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 …

Power Morcellators and the Risk of Ovarian CancerFebruary 20, 2015

Recent studies in the Journal of Obstetrics and Gynecology, as well as the Journal of the American Medical Association, Oncology, have found that women undergoing hysterectomies with the use of a power morcellator have the potential risk of having an unknown and undiagnosed cancer exacerbated.  The power morcellator can be used with the “DaVinci” surgical …

New studies consider the risk of power morcellators

New research is adding to scrutiny of a surgical tool called the laparoscopic power morcellator that the FDA has warned against using in a vast majority of cases because of its potential to spread hidden cancer in common gynecological procedures. Researchers at the University of Michigan’s health department had found that of women who had hysterectomies …