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Reusable device sterilization concerns raised by FDA in letter to hospital groups.

This article was originally published in The Gray Sheet

Executive Summary

STERILIZATION PROCEDURES FOR LEASED REUSABLE MEDICAL DEVICES need to be reviewed by hospitals to ensure proper cleaning, disinfection and/or sterilization, FDA says in an April 17 letter mailed to 25 hospital associations. "Health care facilities renting or leasing reusable medical devices from a third party should review all rental/leasing contracts," to assure that the parties responsible for sterilization are clearly identified, FDA says in the letter.

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