FDA Warns Three Medical Scope Makers Linked to Outbreak in Calif.

Three companies that manufactured duodenoscopes linked to a recent superbug outbreak failed to properly report issues with the devices and ensure they could be cleaned appropriately, according to FDA warning letters released Monday, the Washington Post's "To Your Health" reports (Dennis, "To Your Health," Washington Post, 8/17).

Background

As many as 179 patients could have been exposed to Carbapenem-resistant Enterobacteriaceae, or CRE, after undergoing a procedure with a duodenoscope -- also called an endoscopic retrograde cholangiopancreatography -- at UCLA's Ronald Reagan Medical Center between October 2014 and January 2015. Seven patients were confirmed to have CRE infections, and two of those patients died.

Meanwhile, Cedars-Sinai Medical Center in Los Angeles in March reported that four patients had been infected with CRE and that up to 67 more might have been exposed after being treated with the same type of scope (California Healthline, 5/14).

Warning Letter Details

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).

In its letters to Olympus and Pentax, FDA alleged the companies did not notify it in a timely manner when they discovered one of their scopes may have "caused or contributed to a death or serious injury" ("To Your Health," Washington Post, 8/17). 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. Meanwhile, Pentax also failed to notify FDA of various events related to the scopes within 30 days.

In its letter to Fujifilm, FDA alleged the company violated a range of standards related to manufacturing the scopes and inadequately handled complaints related to the devices (Wall Street Journal, 8/17).

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 two companies were also cited for violating their marketing applications for the scopes and failing to apply for proper approval for at least one of each company's devices.

FDA in a statement said it "takes these violations very seriously and will continue to monitor these firms to ensure they take appropriate corrective action." It added, "However, currently available information indicates that the benefits of these devices continue to outweigh the risks in appropriately selected patients" (Clarke, Reuters, 8/17).

According to the Los Angeles Times, the companies have until Aug. 27 to respond. FDA has not announced any penalties associated with the violations (Terhune/Petersen, Los Angeles Times, 8/17).

Reaction

Olympus said it is reviewing the letter.

Pentax said it is "working closely with FDA to resolve the noted issues and ensuring that [its] devices meet the highest standards of safety and quality."

Likewise, Fujifilm said it is also working closely with FDA, adding, "Actions have been and will continue to be taken to ensure that [its] products and processes meet FDA requirements and pose no risks to the health and safety of the public" (Wall Street Journal, 8/17).

Meanwhile, Rep. Ted Lieu (D-Calif.) said FDA's findings are "disturbing" and called for immediate congressional hearings on the events. He said, "The fact that it took [Olympus] three years to report patient infections is flat out unacceptable," adding, "If scope manufacturers had reported infections earlier, then lives might have been saved" (Los Angeles Times, 8/17).