A commonly used medical device that has contributed to a spate of infections nationwide is getting more scrutiny.
The FDA has ordered companies that make duodenoscopes to conduct detailed studies on how the device is used and cleaned. It also instructed the companies to collect culture samples from the scopes to check for contamination.
Every year more than half a million procedures are done using a duodenoscope. It’s a flexible, lighted tube used to treat conditions associated with the pancreatic or bile ducts. But the device is also complex in design, which makes it hard to clean between uses.
The FDA has evidence that the scopes have led to infections in patients. In Seattle, about 32 people were infected between 2012 and 2014 at Virginia Mason.
In an email statement, the manufacturer Olympus America said it intends to comply and provide the requested information.
Luvera Law Firm, which represents a widow whose husband died from an infection acquired at Virginia Mason, applauded the FDA orders.
In a statement, the lawyer said the scopes will continue to be used and should be safe as possible. But he said the steps are too late for some patients, including his client’s husband.