FDA addresses open-but-unused devices
The Food and Drug Administration (FDA) recently answered three new "frequently asked questions" regarding its sweeping revisions of requirements for reprocessing of single-use devices. Under the new regulations, third-party and hospital reprocessors of single-use devices (SUD) are subject to all the regulatory requirements currently applicable to original equipment manufacturers, including pre-market submission requirements.
Since the initiative began Aug. 14, 2000, the FDA has received numerous questions about its requirements, including these three:
Q. What are the regulatory requirements for opened-but-unused SUDs reprocessed by a third-party (commercial) reprocessor?
A. The FDA’s guidance document Enforcement Priorities for SUDs Reprocessed by Third Parties and Hospitals (dated Aug. 14, 2000), defined opened-but-unused single-use devices as "single-use, disposable devices whose sterility has been breached or compromised, or whose sterile package was opened but not been used on a patient, that is, they have not been in contact with blood or bodily fluids." (Appendix B, p. 40.)
In section "C. Scope" of the guidance document, it states that the enforcement priorities do not apply to opened-but-unused SUDs.
This means that at this time, the FDA is not requiring third-party or hospital reprocessors of SUDs to submit PMAs (pre-market approval applications) or 510(k)s (pre-market notification submissions) for open-but-unused SUDs. However, FDA’s existing policy for opened-but-unused SUDs that are reprocessed by third parties remains unchanged: Opened-but-unused SUDs reprocessed by commercial reprocessors are subject to the Quality System Regulation.
Q. Must a reprocessor of SUDs validate its cleaning/disinfection process if the device being reprocessed is not intended to be sterile?
A. Yes. Validation is needed because the results of the cleaning/disinfection process cannot be fully verified by subsequent inspection and testing. Also, because the device is nonsterile, there will not be a subsequent sterilization process to kill any contaminants remaining on the device after cleaning/disinfection.
Q. Since several extensions have been granted, what are the dates that hospital reprocessors of SUDs must meet?
A. The chart summarizes the regulatory requirements and the enforcement dates that apply to hospital reprocessors of SUDs.
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[Editor’s note: For questions regarding the use or interpretation of the FDA guidance, contact Lily Ng at the FDA at (301) 594-2812, or by e-mail to [email protected].]
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