- Standard Number:
OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov.
October 5, 1998
Mr. Michael D. Weiss, Esq.
The Lyric Center
Houston, Texas 77002
Dear Mr. Weiss:
This is in response to your letter dated June 19. We apologize for the long delay. You have requested that the Occupational Safety and Health Administration (OSHA) provide an interpretation of CFR 1910.1030, Bloodborne Pathogens standard. Specifically you have asked if the use of group purchasing agreements in healthcare facilities is a violation of the Bloodborne Pathogen standard.
OSHA's Bloodborne Pathogen standard has a provision that requires an employer to evaluate medical devices that may eliminate or minimize employee exposure 29 C.F.R. §1910.1030 (c)(1)(iv). In accordance with this provision, the employer is not automatically required to institute the most sophisticated engineering controls, but it is the employer's responsibility to evaluate existing controls and to review the feasibility of instituting more advanced engineering controls. This section of the standard is performance oriented. That is, OSHA does not mandate what products must be evaluated or purchased. The standard provides the necessary flexibility for the employer to choose the most suitable products to fit the needs of the facility. OSHA also requires that employers examine and maintain or replace on a regular schedule engineering controls to ensure their effectiveness 29 C.F.R. §1910.1030(d)(2)(ii).
OSHA requires employers to eliminate or minimize employee exposures through reasonable and feasible engineering and work practice controls; but OSHA does not have jurisdiction over contract agreements and therefore cannot determine the legality of GPO arrangements. OSHA would require compliance with the BBP standard regardless of these contractual obligations between the GPO and the hospitals.
The Food and Drug Administration (FDA) approves medical devices for marketing. Since the Bloodborne standard took effect, there has been a great surge in medical device manufacturing. There are currently many safe needle devices on the market. As you know, OSHA cannot and does not endorse, review, or approve medical devices. The real test of compliance with OSHA standards comes about by observation in the workplace. Medical devices generally have specific instructions that must be followed when using them. The safety features that they provide may become more of a hazard if the employee is not using the device correctly. The compliance with the OSHA standard must be established at the time of inspection.
As a point of further information, OSHA has recently published a Request for Information (RFI) relative to prevention of percutaneous injuries (enclosed). If you would like to submit information or comments in response to the RFI, they should be submitted in quadruplicate to the Docket Officer, Docket No. H370A, Room N-2625, U.S. Department of Labor, 200 Constitution Avenue, NW, Washington, DC 20210. Additional information on submission of comments can be found under the "Addresses" section of the notice.
Thank you for your interest in occupational safety and health. I hope this provides an answer to your questions. If you have further questions, please feel free to call our Office of Health Compliance Assistance at (202) 219-8036.
Richard E. Fairfax
Directorate of Compliance Programs