The Food and Drugs Administration is very much concerned about a letter than brought in companies that proved non-compliant with the reporting requirements for manufacture of certain medical equipment.
FDA sent the letters following inspections of manufacturing plants both in Japan and the U.S. The letters were sent to Fujifilm, Olympus Medical Systems and Hoya’s Pentax, which are all headquartered in Japan (Burton, Wall Street Journal, 8/17).
The agency discovered that the company did not inform about infections in patients, and it also has no standard procedure to report problems in medical devices.
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.
In the last few years, duodenoscopes have been linked to “superbug” infections at a handful of hospitals including the Ronald Reagan Medical Center at the University of California Los Angeles and Virginia Mason Medical Center in Seattle.
Regulators also cited two other examples of late injury reports from Olympus.
The warning came following surprise inspections carried out by FDA teams at the manufacturing units of the three companies.
As per the norms, any medical device manufacturer is supposed to report to the FDA about problems associated with their devices within 30 days of testing. Seven patients were confirmed to have CRE infections, and two of those patients died. For example, Olympus learned that 16 patients contracted the bacterial infection Pseudomonas aeruginosa after endoscopies in May 2012.
Olympus has 15 business days to respond to the FDA’s most recent letter by providing specific actions the company has undertaken to correct the reported issues “including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again”.
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. Superbugs are antibiotic-resistant bacteria, and infections are incredibly hard to treat.
Olympus, which controls 85% of the specialty endoscope market in the U.S., and its devices have been linked to six of the nine recent superbug outbreaks, including at UCLA.
The agency also determined that Fujifilm has been selling a scope without getting the required clearance from the FDA. The agency has received at least 142 reports of duodenoscope-related patient infections since 2010.
FDA first cautioned its potential to be contracted publicly in 2009 and since then a lot of outbreaks happened in multiple US hospitals, many of them were caused by unsterilized duodenoscopies.