The Food and Drug Administration’s (FDA’s) system of monitoring the safety of medical devices is inadequate, posing an unacceptable risk to patients, concluded a year-long investigation into the cause of and response to outbreaks of antibiotic-resistant infections linked to duodenoscopes (http://1.usa.gov/1SisZfg).
“Unfortunately, this investigation makes clear that current policies for medical device safety put patients at risk…,” said Sen Patty Murray (D, Wash), ranking member of the Senate Health, Education, Labor, and Pensions Committee, who had requested the investigation (http://1.usa.gov/20C1TkK).
Rubin R. Problems in Tracking Safety of Medical Devices. JAMA. 2016;315(10):970. doi:10.1001/jama.2016.1311