FDA Updates Guidance on Reprocessing of Single-Use Devices

Late last month, FDA's Center for Devices and Radiological Health (CDRH; Rockville, MD) issued updated guidance on the reprocessing of single-use devices (SUDs). Under the new guidelines, reprocessors of some SUDs that were previously exempt from submitting validation data will now be required to provide the information as part of their premarket notification (510(k)) submissions.

Detailed data on cleaning, sterilization, and functional performance of the device must demonstrate that each SUD will remain substantially equivalent to a predicate device after reaching the designated maximum number of times the device can be reprocessed. In accordance with the revised guidance, FDA has updated the list of critical and semicritical devices that will now require validation data.

“The types of adverse events reported to be associated with the use of SUDs are the same types of events that are also being reported for new, nonreprocessed devices,” CDRH director Daniel Schultz, MD, told the House Committee on Government Reform. He said CDRH drew its conclusions following an extensive review of all available data on reported incidents. Schultz assured the committee that the agency has a number of tools in place to monitor the safety and performance of SUDs, and concluded his testimony by stating, “SUDs that meet FDA's regulatory requirements are as safe and effective as a new device.”

Medtech industry associations remain concerned about the use of SUDs. Testifying before the House committee, Stephen Ubl, president and CEO of AdvaMed (Washington, DC), said, “The reprocessing of medical devices designed to be used once is inherently risky.”

Similarly, Mark Leahey, executive director of the Medical Device Manufacturers Association (Washington, DC), said, “The first priority is safety. Yet, while SUD advocates talk about cost savings, can anyone actually point to a patient bill that reflects savings attributed to the use of SUDs?”

FDA's revised guidance comes at a time when certain states have passed or are considering laws regarding the use of reprocessed SUDs.

A Utah law “requires a reprocessor of a critical single-use medical device to assume the liability associated with the original manufacturing and the reprocessing of the critical single-use medical device.” The Illinois State Assembly passed a resolution that would “ protect the public health and safety by prohibiting the unregulated reuse, recycling, and refurbishing of single-use surgical devices.” The statute permits only state-licensed hospitals and entities that are registered with and regulated by FDA to reprocess SUDs.

Legislation introduced in Massachusetts, Virginia, and Rhode Island would require hospitals and doctors to notify and obtain consent from patients before reprocessed devices could be used in their procedures. The law under consideration in Virginia would ban reprocessed single-use needle or syringes. Similar to the Utah statute, it would also hold the reprocessor—not the original equipment manufacturer (OEM)—liable for the safety and efficacy of reprocessed SUDs.

More than 20 patient-advocacy organizations and the HealthCare Institute of New Jersey (Bridgewater, NJ) recently announced the formation of a coalition known as PatientGUARD (Groups United against Reprocessing Dangers). The coalition's goal is to raise awareness among physicians and the public about the risks it says surgical patients face from reprocessed single-use medical devices.

The group is pushing the New Jersey legislature to enact a law that would require patient consent before reprocessed SUDs are used in their procedures.

“The Food and Drug Administration hasn't done enough to either protect or inform the public of the dangers of reprocessed single-use devices,” said Bob Franks, president of the HealthCare Institute of New Jersey. “Lacking adequate federal oversight, states need to step in to ensure the public's safety.”

The Association of Medical Device Reprocessors (AMDR; Washington, DC) maintains that reprocessed SUDs are safe and effective. The association says that OEM opposition to reprocessing is predicated on a “concern for profits—not patient safety.” AMDR is supported by many hospitals that see the use of reprocessed SUDs as a means of achieving significant cost savings while reducing medical waste.

The use of reprocessed SUDs continues to generate a great deal of controversy. According to several law firms specializing in medical device product liability issues, it is likely that more states will pass legislation regulating reprocessed SUDs.

According to CDRH director Schultz, as of last month, FDA has received nearly 200 510(k) submissions for reprocessed SUDs, of which approximately 67% have been cleared. The remaining ones were not cleared due to inadequate validation data, lack of necessary information from the reprocessors, withdrawal of the applications, or failure to respond to FDA's request for data.

Complete information on FDA's updated guidance on reprocessing SUDs is available via the CDRH Web site at www.fda.gov/cdrh/reuse.

© 2006 Canon Communications LLC

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