Docket Management
Docket: 02N-0456 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -22

Accepted - Volume 1

Comment Record
Commentor Ms. Dorothy Fogg Date/Time 2002-11-04 20:09:37
Organization Association of periOperative Registerd Nurses
Category Association

Comments for FDA General
1. General Comments OPENED AND PLACED ON THE STERILE FIELD IN THE OPERATING ROOM, BUT NOT USED FOR OR PLACED IN THE PATIENT: Any item (single or multiple use) opened and placed on the sterile field is contaminated to that patient. When the item is placed on the sterile back table or on/within any other part of the sterile, one cannot be assured that it is not touched by a member of the sterile field wearing gloves that have touched the patient and/or the patientís blood. Further, it is impossible to assure that soiled items and/or contaminated aerosols have not come in contact with the item. Therefore, the item would require cleaning before any additional processing could take place. Any item that cannot be cleaned cannot be reprocessed. OPENED BUT NOT PLACED ON THE STERILE FIELD: When the packaging of a sterile single-use item is opened, that item is either aseptically delivered to the user for immediate use or discarded. A third option is to retain and reprocess the item for future use. Processing (cleaning, disinfecting/sterilizing) has the potential to affect the single-use product and its safe use, regardless of whether that product was actually used for a patient. Processing the item may lead to subtle changes in the materials composing the device, loss of device functionality, and/or loss of device integrity if even if the device appears to be functional after processing. Because processing has the potential to affect the product, the reprocessed item should be subjected to appropriate post-processing testing to assure that the item is as safe for use as the original (non-reprocessed) item.

EC -22