Single-Use Device Reprocessing Still Controversial

Sterilization, packaging, and labeling issues discussed at MDUFMA meeting.

Erik Swain

Two years into the implementation of the Medical Device User Fee and Modernization Act of 1992 (MDUFMA), the law’s provisions regulating the reprocessing of single-use devices (SUDs) remain controversial. And some of the controversy involves sterilization, packaging, and labeling issues.

At the second annual MDUFMA stakeholders meeting, held in November in Gaithersburg, MD, it was evident that the device industry and the reprocessing industry are still at odds over the safety of the practice. FDA, it appears, has staked out a middle ground. The law required the agency to list the reprocessed SUDs that are no longer exempt from submitting 510(k) applications or validation data. In 2004, the agency got around to reviewing the resulting applications.

Of the 1800 models of devices covered in those applications, FDA found 52% substantially equivalent to the original device, allowing those reprocessed SUDs to remain on the market. It found 33% not substantially equivalent, and 15% of the applications were withdrawn by their reprocessor; those SUDs are no longer allowed to be marketed.

Not surprisingly, some device-industry representatives cited those numbers as evidence that SUDs are not safe, while reprocessing-industry representatives cited them as evidence that most are safe, with some not yet declared safe needing some more time to gather the proper data.

A major source of controversy is a MDUFMA provision that requires the reprocessor’s name to be labeled on an SUD. Device-industry representatives have long complained that the original manufacturer is expected to address the failure of a reprocessed SUD despite never intending for the device to be used more than once. MDUFMA calls for the reprocessor to identify itself, but industry maintains that hasn’t solved all the confusion.

“That provision was designed so healthcare professionals would know who is responsible” for a failure, said Johnson & Johnson’s Robert O’Holla, speaking on behalf of device-industry trade association AdvaMed (Washington, DC). “But confusion still exists. The package label still often refers to the OEM. That appears to us to be extremely misleading. The device inside that package is, by FDA rules, a new device.”

To further complicate the matter, the identification requirement in MDUFMA extends to all devices, whether original or reprocessed. The device industry is lobbying to amend that, saying the intent of the requirement was strictly to identify reprocessors and close a loophole in adverse-event reporting, but the reprocessors argue that all should have to play by the same rules.

On the practical side, in the past two years FDA has had its hands full trying to figure out how to evaluate data for sterilization validation, packaging validation, cleaning validation, and functionality testing.

For sterilization validation, the agency is currently recommending that that reprocessors follow ISO 11134 for industrial moist heat or ISO 11135 for ethylene oxide. “Applicants should provide a summary of the sterilization process design and validation activities,” said Steven Turtil of the infection control branch of FDA’s Center for Devices and Radiological Health (CDRH). “We want to see evidence that the device has been sterilized, and that parameters that can be met consistently have been put in place.”

Sterilization questions also played a role in how FDA recommended cleaning validation methods. There were no existing standards on cleaning validation so FDA had to invent them from scratch. The agency’s definition of “clean” ended up meaning, among other things, that the device could subsequently be sterilized successfully, and that residual soil would not accumulate after multiple cycles of reuse and resterilization.

Still, proper packaging validation by reprocessors remains a sizable challenge, said Larry Spears of CDRH’s Office of Compliance.

“We are looking at supplemental validation submissions to help us identify issues in the field,” he said. “One thing we found is that in many cases there is a question as to whether the packaging validation is adequate.”