1. New OSHA Regulations on Sharps Safety Requirements Baron J. Williamson, M.D. April 29, 2001

2. Introduction

3. Disclaimer The speaker has no financial interests in any product mentioned within this presentation.

4. Background  Health care workers are at risk  Bloodborne pathogens standard  Compliance with the standard improves safety  Percutaneous injuries are still a problem  Nature and magnitude of sharps injury issue  Risks faced by healthcare workers  Sharps safety device technology available

5. Legislative/Regulatory Activity  1991 - Bloodborne pathogens standard  1998 - OSHA request for information  Sept. 1998 - California first of 17 states to pass safety needle law  May 1999 - OSHA report on RFI  Nov. 1999 - OSHA directive to compliance officers  Nov. 1999 - CDC’s NIOSH safety alert  Nov. 2000 - Needlestick safety and prevention act signed  April 18, 2001 - New reg.’s became effective

6. Sharps Safety Why are we concerned?  Employee welfare is paramount  Financial impact of percutaneous injuries  Initial post-exposure treatment  Treatment of infection  Wages and time lost  Liability and workers compensation costs  Litigation  Non-compliance fines  It’s the law

7. Mike Wallace interview with Karen Daley, Massachusetts Nurses Association president, April 25, 2001 600,000 estimated sharps injuries each year. Probable cost per incidence, $2,000-$3,000 to follow them up for 6 months One infected health care worker with one virus can cost anywhere from $500,000 to $1 million.

10. Questions To Ask  How has the law changed?  What records are necessary?  How do I evaluate new devices?  What does compliance really mean?  When do I need to comply?

11. Notable Elements of the Bloodborne Pathogens Standard  Written exposure control plan  Compliance with universal precautions  Engineering and work practice controls  Personal protective equipment  Prohibition of bending, recapping, or breaking sharps  Free hepatitis B vaccinations  Worker training  Post-exposure evaluation, prophylaxis, and treatment

12. Needlestick Safety & Prevention Act What the law requires  Expanded definition of “engineering controls” to include devices with engineered sharps injury protection  Written exposure control plan reflecting changes in technology that reduce exposure to bloodborne pathogens  Documentation of annual consideration and implementation of sharps safety devices  Sharps injury log detailing department where the injury occurred, type and brand of device involved and explanation how injury happened (must maintain confidentiality)  Document participation of non-managerial employees in the identification, evaluation, and selection of effective engineering and work practice controls

13. Obstacles to Implementation  Devices vary considerably in clinical efficacy and effectiveness in reducing injuries  Increased purchase price of safety devices  Staff resistance to change  Time required to train staff  Where does one start?

14. 10 Steps to Take Now 1. Analyze sharps injuries to identify hazards and trends 2. Set priorities and prevention strategies 3. Train employees in safe use and disposal of sharps 4. Modify work practices that pose a hazard 5. Promote safety awareness in the workplace 6. Establish exposure control plan and sharps injury log 7. Evaluate effectiveness of prevention efforts 8. Eliminate sharps if safe/effective alternatives are available 9. Implement use of devices with safety features 10. Establish a team to determine which devices are most the effective and acceptable (document in exposure control plan)

15. Desirable Sharps Safety Characteristics  Device is needleless  Safety feature is integral part of device  Device works passively  If activation required, safety feature engaged with single- handed technique allowing hands to remain behind exposed sharp  User can easily tell is safety feature activated  Safety feature cannot be deactivated  Device performs effectively and reliably  Device is easy to use and practical  Device is safe and effective for patient care

16. Selecting and Evaluating Sharps Safety Devices  Form a multi-disciplinary team to:  Develop a written exposure control plan  Evaluate devices with sharps safety features  Identify priorities based on hazards and trends  When selecting a device, identify its scope of use and special circumstances that will influence its safety, efficiency and acceptability  Conduct product evaluation with frontline staff  Monitor use of device after implementation

17. Samples of Sharps Safety Products currently available General Medical Care

18. Acuvance I.V. Safety Catheter

20. Sample of Sharps Safety Product currently available Ophthalmology

21. Diamatrix S afety Handle

22.  If activation required, safety feature engaged with single-handed technique allowing hands to remain behind exposed sharp  User can easily tell is safety feature activated  Safety feature cannot be deactivated  Device performs effectively and reliably  Device is easy to use and practical  Device is safe and effective for patient care Complies with desired sharps safety characteristics

23. Eliminates cost issues associated safety feature: Added features of the Diamatrix Safety Handle Meets FDA criteria for a reusable when supplied as a non sterile instrument Average cost per case $2.83 vs. $26.50 for similar blade from Surgical Specialties Trapezoid design eliminates need for second blade used to enlarge incision

24. Added features of the Diamatrix Safety Handle Attached cover insures blades sharpness Safe disposal when cover is in place

25. Samples of Sharps Safety Products in development  Automatic passive mechanism (CoverTip )  Active safety mechanism (Incision Guide ) TM

26. CoverTip™ CoverTip™ Superior competitive advantages of Medisys safety needle technology  Easy to use  Safe  Meets healthcare worker needs  Affordable cost

27. CoverTip  Automatic passive mechanism  Protection at point of injection  2 patents, 3 rd pending  1998 – 510(k) TM

28. CoverTip™ Safety sheath ready CoverTip™ Safety sheath activated CoverTip™

29. Validation Testing* Pain Assessment Scale: 0 = No pain 1 = Sensation with slight pain 2 = Moderate pain 3 = Very painful 4 = Extremely painful CoverTip™ 20 Gauge Safety Syringe Standard 20 Gauge Syringe *Essex Testing Clinic Inc

30. The Incision Guide TM Active Safety Mechanism

31. DIAMATRIX ASCRS BOOTH #505 DIAMATRIX Safety Handle TM