Limits on OSHA approval of needle recapping devices

September 15, 1993

The Honorable John D. Rockefeller, IV
United States Senate
[Recipient address omitted]
Dear Senator Rockefeller:

Thank you for your letter of August 11, on behalf of your constituent, Mr. Steve Wade, Vice-President, International Marketing, Medical Safety Solutions, Inc. (Claim #317909001, Case Code WWH), regarding his concern about the Occupational Safety and Health Administration's (OSHA) July 20 correspondence, which stated that OSHA does not approve or endorse products.

Mr. Wade requested that his product, CapSafe, be evaluated by OSHA and recognized as an approved mechanical recapping device. Mr. Wade requested that OSHA grant such approval based on his belief that OSHA granted a hypodermic syringe recapping device produced by OnGard Systems Inc., recognized status as an "approved" device for recapping.

However, as we stated in our previous correspondence, Mr. Wade's interpretation that OSHA "approved" the OnGard device is incorrect. In a May 18, 1992 letter settling a legal challenge to OSHA's bloodborne pathogens standard (29 CFR 1910.1030), OSHA concluded that the OnGard recapping device appeared to be an acceptable mechanical device to be used in those specific circumstances in which recapping is permitted by the standard. However, such conclusions should not be taken out of context or given a broader application than was intended. It is important to note that OSHA specifically informed OnGard Systems that "although OSHA cannot, of course, approve or endorse particular products, the OnGard recapper appears to be an acceptable mechanical device." This statement is consistent with OSHA's long-standing policy regarding product approval requests.

Furthermore, as we stated in our previous correspondence, the final determination of compliance with OSHA's standards cannot be based on an evaluation of the equipment or devices alone. Such a determination must also 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.

Therefore, any OSHA evaluation of a product alone, which obviously cannot take into account the additional factors cited above, does not guarantee compliance with the requirements of OSHA's standard.

We hope that this additional explanation will satisfactorily address Mr. Wade's concerns. Thank you for your interest in occupational safety and health.

Sincerely,
Roger A. Clark, Director
Directorate of Compliance Programs