subjectof peer-reviewed publications or multi-center clini-cal trials. While this approach may be entrepreneuri-ally understandable, it makes for a bewilderingarray of choices for average anesthesia practitioners.For many, it may seem much easier to stick withthe familiar Mac 3 or Miller 2 rather than try to fig-ure out what may be better, either in general or in“difficult airway” scenarios.

There were several updates and variations onthe fiberoptic and video-assisted laryngoscopes,several of which were intended for routine every-day use. Some featured eyepieces and some otherdisplays offered miniature cameras that projectedeither to very small (1.7 inch diagonal and attacheddirectly to the laryngoscope handle) or very largevideo monitors. Several were battery powered fromrechargeable battery packs. Some systems featuredblades containing integral optics that would fit ontoa traditional C battery-powered handle, claiming togive a view around the base of the tongue withoutthe need to displace it as in traditional direct line-of-sight laryngoscopy. One flexible optical styletpowered by 4 AA batteries claimed the ability toturn difficult intubations into routine ones with“success on the first attempt every time.”


Scientific/Technical Exhibits Replete With Safety Themes

See “Exhibits,” Next Page

AAPSF NEWSLETTER Winter 2005-2006 PAGE 79


Reader HighlightsValue of ListeningTo the Editor:

Bravo to Dr. Terring W. Herionimus, III, MD,FACA, FCCP, for his excellent letter published inthe Spring 2005 APSF Newsletter. In his discussionof the tragic cases described in Dr. Lofsky's article,he noted his admonition to residents and studentsto not break contact with the patient.

I have made the observation that newly trainedanesthesiologists routinely forego the use of precor-dial and esophageal stethoscopes. I believe theyhave been trained to rely on the other monitoringdevices in use. While I applaud the ongoing devel-opment of sophisticated monitoring technology, Ihave great difficulty understanding how anyonecan have a secure feeling without this direct patientcontact. I have been in practice for 18 years and findthese tools indispensable. Not only do they helpavert disaster, but they are so important in the prac-tical management of patients. Some of the scenariosin which I feel they are critical are as follows: imme-diate detection of partial or complete airwayobstruction; assessment of proper placement andseating of LMAs; migration of endotracheal tubeinto the right mainstem bronchus, especially inpediatric cases during which I place the precordialon the left chest; diagnosis of wheezing; need forsuctioning; disconnection; and light anesthesia withswallowing and borborygmi.

No doubt, some or maybe all of these condi-tions may be noted with other monitors. But howmuch more rapidly does one hear a wheeze asopposed to noticing a change in the end-tidal car-bon dioxide curve? Or what about noticing anincreased airway inflation pressure: isn't it muchmore instantaneous to just hear secretions cloggingthe endotracheal tube?

These are just a few examples that come tomind. I have been so troubled by this that I con-sulted my mentor from UCLA who told me that hethinks the problem is starting in medical schoolswith less emphasis on auscultation. He feels thatmany residents are uncomfortable with ausculta-tion, and that even if they use an earpiece, theydon't know what they are listening to.

I have also acted as a reviewer for malpracticecases in which these issues have been critical topatient outcome, although sometimes this is hard toprove in retrospect.

What can we do to improve this situation? Dowe need to tighten the ASA standards? Or do oth-ers feel I am completely off base? I look forward tosome answers.

Danielle M. Reicher, MDEncinitas, CA

hypercapnia intended to stimulate increasedminute ventilation and, thus, the faster exhalationof volatile anesthetics, and also by a second internalcomponent that is an “anesthetic absorber” thatcaptures the exhaled volatile anesthetic and pre-vents any return into the patient via the semi-closedcircuit, thus increasing the excretion gradient andspeeding emergence. Three abstracts with 45 totalpatients were cited as supporting clinical trials.

Overall, patient safety remains a central focus ofthe exhibits at the ASA Annual Meeting. This recog-nizes both the current success in improving safetyand also the significant challenges still remaining,such as, for example, in making genuine changes inpractice, leading to lower risk of patient injury asso-ciated with issues in airway management.

Dr. John Eichhorn, Professor of Anesthesiology at theUniversity of Kentucky, founded the APSF Newsletterin 1985 and was its editor until 2002. He remains on theEditorial Board and serves as a senior consultant to theAPSF Executive Committee.

Patient warming was another very commoncommercial theme in the Technical Exhibits. Sev-eral new brands and variations of warming blan-kets or equivalents were displayed. Activelywarmed wraps for the patient’s arms as the solesource of warming were offered as a new solution,particularly for procedures in which traditionalblankets could not be used. One genuinely newtechnology involved a flexible heating fabric con-taining very thin low-voltage heating wires thatmake the slightly stiff fabric become toasty warm.This single-use system was touted as simpler, lessbulky and cumbersome, and much less expensivethan the commonly employed forced-air/plasticblanket system. Further, and apparently the subjectof intense interest at the exhibit booth from manymeeting attendees, was the additional new productthat is a vest or jacket of the same heating materialfor the anesthesia provider who is chilly (or “freez-ing”) in the OR. The material gets fairly warm, butnot hot, and can be turned on and off by connect-ing or disconnecting a power cord to the same elec-tric power supply that is connected to the patient’swarming blanket.

Infusion pump displays touted patient safetywith an increased emphasis and volume that hasnot been seen before. Apparent sensitivity to casereports of patient injuries from infusion pump acci-dents and subsequent regulatory and governmentinquiries seemed to be motivating some of the salesdiscussions from representatives of these compa-nies. Likewise, new features and variations of rapidinfusion devices stressed safety issues, particularlyimproved ability to detect air in infusion lines andthen prevent entry of that air into the patient’sblood stream.

Ventilation monitoring during MAC and seda-tion seemed to reemerge as a targeted safety issuethis year. Several companies heavily promoted thepotential safety benefits of qualitative or near-quan-titative assessment of expired CO2 during sedatedspontaneous ventilation. There was no specific ref-erence to reported hypoventilation accidents with“deep sedation,” such as in plastic surgeons’ officesor even endoscopy or imaging suites, but the impli-cations were unmistakable.

Finally, an intriguing new product that couldhave safety implications was featured. A mechani-cal device inserted in the breathing circuit in placeof the Y-connector is intended to speed up emer-gence from the effects of inhalation anesthetics and,for example, reduce the time in stage 2 deliriumand reduce time to extubation at the end of a gen-eral anesthetic. It functions in 2 ways, by causingsome rebreathing and resulting deliberate mild

APSF ExecutiveCommittee

InvitesCollaboration

From time to time the Anesthesia PatientSafety Foundation reconfirms itscommitment of working with all whodevote their energies to making anesthesiaas safe as humanly possible. Thus, theFoundation invites collaboration from allwho administer anesthesia, and all whoprovide the settings in which anesthesia ispracticed, all individuals and allorganizations who, through their work,affect the safety of patients receivinganesthesia. All will find us eager to listento their suggestions and to work with themtoward the common goal of safe anesthesiafor all patients.

