Tainted scopes cause infections at alarming rate

The number of potentially deadly infections from contaminated medical scopes is far higher than what officials previously estimated, a new investigation shows.

The number of potentially deadly infections from contaminated medical scopes is far higher than what federal officials previously estimated, a new congressional investigation shows.

As many as 350 patients at 41 medical facilities in the U.S. and worldwide were infected or exposed to tainted gastrointestinal scopes from Jan. 1, 2010, to Oct. 31, 2015, according to the Food and Drug Administration.

A separate Senate investigation released in January found 250 scoperelated infections at 25 hospitals and clinics in the U.S. and Europe. That probe looked at a narrower period, from 2012 to 2015.

The FDA supplied the new information in response to a yearlong inquiry by U.S. Rep. Ted Lieu, D-Calif., and staff of the House Oversight and Government Reform Committee.

The FDA says it is not permitted by law to name the medical facilities involved in the 41 incidents it disclosed. But the device manufacturers weren’t identified either.

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

In a Feb. 15 document sent to the House Oversight committee, the FDA listed 404 patient infections and 44 more patients who were exposed to contaminated duodenoscopes. But the regulators warned that these device reports “likely contain duplicate patient reporting” and “we estimate the number of unique patients reported to be 300 to 350” for infections and exposure.

The FDA told the House panel that scoperelated infections or contamination occurred at 30 facilities in the U.S. and 11 overseas.

Lieu said the House investigation uncovered significant gaps in existing law that contributed to a series of superbug outbreaks nationwide, including the ones at UCLA’s Ronald Reagan Medical Center and Cedars-Sinai Medical Center in Los Angeles. Both outbreaks involved scopes from Olympus Corp., a device manufacturing giant based in Tokyo. At UCLA, three patients died and five more were sickened by antibioticresistant superbugs.

Lieu introduced legislation Friday aimed at improving patient safety in response to the House findings and reporting by the Los Angeles Times on the outbreaks.

Lieu is filing a bill, known as the Device Act, that would impose new requirements on manufacturers. The companies would have to notify the FDA when they issue safety warnings in other countries related to the design and cleaning of their devices.