Premier Audio Conference 2001: Outline
Sharps injury prevention: Complying with the law
Gina Pugliese RN MS
Vice President, Premier Safety Institute
This is outline taken from a slide presentation used to organize the information presented in the audio conference in June and July 2001.
Overview
- Risks of Bloodborne Pathogen Transmission
- Summary of Recent Legislation
- Strategies for Compliance
Complexity of the Problem
- Many types of sharps devices
- Injuries occur under a variety of circumstances
- Transmission risks vary by device type
- Not all injuries are preventable
Complexity of the Solution
- Limited data on efficacy
- One device cannot solve every problem
- One device category can have multiple safety designs and vary in mode of activation
- Safety device may limit scope of multiple purpose device
- Implementation does not guarantee acceptability and use
Comparative Risks of Bloodborne Pathogen
Transmission from Percutaneous Injury
- HBV 2 to 30%
- HCV 1.8 to 10%
- HIV 0.2 to 0.4%
Decline in U.S. HBV Cases Among
Healthcare Workers Following Vaccination
- 17,000 cases of HBV in 1983
- 400 cases in 1995
Hepatitis C Virus Infection
- Most common bloodborne infection in US
- 85% chronic infection
- 70% chronic liver disease
- 3.9 million infected (1.8% of US population)
- $600 million medical and work-loss costs
- HCV end stage liver disease most frequent indication for liver transplants among adults
Devices Associated with Percutaneous Exposures
Resulting in Occupational HIV Transmission – CDC Data
87% of occupational exposures resulting in HIV are from hollow needles
Prioritize Safety Device
Evaluation / Implementation
- Frequency of injury (by device, staff, dept)?
- Risk of bloodborne pathogen exposure?
- Studies on device efficacy?
- Willingness of staff to assist in evaluation?
EPINET and NaSH Sharps Injjury Surveillance Systems
EPINet
- Developed by Dr. Janine Jagger at U. VA
- Introduced in 1992
- Used by:
- 1,500 US hospitals
- Adapted in other countries
- Aggregate data available from 52 hospitals
NaSH
- Developed by CDC
- Multi-component system
- Introduced in 1995
- Participation
- 1995 4 hospitals
- 1999 23 hospitals
- Aggregate data available from 23 hospitals
Web Sites
www.cdc.gov CDC’s NaSH
www.med.virginia.edu/~epinetEPINET
Items Most Frequently Causing Sharps Injuries,
US EPINet 1998*
High risk devices are hollow blood-filled sharps
Syringe most frequent cause of needlesticks but only a third are high risk
All phlebotomy needles, winged steel needles, IV catheters, capillary tubes
Mechanism of Injury
by Type of Device, CDC NaSH
Injuries vary by the type of device:
For example-
- Injuries for winged steel needles and phlebotomy needles most commonly occur during use and during disposal
- Injuries related to syringes occur most commonly during and after use.
Mechanism of Syringe-Related Injuries –
By Use of the Device CDC NaSH
For example:
More injuries occur during and after use when syringe is used for subq or skin testing
More injuries occur during use or during disposal if syringe used for IM injection
Circumstances of Exposures Involving
Safety Devices CDC NaSH (167 injuries)
- 41% - Before activation appropriate
- 19% During activation
- 21% Safety mechanism not activate
- 9% Safety mechanism improperly activated
- 4% Safety mechanism failed
Efficacy of phlebotomy safety devices in reducing percutaneous
injuries,
CDC Study 1993-95 MN, NY, CA (167 injiuries)
- Winged steel needle 23% reduction in needlesticks
- Blunt needle 76%
- Hinged recap 66%
CDC - Number of Phlebotomy-Related Injuries
(PIs) Conventional vs Safety Devices
Winged-steel Vacuum blood collection
needle blunt needle hinged recap
Estimated No. Phlebotomies
conventional 2,540,500 523,561 895,054
safety device 1,875,995 501,598 628,092
Percutaneous
injuries per 100,000 phlebotomies*
conventional 4.0 3.6 3.5
safety 3.1 0.9 1.2
Reduction in PI Rate with Safety Device
23% 76% 66%
* Adjusted for Underreporting FROM: CDC. MMWR January 17, 1997
Example of sample size needed to compare needlestick rates of conventional versus safety devices.
Number of needlesticks No. of devices needed for evaluation (p<0.5)
Conventional Safety
- 10 1 100,000-130,000
- 5 1 300,000-400,000
CDC Safety Device Evaluation
Reporting of Needlesticks
% of needlesticks reported
- Nurses 68%
- Phlebotomists 91%
- Medical Students 35%
- Residents 31%
Overall 54%
____________________________________
FROM: MMWR January 17, 1997
Glass Capillary Tubes:Joint Safety Advisory About Potential Risks
February 1999
Dear Colleague:
The FDA, NIOSH, CDC, and 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...
