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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