Evaluating a suction system under the bloodborne pathogens rule

September 27, 1993

Mr. Jeff Baker
Vice President
[Recipient address omitted]
Dear Mr. Baker

Thank you for your letter of August 19, regarding the Occupational Safety and Health Administration's (OSHA) final rule for Occupational Exposure to Bloodborne Pathogens (29 CFR 1910.1030), and your request for an endorsement that your product, the Power Station, can be used in compliance with the standard's requirements.

The agency does not approve or endorse products as you have requested. The final determination of compliance with OSHA's standards 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.

Your letter did not mention whether or not your device has received clearance from the Food and Drug Administration (FDA) for marketing. If not, please be advised the FDA must clear your product before it can be legally marketed, and the FDA plans to consider employee safety and health in its evaluation of products submitted for marketing clearance.

We hope this information satisfactorily addresses your concern. Thank you for your interest in occupational safety and health.

Sincerely,
Ruth McCully, Director
Office of Health Compliance Assistance

[Requester letter reproduced on OSHA page; omitted here.]