Patient Warming, Infusion Pumps, andMonitoring Included Among Exhibits“Exhibits,” From Preceding Page


this is only true when supplementary oxygen isbeing administered. In a patient breathing room air,pulse oximetry is highly effective in signalinghypoventilation and/or airway obstruction! Theproblem, again, is that clinicians who use pulseoximetry to monitor ventilation may fail to appreci-ate the relevant physiology of the Hb-oxygen disso-ciation curve, and how it affects such a practice (i.e.,that the application of oxygen, even 1 or 2 liters bynasal cannulae, moves the patient to the right onthe Hb-oxygen dissociation curve, in which case thePaO2 no longer linearly correlates with the SpO2,and as a result, the SpO2 then no longer correlateswith alveolar ventilation).

The Practice Guidelines for Sedation and Anal-gesia by Non-Anesthesiologists5 recommend thatsupplemental oxygen be administered to allpatients undergoing deep sedation. Unfortunately,the Guidelines, which thousands of practitionerslook to for guidance, are entirely silent on the com-plications of this practice. Interestingly, a recentreport in the emergency medicine literature high-lighted this issue.6 Apparently, these practitionersseem to have more insight into the relationshipbetween the SpO2 and hypercapnea—and the con-founding influence of supplemental oxygen—thanother clinicians who deal with exactly this interface,in every patient they treat, on a daily basis. Forexample, Ramsay was criticized (Anesthesiology2005;102:1066) for failing to use supplemental oxy-gen in patients administered a dexmedetomidineinfusion for airway surgery, the communicatingauthors completely missing the point that pulseoximetry, expressly on room air, was a vitally—ifnot the only—accurate monitor of respiratorydepression in the reported cases.

As Overdyk indicated, respiratory depressioncontinues to be a frequent liability event in manysettings, with PCA use alone translating into “thou-sands of patients with potentially catastrophic res-piratory depression per day.” Similarly, duringprocedural IV sedation, respiratory complicationscontinue to occur commonly, despite a veritableindustry of regulations and policies designed toprevent such critical incidents. Clearly, cliniciansand guidelines are missing the critical practicalmessage that breathing is the only thing that counts. Infact, it could be argued that instead of making opi-ate use and IV sedation safer, pulse oximetry hasintroduced an unforeseen complication, becausenow clinicians are misled by a number, instead ofbeing singularly attentive to the physical act ofbreathing and airway patency—watching the chestgo up and down, and listening to the hiss of airthrough the nose or mouth—as they were in the olddays, because back then, those were the only para-

meters one could monitor to keep the patient safe.Following that rationale leads to the inescapableconclusion that much, if not the majority of respira-tory morbidity and mortality that has occurred inthe current era (of IV sedation with monitoring viapulse oximetry) could have been avoided simplyvia the deliberate and purposeful exclusion of theuse of supplemental oxygen (which would effec-tively put a brake on the level of sedation a clinicianwas willing to administer).

Clinical medicine does need a better mousetrapto directly measure ventilatory sufficiency in non-intubated patients, and we would agree that theAPSF is the ideal organization to tackle the prob-lem. Transcutaneous carbon dioxide monitors mayprovide a solution and certainly warrant furthervalidation. In the meantime, pulse oximetry can bean effective solution, as long as clinicians under-stand how to use it appropriately. If PCA use onroom air results in hypoxemia, then the fix is not toapply oxygen as de facto treatment, but to eitherdecrease the opiate allowed, or if supplementaloxygen is administered,* move the patient to amore closely monitored environment.

Leo I. Stemp, MDSpringfield, MA

Michael A. Ramsay, MD, FRCA.Dallas, TX 75246

(*The decision to use supplemental oxygenshould be clinically based, as with any other drug,not reflexive just because the SpO2 drops. Thebenign nature of isolated hypoxemia was noted inan earlier communication.7)

References

1. Overdyk, FJ. PCA presents serious risks. APSF Newsletter2005;20(2):33.

2. Freeman, ML, et. al. Carbon dioxide retention and oxy-gen desaturation during gastrointestinal endoscopy.Gastroenterology 1993;105:331-9.

3. Ayas N, et al. Unrecognized severe postoperativehypercapnia: a case of apneic oxygenation. Mayo ClinicProceedings 1998;73:51-4

4. Frumin MJ, Epstein RM, et al. Apneic oxygenation inman. Anesthesiology 1959;20:789-98.

5. American Society of Anesthesiologists Task Force onSedation and Analgesia by Non-Anesthesiologists. Prac-tice Guidelines for Sedation and Analgesia by Non-Anesthesiologists. Anesthesiology 2002;96:1004-17.

6. Witting MD, Hsu S, Andres CA. The sensitivity ofroom-air pulse oximetry in the detection of hypercap-nia. Am J Emerg Med 2005;23:497-500.

7. Stemp L. Etiology of hypoxemia often overlooked.APSF Newsletter 2004;19(3):38-9.

To the Editor:

We strongly support Overdyk's communication1

about the many patients daily at risk of respiratorydepression, and would like to elaborate on 3 issueshe raised in order to pinpoint some of the problems.

First, he states that “Cashman reported an inci-dence of respiratory depression of. . . 1.3% bybradypnea (RR <10).” In sedated patients, both res-piratory rate and tidal volume, and even ETCO2, asisolated indices, fail to correlate consistently withalveolar ventilation (VA), and therefore pCO2. Thisof course makes sense when one considers the effectof tidal volume on dead space (VD/VT) and there-fore VA, and the clinical observation that narcotic-induced respiratory slowing is frequentlyassociated with an increase in tidal volume. The lat-ter, in turn, reduces VD/VT and ameliorates theeffect of the decrease in respiratory rate on VA.This, in fact, is the rationale for using opiates as acornerstone of therapy in managing the early phaseof respiratory failure and fatigue characterized byrapid shallow breathing in acutely ill patients. Bot-tom line: Bradypnea is certainly a signal that opiatetherapy may be endangering the patient, but if onlyfor better physiologic understanding, nobodyshould be under the impression that bradypnea cor-relates directly with VA and pCO2. Further, evenETCO2 monitoring is problematic since adequatetidal volumes are required to reflect the alveolarpCO2, and shallow breathing may result in a lowETCO2 because of poor mixing of expired gas.Therefore, careful trained interpretation of ETCO2 isnecessary in using this as a measure of ventilationin nonintubated sedated patients.

