A new investigation has uncovered shocking lapses in reporting contamination problems with a common medical device. Those problems have sickened scores of patients and led to several deaths, including 18 at Seattle’s Virginia Mason Hospital.
The device is the duodenoscope — a flexible, lighted tube used in about 700,000 procedures each year in this country. It is snaked down the throat and stomach and into the small intestine to diagnose and treat problems including cancer and gallstones.
According to the investigation initiated by Sen. Patty Murray, D-Washington, after the Virginia Mason outbreak came to light, the major manufacturer of these scopes knew as early as 2012 that they could harbor potentially deadly bacteria because they can’t always be completely sterilized between uses. The Virginia Mason fatalities occurred between 2012 and 2014. A 2015 outbreak at a Los Angeles hospital linked to contaminated scopes killed at least two patients and exposed many more to dangerous bacteria. In Connecticut, nearly 300 patients were exposed to drug-resistant E. coli by the scopes.
Investigators found 25 outbreaks at hospitals across the country and in Europe from 2012 to 2015, including instances where patients were exposed to a drug-resistant superbug that kills half of those it infects. And they say their findings are probably on the low side because hospitals may not be looking for the infections.
Hospitals that were slow to report infections they were aware of share the blame for endangering patients. Virginia Mason, for example, didn’t file a required report with the Food and Drug Administration until five months after it had made the connection between patient infections and contaminated scopes.
The FDA isn’t covered in glory here either. It had received 142 reports of contaminated scopes since 2010, and it had never reviewed the device manufactured by Olympus, which has been linked to most of the outbreaks. Flaws in FDA oversight, investigators say, continue to put patients at risk “with life-threatening consequences.”
That’s unacceptable. Clearly there’s a breakdown among those who make the devices, those who use them and those who regulate them. There were too many lapses in reporting — and this is just one device. Is this kind of problem going on with other devices, and we just don’t know it yet because no one’s investigated?
The investigators suggest that hospitals be motivated to report outbreaks to regulators by making timely injury reports a condition of receiving Medicare reimbursement. And they called for a sensible work-around that doesn’t depend on manufacturers and providers self-reporting to the FDA: Each device should have a unique identifying number so it can be tracked in insurance claims and electronic health records.
That’s already being done with pharmaceuticals to monitor safety problems, so it doesn’t seem like a stretch to start doing the same with medical devices.