Revised Bloodborne Pathogens Standard WAC 296-823 Safer Medical Device and Sharps Injury Recordkeeping Requirements

Revised Bloodborne Pathogens Standard WAC 296-823

Safer Medical Device and Sharps Injury Recordkeeping Requirements

Bloodborne Pathogens Standard

Federal 29 CFR 1910.1030, Occupational Federal 29 CFR 1910.1030, Occupational Exposure to Bloodborne Pathogens - Effective Exposure to Bloodborne Pathogens - Effective March 1992March 1992

WAC 296-823 Effective January 1993WAC 296-823 Effective January 1993 ScopeScope

““This chapter applies to you if you have This chapter applies to you if you have employees with occupational exposure to blood employees with occupational exposure to blood or OPIM, even if no actual exposure incidents or OPIM, even if no actual exposure incidents have occurred”have occurred”

Bloodborne Pathogens StandardMajor Provisions by Section:Major Provisions by Section:110 – Planning110 – Planning120 – Training120 – Training130- Hepatitis B (HBV) Vaccinations130- Hepatitis B (HBV) Vaccinations140 – Control Employee Exposure140 – Control Employee Exposure150- Personal Protective Equipment150- Personal Protective Equipment160- Post Exposure Requirements160- Post Exposure Requirements170 – Records170 – Records180 Additional Requirements for HIV and HBV 180 Additional Requirements for HIV and HBV

Research Labs and Production FacilitiesResearch Labs and Production Facilities

Occupational Exposure

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

Methods of Compliance Infection Control systemsInfection Control systems Controlling exposure through selection and Controlling exposure through selection and

implementation of safer medical devices and implementation of safer medical devices and administrative controlsadministrative controls

Personal protective equipmentPersonal protective equipment HousekeepingHousekeeping Regulated waste managementRegulated waste management Laundry handlingLaundry handling Signs and labelingSigns and labeling

Use of Safer Medical Devices

Since 1992:Since 1992: Advancements in medical technologyAdvancements in medical technology Union and Congressional involvementUnion and Congressional involvement November 1999, OSHA releasesNovember 1999, OSHA releases CPL 2-2.44DCPL 2-2.44D November 2000, Needlestick Safety and November 2000, Needlestick Safety and

Prevention ACT P.L. 106-430Prevention ACT P.L. 106-430

Needlestick Safety and Prevention Act Timeline P. L. 106-430 signed; November 6, 2000P. L. 106-430 signed; November 6, 2000 Revised Standard published in Federal Revised Standard published in Federal

Register; Jan. 18, 2001Register; Jan. 18, 2001 Effective date; April 18, 2001Effective date; April 18, 2001 Federal enforcement of new provisions; Federal enforcement of new provisions;

July 17, 2001July 17, 2001 WISHA enforcement: Aug. 6, 2001WISHA enforcement: Aug. 6, 2001

2001 Revisions to Standard

Further clarifies the definition of Safer Further clarifies the definition of Safer Medical devicesMedical devices

Requirements to document evaluation of Requirements to document evaluation of and changes in the use of safer medical and changes in the use of safer medical devicesdevices

Requires solicitation of input from non-Requires solicitation of input from non-managerial employeesmanagerial employees

Maintenance of a Sharps Injury LogMaintenance of a Sharps Injury Log

Safer Medical Devices

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

Needleless SystemsNew Definition Device that does not use a needle for:Device that does not use a needle for:

Collection of bodily fluidsCollection of bodily fluids

Administration of medication/fluidsAdministration of medication/fluids

Any other procedure with potential Any other procedure with potential percutaneous exposure to a contaminated percutaneous exposure to a contaminated sharpsharp

“Sharps with Engineered Sharps Injury Protections (SESIP)”New Definition

Non-needle sharp or a needle with a Non-needle sharp or a needle with a built-in safety feature or mechanism that built-in safety feature or mechanism that effectively reduces the risk of an effectively reduces the risk of an exposure incident.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