Second, Overdyk states that, “Supplementaloxygen. . . merely postpones the patient’s insidiousprogress from bradypnea to apnea.” Since supple-mental oxygen has no significant effect on ventila-tion, it has no direct causative effect on theprogression from bradypnea to apnea (other thaneliminating hypoxic drive). What it does do is maskthat natural opiate-induced progression frombradypnea to apnea, by failing to allow the patientto become hypoxemic, which would otherwisecause a pulse oximeter alarm, thereby alerting clini-cians to the respiratory danger. It is crucial toappreciate these points—that clinicians, withoutrealizing that they are doing so, are using the pulseoximeter as a gauge of ventilation, and that oxygenmasks hypoventilation as detected by pulse oxime-try, by maintaining the SpO2, even to the point ofapnea.2-4

Finally, Overdyk writes that using pulse oxime-ters is a “deceptively ineffective approach” to pre-venting catastrophic respiratory depression—but


Oxygen May Mask Hypoventilation—Patient Breathing Must Be Ensured


Technical factors especially concerning themeasurement of core temperature may impair theclinician’s ability to accurately determine a thermaltarget. The appropriate sites for measuring coretemperature are the esophagus, nasopharynx, tym-panic membrane (using an appropriately placedthermocouple), and pulmonary artery. Many ofthese sites are unavailable during different types ofcases. Of note, the bladder temperature may accu-rately reflect other core temperatures, but in condi-tions of low urine flow may be as unreliable asrectal temperature. Relying on patient reports ofcomfort during neuraxial anesthesia when they areequally vulnerable to hypothermia is frustratedbecause patients’ sensation of hypothermia may becompletely disrupted, and they may report comfortwhen in fact they are becoming hypothermic.

Lack of evidence-based guidelines on howbest to warm patients results in practice guidelines(especially ASA standards), which are general andnon-specific. Clinicians are given maximum clinicalflexibility, but little guidance about which tech-nique may prove successful in particular situations.Practice guidelines are in many cases more helpfulthan standards because they are specific enough toovercome institutional and personal practice basedon tradition and convenience.

The benefits of warming may not be immedi-ately apparent. Compared with using a drug orperforming surgery, the results of warming may berelatively delayed. Unlike giving a drug andobserving an immediate response, changes in corebody temperature occur very slowly because of theenergy flow to and from the body during heattransfer. When core temperature falls early in a pro-cedure, despite active warming, clinicians doubt theeffectiveness of the intervention. Also, each patientand procedure is different enough to be an “experi-ment of one” whereby the clinician does not knowwhether a different modality would have a betterresult in the particular patient.

The appropriate stakeholder may not makedecisions about what happens in the OR. Decisionsabout adopting warming technology may be madeat an institutional level where the benefits of nor-mothermia may not be the primary concern. Also,there may be unintentional “turf battles” about whocontrols the treatment of certain complications (e.g.,wound infections) whose inception in the hypother-mic intraoperative period may be hidden toobservers of the problem at a remote time. Educationand closer cooperation is essential. Communicationand feedback from colleagues may be fragmented,such as the lack of reporting wound infections to theanesthesiology area, or the lack of communicatingtemperature information to surgery area.

Some patients are just difficult to warm. Dur-ing spinal surgery, the patient is excessivelyexposed to the cold OR environment with littleavailable area for attaching warming devices. Simi-lar problems occur in some major cardiac and vas-cular procedures where, in addition, activewarming of poorly perfused lower extremities(including during aortic cross-clamping) is pro-scribed. Trauma patients undergoing multiple oper-ations by several surgical teams at the same timerepresent another such problem group.

Safety considerations include hyperthermiaand burns. Adult patients warmed by forced air areunlikely to become seriously hyperthermic becausethey can still sweat. In children and infants, thismethod is less effective due to a relatively largersurface to absorb heat. Burns from forced airdevices have been reported when the delivery hosehas been used without an appropriate blanket. Cir-culating-water garments and pad devices havemore effective heat transfer, and therefore are pro-vided with a servo control to prevent hyperthermia.

Pre-Warming: An ImportantComponent of PerioperativeTemperature Management

One member of the panel suggested that 30minutes of pre-warming would keep patients nor-mothermic during 2 subsequent hours of surgerywithout further active measures being taken. Othersnoted that at least the initial drop in temperature islessened in the pre-warmed patient so that intraop-erative rewarming does not take so long. No inter-vention can counteract the redistribution of heatfrom the core to the periphery during the initialphase of hypothermia. Even forced air warmingduring the first hour or so can only affect theperipheral compartment, having no effect on coretemperature. It is only after the periphery is warmthat the total body heat content increases enough tobegin warming the core. Pre-warming as much as30 minutes outside the OR or during pre-anesthesiaprocedures such as starting lines could preclude theneed for intraoperative warming in short cases, andcould markedly improve the effectiveness of warm-ing during longer ones.

Passive vs. Active WarmingStrategies

Passive warming by insulating to the maximumextent possible all exposed skin surfaces can reduceradiant and convective heat loss by approximately30%. All the common materials usually employedare equally effective, but the benefit drops off

The panel commented on documented causesand effects (summarized in Table 1) of periopera-tive hypothermia. The panel’s concerns included

The Unavoidable Chilling Effectof General and Regional

Anesthesia during SurgeryPhysiologic temperature regulation in warm-

blooded animals is intricately controlled by relyingupon the autonomic and somatic nervous systems’ability to sense changes in ambient temperature,and within a narrow threshold, respond appropri-ately to maintain core body temperature in the nor-mothermic range between 36°C and 38°C.

Induction of either general or regional anesthesiaimpairs thermoregulation, allowing a redistributionof heat from the central compartment of the body(consisting primarily of the major organs) to theperiphery. In addition, heat is lost to the cold ORenvironment over time, furthering the heat deficitthat will ultimately be repaid postoperatively.

The Consequences ofPerioperative Hypothermia

Very young, very old, and very sick patients aremore likely to become hypothermic during anesthe-sia and surgery regardless of procedure. Addition-ally, certain procedures exacerbate perioperativehypothermia by their length or field exposure alone.The systemic changes indicated in the table havebeen noted to occur even as little as 0.5°C below thenormothermic range. Members of the panel believedthese effects are under-appreciated by the generalmedical and surgical community, believed theseverity of damage increased in tandem with thedegree of hypothermia, and discussed some of thereasons for this as well as some solutions.

The General Lack ofAppreciation for the Incidence

and Effects of HypothermiaPanelists noted that despite the importance of

normothermia for surgical outcomes, there persistsan inter- and intra-institutional inconsistency. Someinstitutions uniformly strive for normothermia, andconsistently monitor core temperature, while othersmay not even monitor as much as 40% of theirpatients. Panelists spotlighted several reasons forthis inconsistency, including the following:

Staff turnover contributes to inconsistent prac-tice patterns because a trained constituency forstrict attention to practice patterns for maintainingnormothermia may dissolve as staff moves to newlocations or even just new areas of interest.

Perioperative Temperature Management: RoundtableDiscussion Identifies Need to Avoid Hypothermia

The following are the minutes of a roundtable discussion held in Louisville, KY, on June 11, 2005, chaired by Scott Robinson, MD, and KushagraKatariya, MD. Also participating were Dan Sessler, MD, Andrea Kurz, MD, William Edward Hodges, CCP, and Jan Odom-Forren, MS, RN.

