The report says the events expose systemic weaknesses in the FDA’s approach to protecting the public from medical technology that may be harmful. A review (PDF) conducted by a U.S. Food and Drug Administration advisory committee identified 146 reports of infections from duodenoscopes dating back to 1997, with 142 of those incidents having occurred since 2010.
Through the investigation, authorities said they found at least 25 outbreaks associated with the medical device known as the duodenoscope.
The numbers are the biggest surprise to follow a seven-month investigation launched by Sen. Patty Murray of Washington, the committee’s ranking member.
The latest report from the Senate Committee on Health, Education, Labor and Pensions was commissioned Sen.
“Patients should be able to trust that the devices they need for treatment are safe and effective”.
“Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented”, Murray said. And the FDA, in part hamstrung by an ineffective surveillance system, failed to spot the deadly infections linked to contaminated scopes quickly or to alert the public. “It appears that not a single hospital that experienced infection outbreaks tied to the duodenoscopes sent the required adverse event form to the device manufacturers”, Murray’s aides wrote.
But Wednesday’s Senate report documents a deeper history of infections linked to tainted scopes than previously reported.
Gale Robinette, a Virginia Mason spokesman, said Tuesday hospital officials were eager to read the report.
“We appreciate that the staff report noted Olympus’ cooperation and that the report demonstrates the shared responsibilities of duodenoscope manufacturers, hospitals, manufacturers of automated endoscope reprocessors, and the FDA, each of which can contribute to increasing patient safety”.
Diane Rainey, a spokeswoman for Fujifilm, said safety is a top priority and the company is working with patients, hospitals, and regulators “to ensure the long-term sustainable use of duodenoscopes.”Pentax spokeswoman Shannon Coughlin said the company is working “to reduce the risk of infection in flexible endoscopy” and has established an initiative to promote safety and training around how to clean the devices”.
The investigation found that by early 2013, Olympus, the manufacturer of 85 percent of the duodenoscopes used in the United States, knew of two independent lab reports finding that the closed-channel model duodenoscope could harbor and spread bacteria even after cleaning according to the manufacturer’s instructions.
Investigators said 141 people were infected through the use of a duodenoscope in the three years between first awareness of the problem and the FDA’s initial warning.
Mark Miller, an Olympus spokesman, said in a statement posted on the company’s website Wednesday that the firm cooperated with Murray’s office and that the report recognized the need for regulators, hospitals and manufacturers to address infection risk.
Murray sought records from Olympus, Pentax Medical and Fujifilm Medical Systems to understand ongoing concerns about the scopes used in about 700,000 procedures a year in the USA, often to avoid invasive surgery.
Patients were sickened by unsafe bacteria that remained on specialized scopes even after they were cleaned according to manufacturers’ directions.
Calling on the agency to evaluate whether repairs to closed-channel duodenoscopes are necessary to prevent the spread of infections, and if so, requiring manufacturers to implement those repairs through a phased recall. The agency issued a final rule in 2013 requiring manufacturers to include a unique device identifier on device labels and packages.
And because most hospitals had failed to report the outbreaks to regulators, the investigators called for those injury reports to be required as a condition of participating in Medicare.
At least 32 patients at Virginia Mason contracted infections in 2013 and at least 11 later died, though it’s unclear whether those deaths were a direct result of the infections, the report said.
Original Article: http://www.huewire.com/health/dirty-scopes-needlessly-infected-scores-of-patients-investigation-finds/70481/