Japan’s Ministry of Health, Labor and Welfare (MHLW) released a number of new guidelines and clarifications on medical device regulatory issues including cybersecurity, remanufactured single-use devices (SUDs) and the Medical Device Single Audit Program (MDSAP).
The FDA has posted an update on its surveillance of adverse events for bronchoscopes, noting that the number of medical device reports (MDR) has risen to between 100 and 200 such reports per year in the U.S. However, the agency noted that there are half a million procedures performed with these devices each year in the U.S. alone, and that these data are insufficient to infer a specific incidence of adverse events.
TORONTO – Ambu Inc. has won Health Canada clearance for a flexible, single-use cystoscope for diagnosing, managing, and treating lower urinary disorders such as incontinence and bladder cancer. The disposable Ascope 4 Cysto system goes head-to-head with reusable urology scopes that must be reprocessed after each use, diminishing image quality and mechanical performance, said Jens Kemp, Ambu’s vice president of marketing for North America.
Device reprocessing has intermittently prompted FDA action in an effort to tamp down on infection-driven adverse events for various types of endoscopes, and the latest spate of events involves endoscopes used in urological applications. While the three associated fatalities all took place outside the U.S., the FDA nonetheless indicated that it is considering the possibility that a device redesign is in order, a move the agency endorsed in connection with infections blamed on duodenoscopes.
Boston Scientific Corp., of Marlborough, Mass., has won the U.S. FDA’s nod for the Exalt Model D single-use duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. It is the first single-use duodenoscope on the market and earlier secured breakthrough device designation. “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,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.