1. US Policies and Legislation on Sharp Instrument Safety: Impact and Lessons Learned Janine Jagger, M.P.H., Ph.D. International Healthcare Worker Safety Center University of Virginia European Biosafety Summit Madrid, June 1, 2010

2. 25 years of progress 1984 present

3. 1985 - USA Hepatitis B: 12,000 occupational cases per year – estimated 250 deaths (vaccine available 1981) HIV: unknown number of occupational cases (CDC started surveillance 1986) HCV: Hepatitis non-A non-B – unknown number of occupational cases – no test,no treatment available (identification of HCV 1989)

4. University Hospital, 1985 Overfilled trash Needles in IV lines Inappropriate trash disposal

5. Update: human immunodeficiency virus infections in health-care workers exposed to blood of infected patients. MMWR Morb Mortal Wkly Rep 1987; 36(19):285-289. 1987: Panic results from the CDC report: Six healthcare workers infected with HIV

6. 1 - Pathogen-Specific Hepatitis B vaccine Effective therapies for HCV HIV: PEP for HCWs and ARVs for patients Two Types of Advances: 2 -Exposure Prevention Improved sharps disposal systems Appropriate personal protective equipment Safety-engineered sharp devices universal vaccine

7. THE GOOD NEWS...

8. 1985 12,500 US HCWs occupationally infected with HBV 250 deaths 2010 ?? HBV

9. U.S. Health Care Workers with Occupationally Acquired HIV/AIDS # of cases Cumulative Cases*, 1992-2001 Documented and possible. Source: U.S. Centers for Disease Control and Prevention. For years 1992 through 1999: HIV/AIDS Surveillance Report, year-end reports. For 2000-2001: Fact Sheet: Health Care Workers with HIV/AIDS, pubd on-line at: www.cdc.gov/hiv/pubs/facts/hcwsurv.htm. Anti-retrovirals PEP

10. Giuseppe Ippolito Gabriella de Carli Vincenzo Puro

11. Exposure Prevention

12. Jagger J, Hunt EH, Brand-Elnaggar J, Pearson RD. Rates of needle-stick injury caused by various devices in a university hospital. NEJM 1988; 319(5):284-288.

13. Jagger J, Hunt EH, Brand-Elnaggar J, Pearson RD. Rates of needle-stick injury caused by various devices in a university hospital. NEJM 1988; 319(5):284-288 27 79 7 8 67 9 3 35 1 9 10 5 4 9 2 0 7 1 3 20 Before or during use After use before disposal During or after disposal MECHANISM DISP SYRINGE IV TUBE/ NEEDLE ASSEMBLY PREFILLED CARTRIDGE SYRINGE WINGED NEEDLE IV SET VACU TUBE PHLEBOT NEEDLE IV CATH STYLET OTHER 30% of injuries occurred during recapping (98/326) 38% of injuries from unnecessary needles (123/326) Hollow-bore needles causing needlesticks at UVa Hospital 10 months, 1986 n=326

14. CDC 1987 OSHA 1991 state legislatures 1998 FDA 199 2 199 9 national law 2000 Pulling Levers Universal Precautions Guidelines Bloodborne Pathogens Standard medical device Safety Alerts California then others Clinton signs Nov 6, 2000

15. FDA SAFETY ALERT: Needlestick and Other Risks from Hypodermic Needles on Secondary I.V. Administration Sets -- Piggyback and Intermittent I.V. April 16, 1992 Dear Colleague: This is to alert you to the risk of needlestick injuries from the use of hypodermic needles as a connection between two pieces of intravenous (I.V.) equipment. The use of exposed hypodermic needles on I.V. administration sets or the use of syringes to access I.V. administration set ports or injection sites are unnecessary and should be avoided. Hypodermic needles should only be used in situations where there is a need to penetrate the skin.

16. Needleless/Recessed Needle IV Connectors

17. Glass Capillary Tubes: Joint Safety Advisory About Potential Risks February 1999 Dear Colleague: The Food and Drug Administration (FDA), the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), and the Occupational Safety and Health Administration (OSHA) want to alert you to the potential risk of injury and/or infection from bloodborne pathogens, including human immunodeficiency virus (HIV), hepatitis B and hepatitis C viruses, due to accidental breakage of glass capillary tubes...

