Needle recapping device under bloodborne pathogen rules

April 29, 1994

Mr. James J. Schramm
[Recipient address omitted]
Dear Mr. Schramm:

Thank you for your letter of March 18 addressed to Elise Handelman in the Office of Occupational Health Nursing which provided a description of your proposed product, the Safety Shoe, a sample of the product and an instructional videotape. You have requested informal comments on the product and its acceptability for use by employees covered by the Occupational Exposure to Bloodborne Pathogens Standard (29 CFR 1919.1030).

The Occupational Safety and Health Administration (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. This must include an evaluation through direct observation of employee work practices as well as an evaluation of the equipment or devices alone.

In the specific case of your product, it appears that the device is not a needle disposal system, but rather a recapping device which could also be used to transport the contaminated needle to a proper disposal container. For this reason, paragraph (d)(2)(vii)(A) of the standard would appear to apply. This part of the standard only permits recapping of contaminated needles under very specific and limited circumstances where the employer can demonstrate that no alternative is feasible, or that such action is required by a specific medical procedure. In general, recapping is prohibited by the standard.

Additionally, the standard requires that when recapping must be performed, it must be accomplished by the use of a mechanical device or a one-handed technique. Training must emphasize the need to use this as a one-handed recapping device and only in very specific circumstances; it is not to be used for two-handed recapping.

As you are aware, the Food and Drug Administration (FDA) may have jurisdiction over products like yours. We would advise you to continue your contact there for clarification. Specifically, you may want to contact the FDA's Division of Small Manufacturer's Assistance at 1-800-638-2041.

Thank you for your interest in worker safety and health. OSHA is pleased to see inventors like yourself take a genuine interest in protecting workers.

Best wishes in your endeavors.

Sincerely,
STEPHEN MALLINGER
Acting Director
Directorate of Technical Support

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