What sterilization activities does FDA expect in a hospital reprocessor that is reprocessing single-use devices (SUDs)?
Answer. A hospital reprocessor that reprocesses SUDs is considered a device manufacturer as defined under 21 CFR 820.3(o). As such, FDA expects that its sterilization reprocessing of SUDs will meet the requirements of the Quality System (QS) regulation (21 CFR Part 820). This regulation is applicable to the sterilization activities in many ways. Several key elements affect whether a device is sterile or nonsterile and whether it will function as intended at the conclusion of the process.
Related Questions
- Should my hospital comply with the Quality System regulation even if the SUDs that we are reprocessing do not require premarket submissions to the FDA?
- What kinds of documentation should a hospital reprocessor maintain for sterilization reprocessing of SUDs?
- How can I obtain information about third-party reprocessors of single-use devices (SUDs)?