Glass Capillary Tube Injuries by Place of Occurrence
EPINet 1993-1996
Percents
- Clinical Labs 55%
- ICU CCU 20%
- Outpatient 13%
OSHA Update
Slide 23 Nov 5, 1999 OSHA
Revised Compliance Directive:
Enforcement Procedures for Occupational Exposure to Bloodborne Pathogens, Nov 99
- Show evidence of adoption of devices/engineering controls that reduce exposure
- Document plan annually and any difficulties
- Inspections: complaints & some scheduled inspections
- OSHA does not require a specific device
November 6, 2000
Needlestick Safety & Prevention Act
- Directed OSHA to revise bloodborne pathogen standard:
- Add sharps safety devices to definitions of engineering controls
- Document implementation in written plan
- maintain detailed sharps injury log
- involve frontline workers
OSHA Revised Bloodborne Pathogen Standard (1/18/01)
EFFECTIVE DATE : April 18, 2001
1. New definitions: sharps with engineeringsharps injury protection and needleless systems
Examples: blunt suture needles, plastic/mylar wrapped capillary tubes
OSHA Revised Bloodborne Pathogen Standard (1/18/01)
2. Annual review/update of exposure control plan to include
- consideration and implementation of appropriate safer medical devices to reduce exposure
- reflecting changes in technology
- describe devices identified as candidates
- methods for evaluation
- justification for selection
OSHA Revised Bloodborne Pathogen Standard
Appropriate:
- Device does not jeopardize patient or employee safety
- Device is effective---based on reasonable judgement to reduce risk of exposure
- NOTE: safer devices may not be available in all applications
OSHA Revised Bloodborne Pathogen Standard
3. Solicit input from non-managerial workers in identification, evaluation and selection of devices
- provides flexibility to employer to solicit worker input in any manner appropriate to circumstances
Example of Frontline Worker Input
- Informal problem solving groups
- Safety audits
- Suggestions/comments submitted by workers
- work-site inspections
- Exposure investigations
- Analysis of exposure incident data
- during evaluation of devices in pilot testing
- committee involvement
Involving Frontline Workers
- Frontline workers (non managerial)
- Represent the range of exposures
- Document input in exposure control plan
- identify workers involved
- describe input process for identification, evaluation and selection
- minutes, memos requesting participation, device evaluations
OSHA Revised Bloodborne Pathogen Standard
4. Sharps Injury Log of percutaneous injuries to contaminated sharps, at a minimum to include:
- type and brand of device
- dept/location where injury occurred
- explanation of how the injury occurred
(e.g. procedure being performed, body part affected, object or substances involved) so evaluation of risk and device can be done
OSHA Federal versus State Jurisdication
Half the States have state-run OSHA plans
Summary of Deadlines
- April 18, 2001 published deadeline - Federal states
- July 17, 2001 extended deadline until outreach finished- Federal States
- Oct 18, 2001 deadline for states with state plans
Bloodborne Pathogen Standard
- Performance-oriented standard
- Offers flexibility to meet the intent of the standard
So……..
- Document your plan
- Follow your plan
Are Safety Devices Cost Effective?
GAO Report to Congress
Nov 17, 2000
- Safety Devices Cost
- range: 1 to 3.5 times more than conventional devices
- Cost of Post-Exposure Prophylaxis
- range $500 low; $1,500 moderate; $2,500 high risk
Cost-effectiveness of Safety Devices Over Conventional Devices
Cost Effectiveness of Safety Devices
Cost of safety devices are offset by cost of post-exposure prophylaxis and follow- up IF
- Device is 1.5 to 2.0 times more costly than conventional for moderate and high risk exposures
- Device is 2.0 times more costly for high risk exposures only
- NOT cost effective if 3.5 times more costly for any exposure
Considerations for Selection and Adoption of Safety Devices
Product Performance/Functionality
- Functional reliability
- Suitability- range of uses
- Intuitiveness/ease of use
- Active vs passive
- Single handed use
- Hands behind sharp
- Requires change in technique
- Indication of activation
- Undefeatable
- Packaging
- Needles interchange
- Sharp covered permanently
- Interferes w/ procedure
- Right or left handed use
Considerations for Selection and Adoption of ALL Safety Devices
Procurement
- Speed of procurement
- Disposal volume
- Conversion across a system
- Cross institution variability in choice
End
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