If a surgeon uses what was labeled a "single-use" medical device that has been reprocessed — a common practice in hospitals nationwide regulated by the Food and Drug Administration — who's liable if something goes wrong?
Between discussions of funding for sex offender treatment and restitution payments for crime victims, the Law Enforcement and Criminal Justice Committee Wednesday morning discussed what to do about secondary use of medical devices.
Many medical devices are routinely sent out for reprocessing that's designed to make them basically new again. But Fred Lampropoulos, CEO and chairman of Merit Medical and former GOP gubernatorial candidate, said his company makes many single-use devices, and they are concerned about reuse.
"A reprocessed device is not the same as a new device," he said, just as "a retread is not a new tire." He believes the result is a device that "has different properties" from the original.
Because of that, "it's an unfair burden to have to defend ourselves" if something goes wrong with use of the device.
Committee chairman Sen. Chris Buttars, R-West Jordan, made it clear he wants to see the original manufacturer taken out of the picture if there's liability with a reprocessed device and said the committee would have a bill to consider next month. Although he said there are a number of issues surrounding reprocessing, he limited testimony after Merit Medical representatives spoke to the issue of liability.
Reprocessing cleans, sterilizes, tests and inspects, then sends the device back to the hospital. Nationally, three different reprocessors handle about 90 percent of the product rehabilitation. A couple of panelists questioned whether the issue should be resolved on a national level, rather than state by state.
Greg Fredde, a lobbyist for Merit Medical Systems, assured the committee that a law releasing the original manufacturer from liability for a reprocessed device would become model legislation for other states. He complained that some reprocessed devices look like they're from the original manufacturer, with nothing on the device to indicate it's been reprocessed.
Buttars said that the manufacturers should be protected against the dangers of unauthorized use, which in this case would simply be any reuse of a single-use item. A company, he said, "could go out of business on a thing like this if they get a catastrophic (reprocessed) product."
Sen. Peter Knudson noted the committee had only heard one side. "Realistically, would these systems that provide health care want to put patients at risk?" He urged the committee to hear "the other side before thundering down the road."
The other side came from Pamela J. Furman, executive director of the Association of Medical Device Reprocessors and an attorney specializing in FDA medical device law. She noted the single-use designation is one "chosen by manufacturers, sometimes to sell more, not for patient safety," and not an FDA requirement.
There are clearly many items labeled single use that can be cleaned up and used again, she said, the "reason reprocessing has been standard practice for over two decades." She says doing so saves money and needless waste.
Furman distributed copies of a 2000 General Accounting Office investigation of reprocessing that noted a "lack of meaning of the single-use label."
She also presented material showing the FDA itself has cited "a lack of evidence of adverse effects" from medical-device reprocessing.
Reprocessors should be liable if something in the reprocessing leads to a product failure that harms a patient, she said. But just removing all liability from a product if it's reused doesn't serve the patient well, since some problems can stem from design flaws.
She cited the example of an electrophysiologic catheter. Occasionally, she said, the tip breaks off, but there's no evidence it breaks off more because of reprocessing.
If a problem is the "result of manufacturing, it should be theirs, if reprocessing, ours."