Duodenoscope IFUs

FDA Safety Communication Regarding the Importance of Following Duodenoscope Reprocessing Instructions (IFUs)

The FDA’s latest Safety Communication on duodenoscopes traces its history back to 2013 when the FDA first learned about a potential association between multi-drug resistant bacteria and duodenoscopes. Upon further investigation, it became clear that these cases of infection were occurring despite confirmation that device users were following the manufacturer’s cleaning, disinfection and sterilization instructions (IFUs). Regretfully, some manufacturers had never validated their IFUs to prove that those instructions actually worked to thoroughly decontaminate and clean their duodenoscopes.1

In August of 2015 the FDA sent warning letters to manufacturers whose duodenoscopes had been blamed for spreading deadly CRE bacteria. This action followed dozens of patient deaths from scopes that remained contaminated with CRE after reprocessing in Los Angeles, Chicago, Seattle, and elsewhere earlier in the year. 2

The warning letters were sent because “The FDA says the companies failed to report problems with the scopes as required by law and in some cases failed to ensure that the devices could be adequately cleaned.” Some companies were cited for failing to relay to FDA reports that their devices may have caused or contributed to a death or serious injury within 30 days of learning about the event. Some were also cited for not ensuring their cleaning instructions were valid. 3

In addition to issuing the warnings letters, and as part of an ongoing effort to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes, on October 5, 2015 the FDA ordered the several duodenoscope manufacturers to conduct a postmarket surveillance study to determine whether healthcare facilities were able to properly clean and disinfect the devices.

Specifically, as part of their FDA approved study plans, the manufacturers were required to conduct a study to sample and culture reprocessed duodenoscopes that are in clinical use to learn more about issues that contribute to contamination, as well as a human factors study to assess how well trained hospital staff are following the reprocessing instructions. 4

Following the deadly outbreak of CRE in 2015 from contaminated scopes, many participants in the healthcare industry came together to find solutions to help reduce the patient risk caused by contaminated scopes. As part of that overall effort, on February 26, 2018, the FDA, Centers for Disease Control and Prevention (CDC), and the American Society for Microbiology (ASM), together with other endoscope culturing experts, released voluntary standardized protocols for duodenoscope surveillance sampling and culturing. 5

The FDA issued another round of warning letters on March 9, 2018 to duodenoscope manufacturers for failing to comply with requirements of federal law under which they were ordered back in 2015 to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices. Since then, the FDA has worked with them to review validated processing instructions and to take corrective actions to remove and replace models from the market with faulty designs that made them difficult to clean and reprocess. 6

In its most recent action on duodenoscopes, on April 12, 2019, the FDA issued a Safety Communication entitled “The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions.”

The FDA issued this Safety Communication to update the Safety Communication issued December 2018 regarding results from postmarket surveillance studies mandated under Section 522 of the Federal Food, Drug, and Cosmetic Act (“522 studies”) for duodenoscopes. In this Safety Communication, the FDA is also reminding healthcare facilities about the importance of strictly adhering to the manufacturer’s reprocessing and maintenance instructions, following best practices, and reporting adverse event information to the FDA. 7

According to the Safety Communication, the FDA continues to analyze sampling results submitted by manufacturers, track cases of infection, work with reprocessing personnel to understand their experiences with reprocessing protocols, work with companies to modify cleaning instructions and develop new technology to improve safety. 8

While the FDA’s on-going actions concerning the safety of duodenoscopes is very important, duodenoscopes are not the only reusable medical devices that are causing patient harm and even death. The vast majority of the surgical instrument manufacturers have never validated their cleaning IFUs either. The first step in reducing your patients’ risk of exposure to a contaminated instrument is to only use instruments whose cleaning IFUs have been validated.

  1. https://www.fda.gov/
  2. "FDA issues warning to scope makers over spread of deadly superbugs" (MPS On-Line, 8/18/15)
  3. Cite.
  4. https://www.fda.gov/
  5. Cite.
  6. FDA News Release March 9, 2018
  7. FDA Safety Communication: “The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions” April 12, 2019 https://www.fda.gov/medical-devices/safety-communications/fda-continues-remind-facilities-importance-following-duodenoscope-reprocessing-instructions-fda
  8. Cite.