Just as it is tasked with determining whether prescription drugs should be approved for sale in the United States, the Food and Drug Administration (FDA) is also tasked with determining which medical devices should be approved. While some problems that come up with these devices are simply instances of medical malpractice on the part of a healthcare provider, other times the problems are a result of the devices themselves. That is what makes the approval process so important. It appears now that one medical device believed to be responsible for patient illnesses and deaths was never approved by the FDA for sale to begin with.
Dangerous Superbug Scopes Not FDA Approved
CNN reports that the manufacturer of the endoscope connected to two UCLA patient deaths from a superbug never obtained FDA approval to sell the endoscope. The company, Olympus, started selling the TJF-Q180V duodenoscope in 2010. The FDA then realized in either 2013 or 2014 that Olympus had never even asked for the agency’s permission to market the scope. The device manufacturer says that it did not think it needed to ask for permission, but it has now filed a proper request. Its application is pending.
Was Olympus Required to Ask Permission?
Under the FDA’s rules a medical device manufacturer must seek approval for a new model of a device if the new model includes changes that “could significantly affect the safety or effectiveness of the device.” While it is so far unclear whether Olympus should have realized that this version of the scope included changes that would make it less safe then the previous model, in hindsight that seems to be the case.
When Olympus created the new model which has lead to the outbreak it sealed the part of the device called the “elevator channel.” Its theory was that doing this would make the device less likely to spread infection. In reality what has happened is that sealing the elevator channel made the device more difficult to clean which is the suspected cause of the UCLA outbreak. Because this portion of the scope could not be properly cleaned a deadly drug-resistant bacteria remained in the scope after it was used on an infected patient. Then, when the scope was used on other patients, they were also exposed. In total 179 patients may have been exposed at UCLA alone. Additionally, four patients at Cedars-Sinai Medical Center have also been infected with CRE, the superbug linked to the scopes. There were sixty-four other patients at that hospital who were treated with the infected scope.
FDA Requests More Evidence
As a result of the outbreak, the FDA has requested that Olympus and two other manufacturers of similar scopes, Pentax and Fujifilm, provide the agency with evidence that the scopes can be thoroughly cleaned. So far the companies have not been able to prove that cleaning can rid the scopes of 99.9999% of all microbes, which is required for disinfection.
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