FDA ups estimate of scope-related infections to 350

After originally saying just 142 infections had been linked to improperly cleaned scopes, the Food and Drug Administration now says the number is closer to 350, according to Kaiser Health News.

The FDA released new numbers in response to an inquiry from U.S. Rep. Ted Lieu from California and the House Committee on Oversight and Government Reform. The agency reported 404 patient infections to the House committee, but said that number "likely contain[s] duplicate patient reporting" and lowered the estimate to between 300 and 350, according to KHN.

These infections occurred from Jan. 1, 2010, to Oct. 31, 2015, in 30 facilities in the U.S. and 11 facilities abroad, the FDA reported.

A separate Senate committee investigation, released in January, put the number of infections occurring from 2012 to 2015 at roughly 250.

"It's really disturbing that the number of patients harmed and the number of facilities where this happened keeps rising," Lisa McGiffert, director Consumers Union's Safe Patient Project, told KHN. "It probably indicates the number will continue to increase as authorities dig deeper."

In fact, the House committee report states that because the FDA's infection estimates are based medical device reports, "This continues to raise concerns that the FDA is unaware of the true number of patients affected nationally and is limited to only those reported."

Duodenoscopes are notoriously difficult to clean, with one expert calling them "almost impossible" to clean correctly, meaning they can spread bacteria from patient to patient even after being cleaned. Seattle-based Virginia Mason Medical Center and Ronald Reagan UCLA Medical Center in Los Angeles dealt with outbreaks eventually linked back to these scopes.

Since discovering the link between these scopes and the spread of antibiotic-resistant bacteria, hospitals have changed their reprocessing protocols and Olympus, a major duodenoscope manufacturer, issued a voluntary recall of one type of such scopes for modifications.

The FDA has been under fire for its mishandling of the situation, as have Olympus and the other duodenoscope manufacturers, Fujifilm and Pentax.

Rep. Lieu plans to introduce new legislation that would require device manufacturers to notify the FDA when they issue safety warnings in other countries, as well as a bill that would require cleaning instructions for scopes to be scientifically validated, according to KHN.

See the full report from the House committee here.

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