Urgent Recall Issued for Duodenoscopes
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Medical device manufacturer Fujifilm recently coordinated with the Food and Drug Administration (FDA) to issue a voluntary but urgent recall of a device known as a duodenoscope. Used to examine the upper part of the digestive tract, especially the top of the small intestine (the duodenum), these devices are threaded through a patient’s mouth, throat, and stomach.
Unfortunately, they can also pass infections from patient to patient if not sterilized thoroughly between uses. The recall is specific to the company’s ED-530XT model.
Beginning in October, the company will collect affected scopes from current users and replace several parts, as well as the manual that describes proper cleaning procedures. From this point forward, users will be expected to send their scopes to Fujifilm for an annual inspection to ensure that they are properly maintained.
The FDA has made it known since February of 2015 that it had concerns about duodenoscopes in general. At that time, it estimated that more than half a million procedures were performed annually with the devices, and that potential problems existed with their sterilization between procedures.
The FDA had accumulated reports of 135 patients falling ill after undergoing a procedure with this class of device. Fujifilm has been working with the FDA since May 2015 and released new FDA-approved cleaning procedures in December of that year. It also pulled several older models from the market earlier this year.
It’s not clear how many units the ED-530XT recall applies to or how many patients have been harmed by it, if any. To date, it doesn’t appear that any patient has been the victim of a fatal incident.
That can’t be said of all similar devices, however.
The same week that this recall was announced, a Washington State jury awarded $1 million to the family of a man who died in 2013 after suffering a severe infection traced to a duodenoscope procedure in a Seattle hospital.
That scope, the TJF-Q180V made by Olympus, was not found to be dangerous by design, but the jury determined that Olympus had been aware of problems with its use and cleaning instructions as much as a year before that patient was infected and had avoided warning users. It held Olympus partly to blame for the victim’s death.
At least thirty-five patients have died from this same issue, many from so-called “superbug” infections traced to improperly handled Olympus scopes.
If you or a loved one has been harmed by a defective or dangerous medical device, such as an improperly sterilized duodenoscope, give Craig Swapp & Associates a call. The attorneys in our office have experience with defective medical products and we offer a free consultation to all clients to discuss the specifics of their case.
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