Medical Device User Fee and Modernization Act (MDUFMA)
In October 2002, the FDA’s Medical Device User Fee and Modernization Act (MDUFMA) was signed into law. Highlights include:
- MDUFMA imposed a number of additional requirements to further regulate the reuse of SUDs beyond existing regulations for OEMs.
- MDUFMArequired FDA to review the critical and semicritical reprocessed SUDS that were previously exempt from premarket notification requirements and determine which of these devices now required premarket approval (PMA).
Under MDUFMA, SUD reprocessors were also required to submit:
- Additional supporting documentation for certain devices that were currently being marketed and had already received510 (k) clearance for them to continue to be legally marketed; and
- Submission of additional validation data with certain new510(k) submissions.
- Labeling Requirements:
- As of August 1, 2006 for all reprocessed SUDs, the reprocessor must be identified through a mark on the device or attachment (e.g., detachable label). See FDA labeling requirements
- Adverse Event Reporting Requirements:
- MDUFMA required FDA to modify the mandatory and voluntary MedWatch forms to include boxes indicating whether a device was a reprocessed “single-use” device and the name of the reprocessor. FDA revised the forms in February of 2004 (For additional information and copies of the forms, see Reporting Forms ).
The additional validation data include cleaning and sterilization data and functional performance data demonstrating that each SUD will remain substantially equivalent to its predicate (i.e., original) device after the maximum number of times the device is reprocessed as intended by the person submitting the premarket notification.
FDA’s Registration and Listing database includes all devices a given manufacturer, including reprocessors, has made available on the U.S market. Hospitals can verify reprocessor product offerings by searching this database by the name of the reprocessor. To find the current list of third-party reprocessors, use the drop-down menu for “Establishment Type” in the Search Database section and select “Reprocessor of Single”. Then select “Search” and a list of reprocessors who have registered with the FDA will be displayed. Alternatively, as with any other medical device, hospitals can research FDA’s 510(k) premarket notification (clearance) database by manufacturer or device name for more information on devices that have cleared by FDA.
Third party reprocessors
The Association of Medical Device Reprocessors (AMDR) is a trade association representing third-party reprocessors of single-use medical devices. Membership in this organization is voluntary. It is estimated that AMDR members perform the majority of the third-party reprocessing done in the United States and Germany. Members of the AMDR agree to be registered with the FDA and comply with all FDA requirements including the “Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals.” Members must maintain a minimum of $5 million in liability coverage (range $10 – 50 million) and comply with standards or requirements of the Association for the Advancement of Medical Instrumentation (AAMI), the American Hospital Association (AHA), the Association of Operating Room Nurses (AORN), the Centers for Disease Control and Prevention (CDC), state-licensing boards, and pertinent legislative requirements.