Bloodborne pathogen controls and medical device purchasing

NOTICE: This is an OSHA Archive Document, and may no longer represent OSHA Policy. It is presented here as historical content, for research and review purposes only.

February 4, 1998

The Honorable Dick Armey
U.S. House of Representatives
[Recipient address omitted]
Dear Congressman Armey:

This is in response to your letter dated September 29, 1997. We apologize for the long delay. You have requested that the Occupational Safety and Health Administration (OSHA) review and consider the issues described in a letter from Mr. Thomas J. Shaw, President of Retractable Technologies, Inc. To summarize the concerns of Mr. Shaw, he is seeking assistance from several federal agencies, including OSHA, to review the practice of using Premier and VHA Group purchasing agreements in healthcare facilities. Mr. Shaw's concern is that the purchasing agreements block his company, Retractable Technologies Inc., from marketing their products.

OSHA agrees with Mr. Shaw that healthcare facilities should "put safety first," and that employers are responsible for evaluating safer technology. However, OSHA does not have regulations that govern which new and safer devices are purchased, nor the way in which they are purchased. This area may be more appropriately addressed with either the Department of Health and Human Services (DHHS) or the Food and Drug Administration (FDA).

OSHA's Bloodborne Pathogens standard, 29 CFR 1910.1030, has a section that requires an employer to evaluate medical devices that may eliminate or minimize employee exposure. In accordance with this section, 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 their facility. OSHA requires that employers examine and maintain or replace on a regular schedule, engineering controls to ensure their effectiveness.

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 of 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.

Thank you for your interest in occupational safety and health. I hope this provides an answer to all your questions. If you have further questions, please feel free to call Wanda Bissell of my staff at (202) 219-8036, Ext.49.

Sincerely,

Charles N. Jeffress
Assistant Secretary