See “Hypothermia,” Next Page


Possible Impact of Hypothermia

Organ System/Function Resulting Effect(s)

Adrenergic System • Stimulation of sympathetic nervous system• Significant increase in norepinephrine • Minimal adrenomedullary/adrenocortical response

Coagulation Function • Decreased platelet function• Impaired coagulation cascade• Increased fibrinolysis• Potential for increased blood loss and need for transfusion

Cardiovascular System • Systemic and pulmonary vasoconstriction• Increased blood pressure • Increased likelihood of ventricular dysrhythmia• Increased risk of myocardial infarction

Immune System • Decreased neutrophil and macrophage function• Decreased tissue oxygen levels• Increased risk of wound infection• Potential for delayed wound healing

Metabolic System • Postoperative shivering, which increases total oxygen consumption

Pharmacokinetic Function • Potentiation of neuromuscular blockers• Decreased minimal alveolar concentration of inhaled agents

Psychological/Emotional Effect • Decreased patient satisfaction

Respiratory System • Blunted ventilatory response to oxygen• Decreased tissue oxygen requirements • Left shift in hemoglobin-oxygen dissociation curve

greatly after the first layer. Seventy percent of theheat loss and all of the heat redistribution must bedealt with actively.

Active warming involves the use of a devicethat can both prevent heat loss (insulating the sur-face, but also warming the skin to reduce the gradi-ent for radiant heat loss) while also providing a netpositive thermal flux from the device to the patient,thereby increasing the total heat content of thebody and warming the core. Active warming withforced air is inexpensive, safe, and far more effec-tive in several studies than passive warming.Although the heat capacity of air is low, forced airdevices are effective because the air is dispersedover a wide surface area. There is no demonstrateddifference in effectiveness between brands offorced air systems.

Heat transfer from advanced technology circu-lating-water devices can be up to 5 times greaterthan air per unit area. This accounts for their usagein surgical cases where body surface is at a pre-mium and satisfactory results are difficult toachieve with forced-air.

Summarizing, roundtable participants agreedthat evidence-based practice guidelines could,where implemented, result in widespread mea-

APSF Education committee members Ken Abrams, Tricia Meyer, Susan Polk, Alan Harvey, and Richard Prielippreviewed all 51 Scientific Exhibits and arrived at a consensus opinion for the Ellison C. “Jeep” Pierce, Jr., MD, BestScientific Exhibit in Patient Safety Award. This year’s winner is “MacIntosh and IBM-compatible Laptop-basedVidoegraphy of Airway Management for Teaching Airway Management and Record Keeping” from Brett L. Arron, MD,Richard Gillerman, MD, and James E. Peacock, RN of Rhode Island Hospital, Providence, RI. Dr. Stoelting (left) pre-sents the award while Committee Members Richard Prielipp and Tricia Meyer look on.

The APSFcontinues to accept

and appreciatecontributions.

Please make checks payable to the APSF

and mail donations to

Anesthesia Patient Safety Foundation

(APSF)520 N. Northwest HighwayPark Ridge, IL 60068-2573

“Hypothermia,” From Preceding Page

Hypothermia Has Multiple Effectssurement of core temperature and the use ofactive warming devices in all types of cases whereanesthesia induced hypothermia occurs. This

could, in fact, go a long way toward the goal ofnormothermia for every patient, reducing theattendant consequences.


haps an identifiable problem is the ever-increasingincidence of obesity with attendant comorbid dis-ease processes. Five of the top 10 most “overweightcities” in the U.S. are in Texas.

As a broad classification, the morbidly obesepatient is “apple-shaped” (tight fat) in appearanceor is “pear-shaped” (loose fat) in appearance.4

Based on my experience, the “tight fat” obesepatient tends to have a higher incidence of difficultairway issues.

There are several physical signs that can alertone to the possibility or probability of a patient hav-ing a difficult airway. The 6-Ds of airway assess-ment are 1 method used to evaluate for signs ofdifficulty:

1. Disproportion (tongue to pharyngeal size/Mallampati classification)

2. Distortion (e.g., neck mass)

3. Decreased thyromental distance (receding orweak chin)

4. Decreased interinscisor gap (reduced mouthopening)

5. Decreased range of motion of the cervical spine,and

6. Dental overbite.5,6

Although all 6 points are important, in my opin-ion, “the jaw tells the story.” An over-looked andsimple clinical sign to assess the jaw is the upper lipbite test.7 The patient is asked to touch their upperlip with their lower teeth, i.e., protrude themandible. This simple test addresses D3 and D6.Concerning point D5, ask the patient to look up atthe ceiling or tilt their head backward. Any launch-ing forward of the patient’s shoulders confirms thatthe range of motion of the cervical spine is limited.

Having clinically identified a potentially diffi-cult airway and especially for the “tight-fat”/“apple shaped” obese patient, here are somepersonal, practical suggestions:

1. Start from a position of strength. The termHELP (head elevated laryngoscopy position) wascoined by Dr. R. Levitan.8 Two articles on pre-positioning the morbidly obese patient haveshown that this position improves thelaryngoscopy view9 and that there is an increasein the desaturation safety period.10 Rescueventilation techniques, (oral airway/bag andmask) are facilitated by the HELP position. Thehead and neck are elevated above the chest andabdomen. The airway is therefore more isolatedand easier to work with. Further, the weight ofthe abdomen is falling away from the diaphragmand less positive airway pressure is required.Stacking with blankets can create the HELPposition, but may cause variable and/or unstable

results. A pre-cut foam positioner designed toquickly achieve the HELP position iscommercially available.

2. Have airway management plans A, B, and Cworked out, and all materials immediatelyavailable in the OR before the induction ofanesthesia. If plan A is not achieving the desiredresult, activate plan B, or C early. There is muchwisdom in the phrase, “Don’t persist in the sametechnique and expect a different result.” Thereare numerous airway devices available foradvanced airway management. In my opinion, itis important to master 3 or 4 different techniques,and maintain a comfort level with each throughconstant practice.

Again, the above suggestions are my opinionsbased on personal experience. For more informa-tion, please review the ASA algorithm for manag-ing difficult airways, available at www.asahq.org/publicationsAndServices/Difficult%20Airwaypdf.

References 1. Cormack RS, Lehane J. Difficult tracheal intubation in

obstetrics. Anaesthesia 1984;39:1105-11. 2. Caplan RA, Benumof JL, Berry FA, et al. Practice guide-

lines for management of the difficult airway. A reportby the American Society of Anesthesiologists TaskForce on Management of the Difficult Airway. Anesthe-siology 1993;78:597-602.

3. Caplan RA, Benumof JL, Berry FA, et al. Practice guide-lines for management of the difficult airway: anupdated report by the American Society of Anesthesiol-ogists Task Force on Management of the Difficult Air-way. Anesthesiology 2003;98:1269-1277.

