November 21, 2002

Ms. Audrey Taffet
Manager, Business Development
Terumo Medical Corporation
2101 Cottontail Lane
Somerset, NJ 08873

Dear Ms. Taffet:

Thank you for your July 2002 letter to the Occupational Safety and Health Administration (OSHA) regarding the application of the requirement in the Bloodborne Pathogens Standard (29 CFR 1910.1030) to use safer medical devices, specifically for facilities working under Group Purchasing Organization (GPO) contracts. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence. Your letter is paraphrased below followed by OSHA's response.

We (Terumo) understand that the evaluation of new sharps safety devices should be conducted by frontline healthcare workers. Many healthcare facilities operate under a Group Purchasing Organization (GPO) contact, intended to organize purchasing and availability of medical supplies. The GPOs typically offer little, if any, variation with regard to needlestick safety products. In light of the OSHA requirements to use safer medical devices dependent on an evaluation performed by healthcare workers, GPOs should not restrict the selection and evaluation of such products. What is OSHA's viewpoint on this?

Your interpretation is correct. Devices must be selected based on employee feedback (29 CFR 1910.1030(c)(1)(v)). They must be evaluated for appropriateness for each procedure and effectiveness in preventing occupational exposures to blood and other potentially infectious materials (OPIM). If the availability and variety of devices is restricted, the employer may be in violation of the requirements: (1) to review and update the exposure control plan to reflect changes in technology that eliminate or reduce exposure to blood and OPIM (29 CFR 1910.1030(c)(1)(iv)(A)); (2) to review and update the plan annually, documenting the consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure (29 CFR 1910.1030(c)(i)(iv)(B); and (3) to use engineering controls to eliminate or minimize employee exposure (29 CFR 1910.1030(d)(2)(i)).

Remember, selecting a safer device based solely on the lowest cost is not appropriate. Selection must be based on employee feedback and device effectiveness. OSHA compliance officers have issued citations to employers at facilities that were not using effective engineering controls because of the product availability limits of their purchasing contracts. Again, if during an OSHA inspection, it is determined that an employer did not evaluate and select appropriate and effective devices, the employer may be cited. In an effort to best serve the safety and regulatory needs of their clients, GPOs should offer a variety of different safer devices.

Thank you for your interest in occupational safety and health. We hope you find this information helpful. 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. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.

Sincerely,



Richard E. Fairfax, Director
Directorate of Enforcement Programs