1. Needlestick Safety and Prevention Act
Directed OSHA to revise BBP standard
Effective 4/18/01
Compliance directive 11/27/01
Requires use of engineering and work practice controls
Sharps safety devices included as engineering controls
Alternatives to needles are preferable
Document implementation in written plan
Review at least annually
Maintain detailed sharps injury log
Include device type & brand
Involve frontline workers

2. Bloodborne Pathogens Exposure Control Plan
Statement of employer policy
Designation of responsible employees
Determination of employee exposures
Implementation
Standard (universal) precautions
Engineering controls
Work practices controls
Personal protective equipment
Training
Hepatitis B immunizations
Implementation
HB surveillance (optional)
Post-exposure evaluation and follow-up
Housekeeping
Labeling
Mandated use of needles and other sharps with integrated safety features
Safety Device Evaluation Committee
Documentation of waivers
Recordkeeping and reporting

3. HBV Preexposure Prophylaxis
Recombinant DNA vaccine available since 1986
From yeast cells
Subunit HBsAg
1.0 ml IM given at 0, 1 and 6 months
Accelerated 0, 1, 2 and 12 months
For HCWs, document immunity anti-HBS 2-6 months post-vaccination
6 doses maximum
Once immune, no boosters

4. Recordkeeping Rule Effective 1/1/02
New OSHA forms 300 log, 300A summary and 301 incident report
Expanded general recordkeeping requirements
May use new log for recording contaminated sharps injuries if
Record all data required, including brand
Able to segregate sharps info from log for privacy concerns

5. Joint Commission on Accreditation of Healthcare Organizations
Preventing Needlestick and Sharps Injuries - Sentinel Event Alert, Issue 22, August 2001
Cites and reviews NIOSH Alert and the Needlestick Safety and Prevention Act.
“In April 2002, JCAHO will begin assessing organizational compliance with the new provisions of the Needlestick Safety and Prevention Act.”

6. Industrial Toxicology, 1949
“The prevention of occupational diseases is primarily the function of the industrial management, secondarily, the function of the plant physician. In an ideal industrial establishment the two work together; the physician is conversant with all the processes of manufacture and is therefore able to link up the disturbances of health he observes among the workers with the processes in which they are engaged. He cooperates with management in the effort to introduce safeguards He is, however, in a subordinate position and therefore the prime responsibility in the prevention of occupational disease lies with the management, which has the last word in regard to methods of work, substances used, and equipment for the prevention of disease.”
Alice Hamilton, MD & Harriet L. Hardy, MD
Industrial Toxicology, 1949

7. Prevention of Work-related BBP Infection
Haddon, 1970

8. Controlling Exposures
In order of preference T R A I N G
Substitution
Isolation or enclosure
Ventilation (general/dilution & local exhaust)
Work and hygiene practices
Personal protective equipment
(last line of defense)

9. Types of Safety Features
SLIDE 40: (Types of safety features)
What are some of the types of safety features used in safer needle devices?
The types of safety features used in safer needle devices can be categorized according to certain aspects of the safety feature, i.e. whether the feature is active or passive and whether or not the engineering control is part of the device (Chiarello, 1995).
$Passive safety features remain in effect before, during and after use; health care workers do not have to activate them. Passive features enhance the safety design and are more likely to have a greater impact on prevention.
$Active devices require the health care worker to activate the safety mechanism. Failure to do so leaves the worker unprotected. Proper use by health care workers is the primary factor in the effectiveness of these devices.
$An integrated safety design means that the safety feature is built in as an integral part of the device and cannot be removed. This design feature is preferred.
$An accessory safety device is a safety feature that is external to the device and must be carried to or temporarily or permanently fixed to the point of use. This design also is dependent on employee compliance and, according to some researchers, is less desirable.
Chiarello, 1995

10. Design Features of a Safer Needle Device
Barrier between hands and needle after use
Allow or require worker’s hands to remain behind needle at all times
Integral part of device and not accessory
Be in effect before disassembly and remain in effect after disposal
Be simple, self-evident to operate and require little or no training
FDA, 1992, 1995

