Post on 30-Apr-2023
Health technology assessment of safety-Health technology assessment of safety-
engineered, needlestick-prevention devices to engineered, needlestick-prevention devices to
enhance safety of health care workersenhance safety of health care workers
Nicolotti N*, De Carli G*, La Torre G^, Saulle R^,
Mannocci A^, Boccia A^, Ippolito G*, Puro V*
* Department of Epidemiology, L. Spallanzani National Institute for Infectious Diseases (INMI), IRCCS,
Rome, Italy
^ Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy
6
The Needlestick Safety and Prevention Act (6/11/2000)
23,908 injuries
(85 hospitals in 10 states)
38% (95% CI: 35% - 41%)
Biological risk for HCWs
Health-care workers (HCWs) are at risk of acquiring infections in their
workplace (airborne, bloodborne, droplets or contact).
Exposures to bloodborne pathogens have received increased attention since
the HIV pandemic. The transmission of bloodborne pathogens (in particular
HCV, HBV and HIV) may occur through percutaneous and mucocutaneous
(i.e. contact with non-intact skin or mucous membranes) exposure to blood, and
other at-risk body fluids.
Strategies are available to prevent infections due to sharps injuries including
education of HCWs on the risks and precautions, reduction of invasive
procedures, use of safer devices and procedures and management of
exposures.
Attributable fraction of HCV, HBV and HIV infection
in HCWs after sharp injuries:
39% HCV
37% HBV 80.4%
4.4% HIVPrüss-Ustün A, Rapiti E, Hutin Y. Estimation of the global burden of disease attributable to
contaminated sharps injuries among healthcare workers. Am J Ind Med 2005; 48: 482-90.
Probability of seroconversion as a result of exposure to
contaminated needles/sharps used on infected patients:
Hepatitis B Virus (HBV)
no vaccine
Hepatitis C Virus (HCV)
Human Immunodeficiency Virus (HIV)
18%
Acute hep B 6% HBeAg neg
30% HBeAg pos
[Werner, Ann Intern Med 1982]
0.8% (0.5%-1.2%)[SIROH]
0.1% (0.002%-0.5%)[SIROH]
Biological risk for HCWs
ProtozoalProtozoal• Toxoplasmosis 1951
• Malaria 1972
• Leishmaniasis 1997
• Scrub typhus 1945
FungalFungal• Blastomycosis 1903
• Sporotrichosis 1977
• Cryptococcosis 1985
• - from HIV+ 1994
TumoralTumoral• Human colonic
adenocarcinoma 1986
• Sarcoma 1996
ViralViral• Herpes Simplex 1962
• Haemorragic fevers (Ebola/Marburg)
1974
• Herpes Zoster 1976
• Hepatitis B 1982
• HIV 1984
• Hepatitis D 1986
• Hepatitis nAnB 1987
• Creutzfeldt-Jakob 1988
• Herpesvirus simiae 1991
• Hepatitis C 1992
• Simian immunodeficiency virus 1994
• Dengue 1998
• Hepatitis G 1998
• HTLV II 2006
• Chikungunya 2006
• HCV-NS3 recombinant vaccinia virus
2007
• Hepatitis E 2007
• Cytomegalovirus 2008
• Vaccinia virus 2008
BacterialBacterial• Syphilis 1913
• Diphteritis 1923
• Leptospirosis 1937
• Scrub typhus 1945
• Gonhorrea 1947
• Brucellosis 1966
• Rocky Mountain
Spotted Fever 1967
• Mycoplasmosis 1971
• Mycobacteriosis 1977
• Staph.aureus 1983
• Strept.pyogenes 1980
• -necrotizing fasciitis
1997
• Tuberculosis 1931
• - from HIV+ 1998
Jagger J, De Carli G, Perry J et al. In
Wenzel RP: Prevention and Control of
Nosocomial Infections, 2003. Updated
09/12
Jagger J, De Carli G, Perry J et al. In
Wenzel RP: Prevention and Control of
Nosocomial Infections, 2003. Updated
09/12
…not only HBV, HCV and HIV…
SIROHSTUDIO ITALIANO RISCHIO OCCUPAZIONALE DA HIV
Incidenti occupazionali per punture da ago o lesioni da altri oggetti taglienti
SIROHSTUDIO ITALIANO RISCHIO OCCUPAZIONALE DA HIVContaminazioni muco cutanee con sangue e materiali biologici
The Studio Italiano Rischio Occupazionale da HIV (SIROH) is a well established
network of Italian hospitals. Since 1986, the SIROH program contributed significantly
to knowledge on the rate of, and risk factors for, occupational transmission of HIV and
other bloodborne pathogens, and to advances in exposure prevention at a national
and international level, developing national and European recommendations on the
management of occupational exposures. Its results supported the proposal which
resulted in Directive 2010/32/EU, aiming at enhancing HCW safety through a global
preventive strategy, including also the adoption of Safety Engineered Devices (SED)
Our HTA project
The project consists of two main work-packages:
a) Evaluation of clinical (effectiveness, indications of use),
economic, organizational, ethical, juridical, social and
cultural implications of the introduction or the
implementation of safety-engineered devices (SED) by
systematic review of scientific literature and consulting
national and international reports and experts; (month 1-
10);
b) Before-after observational study on SED implementation
in hospitals participating in the SIROH Network (month
1-10 and 11-30, respectively), followed by data analysis,
development of a cost-utility analysis and of an
economic evaluation model, reports and dissemination
of results (month 31-36).
1. Starting from our systematic review, sharps injuries in Italy and in the
other European and extra-European countries remain common and
under-reported.
2. In particular, SIROH network data showed an incidence rate per year,
using conventional devices (CD), of 9.82 per 100,000 used devices:
this rate is higher among nurses.
3. The underreporting of blood and body fluid exposures ranged between
17% and 97%, the greatest percentage in case of complex reporting
procedure or in the absence of specific educational programmes (SIROH
survey 44%).
4. Retrieved studies showed the efficacy of SED in reducing injuries. The
reduction ranged between 16% and 100%, the greatest reduction
achieved by blunt suture needles and safety cannulae.
Preliminary results - HTA
0
2
4
6
8
10
12
14
Vacuum tube
phleb set, straight
needle
Vacuum tube
phleb set, winged
needle
Arterial Blood Gas
syringe
Intra Venous
catheter
Lancet
Overall Injury Rate per 100,000 used devices
SIROH, 22 hospitals – 1997-2010
Baseline CD SED
1.In Italy, the economic impact of injury management is € 61,969,218 (year
2006), 852€/injury. With the introduction of safety-engineered devices, the direct
cost increase was €0.558 (US$0.753) per patient in the emergency department
and €0.636 (US$0.858) per patient-day in the hospital wards*.
2.The organizational impact would be positive for both patients (improvement of
quality) and HCWs (safety climate).
3.The use of SED would also reduce (unethical) diagnostic tests on patients
unable to provide an informed consent.
4. Currently, 20 hospitals are collecting data for the study on SED
effectiveness.
The use of SED could improve safety of HCWs and reduce the incidence of
needlestick injuries. Their introduction in an health care setting should be
preceded by appropriate educational programmes and HCWs should be
involved in evaluating products before introduction.
Preliminary results - HTA
* Valls V, Lozano MS, Yánez R, Martínez MJ, Pascual F, Lloret J, Ruiz JA. Use of safety devices and the prevention of percutaneous
injuries among healthcare workers. Infect Control Hosp Epidemiol. 2007 Dec;28(12):1352-60.