4. American Society of Bariatric Surgery. Rationale forthe surgical treatment of morbid obesity. Available atwww.asbs.org/html/patients/rationale.html.Accessed August 22, 2005.

5. Mallampati S. Clinical Assessment of the Airway. Anes-thesiology 1995;13:301-308.

6. Benumof JL. Airway Management: Principles and Prac-tice. St. Louis: Mosby, 1996:126-42.

7. Khan ZH, Kashfi A, Ebrahimkhani F. A comparison ofthe upper lip bite test (a simple new technique) withmodified Mallampati classification in predicting diffi-culty in endotracheal intubation: a prospective blindedstudy. Anesth Analg 2003;96:595-9.

8. Levitan RM, Mechem CC, Ochroch EA, et al. Head-ele-vated laryngoscopy position: improving laryngealexposure during laryngoscopy by increasing head ele-vation. Ann Emerg Med 2003;41:322-30.

9. Collins JS, Lemmons HJ, Brodsky JB, et al. Laryngoscopyand morbid obesity: a comparison of the “sniff” and“ramped” positions. Obes Surg 2004;14:1171-5.

10. Dixon BJ, Dixon JB, Carden JR, et al. Preoxygenation ismore effective in the 25 degrees head-up position than inthe supine position in severely obese patients: a random-ized controlled study. Anesthesiology 2005;102:1110-5.

DISCLOSURE: Dr. Troop is the inventor of acommercially available pre-formed positioning aidmentioned in this article.

by Craig Troop, MD

Reprinted with permission of Texas Medical Liability Trust.

The following scenario is a synopsis of the anes-thesiologist’s worst nightmare: can’t intubate/can’tventilate. This ongoing concern in anesthesiology isbeing revisited in light of the personal observationthat as the prevalence of obesity increases, standardoral intubation is becoming more difficult. The follow-ing summary is based on an actual closed claim case.

CaseA 54-year-old man was scheduled for a total

knee replacement. The patient was 5’6” andweighed 250 pounds. His BMI was 40 kg/m2. Inaddition to obesity concerns, his medical historyincluded hypertension, hypercholesterolemia,GERD, type II diabetes (diet controlled), and possi-ble sleep apnea. The patient agreed to the placementof an epidural catheter for postoperative pain con-trol but demanded to “be asleep” for the surgery.

Following the uneventful placement of anepidural catheter, the patient was placed in a fullysupine position, monitors were connected, and arapid sequence induction was performed. Orallaryngoscopy with a MAC 3 blade was attemptedwhich revealed a grade 4 view (no identifiablelaryngeal anatomy).1 Mask ventilation with an oralairway/bag and mask was attempted and noted tobe difficult requiring high positive inspiratory pres-sures. Oral laryngoscopy with a MAC 4 and then aMiller 2 blade was attempted. The difficult airwaycart, an intubating LMA, and additional anesthesiaassistance were summoned. Between each attemptto secure an airway, mask ventilation becameincreasingly difficult; peak airway pressures werereported to be “sky high.” After several minutes ofunsuccessful airway management, a general sur-geon arrived. As the surgeon attempted a difficulttracheotomy, the patient arrested and further resus-citation efforts failed.

DiscussionFor every dramatic, worst-case scenario as

above, how many countless near misses occur? Thisarticle is not intended to be a lengthy review of thedifficult airway. There are many excellent resourcesaddressing this topic by notable national airwayeducators. (Please see Caplan, et al.’s “PracticeGuidelines for Management of the Difficult Air-way.”2,3 The House of Delegates of the AmericanSociety of Anesthesiologists spent more than 18months and more than $150,000 in approving theseguidelines.) The intent of this article is to sharesome suggestions based on personal experience.

As mentioned earlier, I have observed a trend ofan increase in the overall number of difficult airwaypatients. There are several reasons for this, but per-

Difficult Intubation in the Obese Patient


To the Editor:

I would like to comment on 2 articles in the fallAPSF Newsletter, “Complications of CervicalEpidural Blocks Attract Insurance Company Atten-tion” and “DepoDur™: A New Drug Formulationwith Unique Safety Consideration.” I believe thearticles have major problems and reflect poorly onhow the APSF handles emerging safety issues.

The article on cervical epidural blocks is actuallya nice mini-review; however, the entire focus of thearticle is on how to reduce insurance risk and itmakes several recommendations. The article recom-mends the use of fluoroscopy, use of the proneposition, avoiding injections if pain is experienced,and limiting sedation if possible. However, it is notclear in reading the case reports presented that anyof these measures do any good! Fluoroscopy withepidurograms was used in the majority of cases, theuse of sedation was about 50%, and the articlepointed out, it is not clear that needle contact withthe spinal cord is painful.

Thus, given that cervical spinal cord traumamay be reduced but not eliminated, the correctquestion is what is the risk versus benefit of cervicalepidural injection? It is not a secret that there is acontroversy and a paucity of randomized controlleddata to show that epidural steroids are of benefit;1some do not use them in their practice at all. If thereare any benefits, they seems to be short lived and oflimited clinical usefulness.2

The real story is not reducing the risks of cervi-cal epidural steroids, but whether they should bedone at all. If a drug were released by a pharmaceu-tical company that had an incidence of paralysis,arachnoiditis, anoxic brain injury, and death, andthe company had difficulty showing that it hadclinical utility, it would never be released. If theAPSF had properly reviewed the literature, Ibelieve a reasonable conclusion is to call for a mora-torium on cervical epidural outside of randomizedcontrol studies, rather than to improve theinformed consent process.

The second article, “DepoDur™: A New DrugFormulation with Unique Safety Considerations,”also missed the opportunity to improve patientsafety. The headline on the second page of this arti-cle reads “Appropriate Protocols Needed for Depo-Dur™.” I was excited to read this article as themanufacturer has been widely advertising thismedication, and drug representatives were makingthe rounds selling this drug.

This article, again well-researched and written,goes over the “benefit” of the drug avoiding theneed for a “cumbersome epidural pump.” How-ever, the article states that 4% of patients receivingthis drug required naloxone. A recent review ofepidural opioids put the established incidence ofrespiratory depression at 0.09% to 0.4% from con-tinuous infusion of epidural opioids.3 I was expect-ing to get an appropriate protocol for use of thisdrug that has at least a 10-fold greater incidence ofrespiratory depression then current therapy. In fact,under the monitoring section of this article the onlyconclusion is that “there are no universallyaccepted stands or published guidelines for respira-tory monitoring with opioid therapies by an accred-itation body or society.”

Again the APSF has missed the big picture ofputting patient safety first. A risk-benefit analysisagain might call into question the need for this drugwhen its risk of respiratory depression is so muchgreater than current therapy, and its benefit is sotrivial. Because of these questions, perhaps contin-uous pulse oximetry should be used until moredata establish this drug’s safety. Perhaps, if the arti-cle were written by someone else other than aninvestigator involved in development of this drug,a more balanced view would be obtained.

