FDA Safety Communication Addresses Importance of Following Duodenoscope Reprocessing Instructions
The U.S. Food and Drug Administration (FDA) is issuing this 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 used in Endoscopic Retrograde Cholangiopancreatography procedures (ERCP). The FDA is also reminding 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.
In early December 2018, the FDA observed a decline in the number of medical device reports associated with patient infections after safety measures to improve reprocessing techniques were implemented. However, late in 2018 FDA received additional medical device reports of patient infections and device contamination. FDA’s analysis of 205 medical device reports received from October 15, 2018 through March 31, 2019 includes 45 reports of patient infection, one (1) report of patient exposure, and 159 reports of device contamination. In 2018, 3 deaths were reported in the US related to duodenoscopes. These reports indicate that although the number of reports has declined, there continues to be a need for improvement of the safety of reprocessed duodenoscopes.
The FDA recommendations have not changed. Facilities and staff are reminded of the importance of strictly adhering to the manufacturer’s reprocessing and maintenance instructions and following the following best practices:
- Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using an automated endoscope reprocessor (AER). Raise and lower the elevator throughout the manual cleaning process to allow brushing and flushing of both sides. After cleaning, carefully inspect the elevator recess and repeat cleaning if any soil or debris is visible.
- Implement a comprehensive quality control program for reprocessing duodenoscopes. Your reprocessing program should include written procedures to monitor training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure.
- Follow the duodenoscope manufacturer’s recommendations for inspection, leak testing, and maintenance of the duodenoscope.
- Prior to each use, closely inspect and remove from service for assessment, and repair or replace any duodenoscope that shows visible signs of damage, as recommended in the duodenoscope instruction manuals. Examples of damage may include: loose parts, protrusions or abnormal bulging from the endoscope, kinks or bends in tubing, cracks and gaps in the adhesive that seals the device’s distal cap, or other signs of wear or damage.
- During each reprocessing cycle, conduct leak testing and remove from service for assessment, and repair and replace any duodenoscope that shows signs of leakage. Follow the duodenoscope manufacturer’s leak testing instructions for angulating the bending section and elevator during leak testing.
- As recommended in the duodenoscope instruction manuals, return the duodenoscope to the duodenoscope manufacturer for inspection, servicing, and maintenance of the device at least once per year.
- Be aware that FDA has previously issued a Safety Communication and provided a detailed list of supplemental duodenoscope reprocessing measures that can be implemented to reduce the risk of infection transmission, such as: microbiological culturing, sterilization, use of a liquid chemical sterilant processing system and repeat high-level disinfection. Hospitals and health care facilities that utilize duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take one or more of these additional steps to further reduce the risk of infection and increase the safety of these medical devices.
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