FDA Releases Recommendations for Duodenoscope Reprocessing

May 20, 2015

Responding to contamination and infection concerns, the Food and Drug Administration (FDA) has released new recommendations on how to enhance the reprocessing of a complex type of endoscope.

The list of supplemental measures, as the FDA called the recommendations, applies to duodenoscopes, which are used in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The devices, which are flexible, lighted tubes, are threaded through the mouth, throat, and stomach to examine the top of the small intestine or duodenum.

While the devices have proved to be a very helpful medical tool, they also have been linked to serious, sometimes fatal, infections in patients because they are hard to clean, and antibiotic-resistant bacteria or superbugs can survive even in the tiniest of areas.

“If not thoroughly cleaned and disinfected, tissue or fluid and residual bacteria from one patient may remain in devices crevices of a duodenoscope, exposing subsequent patients to risk of infection,” the FDA warned.

In its safety communication, the agency stressed the importance of “meticulously” following manufacturers’ reprocessing instructions, called on healthcare facilities to “implement a comprehensive quality control program” for the reprocessing of duodenoscopes, and emphasized sterilization—as opposed to high-level disinfection alone.

Additionally, the agency recommended that healthcare facilities using duodenoscopes implement “one or more” of the following supplemental measures to bolster their reprocessing efforts:

  1. Microbiological culturing of duodenoscopes to identify possible bacterial contamination on the devices after they have been reprocessed
  2. Ethylene oxide (EtO) sterilization following cleaning and high-level disinfection
  3. Use of a liquid chemical sterilant processing system following cleaning and high-level disinfection
  4. Repeat high-level disinfection

Even as it listed its recommendations, the FDA acknowledged that some healthcare facilities lack the resources, training and expertise to follow them.

“Therefore, it is critical that staff responsible for reprocessing duodenoscopes have the manufacturer’s instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling, understand the importance of their role in reprocessing the devices, and maintain proficiency in performing these reprocessing tasks,” the FDA said.

Despite the infection risks, the agency underscored the value of duodenoscopes. “The benefits of these devices continue to outweigh the risks in appropriately selected patients,” the FDA said.

The agency’s recommendations come less than three months after an FDA advisory panel met to discuss the problem of multidrug-resistant infections associated with the use of duodenoscopes. The panel concluded that current methods for cleaning and disinfecting the devices do not provide a reasonable assurance of safety and effectiveness.