Docket Management
Docket: 00D-0053 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -5

Accepted - Volume 5

Comment Record
Commentor Mrs. Susan Klacik Date/Time 2002-09-06 09:41:21
Organization IAHCSMM
Category Association

Comments for FDA General
1. General Comments How can a person tell if an item was open and not used opposed to being used? If an item is re-sterilized will it affect the tensile strength, torque, lubricants, etc. Should manufacturer written recommendations be required?

EC -5