Gastrointestinal scope maker Olympus Corp. waited three years to alert federal regulators about 16 patient superbug infections the company learned about in 2012.
The Food and Drug Administration (FDA) cited that lapse in reporting and other safety-related violations in warning letters to Olympus and two other scope manufacturers. The letters were posted online Monday, the Los Angeles Times reports.
These findings offer further evidence that manufacturers knew about problems with the gastrointestinal scopes well before deadly infections became a major issue this year. Under federal rules, manufacturers are supposed to report potential injuries and deaths related to their devices to the FDA within 30 days. Medical experts and federal lawmakers welcomed the agency’s action, but continue to question why regulators have taken so long to act despite earlier warnings about the risk, according to the Times. Rep. Ted Lieu called the revelations “disturbing” and a reason to hold congressional hearings right away. The reporting delay is “flat out unacceptable,” Lieu said, and lives might have been saved if manufacturers had reported the infections in a timely manner.
Duodenoscopes are used in a procedure known as ERCP—endoscopic retrograde cholangiopancreatography. 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 problem is that the tip of the instrument is difficult to clean and dangerous bacteria can remain trapped in a channel that holds guide wires and catheters even when the manufacturer’s cleaning instructions are carefully followed, the Times explains.
The FDA warning letters cited a range of violations found in inspections of Olympus, Pentax Medical and Fujifilm facilities in March and April. The companies have 15 business days from receipt of the August 12 letters to respond to the violations. Olympus, which controls 85 percent of the specialty endoscope market in the U.S., has been linked to six of nine recent superbug outbreaks, including at UCLA where three patients died, the Times reports.
The FDA said Olympus became aware of one incident in November 2013 and another in June 2014 and the company submitted data on both events to the FDA in March — a month after the Times reported the UCLA outbreak. The 2012 incident appears to be an outbreak that occurred at a Netherlands hospital. 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. But Olympus did not notify U.S. hospitals or the FDA. The FDA says it did not learn of the European alert until last year. In addition to the ongoing FDA investigation, the Justice Department has sent subpoenas to the three scope makers in connection with the recent outbreaks.
Despite the risks, the FDA said on Monday that the scopes should remain on the market because there is no better alternative for patients who can benefit from their use.