Olympus Corporation subsidiary Olympus Medical Systems has reached a final plea deal with the U.S. Department of Justice over its errors filing and supplementing Medical Device Reports for its TJF-Q180V duodenoscopes concerning infections linked to the device, and to selling the device during that period.
The company, in a statement, “acknowledged that it failed to submit two required supplemental MDRs and one initial MDR” to the FDA over the problems with the devices that led to a rash of patient illnesses from 2012 to 2014, some of which proved fatal.
Olympus Medical has pleaded guilty to three criminal misdemeanors and will pay $80 million in fines and $5 million in forfeitures. In addition it will enhance how it handles regulatory affairs processes and procedures, and will make regular certifications that the company is living up to the settlement deal.
The company also stated that the investigation did not uncover “any direct harm to patients as a result of the disclosure failures,” it stated, while admitting to failure to meet federal reporting requirements.
Former Olympus senior executive Hisao Yabe also pleaded guilty to distributing misbranded devices, and could get a year in prison at his scheduled sentencing March 27, according to Reuters.
“Olympus deeply regrets its failure to file and supplement the MDRs identified in the plea agreement and accepts full responsibility for these failures,” said Hiroyuki Sasa, Olympus president and representative director.
In the years since these events occurred, Olympus has made “notable compliance improvements” addressing issues with its regulatory affairs function, including reorganizing staff and enhanced training, according to the DOJ.
Such improvement are essential as “these flexible, lighted tubes are vital for minimally-invasive, lifesaving procedures to diagnose and treat problems in the pancreas and bile duct,” said the FDA in a statement, noting, “however, because they contain many small working parts that come in contact with a patient’s bodily fluids, they must be thoroughly cleaned and disinfected between each use to prevent transmission of infections.”
The DOJ also issued a safety communications letter December 10th reporting interim results of real-world reprocessing of the devices. It advised users that best practices at present should include:
- “Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using automated endoscope reprocessors (AERs).” It also advised raising and lowering the elevator all through a manual cleaning process to ensure that both sides get brushed and flushed. And “repeat cleaning if any soil or debris is visible.”
- Put in place a comprehensive quality control program for reprocessing duodenoscopes, including “written procedures for monitoring training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure.”
- Follow all maker instructions for inspection, leak testing and maintenance.
- Before using, closely inspect and don't use any scopes that show visible damage.
- Test for leaks during reprocessing and pull any devices that do from use.
- Return duodenoscopes to the the manufacturer at least once a year for servicing.
- Make sure all involved are aware of previous FDA safety communications regarding the devices and the “supplemental duodenoscope reprocessing measures that can be implemented to reduce the risk of infection transmission, such as: microbiological culturing, sterilization, use of a liquid chemical sterilant processing system and repeat high-level disinfection.”
In March, the FDA issued warning letters
to all three duodenoscope manufacturers after the trio failed to comply with postmarket reprocessing surveillance studies, which were required of scope makers Olympus, Fujifilm and Pentax in 2015, when failures in reprocessing caused bacterial contamination that made some patients sick and led to the death of others.
A spokesman from Olympus stated at the time that the issue was taken "extremely seriously, and we intend to comply and provide the requested information." And a Pentax Medical representative said it "intends to cooperate fully with FDA to meet this request."
The endoscopic retrograde cholangiopancreatography (ERCP) procedure uses the scope – and exposed 179 patients at UCLA to deadly bacteria, with two deaths confirmed
and seven other patients infected. In the UCLA case, scope cleaning followed maker guidelines, but the process failed to kill the bacteria, according to reports at the time.
In March, 2016, ECRI held a webinar about the problem. The group noted that endoscope cleaning practices had killed 21 patients
and sickened hundreds at U.S hospitals.
“It came as a surprise to those investigating contamination that [hospital] staffs doing the reprocessing were often following the manufacturers process to the letter,” Chris Lavanchy, engineering director at ECRI, and one of the presenters, told HCB News at the time.