Docket Management
Docket: 00D-0053 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -12

Accepted - Volume 5

Comment Record
Commentor Ms. Terry Alston Date/Time 2002-09-17 09:16:13
Organization Brunswick Community Hospital
Category Health Professional

Comments for FDA General
Questions
1. General Comments If the facility has the means to resterilize items that have been designated single use and have been opened on the field and have not been used, a policy should be written by the facility to accomodate that action. A clear definition of opened but unused should be established. Any item opened on a non patient contaminated field can be reprocessed.




EC -12