Docket Management
Docket: 01D-0514 - Medical Devices; Guidance on Labeling of Reprocessed Single Use Devices
Comment Number: EC -4

Accepted - Volume 1

Comment Record
Commentor Mrs. Norene Fields Date/Time 2002-02-05 13:49:36
Organization St. John's Hospital
Category Health Professional

Comments for FDA General
1. General Comments To afford our patients the same level of safety for both first use and subsequent reuse of a reprocessed SUD, it is important that device labels of reprocessed SUDs include the name of the OEM with the OEMs lot control information, latex content information, and original material degradation expiration dates. OEM product recalls cannot be identified on a reprocessed SUD if the OEM name and lot control information are not required, along with the reprocessor's name and lot controls. Also, when the material shelf life of a device may have been changed through the act of reprocessing, the reprocessor should provide a new or revised expiration date on the label. Thank you for the opportunity to comment. N. Fields, CSPDM

EC -4