Voluntary Recall of Olympus Duodenoscope Announced While Regulators Slam Device Makers

Washington, DCOlympus Corp. has announced a voluntary recall of its duodenoscope, which has been linked to serious infections in patients who underwent procedures using the device. Endoscopes and other medical devices have come under fire recently for increasingly complex designs that make proper sterilization of the devices almost impossible. In the case of the Olympic duodenoscope, reports indicate that Olympus will redesign a portion of the device to make it easier to disinfect.

The Los Angeles Times (1/15/16) reports that Olympus announced the voluntary recall in January 2016, which followed a report from a US Senate committee that 25 outbreaks and three deaths were linked to dirty scope devices made by three manufacturers, including Olympus. The Times reported that Olympus knew about issues with its scope by spring 2012, but took no action to report the issue to medical care providers or officials.

Since Olympus learned of the issue, more than 140 patients in the United States have reportedly developed serious infections, mostly the deadly carbapenem-resistant Enterobacteriaceae. Prior to announcing the recall, Olympus had blamed improper hospital cleaning procedures for the outbreaks.

Regulators have taken device makers including Olympus to task for their role in the outbreaks. The US Senate Health, Education, Labor, and Pensions Committee recently released a report titled “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients.” The 301-page report cites numerous serious infections linked to duodenoscopes and blamed device makers for failing to meet their regulatory obligations, including not properly seeking FDA clearance before selling their duodenoscopes and not properly testing whether the scopes could be adequately cleaned in real-world settings. The Senate report also took the FDA to task for not having a proper reporting system for medical devices.

Worldwide, according to the report, there were more than 25 incidents of antibiotic-resistant infections affecting at least 250 people.

The manufacturers listed in the report (Olympus, Pentax and Fujifilm) “failed at every level to meet basic expectations of transparency and openness and to actively engage with FDA to address contamination issues,” the report states. “This disregard for the spirit, and sometimes the letter, of the law resulted in potentially preventable serious and potentially fatal illnesses in hospitals around the world.”

The report argues that because the FDA did not have adequate information regarding the cause or nature of the outbreaks, it was unable to effectively investigate the issues and take necessary action. But rather than being a victim of inadequate reporting, the FDA has set up a flawed device reporting system, according to the Senate committee, which allows these situations to occur.

Lawsuits have been filed against Olympus, alleging patients suffered serious health problems as a result of the use of the Olympus duodenoscope.