Safety Concerns Prompt FDA to Recommend Transition to ‘Innovative’ Duodenoscopes


Posted September 9, 2019

In a recent Safety Communication, the Food and Drug Administration (FDA) urged hospitals and endoscopy facilities to “transition to duodenoscopes with innovative designs to enhance safety.” The agency's concerns stem from elevated contamination rates of "high-concern organisms” connected with conventional, fixed endcap duodenoscopes.

In October 2015, the FDA began mandating U.S. duodenoscope manufacturers to conduct postmarket surveillance studies "to determine the real-world contamination rates for duodenoscopes in clinical use and serve as measures of the effectiveness of reprocessing." According to the agency, the most recent results of those ongoing studies showed continuing high levels of contamination, including the presence the bacteria E. coli and P. aeruginosa.

"We have asked each duodenoscope manufacturer to transition away from fixed endcap duodenoscopes to those with more modern design features that facilitate or eliminate the need for reprocessing," wrote the FDA. "Hospitals and endoscopy facilities should transition to innovative duodenoscope designs that include disposable components such as disposable endcaps, or to fully disposable duodenoscopes when they become available."

Duodenoscopes are used in more than 500,000 potential life-saving procedures to diagnose and treat diseases in the pancreas and bile ducts each year. But given their complexity and the presence of small working parts, these devices require thorough reprocessing to prevent tissue or fluid from one patient remaining in the device and potentially contaminating a subsequent patient, according to the FDA.

In April, based on interim results from manufacturer-conducted studies showing "higher than expected levels of contamination," the agency issued a reminder to facilities on the importance of adhering to duodenoscope reprocessing instructions. Since that April update, FDA actions have included:

  • Requesting that duodenoscope manufacturers include real-world contamination rates in the labeling of currently marketed fixed endcap duodenoscopes.
  • Looking at whether options for validated reprocessing methods for duodenoscopes can be expanded. This focus on innovation included the agency challenging manufacturers to "advance the science of sterilization with the goal of developing sterilization technologies that are compatible with a variety of medical devices."
  • Contacting manufacturers of adenosine triphosphate (ATP) test strips in an effort to determine whether these test strips can be used to monitor duodenoscope reprocessing effectiveness. The FDA said that as of August, it was "not aware of any ATP test strips legally marketed for this use."
  • The intent to hold a General Hospital and Personal Use Devices Panel of the Medical Device Advisory Committee in November, with the goal of gathering additional expert recommendations on reducing the risk of infection from reprocessed duodenoscopes.

In the recent Safety Communication, the FDA also sought to reassure patients that the risk of infection from inadequately reprocessed duodenoscopes is relatively low. The agency advised that procedures should not be canceled or delayed prior to patients discussing the benefits and risks with their healthcare provider.