The field of anesthesiology is routinely laudedfor the great strides in improving patient safety andis held up as a model for other disciplines to follow.We need to continue being ever vigilant and toplace our patients first, maximizing their safety andminimizing their risks. But we cannot rest on ourlaurels; we need to critically examine new medica-tions and new procedures from an objectivepatient-oriented viewpoint. In the long run, this iswhat will keep our discipline strong and wellrespected.

Amir Tulchinsky, MDHartford, CT

References

1. Butler, SH. Primum non nocere-first do no harm. Pain2005;116:175-176.

2. Koes BW, Scholten RJPM, Mens JMA, et al. Efficacy ofepidural steroid injection for low-back pain and sciatica:a systemic review of randomized clinical trials. Pain1995;279-288.

3. Rathmell JP, Lair TR, Nauman B. The role of intrathecaldrugs in the treatment of acute pain. Anesth Analg2005;101:S30-43.


Monitoring andVigilance NeededWith DepoDur™

To the Editor:

DepoDur™ will certainly find its niche in theacute pain management arena; however, this for-mulation should be used with extreme caution. Notonly did 75% of the patients need additional anal-gesia via an IV-PCA pump with all its associatedproblems as described by Dr. Viscusi,1 the drug alsohad a higher side-effect profile. Whether it was 5%of the patients or 12.5%2 needing an opioid antago-nist, these figures compare with 0% in the IV-PCAgroup. The higher side-effect profile was in theelderly patients with comorbid conditions, the sub-group who could potentially benefit most from thisformulation. As the package insert highlights,3

extreme vigilance and close monitoring is neededwhen DepoDur™ is used, a condition that is notachievable in the surgical wards of most hospitals.

Babak Roboubi, MDDirector, Acute Pain ServiceWashington Hospital CenterWashington, DC

References

1. Viscusi ER. DepoDur™: A new drug formulation withunique safety considerations. APSF Newsletter 2005;20:50-1.

2. Viscusi ER, Martin G, Hartrick CT, et al. Forty-eighthours of postoperative pain relief after total hip arthro-plasty with a novel, extended-release epidural mor-phine formulation. Anesthesiology 2005;102:1014-22.

3. DepoDur™ Package Insert: Full Prescribing Information,Endo Pharmaceuticals, Chadds Ford, PA, 2005


Reader Calls for FairRisk-Benefit Analyses

2006 APSF Grant Application

Guidelines See Page 74


To the Editor:

Please allow me to commend Celestive O.Okwuone, MD, for his letter to the editor on “Anes-thesia May Predispose Patients to Corneal Abra-sions” in the fall 2005 issue of the APSF Newsletter.

As he points out the exact mechanisms of theinjury to the cornea is unknown, but it is our dutyas anesthesiologists to use all precautions to pre-vent it.

In my opinion most corneal abrasions arecaused by the rubbing of the eyes during emer-gence from anesthesia. Certainly the pulse oximetersensor in this situation is the most likely cause ofinjury. To prevent that, I ask the PACU nurses toplace the pulse oximeter sensor on one of the toesrather than the finger.

M. Saeed Dhamee, MD Milwaukee, WI

To the Editor:

I read with interest the letter in the Fall 2005issue of the APSF Newsletter from Dr. Okwuone.Corneal abrasions have been the most frequentcomplication of anesthesia in my practice, and, ifanything, the incidence seems to be rising, despiteour best efforts to prevent them.

It is difficult for me to imagine why patients,lying supine for short cases, with nothing (otherthan eyelid tapes) touching their eyes, who havenot been ventilated with a mask, should suffer suchinjuries.

My belief is that a large number of corneal abra-sions are self-inflicted, either during or after emer-gence from general anesthesia. My experience isthat many, if not most patients will reach for theirfaces as they wake up in particular, in order to rubtheir eyes. We spend a considerable amount of timein the OR, during transport, and in the PACU ver-bally and physically restraining patients fromtouching their faces.

Few things are more irritating, both to anesthe-siologists and their patients, than to have a cornealabrasion become manifest after an otherwiseuncomplicated anesthetic. I personally have on sev-eral occasions received a call from the PACU nursestating, “Mrs. Jones is ready to go home, but one ofher eyes is red and hurting.” This an hour after see-ing her in PACU with both eyes open (not red),responding appropriately, and denying any dis-comfort. My guess is that this injury has occurredsubsequent to that time, but I am somewhat mysti-fied as to how. I try to watch as the oxygen mask isapplied in PACU, since I think that is a potentialcause of eye injury, but failing that as the etiology,one must look to the patient.

I don't have an easy solution to this seemingdilemma. Restraining patients for more than a fewminutes is impractical for a variety of reasons, notthe least of which is medicolegal. Eye ointment, asnoted by Dr. Okuone, is usually of dubious valueand involves some minor drawbacks of its own—blurry vision, risk of transmitting infection, and theoccasional allergic reaction. I would be very inter-ested to hear the views of other anesthesiologists onthis subject.

Eric A. Wardrip, MDEncinitas, CA

To the Editor:

I share Dr. Okwuone's concern regarding thepotential for corneal injury in the perioperativeperiod. I would add 2 more possible mechanisms ofinjury. During surgery involving the head or neckin which the eyes are draped, it is possible for thesurgeon or assistant to put continuous pressure onthe cornea by inadvertently resting an arm on theeye. Another period of vulnerability occurs beforeor after transport to the PACU when the plasticoxygen mask is placed on the patient’s face and caneasily pull the eyelid up, scratching the cornea.

Heidi Smith, MDSeattle, WA

Letters to the Editor

Postoperative Period Perceived As MostLikely Opportunity for Corneal Abrasions

Improved APSF website:

www.apsf.org

®

working for patient safety

by Patrick Foster, MD

Placing a label on an otherwise unmarkedsyringe containing a drug intended for intravenoususe would seem an uncontroversial contribution topatient safety. Yet 20 years after the original specifi-cation was published, we still await universalacceptance of the idea.

The ProblemThe need for such a marker has existed since those

early days in anesthesia when intravenous barbituratesfirst challenged inhaled drugs at Pearl Harbor, andwhen Cecil Gray established the pivotal role of curarein general anesthesia. The speed of response to anintravenous (IV) injection may not allow time to man-age the consequences of an error, and use of the IVroute in general anesthesia has become more wide-spread. Many of us have devised systems for labelingour drugs. But now, the single anesthesiologist oranesthetist, once independently responsible for patientwell-being during surgical assault, is being integratedinto a surgical team, where responsibility for mostaspects of a patient’s care is shared; others now expectinsight into the gasman’s codes. So our once simplelabeling system, designed as a rapid recognition codefor the anesthesiologist or anesthetist, now has toevolve into a nationally agreed code for the preciserecognition of pre-prepared injectable drugs for use byother surgical team members.

