FDA clears first single-use, disposable duodenoscope
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The FDA on Friday authorized marketing of Boston Scientific’s EXALT Model D Single-Use Duodenoscope, the first fully disposable version of the device that allows physicians to view the upper gastrointestinal tract, according to an FDA news release.
The EXALT is designed for use on a single patient to avoid the need for cleaning and sterilization required for devices intended to be reused for multiple patients, which should reduce the potential for spreading infection among patients, according to the FDA.
“The availability of a fully disposable duodenoscope represents another major step forward for improving the safety of these devices, which are used in more than 500,000 procedures in the U.S. each year. Unlike duodenoscopes that are used on multiple patients, a fully disposable duodenoscope doesn’t need to be reprocessed, eliminating the risk of potential infection due to ineffective reprocessing,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said. “Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients, and the FDA continues to encourage innovative ways to improve the safety and effectiveness of these devices.”
In August, the FDA recommended that manufacturers of the devices and health care facilities begin to adopt duodenoscopes with disposable components. The EXALT was granted Breakthrough Device Designation from the FDA and worked with the company to bring the device up for review.
Perspective
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Raman Muthusamy, MD
The recent FDA approval of the Exalt Model D single use duodenoscope is important for practitioners of ERCP for several reasons. Given the recent data from the FDA that the rates of pathogenic bacteria identified on surveillance cultures obtained from reprocessed duodenoscopes was 5.4% when the pre-study expectation had been for 0.4%, this device provides clinicians and health care facilities with a new option in combating the potential for patient to patient transmission of infections via duodenoscopes. The FDA has previously recommended in late August 2019 that facilities transition away from fixed endcap duodenoscopes to those with newer design features that facilitate or even eliminate the need for reprocessing. While progress has been made by manufacturers of reusable devices in developing duodenoscopes with disposable tips and even disposable elevators, this device represents the first completely disposable device that eliminates the potential for patient to patient transmission of infection. In realizing the significance of this achievement, the product was granted breakthrough device designation by the FDA. In an initial human consecutive case series of 60 patients undergoing ERCP at six centers by seven endoscopists, 96.7% of cases could be completed using only the single use device. The endoscopists found the performance comparable to the reusable duodenoscope they currently used in over 90% of cases. While issues remain regarding the generalizability of these data along with issues of cost and device recyclability, practitioners and facilities now have another alternative to consider as they transition away from current endcap models.
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