Scope maker Olympus Corp., already under investigation for several superbug outbreaks, waited three years to alert federal regulators about 16 patient infections the company learned about in 2012.
The Food and Drug Administration cited that lapse in reporting and other safety-related violations in warning letters to Olympus and two other scope manufacturers. The FDA posted the letters online Monday.
The government's findings offer further evidence that manufacturers knew about problems with these gastrointestinal scopes well before deadly infections became a major public health issue this year.
Under federal rules, companies are supposed to report potential injuries and deaths related to their devices to the FDA within 30 days.
The warning letters mark the FDA's strongest action against the device makers since an outbreak of antibiotic-resistant bacteria at UCLA's Ronald Reagan Medical Center grabbed national headlines in February.
Some medical experts and federal lawmakers welcomed the agency's moves Monday. But they continued to question why regulators have taken so long to act despite earlier warnings about the risk to patients.
Rep. Ted Lieu (D-Los Angeles) called the latest revelations “disturbing” and further reason to hold congressional hearings right away.
“The fact that it took the leading scope manufacturer three years to report patient infections is flat out unacceptable,” Lieu said. “If scope manufacturers had reported infections earlier, then lives might have been saved.”
In its warning letters, the FDA cited a wide range of violations after officials inspected facilities of Olympus, Pentax Medical and Fujifilm in March and April, records show. The inspections took place in Japan and the U.S.
The agency gave the companies 15 business days from receipt of the Aug. 12 letters to respond to the violations that were found. No penalties were announced.
“The FDA takes these violations very seriously and will continue to monitor these firms to ensure they take appropriate corrective action,” said agency spokeswoman Jennifer Dooren.
Olympus, which controls 85% of the specialty endoscope market in the U.S., has been linked to six of the nine recent superbug outbreaks, including at UCLA where three patients died.
Mark Miller, a spokesman for Olympus, said “we are reviewing the FDA's warning letter so that we can provide the required response.”
The FDA said Olympus became aware of 16 patient infections in May 2012, but didn't report them to U.S. authorities until March 2015.
Regulators also cited two other examples of late injury reports from Olympus.
The company became aware of one incident in November 2013 and another in June 2014. Olympus submitted data on both events to the FDA in March — a month after The Times broke the news about the UCLA outbreak.
“Failing to file a report on time places patients at serious risk unnecessarily,” said Lawrence Muscarella, a hospital safety consultant in Montgomeryville, Pa. “A three-year delay in filing a report is unreasonable, compromises safety and should have been flagged months ago.”
The 2012 incident appears to be an outbreak that occurred at a Netherlands hospital. The FDA wouldn’t comment further on the details.
As a result of the Dutch outbreak, Olympus sent an urgent warning to European hospitals in January 2013, telling them to use a special brush in cleaning the duodenoscopes. Even so, the company didn’t notify U.S. hospitals or regulators.
The FDA said it didn’t learn until last year of the company’s European alert.
For Pentax, federal regulators said the company filed reports last year regarding “fragments of cleaning brushes, stents and a dilation balloon” left inside duodenoscopes after they were cleaned.
But U.S. officials said Pentax’s response failed to address how hospitals and doctors should deal with these “obstructions” that could be left inside patients and harm them.
Pentax said it’s reviewing the FDA warning letter. “We take regulatory compliance very seriously,” said Mark Koppel, chief medical officer at Pentax Medical Americas.
The disclosures Monday also revealed that Fujifilm has been selling a duodenoscope without the necessary FDA clearance.
The agency had previously disclosed the same problem with the latest scope model from Olympus, which has been on the market since 2010. Both companies had contended that their designs were similar enough to previous versions to avoid additional regulatory review.
The FDA disagreed and told both companies to submit applications, which are pending. The agency said it’s seeking more information from Pentax on whether its devices face a similar compliance problem.
In a statement, Fujifilm said “actions have been and will continue to be taken to ensure that our products and processes meet FDA requirements.”
Sen. Patty Murray (D-Washington) said the information released Monday raises more questions about FDA oversight of device makers.
“The patients and families who have been impacted deserve the facts,” Murray said. “That’s why I asked the FDA to conduct a full investigation into how this happened in the first place.”
In addition to the ongoing FDA investigation, prosecutors with the U.S. Justice Department have sent subpoenas to all three scope makers in connection with the recent outbreaks.
Duodenoscopes are used in a procedure known as ERCP, or endoscopic retrograde cholangiopancreatography.
During the procedure, a flexible scope is put down a patient’s throat to diagnose and treat problems in the digestive tract such as cancers and blockages in the bile duct. Nearly 700,000 such procedures are performed annually in the U.S.
The tip of these intricate instruments has proved to be the most difficult part to clean. Infections have occurred because dangerous bacteria became trapped around an elevator channel that holds guide wires and catheters.
Despite the risks, the FDA reiterated Monday that these scopes should remain on the market because there isn’t a better alternative for patients who can benefit from their use.
Dooren, the FDA spokeswoman, said “removing these devices from the market would prevent thousands of patients from accessing this beneficial and often life-saving procedure.”