Manufacturers Skip FDA Panel's Meeting to Discuss Their “Unsafe” Medical Scopes

Tuesday, May 19, 2015
CRE superbug

Doctors and health advocates met with a U.S. Food and Drug Administration (FDA) panel last week to discuss the medical scopes responsible for deadly bacteria reaching patients at Ronald Reagan UCLA Medical Center and elsewhere around the country.

All that was missing at the meeting to hear the panel definitively say the scopes weren't safe enough were representatives of the manufacturers.

“I'm a little disappointed industry did not represent themselves,” committee member Dr. Bryce Mays said, according to the Los Angeles Times. “I think they may have data critical to our thinking in terms of reaching a decision, and they chose not to.”

They probably didn't want to hear panel member Dr. Irving Nachamkin say, “We have heard enough data to say these devices are not safe using current conditions.”

Over the years, the scopes has been a subject at gatherings of medical authorities and prompted warnings by government agencies. A 2011 summit sponsored by the FDA produced seven “clarion themes” about the reusable medical devices, including an admonition to “create a greater sense of urgency and understanding throughout the healthcare community about the consequences of inadequate reprocessing.”   

A report (pdf) from the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee said there are 142 known reports since 2010 of exposure to multi-drug-resistant bacteria using duodenoscopes, primarily from Japanese manufacturer Olympus. UCLA warned 179 recent patients earlier in the year that they may have encountered a deadly superbug already linked to the deaths of two people.

The drug-resistant bacteria CRE (carbapenem-resistant Enterobacteriaceae) was found on two pieces of equipment used in a “complex” endoscopic procedure that they underwent at the hospital between last October and January.

The UCLA outbreak accelerated international concern over the commonly-used medical device. More than 500,000 endoscopic procedures are performed every year in the United States and many of them use the equipment. The scopes contain many working parts with tiny crevices that cannot be easily cleaned. The question is can they be cleaned sufficiently, considering the possible result of failure.

Olympus upgraded its initial instructions and tools for sterilizing the instrument, but problems persist. Many hospitals are now using an elaborate cleaning process that involves taking the scopes out of action for 48 hours. Virginia Mason Medical Center began doing that and applying a “meticulous manual cleaning” after 32 people became infected and 11 died, according to BloombergBusiness. The medical center reported that even with its intense efforts, 3% of the scopes remained infected.

William Rutala, a professor of infectious disease at the University of North Carolina, testified that it was worse than that. He put the number between 10% and 30% and argued, “Doing nothing is not an option.”  

For now, that does seem to be the favored option. The panel did not recommend that the FDA stop use of the device or take any other specific actions beyond sending its dire assessment of the issue to the agency where, FDA official Suzanne Schwartz told the Times, “We are looking at this problem from A to Z.”

–Ken Broder


To Learn More

Federal Panel Calls Medical Scopes Unsafe (by Chad Terhune and Melody Petersen, Los Angeles Times)

FDA: 142 Reports of Tainted Duodenoscopes Since 2010 (by Jof Enriquez, Med Device Online)

Effective Reprocessing of Endoscopes Used in Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures (FDA Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee)

European Hospitals Got Medical Alerts on Deadly Scopes 2 Years Before U.S. (by Ken Broder, AllGov California)

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