The US Food and Drug Administration (FDA) needs to do more to quickly and substantially reform its system for reporting adverse events caused by medical devices, two researchers wrote in an Editorial published in JAMA Internal Medicine.
The editorial notes several instances where information on a medical device was withheld from the public or not reported fully.
The current adverse events reporting system relies on device makers to voluntarily report adverse events, which the authors say does not place patient safety as a priority.
The editorial specifically highlights a study involving Medtronic's Insync III model 8042 heart failure pacemaker, which the authors said caused a "high burden of serious adverse events (including death)." The authors said it took the FDA 19 months to recall the device after the first instance of the device failing was reported. The FDA also decided to classify the recall as Class II, which signifies a low probability of serious adverse events.
"This long unexplained delay before the recall and the inappropriate recall classification raise concerns about patient harms that could have been prevented by speedier and stronger regulatory actions," the authors wrote.
Source: Becker's Hospital Review, 10 January 2020
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