The Food and Drug Administration sent warning letters to the three makers of a specialized medical device that has been linked to outbreaks of so-called superbug infections at U.S. hospitals. The FDA additionally cited Olympus and Pentax for failing to correctly notify the company after the businesses discovered that infections had been linked to their scopes.
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The FDA cited Oympus and Pentax for failing to notify regulators that their devices “may have caused or contributed to a death or serious injury” within 30 days of learning about the event, as required by the FDA.
Olympus spokesman Mark Miller told Bloomberg in an email that the company is reviewing the warning letter “so that we can provide the required response in a timely manner”.
Sent last August 12, the letter mentioned Fujifilm’s Holdings Corp and the Olympus Corp Pentax Medical that gained multiple violations during the audits of their facilities here in the US.
In addition, FDA’s letters to Fujifilm and Pentax claimed the companies did not validate their detailed cleaning instructions for the scopes (“To Your Health”, Washington Post, 8/17). The agency has received at least 142 reports of duodenoscope-related patient infections since 2010.
The device, known as a duodenoscope, is snaked down the esophagus into the top of the small intestine and is used in diagnostic and treatment procedures related to cancer and other conditions. According to FDA, Olympus knew of an outbreak involving 16 patients in May 2012 but did not inform FDA of the event until this year.
The FDA argues Fujifilm made significant changes in its ED-530XT and ED-450XT5 devices and ought to have filed a separate 510(k) application to guarantee the safety and effectiveness of the device before marketing it. And the same goes for Pentax’s ED-3670TK and ED-3490TK devices. And the risk of getting an infection from an inadequately cleaned device is “relatively low” given the number in use, FDA spokeswoman Jennifer Dooren told The Los Angeles Times earlier this month. But the experts agreed with regulators that the devices should remain in use because there isn’t a better alternative for patients who can benefit from the procedure.
Despite these problems, the FDA previously ruled it would keep the devices on the market because they fill an important need in a half-million procedures performed each year.
Olympus accounts for about 85 percent of sales of endoscopes in the U.S., according to the FDA.
Woods said patient safety is paramount when it comes to endoscopies and urged clinicians to work with their institutions to “ensure vigilance around cleaning and reprocessing of scopes”.
The agency issued the warning letters based on the inspection reports.
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Since 2013, there have been eight outbreaks of antibiotic-resistant bacteria linked to the devices at U.S. hospitals, according to government figures. This yr, the FDA stated Olympus ought to have gotten a brand new 510Okay clearance for its newest scope, and now it cites FujiFilm for a similar drawback.