How it StartedIn the mid 1950s the University of Stellenbosch

started planning a new medical school campus inCape Town, South Africa, that would integrate med-ical, dental, and nursing schools with a major generalhospital. All of this came into being in the early 1970sas the largest “school under one roof” in the Southernhemisphere, known as the Tygerberg Hospital.Design ideas were sought throughout Britain,Europe, and the United States, and major equipmentsources were expected to come from Britain. How-ever, 6,000-mile supply lines and misunderstandingsof local circumstances meant that needs were oftenbest met by local design and manufacture. Againstthis background, the incidental production of asyringe labeling system for a large anesthesia servicewas a minor undertaking, supported by the localAnesthesia Society. After testing designs in the mid1970s Avery printed the original design and suppliedinternational color definitions in the national specifi-cation. Rolls, each with 100 individual names on thecode color, were mounted alongside each other on adowel comprising a multiple dispenser. Some colorswere chosen to reflect the class characteristics: “dan-ger” red for muscle relaxants; blue to signify thecyanosis of opiate-induced respiratory depression;green for atropine-like drugs used in a syringe sizesmaller than (red) relaxants. There were few specificantidotes to the IV drugs used in anesthesia, but thesewere considered important enough to have some linkto the color code of the agonist. This was done byusing diagonal white stripes and color stripes in thecolor bar of the agonist. Thus nalorphine, atropine,and flumazenil share the color of opiates, relaxants, orbenzodiazepines, respectively. With mixtures someinteresting stripe patterns emerged, such asred/green/white alternating for the usual standardrelaxant reversal of neostigmine and anticholinergic.

Visiting anesthesiologists to the Tygerberg Hos-pital took labels home to the United Kingdom,many European countries, Canada, and the UnitedStates, thus leading to the development of severalinformal versions. Dr. Rendell Baker was one of thefirst to introduce these ideas to the United States.

The original specifications were published in1985 by the South African Bureau of Standards asSABS 0207-1985, and placed in the catalog of theInternational Standards Organization, of which theSABS is a member. Currently this standard is pub-lished by the Standards South Africa division of theSABS as SANS 10207 (www.stansa.co.za). A secondrevision is now under preparation to appear on this20th anniversary of the original.

A Need for ChangeAfter 20 years a revision is necessary, if only to

incorporate the changes brought by new technology.There were few applications for computers in a1970s OR, but today, a syringe label can provide theinterface between anesthesia machine and a com-puter that can “autopilot” a general anesthetic whilerecording the data. A revision also provides achance to revisit some of the basic aims that shapedthe first standard, which sometimes may have beenmisunderstood. There were drug representativeswho believed the labels would replace the identify-ing “house colors” of their products. (Today, somemakers wishing to support the color code concept,pack drugs of a similar class in boxes of the speci-fied color. This is even more dangerous since drugssuch as ephedrine and epinephrine can be mixed upin the same drawer of a drug cart stocked by ajunior aid). The main goal was to reduce the dangerof the wrong IV injection during the process of anes-thesia. A design was proposed for a series of labelseasily identifiable by color and print. These were tobe applied to any syringe containing any drug,intended for IV use, after it had been transferredfrom its original pack into an anonymous syringe.Implied in the standard is observance of the safepractice that only the ultimate user of an IV drugshould prepare the injection and affix the label. Foroptimum safety, it is essential to use one standarddesign as variations may lead to confusion.

Originally the focus of the 1985 standard was onanesthesia practice; however, this need nowextends to cover PACU or postoperative ICU care.Recently, JCAHO regulations have addressed awider range of drugs:

“A new requirement for all types of accreditedorganizations that provide surgical or otherinvasive services specifies that all medications,medication containers, and other solutionsused in peri-operative settings be labeled.”This innovation, that includes syringes with

other medication containers, seems eminently rea-sonable so long as one notes the following items:

First, a single unlabeled syringe is an anathema;unidentified content is presumed dangerous and tobe discarded. Creative solutions will be found tocover simple routine clinical procedures such as the“flu shot.” For example, “Provided that the syringenever leaves the hand of the user from the time of its load-ing from a manufacturer’s container until its discharge,no label need be applied.” Second, the simplest label

must now include four data fields: drug name, drugmass per unit volume, date and time of preparation,and dispenser’s identity. The standard label nowused in most OR’s has space for the extra details.Third, these changes are brought about by the chal-lenge to the prime status of the syringe as drugdelivery container by the larger medication contain-ers, which deliver more drug over a longer period atless cost in material and supervision. As our “drugsfor use in anesthesia” is revised to become “drugs foruse in anesthesia and intensive care,” so must ourdesigns include new large containers labels withextra data fields relevant to the longer stay within anintensive care system. For this use present syringelabels are too small. Will there be 24-48 hour labels, 7day specials, or Medicare monthly concessions?

We approach an era when general anesthesia,once provided by the skilled hand, operating a gasdispenser to meter oxygen flows and narcoticvapors, is to be replaced by a ventilator controlledby a dedicated computer that drives a series of gasand infusion meters. As a stranger among thesebinary controls, may there still be a handheldsyringe? Will some experience nostalgia for thedays of one provider responsible for the full care ofone patient at a time?

On Basic DesignThe widespread acceptance of the color coded

label system almost certainly depends on easyrecognition of a pattern that combines 3 simple ele-ments: the syringe size, label color, and printing.Most times a person will use several drugs, fromdifferent classes, as identified by the color code, andeach in a syringe large enough for the dose. Often,it is possible to pick out a drug from across theroom by the syringe size and color, at a distancewhere printing would be illegible. Print confirms aninitial selection based on syringe size and color pat-tern. Critics of the system object that color blindnessmust make the system unreliable. Years of fullacceptance and recently a well designed study1

have shown this to be untrue.

Why aren’t our traffic signals red, amber, andblue to suit our many red/green blind users? Infact, this use of color has proven valuable with thesmall label size imposed by the size of a 2-3 mlsyringe: a whole colored label stuck on a roundedsurface is easier to interpret than the print.

Enlarging the CodeShould the color code be enlarged to include all

drugs used in intensive care as some enthusiasts sug-gest? I believe that the acceptance of the present sys-tem has depended in large part on its simplicity; fromthe start it was never intended to include all classes inthe pharmacopoeia. It would be difficult to find morethan about 15 distinct colors and for most users tomemorize all 15 (when they daily rely on only 5 or 6classes in most patients). There are 1 or 2 colors still“available”. That should be enough. Meanwhile awhite label can be used for all other drugs while therole for color coding remains safe with anesthesia.

In passing, one notes that there are other acceptedcolor codes for volatile anesthetics and for compressedgases that do not interact with the label code.


In My Opinion

Labeling History Reviewed and Future Explored

See “Labeling,” Next Page


Code could be extended by extra markings on asyringe. Better than color coded syringe caps wouldbe a form of coding, color or print, on the thumbplate of the plunger. One could suggest a use toindicate the refrigerated shelf life of pre-filledsyringes from a central pharmacy. Stacked syringesare then sorted by end colors.

