Reprocessing of single-use devices rakes in US$87M per year as an industry in itself. Of course OEMs of single use devices would prefer that were a US$0 per year industry. Here’s what a gaggle of experts had to say to the Associated Press….
Federal regulators say reprocessing is safe, but original device manufacturers say they can’t guarantee recycled products will work correctly – and that they are wrongly blamed for malfunctions and patient harm caused by reprocessing.
A federal law taking effect Tuesday, requiring reprocessors to put their company name on recycled devices as well as the packaging, could help determine who’s at fault when problems occur. For devices too small to mark, detachable stickers could be transferred to the patient’s chart.
“That’s like a ‘Sue Me!’ sticker,” and may not be used much, said Josephine Torrente, a lawyer and biomedical engineer who consults for device manufacturers.
Dan Vukelich, executive director of the Association of Medical Device Reprocessors, argues reprocessed products are totally safe because each item is inspected before being shipped.
Reprocessed devices are soaked in sterilizing solutions, disassembled, blasted clean with a fine powder, reassembled and inspected, then packaged, sterilized and resealed. On average, they’re reused three to six times.
“It is as safe and effective as a new device if they meet our requirements,” said Larry Spears, compliance chief for medical devices at the Food and Drug Administration.
Since early 2004, when reports of problems with medical devices were first required to note if they had been reprocessed, the FDA has received 13 reports of patient deaths and 421 other trouble reports, including 130 involving serious patient harm, although some may be duplicate reports.
Reprocessors say they must meet stringent FDA standards after first proving they can safely clean and sterilize each type of device. But the manufacturers main trade group, the Advanced Medical Technology Association, notes about half of the reprocessors’ applications for reprocessing of individual devices were rejected by FDA, a sign of the difficulty of properly cleaning complex devices.
University of Pennsylvania bioethicist Arthur Caplan has “qualms” about the practice, particularly because patients don’t give informed consent – required when deviating from the standard of care raises safety or efficacy concerns.
“I just think people ought to know what’s going on,” Caplan said.
All this talk about getting specific consent from the patient seems a bit odd, given how few aspects of patient care they’re required to specifically authorize. Such efforts definitely seem unfairly geared towards OEMs, as we could imagine the average patient’s response to “We’d like your consent to use re-used single-use devices during your surgery.” Wouldn’t a medical professional (a doctor perhaps?) be better suited to make that call?
There wouldn’t be an issue if patients and professionals alike trusted the FDA’s quality regulation of the reprocessed devices. If a reprocessed device was as carefully monitored for quality and safety as it was the first time around, by definition there shouldn’t be any increased risk.
Our advice to OEMs: First, this is what happens when your razor and razorblade costs are out of line with the market – people look for new ways to not pay you money. Second, for all your engineering budgets, make it so that the device is rendered physically un-reusable upon completing it’s task. One way screws and breakaway tabs are your friend.
It’s pretty clear that many devices out there are built around the “razors and razorblades” business model, and reprocessing takes a big chunk out of that market, which can’t be a small part of OEM trade organizations trying to crack down on this. On the other hand, it’s drastically important that reprocessing be conducted with appropriate quality standards and a shift in product liability to the reprocessor, which seems to be the case with this new regulation. Of course, in reality, liability is usually shifted towards the potential defendant with the largest bank account.
More from the FDA…
