Specifically, the manufacturers’ studies are required to answer three main questions, including, according to the FDA statement:

"Are user materials, such as user manuals, brochures and quick reference guides included in the manufacturers’ duodenoscope labeling and instructions for use, sufficient to ensure user adherence to the manufacturers’ reprocessing instructions?


"After use of the manufacturer’s validated reprocessing instructions, what percentage of clinically used duodenoscopes remain contaminated with viable microorganisms?

"For devices that remain contaminated after use of the manufacturers’ labeled reprocessing instructions, what factors contribute to microbial contamination and what steps are necessary to adequately decontaminate the device?"

These new studies "will provide critical information about the effectiveness of current reprocessing instructions and practices that may provide additional information to inform the FDA's actions to protect the public health and help reduce the risk of infections," said FDA's Maisel.

As there are no real alternative devices for ERCP, the FDA still backs the continued availability of the scopes. But results of the new studies might well lead to new steps and strategies coming from the agency to reduce contamination risks in the future.

Earlier this year, contaminated duodenoscopes led to outbreaks that claimed the lives of two patients at Ronald Reagan UCLA Medical Center in Los Angeles. According to Cedars-Sinai Medical Center, also in Los Angeles, four patients there also had been infected by a superbug after undergoing a duodenoscope procedure.

There have been other cases of infection from the superbug carbapenem-resistant Enterobacteriaceae, or CRE, in recent years nationwide, including in North Carolina, Illinois and Washington.

In February the FDA issued an alert about duodenoscopes, stating that they can be hard to sanitize between patients and that they “may facilitate the spread of deadly bacteria.”

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