This article was originally published in the Medical Device User Facility Bulletin, Issue 40, Fall 2002
A THIRD-PARTY REPROCESSOR FOR SIGNLE-USE DEVICES
When selecting a third-party reprocessor of single-use devices (SUDs), FDA suggests you talk with other hospitals to determine their experiences with third-party reprocessors and arrange to visit the reprocessor's facilities. In addition, you might consider asking a potential reprocessor the following questions:
- When did FDA last inspect your facility? What were the results of that inspection?
- Do you have documentation that your company has premarket clearance or approval for each type of SUD that it reprocesses?
- How do you monitor the manufacturing processes and what records do you maintain in order to comply with FDA's Quality System Regulation?
- What aspects of your overall process have been validated, for example, cleaning, packaging, sterilization?
- Has your company set limits on the number of times a SUD can be reprocessed? If yes, how did you determine the number of times a SUD can be reprocessed? What procedures do you have in place to ensure that a SUD is not reprocessed beyond the set number of times?
To obtain the 483 inspection report from a reprocessor's most recent FDA inspection, contact FDA's Freedom of Information Staff by fax at 301-443-1719 or 301-443-1726. Also, you can obtain information about a reprocessor's inspection history at CDRH FOIA Electronic Reading Room.