FDA: Intricate Scopes Still Contaminated After Reprocessing

June 28th, 2019

By Gary Evans, Medical Writer,

Posing a clear patient risk, 3% to 5% of duodenoscopes – complex devices used to access the pancreas and other organs -- remain contaminated with bacterial pathogens after reprocessing, the Food and Drug Administration reports.

Compiled from post-market surveillance data, the disturbing findings were disclosed at a recent meeting at the Centers for Disease Control and Prevention by Shani Haugen, PhD, microbiologist at the FDA Center for Devices and Radiological Health.

The FDA post-market surveillance studies mirror contamination levels that have been reported in the medical literature. The clear conclusion was that the standard protocol at many hospitals of reprocessing these scopes with high-level disinfection leaves patients at risk.

“Current practices for reprocessing duodenoscopes are not sufficient to avoid all infections,” Haugen told the CDC's Healthcare Infection Control Practices Advisory Committee (HICPAC). “With that said, however, in appropriately selected patients, the benefits of using a duodenoscope still outweigh the risks of infections.”

The scopes became a national concern in 2014, when the CDC reported outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) linked to the devices. Over the ensuing years, there has been a series of FDA actions and alerts, device recalls, modifications, and new reprocessing instructions. According to the FDA, the levels of exposures, infections, and deaths linked to the devices have declined since 2015.

However, HICPAC members expressed considerable concern at the remaining level of risk to patients, emphasizing that informed consent conversations typically do not include a warning that a device cannot be cleaned adequately. HICPAC members said the onus should be on the scope manufacturers to ensure the devices can be disinfected before putting them on the market.

“It is fundamentally different from a side effect of a medication or the risk of a procedure,” said Lisa Maragakis, MD, MPH, co-chair of HICPAC. “This is really a safety flaw in the device itself if it cannot be adequately cleaned and disinfected.”

For more on this story see the July 2019 issue of Hospital Infection Control & Prevention.