Patient-safety devices and bloodborne pathogens rule coverage

August 10, 1992

James H. O'Connor, DMD
Health Care Consultant
Enterprises, Inc.
[Recipient address omitted]
Dear Dr. O'Connor:

This is in response to your letter of March 7, requesting clarification of the Occupational Safety and Health Administration (OSHA) standard, 29 CFR 1910.1030, "Occupational Exposure to Bloodborne Pathogens." Specifically, you requested that we review literature on your Purification/Distillation - Sterilization/Disinfection systems and comment on the equipment in the context of the compliance requirements of the standard. We apologize for the delay in this response.

OSHA does not review or endorse products as you have requested. The final determination of compliance must take into account all factors pertaining to the use of such devices at a particular worksite with respect to employee safety and health. This must include an evaluation through direct observation of employee work practices and all conditions of use in the workplace as well as an evaluation of the equipment or devices alone. In the specific case of your system, the standard is only applicable if the hazards you address affect employee safety and health. Matters solely concerning the safety of patients is not within OSHA's jurisdiction.

OSHA is co-sponsoring (together with the Centers for Disease Control and the Food and Drug Administration) a conference on device-mediated bloodborne infections. The upcoming conference is designed to bring together health professionals and regulatory personnel to facilitate understanding of needs and devices. It is scheduled for August 17-19, 1992, in Washington, DC. Enclosed is a bulletin on this conference.

For further information, please contact:

PACE Enterprises, Inc.
Attn: Laura Timperio
17 Executive Park Dr,
Suite 200
Atlanta, GA 30329
Telephone: 404-633-8610
Facsimile: 404-633-8745

Thank you for contacting OSHA. Your ideas would certainly be a valuable contribution to the conference and we hope this information is helpful to you.

Sincerely,
Patricia K. Clark, Director
Directorate of Compliance Programs