May 11, 2015 — Lawmakers are criticizing the FDA for failing to act after the agency admitted receiving nearly 150 reports of infections on contaminated medical scopes since 2010.
Earlier this year, a deadly outbreak of antibiotic-resistant infections were traced to a duodenoscope with complex mechanisms that were difficult to sterilize.
Last week, when lawmakers demanded answers, the FDA said it did not learn about the risk until the fall of 2013. However, this week the FDA said there were reports linking “superbug” infections with contaminated scopes before 2013.
The agency has disclosed 142 reports of infections on contaminated scopes since 2010. Some of those reports involve multiple patients.
Representative Ted Lieu (D-Los Angeles) told the Los Angeles Times:
“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 fact, the FDA has not warned about this risk since 2009 when the agency issued a Safety Communication to warn that “flexible endoscopes are fundamentally difficult to clean.” That warning was issued shortly after 16 people were infected in an outbreak in France.
Over the next five years, there were at least five infection outbreaks on contaminated scopes in the United States. However, it was not until February 2015 that the FDA issued updated warnings.
U.S. Senator Patty Murray (D-Washington) has also questioned the 510(k) approval process, which allows new devices on the market without new safety studies so long as they are “substantially equivalent.” Unfortunately, the Olympus scope linked to several infection outbreaks has been on the market since 2010 without proper clearance.