Reprocessed medical devices are already a controversial subject in medical device circles. A recent deadly "superbug" at UCLA may have just made them even more worrisome.
Chris Newmarker and Brian Buntz
Updated February 25, 2015
|A close-up view of an ERCP endoscope tip. (Image courtesy of FDA)|
Reprocessed medical devices of all stripes could receive more scrutiny than ever in the United States, after news that at least seven patients were infected and two died from a drug-resistant "superbug" at UCLA's Ronald Reagan Medical Center. In total, 179 patients may have been exposed to bacteria from a contaminated reprocessed medical device.
Already last week, FDA was warning about the dangers of infections connected with reprocessed ERCP endoscopes (also called duodenoscopes), which are involved in about half a million U.S. procedures annually. UCLA traced the bacterial strain carbapenem-resistant Enterobacteriaceae from one patient to two of these endoscopes, according to the LA Times. (The plot thickened this week with a lawsuit against duodenoscopes maker Olympus, and criticism that FDA should have done more.)
Particular scrutiny is now turning to reprocessed duodenoscopes, which are made by companies including Fujifilm, Olympus, and Hoya's Pentax Medical. Threaded down through the digestive tract and into the small intestine, duodenoscopes provide the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions. But the duodenoscopes' movable "elevator" mechanism at the tip, while improving efficiency and effectiveness, are challenging to disinfect, according to the FDA.
"Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly," FDA said in its announcement. "Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it."
For now, the FDA is recommending that health providers closely follow manufacturing instructions for cleaning and processing, and discuss the risks with patients.
The ERCP endoscopes in question are actually designed for reuse. But it is worth noting that the third-party reprocessing of medical devices designed for single use has stirred controversy in recent years.
If a reusable device sterilized in a hospital is problematic, what about a device supposedly for single use that is sterilized by a third party?
The Association of Medical Device Reprocessors insists the two scenarios are different. "It's not the same kind of reprocessing," Dan Vukelich, the AMDR's president and CEO, said in an email.
"Our members operate independent facilities that are subject to all of FDA medical device manufacturer requirements," Vukelich said. "All U.S. members of AMDR are in substantial compliance with FDA's requirements."
The uptick in reprocessing has cut into the bottom line of some medical device companies, which have watched in dismay as their products were cleaned and then resold by a third party. Reprocessed devices, however, have proven to be popular among hospitals, as they often cost substantially less than new devices and are billed as a "greener" alternative to brand-new devices.
Although the FDA requires reprocessed devices to meet certain specifications related to cleanliness, sterility, and functionality, critics of the process--which include many device companies--point out that reprocessed medical devices represent a safety risk. They could either cause bacterial infection, or the sterilization process itself could cause potentially risky unintended mechanical changes to the device.
In 2008, the Government Accountability Office released a report persuading that reprocessed single-use devices were safe. It noted that, of 320,000 adverse events tracked by FDA from 2000 to 2006, only 65 adverse events suspected to be caused by reprocessed single-use devices.
In recent years, Europe has also become more cautious with respect to reprocessing of medical devices. While ruling that devices could be reused by default, the European Parliament ruled that devices designed for a single use could not be reprocessed to be reused in the future.
The European trade organization Eucomed has argued that reprocessing of single-use devices is unsafe, owing to the risk of potential risk of cross infection, leaching of disinfectants, material alteration, and mechanical failure.
|Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.|
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