18. Non-Breakable Plastic Hematocrit Tubes

19. safety-engineered devices conventional devices A New Generation of Protective Devices illegal International Healthcare Worker Safety Center, University of Virginia

20. The Needlestick Safety and Prevention Act November 6, 2000

21. NO DATA NO PROBLEM Exposure Prevention

22. International Healthcare Worker Safety Center, University of Virginia Multi-hospital surveillance in U.S. begins 1993

23. Sharps Injury Rates per 100 Occupied Beds Teaching Hospitals 1986 - 2007 Injuries per 100 occupied beds 1 hosp 11 hosp 7 hosp OSHA 1991 FDA 1992 Law 2000 Exposure Prevention Information Network (EPINet) - International Healthcare Worker Safety Center, University of Virginia

24. Injury Rates from Needles on IV Lines Before & After the 1992 FDA Safety Alert EPINet hospitals, International Healthcare Worker Safety Center Injuries per 100 hospital beds 85% 1 teaching hospital 99.9% FDA alert 9 teaching hospitals 14/550 84/513 17/4,454

25. safety IV catheter injury rates per 100,000 devices Injuries per 100,00 devices 18.4 7.5 1.2 1 hospital3 hospitals International Healthcare Worker Safety Center, University of Virginia **Jagger J. Bentley M. J Intraven Nurs 1997;20(6):S33-S39 *** *Jagger J, Hunt EH, Brand-Elnaggar J, Pearson RD.. NEJM 1988; 319(5):284-288.

26. Safety IV Catheters/ Infusion Sets

27. A misconception about safety- engineered sharp devices

28. Question: What is the best safety device? The answer is.....

29. Wrong question The correct question is..... What is the appropriate safety device for the procedure being performed?

30. Appropriate applications for syringes with different safety features

31. Hinged Cap/Retracting Safety Syringes

32. Retracting/Sliding Sheath Safety Syringes

33. Injuries per 100,000 devices Injury Rates from Safety-engineered Needles with Different Safety Features (denominator = 22 million safety devices, numerator = 453 needlesticks GERES Research Group. Tosini W et al. Infect Control and Hosp Epidem 2010;31:402-407.

34. Passive Devices

35. Increase in Percent Market Share of 3 Safety Devices, U.S., 1998-2003 (1998-2005 applies to all US hospitals; 1998, 2001 also includes clinics, offices, labs) *Source: Advances in Exposure Prevention * * Source: Healthcare Products Information Services, Philadelphia *** Amber Hogan, Materials Management Magazine, Nov 29, 2005, Vol 14, No 11 <10 28 % US Market Share Figure 1 79 83 95

36. Injury Rates from Hollow-bore Needles: Safety versus Conventional, U.S. EPINet 1995-2006 87 hospitals; total injuries = 24,440 (excludes injuries occurring before use of device) International Healthcare Worker Safety Center, University of Virginia Injuries per 100 occupied beds law Conventional Safety

37. Device Specific Injury Rates Before (1993-2000) versus After (2001-2004) US EPINet 1993-2004: 87 hospitals; total injuries = 10,778. Excludes injuries occurring before use of device International Healthcare Worker Safety Center, University of Virginia Rate per 100 occupied beds Figure 3 Conventional Safety syringephlebotomybutterflyIV catheter -22% -59% -23% -53%

38. Relative Bloodborne Pathogen Risk to Healthcare Workers blood drawing needles blood specimen containers (glass) vascular access needles mucocutaneous contact, specimen aspiration needles injection needles International Healthcare Worker Safety Center, University of Virginia

39. Two areas where progress lags: Operating Room Non-hospital settings

40. OR versus Non-OR Injury Rates EPINet 1993-2003: 87 hospitals; total injuries = 28,895. Excludes injuries occurring before use of device International Healthcare Worker Safety Center, University of Virginia law

41. A Global Standard for Healthcare Worker Protection

42. Goal: To provide basic protection to all healthcare workers - free hepatitis B vaccination - elimination of unnecessary sharps - legislation requiring safety-engineered sharp devices - appropriate personal protective equipment (PPE) - HIV post-exposure prophylaxis (PEP) - Hepatitis C treatment