Delay in reporting medical device malfunctions to FDAJuly 26, 2017

Agreement would ease FDA requirements for reporting medical device malfunctions. The New York Times (7/11, Kaplan, Subscription Publication, 13.9M) reports “an agreement headed for a vote in Congress” would give medical device makers the ability to “delay reporting dangerous malfunctions to the Food and Drug Administration.” While device makers “will still have to quickly report any injuries …

Medical ErrorsNovember 3, 2016

Two patients die due to dosing errors with Medtronic infusion pump. The Minneapolis Star Tribune reports Medtronic “said two people have died following dosing errors with its problem-plagued SynchroMed II infusion pump, an implanted device…that slowly injects pain medications into a patient’s spinal canal.” The Tribune mentions that the Food and Drug Administration “filed a …