The Role for BarcodesTwo questions still await a good answer; what are

you going to code, and who will be reading it? Withthe inclusion of critical care in our label code, theremay now be a role for such a vehicle for rapid, accu-rate patient data transfer. JCAHO, in the documentquoted above, places special emphasis on full, accu-rate data transfer at every patient “hand off” (transfer)between caregivers. The syringe label even has lim-ited space for small barcodes, although the valuecould be in routine anesthesia may be difficult to see.

Reading barcode requires a computerized scan-ner. Ultimately this can take the form of a peripheralsyringe reader-driver that also detect drug and vol-ume in the syringe by reading code, and, by, follow-ing plunger head movement, record dose and time.

Printed LabelsDo people realize that buying into a system of

pre-printed labels can lead to a problem? Oneassumes that members of a department first agreedto their label list of standard drug names and doses.This means that an unscheduled format must be sig-naled using a (non-color code) white label. Realdanger may arise when drug indicates an “almostthe same” drug, as when the name remainsunchanged but concentration is only changed on thelabel. If a standard label is used, flag it. Otherwise a

Letters to the Editor:

To the Editor:Dr. Lambert clearly presents the need for com-

mercially prepared appropriately diluted resuscita-tion medications.1 In the absence of such, some ofthe concerns that he identifies can be addressed bya hospital (or OR satellite) pharmacy.

A pharmacy can prepare batch sealed 10 mLsyringes of phenylephrine 80 mcg/mL andephedrine 5 mg/mL. If kept refrigerated, thesesyringes are good for 7 days after preparation.Advantages of this system include standardizingthe dilution concentration in every location, areduced risk of infectious contamination, a pre-sumed reduced risk of dilution errors (especially ifanesthesia trainees are present), anesthesia providertime saving, and appropriate labeling as required bythe JCAHO and Department of Health. There is lesswastage of medications and diluent since a pharma-cist can produce 25 10mL syringes of 80 mcg/mLphenylephrine from just two 10-mg phenylephrinevials and one 250 mL IV solution bag.

Forced Air WarmerBurn Can Occur WithPoor CirculationTo the Editor:

We recently had a child in the cardiac catheteri-zation lab experience extensive third-degree burns ofa leg due to the forced-air warmer. After analysis ofthis case, it is apparent that the cause for the burnwas poor circulation to the affected leg. Under nor-mal conditions, blood flow removes the heat locallyand redistributes it to the rest of the body. In condi-tions of extremely poor blood flow, temperaturesthat would normally cause no consequences maylead to significant burns. In this patient as well asmany others in the cardiac catheterization lab, causesfor diminished lower extremity perfusion includesheaths placed in the groin vessels, thrombosedgroin vessels from previous procedures, and low car-diac output. We urge anesthesia providers in the car-diac catheterization lab to use extreme caution whenapplying forced air warmers to the lower extremitiesof children, including keeping an adequate amountof space between the warmer and the skin, not usinghigher temperature settings, and considering placinga blanket between the legs and warmer. Also, thewarming sleeve can be placed from the cephaladposition toward the torso instead of around thelower extremities first, if there is adequate room atthe head of the bed for the warming unit.

Samuel Golden, MDCathy Bachman, MDChicago, IL

Fatigue Must BeAddressedTo the Editor:

I appreciate the attention that your newsletterhas given to the threats to patient safety that arisefrom fatigued anesthesia providers. I agree with Dr.Curry's letter (Fall 2005 issue) that more providersare needed to enhance safety for our patients. Facedas we are with a shortage of anesthesiologists andCRNAs, it is unlikely that bolstered staff ranks willsoon alleviate this problem. A brief review of inter-disciplinary literature reveals that the impact offatigue is being acknowledged in many practicespecialties, even those that do not face the man-power issues that we experience. I believe that it istime for the anesthesia community to forge a posi-tion paper that deals with the scheduling ofproviders. Through this, health care administra-tions may be made more aware of the significantthreats that face patients due to overworked andunder-supported providers. Vigilance is the key tosafer anesthesia.

Brian K. Miller, CRNA, MSHudson, WI

Bar Coding, Computerization May Be Future for Labels“Labeling,” From Preceding Page

Hospital Pharmacy May Help in Meeting JCAHO RequirementsSimilarly, a pharmacy can prepare 250 mL bags

of vasoactive medications (e.g., phenylephrine 80mcg/mL, epinephrine 16 mcg/mL, and norepineph-rine 16 mcg/mL) that are kept immediately avail-able in a conveniently located refrigerator for majorcases (e.g., liver transplants, cardiac surgery, andsignificant trauma cases). Often there is timeurgency in starting these cases; having these drugsalready prepared could save critical time. Bolusdoses can be withdrawn from these bags.

However, with the recently issued USP Chapter797 standards, it is more difficult for hospital phar-macies to prepare batch medications. For those hos-pitals that can, the above benefits can be accrued.

Jonathan V. Roth, MDPhiladelphia, PA

Reference

1. Lambert DH. System fixes needed to prevent drugerrors. APSF Newsletter 2005;20:54-5.

user, seeing the familiar color and drug name,might miss the small following figure.

(Was it thiopentone 2.5% or 5%? Did youdilute the sufentanil?).

The practical value of color codes on syringeslies ultimately in ease of use. With a color printersheets of labels can be printed and kept in a loose-leaf cover. Simpler, but more costly, is to buy rollsof 100 preprinted labels and mount a series on adowel as dispenser. More elegant and versatilemight be an adaptation of a dedicated label printerprogrammed to produce any selected drug, name,color, and dose, with today’s date and preparer. Itmight even barcode patient name, age, sex, weight.But for millions this last will remain a dream wher-ever basic drugs, syringes, even oxygen, are still ontheir wish list.

Patrick Foster is a Professor Emeritus in the Depart-ment of Anesthesia, Penn State University, Milton S.Hershey Medical Center, Hershey, PA.

Reference

1. Cumberland P, Rahi JS, Peckham CS. Impact of congen-ital colour vision deficiency on education and uninten-tional injuries: findings from the 1958 British birthcohort. BMJ 2004;329:1074-5.

Until final decisions are made, new label designs mightappear as shown.

Anesthesia Patient Safety FoundationBuilding One, Suite Two8007 South Meridian StreetIndianapolis, IN 46217-2922

NONPROFIT ORG.U.S. POSTAGE

PAIDWILMINGTON, DEPERMIT NO. 1387


In the Next Issue:The focus of the Spring 2006 issue of theAPSF Newsletter will be “What to Do AfterAn Adverse Event” and will include

• Immediate management• Communication• Disclosure• More patient and family perspectives• Effect on the provider• Effect on the trainee

From left to right (front row): Sue Stratman, Dr. Julianne Chase, Linda Kenney, and (back row)Dr. Jeffrey Cooper and Dr. Frederick van Peltshared stories of patient and family perspectives onadverse events at the 2005 APSF Board of DirectorsWorkshop (see this issue’s lead article).

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