Before During After

In use After use

Disposable scalpels with safety features

Retracted position

Protracted positionProtracted position

Additional Information About Safety Devices Available

At…

www.med.virginia.edu/~epinetwww.med.virginia.edu/~epinet

www.tdict.orgwww.tdict.org

www.osha.govwww.osha.gov

www.lni.wa.gov/wisha/www.lni.wa.gov/wisha/

Exposure Control Plan:

The ECP must be updated to include:The ECP must be updated to include: changes in technology that reduce/eliminate changes in technology that reduce/eliminate

exposureexposure annual documentation of consideration and annual documentation of consideration and

implementation of safer medical devicesimplementation of safer medical devices solicitation of input from non-managerial solicitation of input from non-managerial

employeesemployees

Solicitation of Non-Managerial Employees

Identification, evaluation, and selection of Identification, evaluation, and selection of safer medical devicessafer medical devices

Must select employees that are:Must select employees that are: Responsible for direct patient careResponsible for direct patient care Representative sample of those with Representative sample of those with

potential exposurepotential exposure

Controlling Employee Exposure

Employers must Employers must selectselect and and implementimplement appropriate safer appropriate safer medical devices to reduce or medical devices to reduce or

eliminate employee exposure.eliminate employee exposure.

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

CPL 2-2.44DCPL 2-2.44D


The employer must:The employer must: Evaluate available safer medical devicesEvaluate available safer medical devices Train employees on safe use and disposal Train employees on safe use and disposal

when neededwhen needed Implement appropriate devicesImplement appropriate devices

Controlling Employee Exposure

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

Exposure Determination

The employer must:The employer must: Identify worker exposures to blood or Identify worker exposures to blood or

OPIMOPIM Review all processes and procedures with Review all processes and procedures with

exposure potentialexposure potential Re-evaluate when new processes or Re-evaluate when new processes or

procedures are usedprocedures are used


The employer must:The employer must: Document evaluation and Document evaluation and

implementation in ECPimplementation in ECP Review, update ECP at least annuallyReview, update ECP at least annually Review new devices and technologies Review new devices and technologies

annually annually Implement Implement new new device use, as appropriate device use, as appropriate

and availableand available

Safer Medical Devices (con’t)

The employer must:The employer must: Train employees to use new devices Train employees to use new devices

and/or proceduresand/or procedures Document in ECPDocument in ECP

Phlebotomy Needles

Section 823-14010 prohibits bending, Section 823-14010 prohibits bending, recapping, or removal of needles or other recapping, or removal of needles or other contaminated sharps unless you can contaminated sharps unless you can demonstrate that there is no feasible demonstrate that there is no feasible alternativealternative

Routine removal of phlebotomy needles Routine removal of phlebotomy needles from the holder is prohibited.from the holder is prohibited.

Recordkeeping

Sharps Injury LogSharps Injury Log Documents all contaminated sharps Documents all contaminated sharps

exposuresexposures Must also be documented on OSHA 300 Must also be documented on OSHA 300

LogLog Confidential recordConfidential record Sharps exposure must be documented Sharps exposure must be documented

separately from other injuriesseparately from other injuries

Sharps Injury Log

At a minimum, the log must contain, for At a minimum, the log must contain, for eacheach incident:incident:

Type and brand of device involved Type and brand of device involved Department or area of incidentDepartment or area of incident Description of incidentDescription 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 New requirements to evaluate existing

medical devices and implement safer medical devices and implement safer technologiestechnologies

Non-managerial employees involved in Non-managerial employees involved in selection of safer medical devicesselection of safer medical devices

Sharps injury logSharps injury log

Department of Labor and IndustriesDepartment of Labor and Industries

WISHA Services DivisionWISHA Services Division

Policy and Technical ServicesPolicy and Technical Services

John Furman (360) 902-5666John Furman (360) 902-5666

[email protected]@lni.wa.gov