New OSHA Regulations on New OSHA Regulations on Sharps Safety Sharps Safety RequirementsRequirements

Baron J. Williamson, M.D.Baron J. Williamson, M.D.April 29, 2001April 29, 2001

IntroductionIntroduction

DisclaimerDisclaimer

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

BackgroundBackground

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

Legislative/Regulatory ActivityLegislative/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

Sharps SafetySharps SafetyWhy are we concerned?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

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-$3,000to follow them up for 6 months

One infected health care worker with onevirus can cost anywhere from $500,000 to$1 million.

Causes of Percutaneous Injuries

Improperly disposed sharp

13%

Other5%

Handling/passing device

during/after use13%

Handling/transfer specimens

6%

Manipulating needle in patient

9%

IV line-related causes

10%

Recapping6%

Cleanup14%

Disposal-related causes

14%Collision with health care

worker or sharp10%

Devices Associated with Percutaneous Injuries

Hypodermic needle29%

Other sharp6%

Glass17%

Winged-steel needle13%

Phlebotomy needle

4%

IV stylet6%

Suture needle15%

Other hollow-bore needle

10%

Questions To AskQuestions 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?

Notable Elements of the Notable Elements of the Bloodborne Pathogens StandardBloodborne 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

Needlestick Safety & Prevention ActNeedlestick Safety & Prevention ActWhat the law requiresWhat 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

Obstacles to ImplementationObstacles 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?

10 Steps to Take Now10 Steps to Take Now1. 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)

Desirable Sharps Safety Desirable Sharps Safety CharacteristicsCharacteristics

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

Selecting and Evaluating Selecting and Evaluating Sharps Safety DevicesSharps 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

Samples of Sharps Safety Samples of Sharps Safety ProductsProducts

currently availablecurrently available

General Medical Care

AcuvanceAcuvance

I.V. Safety CatheterI.V. Safety Catheter

Sample of Sharps Safety Sample of Sharps Safety ProductProduct

currently availablecurrently available

Ophthalmology

Diamatrix SDiamatrix Safety Handleafety Handle

Diamatrix SDiamatrix Safety Handleafety Handle

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

• Eliminates cost issues associated safety feature:

Added features of theAdded features of the Diamatrix Safety HandleDiamatrix 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

Added features of theAdded features of the Diamatrix Safety HandleDiamatrix Safety Handle

• Attached cover insures blades sharpness

• Safe disposal when cover is in place

Samples of Sharps Safety Samples of Sharps Safety ProductsProducts

in developmentin development

Automatic passive mechanism (CoverTip )Active safety mechanism (Incision Guide )

TM

TM

CoverTipCoverTip™™Superior competitive advantages of Medisys safety needle technology

Easy to useSafeMeets healthcare worker needsAffordable cost

CoverTipCoverTip

Automatic passive mechanismProtection at point of injection2 patents, 3rd pending1998 – 510(k)

TM

CoverTip™

Safety sheath ready

CoverTip™

Safety sheath activated

CoverTipCoverTip™™

CoverTipCoverTip™™ Validation Testing*

0

1

2

3

4

Inte

nsit

y of

pai

n

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

The Incision GuideThe Incision Guide TM

Active Safety Mechanism

DIAMATRIX ASCRS BOOTH #505

DIAMATRIX Safety HandleTM