The 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.
Written by Rita Redberg, MD, and James Salazar, MD, both of whom work in the department of medicine at University of California San Francisco, 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 devicemakers 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.
The FDA has been working to develop a unique device identifier, or UDI, for each medical device since 2007. It took until 2014 to begin requiring UDIs for Class III, high-risk devices and until 2016 to begin requiring them for Class II devices. The requirement for Class I devices, which are low to moderate risk devices, is set to take effect in September.
However, devices may have multiple UDIs, which the authors said "has created challenges that medical centers are addressing."
"When there is a device safety signal or recall, it is appalling that the United States, unlike Iceland, lacks even a rudimentary means to track medical devices," the authors wrote.
In a statement to MassDevice, the FDA said it "takes seriously its responsibility to monitor device safety and performance, take action when needed and help ensure patients and providers have the information they need to make informed healthcare decisions."
The agency said it is taking steps to improve medical device tracking, such as creating a national evaluation system for health technology.
Read the full editorial here.