The New Directive applying the EU Framework Agreement:

Facts and numbersGabriella 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 groupsMinistero della Salute-Progetti AIDS ISS e Ricerca Corrente IRCCS

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, 29th January 2008

ENSI

Expert team on

Needle Stick Injuries

3

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.

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

0

5

10

15

20

25

30

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

30/35 had adopted at

least one NPD + SIOP 33/52

SIROH 2010

Updated situation - Hospitals adopting NPD per year

0 5 10 15 20Other butterfly Blood donation setLancet ABG syringe IV catheterVTPS-st VPTS-but

Type of NPD adopted

• 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

0

2

4

6

8

10

12

GM MS GS SS ID ICU D L O

%

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; 22:206-10.

Puro V, De Carli G, Petrosillo N, Ippolito G and the SIROH Group. Infect Control Hosp Epidemiol 2001; 22:206-10.

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

0

2

4

6

8

10

12

GM MS GS SS ID ICU D L O

%

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; 22:206-10.

Puro V, De Carli G, Petrosillo N, Ippolito G and the SIROH Group. Infect Control Hosp Epidemiol 2001; 22:206-10.

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 1980- necrotizing fasciitis 1997

Syphilis 1913

Tuberculosis 1931- from HIV+ 1998

Fungal

Protozoal

Blastomycosis 1903

Malaria 1972

Cryptococcosis 1985- from HIV+ 1994

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, 2003. Updated

03/10

Jagger J, De Carli G, Perry J et al. In Wenzel RP: Prevention and Control of Nosocomial Infections, 2003. Updated

03/10Corynebact. 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 1998HTLV II 2006

Hepatitis E 2007

Chikungunya 2006HCV-NS3 recombinant vaccinia virus 2007

Cytomegalovirus 2008Vaccinia virus 2008Lujo virus 2008

8 out of 35 not preventable5 of these could possibly have been prevented by passive devices

Couldhave been prevented

Follow up32 occupational

HCV Infections (1994-

2009)

5 cases ofspontaneous

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 occupationalacute hepatitis B

despite PEP Resolved

No seroconversion

2 occupationalHIV infections

0

1

2

3

4

5

6

7

8

9

10

CD NPD

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, 2003-2006

De Carli G, Puro V, Jagger J. Needlestick-prevention devices: we should already be there. J Hosp Infect 2009;71:183-4.

De Carli G, Puro V, Jagger J. Needlestick-prevention devices: we should already be there. J Hosp Infect 2009;71:183-4.

Injury rate per 100,000 IV catheters10 hospitals+1 regional system, SIROH 1999-2009

0123456789

101112131415

hosp 11 11 11 10 8 7 4 4 3

CD 637851 419100 541481 518326 373492 307478 192142

184533

199180

NPD 209581 315930 344664 331644 400624 73512 106313

108528

Rate

p

er

10

0,0

00

d

evic

es

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 <2 or >15 years, due to lack of training and reluctance in changing previous techniques, respectively.

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