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The New Directive applying the EU Framework Agreement: Facts and numbers Gabriella De Carli, MD Department of Epidemiology and Pre-Clinical Research National.

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Presentation on theme: "The New Directive applying the EU Framework Agreement: Facts and numbers Gabriella De Carli, MD Department of Epidemiology and Pre-Clinical Research National."— Presentation transcript:

1 The New Directive applying the EU Framework Agreement: Facts and numbers Gabriella De Carli, MD Department of Epidemiology and Pre-Clinical Research National Institute for Infectious Diseases L. Spallanzani Rome, Italy on behalf of the SIROH-IRAPEP groups Ministero della Salute-Progetti AIDS ISS e Ricerca Corrente IRCCS

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3 3 In depth study on the socio economic, health and environmental impacts of a possible Community initiative on the protection of EU HCW against blood borne infections due to NSI Kick off meeting Brussels, 29 th January 2008 ENSI Expert team on Needle Stick Injuries 3

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5 5 From an aspect of benefit for the health care worker it seems best to implement a Legislative initiative at Community level to amend Directive 2000/54/EC, in order to introduce stricter specific measures for prevention and protection, namely: the training of workers in the safe use and disposal, and in the correct handling of containers; the modification of work practices which pose a risk of needle injury; a complete end to the recapping of needles; the use of instruments with safety features; the use of safe and effective systems to minimise the use of cannulae; the general provision of written instructions and notices indicating the procedures to be followed in the event of an accident involving needles or other medical sharps; immediate and effective response and follow-up to any accidental exposure, including rapid post-exposure prophylaxis; the offer of vaccination against hepatitis B to all workers who may come into contact with needles and other medical sharps; the recording in a special register of all injuries caused by needles or other medical sharps Reduction potential 90% It should be taken in mind that technological improvements can only be part of the solution, but that effective guidance of the HCW is necessary to reduce NSI to the best extent.

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8 Four good reasons to report an occupational exposure It is important for your own health: it allows the prompt administration of a prophylaxis, if available, or of a therapy whenever indicated, and the prevention of secondary transmission (spouse, family) It protects you: the epidemiological investigation allows to identify the source and the possible risks, and to demonstrate a causal relationship to receive workers’ compensation in case an infection should develop; It allows to identify the causes and prevent other exposures: we need the data to support preventive interventions! …..It is mandatory by law

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10 30/35 had adopted at least one NPD + SIOP 33/52 SIROH 2010 Updated situation - Hospitals adopting NPD per year

11 Type of NPD adopted

12 21 hospitals provided detailed data on 63 NPD In 68.2% CD were completely replaced by NPD; in the remaining 31.8% of cases, CD are still available (but increasingly abandoned) One third implemented in single units or department (frequently ED, infectious diseases, pediatrics), mostly IV catheter Updated situation-NPD adoption

13 % Percutaneous exposures per 100 full-time equivalents, by job category and area SIROH, Italy Puro V, De Carli G, Petrosillo N, Ippolito G and the SIROH Group. Infect Control Hosp Epidemiol 2001; 22: Housekeeper MD Nurse Midwife Technician GM general medicine MS medical specialties GS general surgery SS surgical specialties ID infectious diseases ICU intensive care D dialysis L laboratory O other

14 % High-risk percutaneous exposures per 100 full-time equivalents, by job category and area Housekeeper MD Nurse Midwife Technician GM general medicine MS medical specialties GS general surgery SS surgical specialties ID infectious diseases ICU intensive care D dialysis L laboratory O other Puro V, De Carli G, Petrosillo N, Ippolito G and the SIROH Group. Infect Control Hosp Epidemiol 2001; 22:

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16 Occupational infections following percutaneous or mucous exposures Bacterial Brucellosis 1966 Diphteritis 1923 Gonhorrea 1947 Leptospirosis 1937 Mycobacteriosis 1977 Mycoplasmosis 1971 Rocky Mountain Spotted Fever 1967 Scrub typhus 1945 Staph.aureus 1983 Strept.pyogenes necrotizing fasciitis 1997 Syphilis 1913 Tuberculosis from HIV Fungal Protozoal Blastomycosis 1903 Malaria 1972 Cryptococcosis from HIV Toxoplasmosis 1951 Sporotrichosis 1977 Leishmaniasis 1997 Tumors Human colonic adenocarcinoma 1986 Sarcoma 1996 Jagger J, De Carli G, Perry J et al. In Wenzel RP: Prevention and Control of Nosocomial Infections, Updated 03/10 Corynebact. striatum 1998 Viral Haemorragic fevers (Ebola/Marburg) 1974 HIV 1984 Herpes Simplex 1962 Simian immunodeficiency virus 1994 Herpesvirus simiae 1991 Dengue 1998 Creutzfeldt-Jakob 1988 Herpes Zoster 1976 Hepatitis nAnB 1987 Hepatitis B 1982 Hepatitis C 1992 Hepatitis G 1998 HTLV II 2006 Hepatitis E 2007 Chikungunya 2006 HCV-NS3 recombinant vaccinia virus 2007 Cytomegalovirus 2008 Vaccinia virus 2008 Lujo virus 2008

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20 8 out of 35 not preventable 5 of these could possibly have been prevented by passive devices Could have been prevented

21 Follow up 32 occupational HCV Infections ( ) 5 cases of spontaneous resolution 21 Sustained Virologic Response (8 treated during acute hep, 10 treated for CAH, 3 treated during acute and CAH) 6 cases of chronic active hepatitis (3 refused tx, 1 interrupted because of AE, 1 retired, 1 normal ALT tx not recommended) 10 had psychological consequences (1 had PTSD) 7 needed redeployment, 1 pending 1 occupational acute hepatitis B despite PEP Resolved No seroconversion 2 occupational HIV infections

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26 Average Device-specific Injury Rates per 100,000 Devices Used: Needlestick Prevention Devices (n=3,300,000) vs. Conventional Devices (n=3,600,000) (IV catheters, blood-collection winged-steel needles, arterial blood gas syringes) SIROH, 16 hospitals, De Carli G, Puro V, Jagger J. Needlestick-prevention devices: we should already be there. J Hosp Infect 2009;71: De Carli G, Puro V, Jagger J. Needlestick-prevention devices: we should already be there. J Hosp Infect 2009;71:183-4.

27 Injury rate per 100,000 IV catheters 10 hospitals+1 regional system, SIROH hosp CD NPD Rate per 100,000 devices

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29 An in depth analysis of NPD injuries in 8 hospitals revealed that accidents occurred: -before safety mechanism activation was possible (35%); -during activation (30%); -due to failure of safety feature (15%) - 20% of NPD were not activated, mostly by workers with a work experience 15 years, due to lack of training and reluctance in changing previous techniques, respectively.

30 Clause 6 Elimination, prevention and protection -sharps containers as close as possible --overall prevention policy ---training ----conducting health surveillance procedures ---use of personal protective equipment --free of charge vaccination -information on vaccination


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