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

Why an HTA?

Why an HTA?

Council Directive 2010/32/EUwill be in effect since 11 May 2013

In Italy?

The Needlestick Safety and Prevention Act (6/11/2000)

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.