May 11, 2015 — Lawmakers want answers on why the FDA waited until after several deadly infection outbreaks before issuing its strongest warnings about disease-transmission on contaminated medical scopes.
Last week, the FDA told lawmakers it became aware of a link between “superbug” infections and contaminated scopes back in the fall of 2013. However, this week the agency said it had received nearly 150 reports linking infections to the scopes since 2010.
According to the Los Angeles Times, Rep. Ted Lieu (D-Los Angeles) criticized the FDA’s slow response, and said:
“I believe the FDA started to miss red flags in 2010 and even after they were told about the precise problem with these scopes. We absolutely need to have congressional hearings where FDA officials can testify under oath.”
In November 2009, the FDA issued its first Safety Communication about the risk, warning that “flexible endoscopes are fundamentally difficult to clean.”
That warning was issued shortly after 16 patients in France were infected on contaminated scopes. In the United States, there were at least six additional outbreaks before the FDA issued updated warnings in February 2015.
Another lawmaker, U.S. Senator Patty Murray (D-Wash.) has asked the FDA for a full review of problems with the devices. She also questioned the adequacy of the agency’s 510(k) approval process, which allows new devices on the market without new safety studies.
Earlier this year, the FDA revealed that the Olympus scope implicated in a deadly “superbug” outbreak had been on the market since 2010 without proper clearance.