11. Click for larger picture

12. MMWR 1/17/97

13. Recommended Personal Protective Equipment
Y=Yes, N=No, M1=Yes if splashing likely,
M2=Yes if soiling likely, M3=At certain times
CDC 1989

14. Management of Occupational Blood Exposures
Provide immediate care to the exposure site
Wash wounds and skin with soap and water.
Flush mucous membranes with water.
Determine risk associated with exposure by
Type of fluid (e.g., blood, visibly bloody fluid, other potentially infectious fluid or tissue, and concentrated virus) and
Type of exposure (i.e., percutaneous injury, mucous membrane or nonintact skin exposure, and bites resulting in blood exposure).

15. Management of Occupational Blood Exposures
Evaluate exposure source
Assess risk of infection using available information.
Test known sources for HBsAg, anti-HCV, and HIV antibody (consider using rapid testing).
For unknown sources, assess risk of exposure to HBV, HCV, or HIV infection.
Do not test discarded needles or syringes for virus contamination.

16. Management of Occupational Blood Exposures
Evaluate the exposed person
HBV immune status
Tetanus prophylaxis
Baseline lab tests for HCV, HIV, chemistry profile, complete blood count, urinalysis, pregancy test PRN
Give PEP for exposures posing risk of infection transmission

17. HBV Postexposure Prophylaxis
Always indicated unless
Documented immune
Waiver signed

18. Hepatitis B Virus Postexposure Prophylaxis
Click for larger picture

19. HCV Postexposure Prophylaxis

20. HIV Postexposure Prophylaxis
Depends on
Type of exposure
Severity
Volume
Source HIV status
Prophylactic treatment
May not be warranted
Basic regimen
Expanded regimen

21. HIV Infection Status HIV-Positive Class 1 Asymptomatic
Known low viral titer, <1500 RNA copies/ml
HIV-Positive Class 2
Symptomatic
AIDS
Acute seroconversion
Known high viral load

22. Selected HIV PEP Regimens
BASIC REGIMEN
Zidovudine (Retrovir™; ZDV; AZT) + Lamivudine (Epivir™; 3TC); available as COMBIVIR™
ZDV: 600 mg per day, in 2 or 3 divided doses
3TC: 150 mg twice daily
EXPANDED REGIMEN Basic regimen plus
Indinavir (Crixivan™; IDV)
800 mg every 8 hours, on an empty stomach

23. Recommended HIV Postexposure Prophylaxis for Percutaneous Injuries
CDC. MMWR 2001.

24. Recommended HIV Postexposure Prophylaxis for Mucous Membrane and Non-intact Skin Exposures
CDC. MMWR 2001.

25. Reported Failure of Combination Drug PEP to Prevent HIV Infection in HCWs Exposed to HIV-Infected Blood

26. Management of Occupational Blood Exposures
Initiate HIV PEP as soon as possible, preferably within 2 hours of exposure
Offer pregnancy testing to all women of childbearing age not known to be pregnant
Seek expert consultation if viral resistance suspected
HIV PEP for 4 weeks if tolerated

27. Management of Occupational Blood Exposures
Provide counseling
Emotional effects
Risks of transmission
Medications, including adherence
Advise exposed persons to seek medical evaluation for any acute illness occurring during follow-up
Perform follow-up testing
Monitor for adverse effects
Seroconversion

28. Sample Protocol for Follow-up if on HIV PEP Medications

29. Primary Side Effects of Antiretroviral Agents

30. Compliance with HIV PEP
N=449 subjects with follow-up at 4-6 weeks
HIV PEP Registry, 3/31/99

31. Reasons HIV PEP Discontinued
HIV PEP Registry, 3/31/99

32. Management of Occupational Blood & Body Fluids Exposures
Summary
Provide immediate care to the exposure site.
Determine risk associated with exposure.
Evaluate the exposed person.
Give PEP for exposures posing risk of infection transmission.
Provide counseling.
Perform follow-up testing.

33. Resources