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Resheathing devices and OSHA product review policy

Summary A catheter manufacturer asked OSHA to review a safety device's product literature. OSHA said its then-current enforcement instruction allowed appropriate resheathing devices, but resource limits meant it would not review particular products or their literature. It referred the company to a forthcoming conference on device-mediated bloodborne infections.
Document
Federal opinion letter
Agency
Occupational Safety and Health Administration (OSHA)
Document number
1991-12-30-2
Date issued
December 30, 1991
Status
Archived by the agency
OSHA labels this an archive document that may no longer represent its policy; it does not identify a replacement on this page.
Status last verified October 10, 2026

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OSHA labels this an archive document that may no longer represent its policy; it does not identify a replacement on this page. It may no longer reflect the agency's current position. Treat this page as historical context, not current guidance, and verify current law before relying on anything here.
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NOTICE: This is an OSHA Archive Document, and may no longer represent OSHA Policy. It is presented here as historical content, for research and review purposes only.

December 30, 1991

Mr. Gerald J. Kovalic
Product Director
Vascular Access Products
CRITIKON, Inc.
[Recipient address omitted]
Dear Mr. Kovalic:

This is in further response to your letter of October 24, in which you requested that the Occupational Safety and Health Administration (OSHA) review the product literature for PROTECTIV I.V. Catheter Safety System.

OSHA Instruction CPL 2-2.44B, "Enforcement Procedures for Occupational Exposure to the Hepatitis B Virus and the Human Immunodeficiency Virus" allows appropriate resheathing devices to be used. Due to limited resources, however, OSHA's current policy is not to review either specific products or product literature.

OSHA will be sponsoring a conference on "Prevention of Device Mediated Bloodborne Infections" together with the U.S. Department of Health and Human Services, the Centers for Disease Control, and the Food and Drug Administration (brochure enclosed). We recommend that you present your data in that context.

We hope this information is helpful to you.

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

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