A single-use gastroscope has received 510(k) clearance from the U.S. Food and Drug Administration and could be on the market in the next few months.
The gastroscope — as well as a next-generation display unit — from Danish medical device company Ambu A/S is designed to be used once and discarded, protecting patients from possible device cross-contamination and addressing workflow challenges that arise when scopes are out of service being reprocessed or repaired.
Those challenges have been exacerbated, company executives say, by the COVID-19 pandemic, which has caused staff shortages at overtaxed healthcare and hospital systems.
"Gastroscopy is not only one of the largest segments in endoscopy, but also has all the conditions to benefit from single-use endoscopy,” Ambu CEO Juan Jose Gonzalez said in a statement. “There is a clear need for more convenience, flexibility, and infection control, which are all addressed with the introduction of our aScope Gastro.”
Gastroscopes are used for an estimated 20 million procedures annually to examine the esophagus, stomach, and part of the duodenum. Medical device makers are angling to offer single-use endoscope alternatives to eliminate reprocessing and address patient contamination concerns raised by regulators.
Ambu introduced the world’s first single-use flexible bronchoscope in 2009 and has plans to launch more than 20 new flexible endoscopy products over the next few years. Boston Scientific Corp. was granted 510(k) clearance in December 2019 for the first single-use duodenoscope; Ambu’s single-use duodenoscope was cleared in July 2020.
The FDA’s 510(k) clearance takes its name from Section 510(k) of the federal Food, Drug, and Cosmetic Act, which requires medical device manufacturers to notify the FDA of their intent to market a device at least 90 days in advance.
Reusable flexible endoscopes have been under increasing scrutiny from the FDA in recent years due to reported device-related infections — including from multidrug-resistant bacteria — and, while rare, patient fatalities. Post-market surveillance studies identify several reasons for inconsistencies in reprocessing success. They include the complexity of reprocessing such delicate instruments as well as the time pressures on technicians that may cause vital steps to be performed inadequately or skipped entirely.
In June 2021, the FDA updated a safety communication on reprocessing flexible bronchoscopes and is recommending that healthcare providers consider using single-use bronchoscopes when there is increased risk of spreading infection and when treating COVID-19 patients.
This followed an announcement from the agency of new investigations into numerous medical device reports related to urological endoscopes. And in August 2019, the FDA recommended duodenoscope manufacturers and healthcare facilities transition to partially or fully disposable duodenoscopes. Investigations into device-related infection in endoscopic retrograde cholangiopancreatography (ERCP), the procedure duodenoscopes are used for, began in 2015.
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