OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at https://www.osha.gov.
December 30, 1991
Mr. Gerald J. Kovalic
Product Director
Vascular Access Products
CRITIKON, Inc.
Post Office Box 31800
Tampa, Florida 33631-3800
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