AAMI News September 2015

FDA Beefs Up Reprocessing Guidance

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

DuodenoscopesThe 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 in the tiniest of areas.

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

In its announcement, 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” supplemental measures to bolster their reprocessing efforts, such as microbiological culturing of the devices.

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-resistance 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.

What Can HTM Professionals Do?

Bacterial contamination from endoscopes is just one part of the bigger problem of hospital-acquired infections (HAIs). According to the Centers for Disease Control and Prevention, one in 25 hospital patients has at least one HAI. In 2011, that added up to an estimated 722,000 in U.S. acute care hospitals.

At the AAMI 2015 Conference & Expo in June, George Mills, director of engineering at The Joint Commission, said that healthcare technology management (HTM) professionals have a key role to play in combatting this problem.

At the least, they need to emphasize the value of hand hygiene. Additionally, he urged HTM professionals to visit sterilization areas in their facilities to look for potential contamination problems with medical equipment.

Reporting Problems

In its Aug. 4 Safety Communication on duodenoscope reprocessing, the FDA said that “prompt reporting” of adverse events can help the agency tackle patient safety problems faster and more effectively.

The agency emphasized that both device manufacturers and user facilities “must comply with the applicable Medical Device Reporting (MDR) regulations.” Furthermore, the FDA noted that “healthcare personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.”

The FDA also highlighted MedWatch, its voluntary reporting program.