The February outbreak of carbapenem-resistant Enterobacteriacaea (CRE) at a Los Angeles hospital prompted the FDA to assemble a panel of experts to determine the fate of the device responsible for spreading the infection.
A couple of weeks ago, the Gastroenterology and Urology Devices advisory committee unanimously agreed that the device, a specialized endoscope inserted into a patient’s throat, does not offer “reasonable assurance of safety and efficacy,” according to a report on MedPageToday.com.
That conclusion was no surprise, because several other hospitals had documented outbreaks related to its use, and the FDA had known about for a couple of years.
The panel decided that although the equipment was difficult if not impossible to disinfect thoroughly between patients, it should not be banned from use because it was needed to treat people with certain life-threatening conditions. It advised the FDA to reclassify duodenoscopes from semi-critical medical devices to critical medical devices.
The advisors called for new protocols to ensure that the scopes can be made reliably sterile, and in deciding to allow them, came down on the “benefit” side of the risk/benefit analysis because the devices provide a unique method of visualizing internal body parts that can’t be duplicated via other means.
Their intricate design affords them superior viewing, but the complex, tiny parts are also what make more difficult to sterilize.
The committee laid out several criteria by which to determine if a patient’s condition demands the endoscopes’ use and, if so, measures that should be followed strictly to enhance the chances of complete sterilization.
The advisors’ recommendations aren’t binding, but the FDA usually relies on them heavily when devising final rules and guidance.
The FDA lacks authority to require device manufacturers to alter their designs, but it can withdraw those deemed too unsafe to justify continued use, and to require changes to device labeling. But it can’t require hospitals to follow label directions.
If you or a loved one are scheduled for an endoscopic procedure, ask your doctor what all of the risks are and what outcome is expected. Find out as much as you can about the device and the protocols used to sterilize it. If it is manufactured by Olympus, whose device caused the recent outbreaks, make sure there is no alternative treatment.
If you are unsatisfied with the answers or the measures taken to protect you from contamination, go elsewhere. You can read the advisory committee’s report here.