Single-use Endoscopy’s top two gastroenterology stories from 2023 featured U.S. Food and Drug Administration warning letters sent to companies over medical device reporting lapses and quality systems regulations.
Other recurring themes included contamination and infection risk posed by reprocessed GI endoscopes as well as novel single-use technology. Here are our 10 most read stories from the past year.
Reprocessed flexible gastroscopes stored overnight and over the weekend in conventional storage cabinets contained bacterial contamination.
Patient-ready duodenoscopes may harbor high rates of contamination, warranting the additional step of microbiological culturing following reprocessing, researchers found.
Switching to single-use gastroscopes may enable healthcare facilities to increase procedure volume through improved workflow efficiency — and potentially boost revenue generation.
Disposable tips decrease duodenoscope bacterial contamination but don’t eliminate it entirely.
The first study reporting the recyclability of single-use duodenoscopes found the process to be “technically demanding” but with “quite promising” results.
A literature review calculated a total cost per procedure for an ERCP with a reusable duodenoscope and found that it was lower in higher procedure-volume centers than in low procedure-volume centers despite increased capital requirements.
A report filed with the U.S. Food and Drug Administration in November 2022 linked two gastroscopes to three patients who tested positive for a rare strain of antibiotic-resistant E. coli bacteria.
Three trends in particular caught our eye at the beginning of the year.
The letter was issued following a November 2022 inspection of the company’s Tokyo, Japan, facility which manufactures endoscopes and endoscope accessories.
The FDA initially issued two warning letters to the endoscope manufacturer for violations, including failure to adhere to medical device reporting (MDR) requirements and quality systems regulations.