Revised Bloodborne Pathogens Standard WAC Safer Medical Device and Sharps Injury Recordkeeping Requirements

Bloodborne Pathogens Standard Federal 29 CFR , Occupational Exposure to Bloodborne Pathogens - Effective March 1992 Federal 29 CFR , Occupational Exposure to Bloodborne Pathogens - Effective March 1992 WAC Effective January 1993 WAC Effective January 1993 Scope Scope “This chapter applies to you if you have employees with occupational exposure to blood or OPIM, even if no actual exposure incidents have occurred”

Bloodborne Pathogens Standard Major Provisions by Section: 110 – Planning 120 – Training 130- Hepatitis B (HBV) Vaccinations 140 – Control Employee Exposure 150- Personal Protective Equipment 160- Post Exposure Requirements 170 – Records 180 Additional Requirements for HIV and HBV Research Labs and Production Facilities

Occupational Exposure “Means reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or OPIM that may result from the performance of an employee’s duties”

Methods of Compliance Infection Control systems Infection Control systems Controlling exposure through selection and implementation of safer medical devices and administrative controls Controlling exposure through selection and implementation of safer medical devices and administrative controls Personal protective equipment Personal protective equipment Housekeeping Housekeeping Regulated waste management Regulated waste management Laundry handling Laundry handling Signs and labeling Signs and labeling

Use of Safer Medical Devices Since 1992: Since 1992:  Advancements in medical technology  Union and Congressional involvement  November 1999, OSHA releases CPL D CPL D  November 2000, Needlestick Safety and Prevention ACT P.L

Needlestick Safety and Prevention Act Timeline P. L signed; November 6, 2000 P. L signed; November 6, 2000 Revised Standard published in Federal Register; Jan. 18, 2001 Revised Standard published in Federal Register; Jan. 18, 2001 Effective date; April 18, 2001 Effective date; April 18, 2001 Federal enforcement of new provisions; July 17, 2001 Federal enforcement of new provisions; July 17, 2001 WISHA enforcement: Aug. 6, 2001 WISHA enforcement: Aug. 6, 2001

2001 Revisions to Standard Further clarifies the definition of Safer Medical devices Further clarifies the definition of Safer Medical devices Requirements to document evaluation of and changes in the use of safer medical devices Requirements to document evaluation of and changes in the use of safer medical devices Requires solicitation of input from non- managerial employees Requires solicitation of input from non- managerial employees Maintenance of a Sharps Injury Log Maintenance of a Sharps Injury Log

Safer Medical Devices “Medical devices that have been engineered to reduce the risk of needlesticks and other contaminated sharps injuries. These include not only sharps with engineered sharps injury protections and needleless systems but also other medical devices designed to reduce the risk of sharps injury exposures” “Medical devices that have been engineered to reduce the risk of needlesticks and other contaminated sharps injuries. These include not only sharps with engineered sharps injury protections and needleless systems but also other medical devices designed to reduce the risk of sharps injury exposures”

Needleless Systems New Definition Device that does not use a needle for: Device that does not use a needle for:  Collection of bodily fluids  Administration of medication/fluids  Any other procedure with potential percutaneous exposure to a contaminated sharp

“Sharps with Engineered Sharps Injury Protections (SESIP)” New Definition Non-needle sharp or a needle with a built-in safety feature or mechanism that effectively reduces the risk of an exposure incident.

Hypodermic syringes with “Self-Sheathing” safety feature Self-sheathed protected position

Hypodermic syringes with “Retractable Technology” safety feature Retracted protected position

Phlebotomy needle with “Self-Blunting” safety feature Blunted protected position

“Add-on” safety feature Attached to syringe needle Attached to blood tube holder

Retracting lancets with safety features Before During After In use After use

Disposable scalpels with safety features Retracted position Protracted position

Additional Information About Safety Devices Available At…

Exposure Control Plan: The ECP must be updated to include: changes in technology that reduce/eliminate exposure changes in technology that reduce/eliminate exposure annual documentation of consideration and implementation of safer medical devices annual documentation of consideration and implementation of safer medical devices solicitation of input from non-managerial employees solicitation of input from non-managerial employees

Solicitation of Non-Managerial Employees Identification, evaluation, and selection of safer medical devices Identification, evaluation, and selection of safer medical devices Must select employees that are: Must select employees that are:  Responsible for direct patient care  Representative sample of those with potential exposure

Controlling Employee Exposure Employers must select and implement appropriate safer medical devices to reduce or eliminate employee exposure.

“ Where safer medical devices will reduce employee exposure either by removing, eliminating, or isolating the hazard, they must be used.” CPL D

Safer Medical Devices The employer must: The employer must:  Evaluate available safer medical devices  Train employees on safe use and disposal when needed  Implement appropriate devices

Controlling Employee Exposure Selection of safer medical devices and work practice controls is dependent on the employer’s Exposure Determination.

Exposure Determination The employer must: The employer must:  Identify worker exposures to blood or OPIM  Review all processes and procedures with exposure potential  Re-evaluate when new processes or procedures are used

Safer Medical Devices The employer must: The employer must:  Document evaluation and implementation in ECP  Review, update ECP at least annually  Review new devices and technologies annually  Implement new device use, as appropriate and available

Safer Medical Devices (con’t) The employer must: The employer must:  Train employees to use new devices and/or procedures  Document in ECP

Phlebotomy Needles Section prohibits bending, recapping, or removal of needles or other contaminated sharps unless you can demonstrate that there is no feasible alternative Section prohibits bending, recapping, or removal of needles or other contaminated sharps unless you can demonstrate that there is no feasible alternative Routine removal of phlebotomy needles from the holder is prohibited. Routine removal of phlebotomy needles from the holder is prohibited.

Recordkeeping Sharps Injury Log Sharps Injury Log  Documents all contaminated sharps exposures  Must also be documented on OSHA 300 Log  Confidential record  Sharps exposure must be documented separately from other injuries

Sharps Injury Log At a minimum, the log must contain, for each incident: Type and brand of device involved Type and brand of device involved Department or area of incident Department or area of incident Description of incident Description of incident ( may be documented on the ( may be documented on the 301 form) 301 form)

Summary Additional definitions Additional definitions New requirements to evaluate existing medical devices and implement safer technologies New requirements to evaluate existing medical devices and implement safer technologies Non-managerial employees involved in selection of safer medical devices Non-managerial employees involved in selection of safer medical devices Sharps injury log Sharps injury log

Department of Labor and Industries WISHA Services Division Policy and Technical Services John Furman (360)