By Christine Kern, contributing writer
Olympus devices linked to two more deaths and six infections.
Earlier this year, Health IT Outcomes report medical device maker Olympus announced it was recalling and redesigning its duodenoscopes, pledging to take steps to help prevent further superbug infections linked to their product.
Now, however, a company regulatory report indicates the scopes have been linked to at least two additional patient deaths and six more illnesses, according to The Los Angeles Times. The report’s author notes an unnamed hospital continued to use the device after the recall announcement.
In February, according to U.S. News & World Report, the FDA approved Olympus’ redesign plan saying that until devices in question can be replaced, hospitals can continue to use the TJF-Q180V scope as long as they “meticulously follow” the cleaning instructions provided by the company.
The voluntary recall and redesign by Olympus is significant. Olympus sells approximately 85 percent of all duodenoscopes used in the United States. The company has pledged to revamp an internal mechanism inside the reusable device, fixing the difficulties in disinfection.
The scope used to treat the eight patients at the hospital noted in the new report had not yet been sent back under Olympus’ recall. The company has stated it began replacing the scopes known as model number TJF-Q180V in February, and expects to have all 4,400 scopes in use by hospitals and clinics recalled by August.
Lawrence Muscarella, a medical safety expert in Montgomeryville, PA, told The L.A. Times that hospitals need to be warning patients of potential risks before each scope procedure, and noted the outbreak was reported to the FDA not by the affected hospital, but by Olympus itself.
Federal law requires hospitals to report deaths due to medical devices within ten days of the event. In the Senate investigation, not one of at least 16 affected hospitals had properly filed the required federal report.
The affected hospital in the latest report was using an automatic washer sold by Olympus to clean its scopes, as recommended by the company. Olympus is now examining the washer in question to evaluate its effectiveness, according to the report.
Olympus was notified of the outbreak January 26, and the hospital ordered an autopsy on the two patients who died to determine their cause of death. According to Olympus, an independent lab found Stenotrophomonas maltophilia — a dangerous bacteria that resists many antibiotics — inside the scope’s suction channel.
The scope was purchased in June 2012 and was last repaired by the company in August 2014. The hospital had used the scope almost 800 times, according to the report, but Olympus technicians found cracks in the device and brown stains inside.