US Policies and Legislation on Sharp Instrument Safety: Impact and Lessons Learned

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 present 1984

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. 1987: Panic results from the CDC report: 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. Six healthcare workers infected with HIV

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

7. THE GOOD NEWS . . .

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

9. U.S. Health Care Workers with Occupationally Acquired HIV/AIDS Cumulative Cases*, 1992-2001 Anti-retrovirals PEP # of cases 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, pub’d on-line at: www.cdc.gov/hiv/pubs/facts/hcwsurv.htm.

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 Hollow-bore needles causing needlesticks at UVa Hospital 10 months, 1986 n=326 IV TUBE/ NEEDLE ASSEMBLY PREFILLED CARTRIDGE SYRINGE WINGED NEEDLE IV SET VACU TUBE PHLEBOT NEEDLE DISP SYRINGE IV CATH STYLET MECHANISM OTHER Before or during use 27 79 7 8 67 9 3 35 1 9 10 5 4 9 2 0 7 1 3 20 20 After use before disposal During or after disposal 38% of injuries from unnecessary needles (123/326) 30% of injuries occurred during recapping (98/326)

14. Pulling Levers CDC 1987 OSHA 1991 FDA 1992 1999 Universal Precautions Guidelines Bloodborne Pathogens Standard state legislatures 1998 medical device Safety Alerts national law 2000 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. A New Generation of Protective Devices safety-engineered devices conventional devices illegal International Healthcare Worker Safety Center, University of Virginia

20. The Needlestick Safety and Prevention ActNovember 6, 2000

21. Exposure Prevention NO DATA NO PROBLEM

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

23. Sharps Injury Rates per 100 Occupied Beds Teaching Hospitals 1986 - 2007 1 hosp Injuries per 100 occupied beds OSHA 1991 FDA 1992 1 hosp Law 2000 11 hosp 7 hosp 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 84/513 FDA alert 85% 99.9% Injuries per 100 hospital beds 14/550 17/4,454 1 teaching hospital 1 teaching hospital 9 teaching hospitals

25. IV catheter injury rates per 100,000 devices 18.4 Injuries per 100,00 devices 7.5 1.2 * ** ** safety 1 hospital 3 hospitals 3 hospitals *Jagger J, Hunt EH, Brand-Elnaggar J, Pearson RD.. NEJM 1988; 319(5):284-288. **Jagger J. Bentley M. J Intraven Nurs 1997;20(6):S33-S39 International Healthcare Worker Safety Center, University of Virginia

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

34. Passive Devices

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

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) law Conventional Safety Injuries per 100 occupied beds International Healthcare Worker Safety Center, University of Virginia

37. Figure 3 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 Rate per 100 occupied beds -22% Conventional Safety -23% -53% -59% syringe phlebotomy butterfly IV catheter International Healthcare Worker Safety Center, University of Virginia

38. Relative Bloodborne Pathogen Risk to Healthcare Workers injection needles mucocutaneous contact, specimen aspiration needles vascular access needles blood drawing needles blood specimen containers (glass) 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 RatesEPINet 1993-2003: 87 hospitals; total injuries = 28,895. Excludes injuries occurring before use of device law International Healthcare Worker Safety Center, University of Virginia

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