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Reusable phlebotomy collection device

Summary A medical device maker asked whether its reusable phlebotomy holder complied with OSHA’s bloodborne-pathogens standard. OSHA said the device appeared to allow a contaminated needle to be recapped while retracted and unexposed, but emphasized that it does not approve products and that workplace compliance depends on actual use. OSHA identified the device’s use as potentially fitting an exception for removing needles from a phlebotomy collection apparatus.
Document
Federal opinion letter
Agency
Occupational Safety and Health Administration (OSHA)
Document number
1993-03-09
Date issued
March 9, 1993
Status
Archived by the agency
OSHA marks this page as an archive document and says it may no longer represent OSHA policy.
Status last verified October 9, 2026

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NOTICE: This is an OSHA Archive Document, and may no longer represent OSHA Policy. It is presented here as historical content, for research and review purposes only.

March 9, 1993

Alan A. Wanderer, M.D.
[Recipient address omitted]
Dear Dr. Wanderer:

This is in response to your letter of November 9, in which you requested that the Occupational Safety and Health Administration (OSHA) review your ACCI-GUARD Reusable Holder for compliance with the requirements of 29 CFR 1910.1030, the "Occupational Exposure to Bloodborne Pathogens" standard. This reusable device is used in blood collection procedures.

As you correctly noted in your letter, the standard prohibits the recapping and/or removal of contaminated needles unless no alternative is feasible or it is required by a specific medical procedure. OSHA Instruction CPL 2-2.44C, "Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens Standard", gives examples of circumstances in which the recapping and/or removal of a contaminated needle may be necessary. These circumstances may include "removing the needles from a phlebotomy collection apparatus".

After reviewing your device and its accompanying literature, we believe that its intended use does not appear to violate the requirements of 29 CFR 1910.1030. While the device adds an extra step prior to removal of the contaminated needle, it appears to allow the needle to be recapped while it is retracted and in an unexposed position; it thus appears to adequately protect the fingers while recapping. Please bear in mind that OSHA does not endorse or approve products and that the final determination regarding compliance is made in the workplace by direct compliance officer observation of employee work practices and taking into account all factors pertaining to the use of such a device at the particular worksite.

We hope this information is responsive to your concerns and thank you for your interest in worker safety and health.

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

[Attached correspondence reproduced on OSHA page; omitted here.]

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