The FDA recently revealed, after a year-long investigation, that as many as 350 patients at 41 facilities in the United States and overseas have been infected by tainted scopes between Jan. 1, 2010 and Oct. 31, 2015, according to Gastroenterology & Endoscopy News.
Here are four insights:
1. Olympus America's TJF-Q180V duodenoscope was linked to an outbreak of carbapenem-resistant Enterobacteriaceae at Ronald Reagan UCLA Medical Center in Los Angeles between October 2014 and January 2015.
2. In March 2015, four patients were reportedly infected with CRE and 67 others were potentially exposed at nearby Cedars-Sinai Medical Center in Los Angeles.
3. A senate report from January 2016 found 250 scope-related infections at 25 hospitals worldwide from 2012 to 2015. The report also found that Olympus and Fujifilm, another scope manufacturer, never applied for FDA clearance for the new design that was issued for closed-channel scopes.
4. Rep. Ted W. Lieu (D-Calif.) has introduced two new bills that would require device manufacturers to notify the FDA about changes in cleaning instructions or design.