Docket Management
Docket: 01D-0514 - Medical Devices; Guidance on Labeling of Reprocessed Single Use Devices
Comment Number: EC -9

Accepted - Volume 1

Comment Record
Commentor Mr. Don Selvey Date/Time 2002-03-19 15:15:20
Organization Alliance Medical Corporation
Category Company

Comments for FDA General
Questions
1. General Comments March 19, 2002 Food and Drug Administration Dockets Management Branch (HFA-305) 5630 Fishers Lane Room 1061 Rockville, Maryland 20852 Re: Docket No. 01D-0514 Dear Sir or Madam: Alliance Medical Corporation, a leading reprocessor of single use medical devices, appreciates the opportunity to comment on the above-referenced docket, regarding the need for and contents of a guidance document on the labeling of reprocessed single use devices. We do not believe additional guidance is necessary. It is very clear to us as a reprocessor, as well as to our customers, that we bear responsibility for device problems resulting from reprocessing. Our package labels clearly identify each device as “Reprocessed by” Alliance Medical Corporation. It is also our viewpoint that information identifying the original manufacturer of the device should remain visible on the device and be included on the package label. Our hospital customers have informed us of the importance of this information in order to be able to make informed decisions regarding purchase and use of these products. They typically offer a couple of reasons: First, not all medical devices, even of the same type and for the same use, have the same quality, durability, and robustness. Medical devices of some manufacturers are inferior to similar devices made by other manufacturers. Consequently, it is important to hospital material managers to know which devices provide the greatest value. Second, some surgeons develop a strong loyalty to a particular brand of device, usually related to the quality of the device. Removing manufacturer information from the labeling of reprocessed devices will make it more difficult for the staff of hospitals using reprocessed devices to identify the device the surgeon prefers. Although merely an inconvenience, it is one that is not necessary to impose on surgeons. No additional guidance is needed. We suggest to you that adequate controls are already in place to assure that device problems are attributed to the reprocessors, when appropriate. Further, premarket submissions include prototypical labeling which is reviewed by the agency. Any potentially misleading statements regarding the responsibility of an original manufacturer for a reprocessed device can be identified and corrected during the review process. Thank you for allowing us to offer our comments on this matter. Best regards, Don Selvey, Vice President Regulatory Affairs and Quality Assurance Alliance Medical Corporation (888) 888-3433 x 5339




EC -9