This article has been updated with comments from the FDA.
A recent JAMA Internal Medicine editorial takes another swipe at the FDA for delays in improving its medical device adverse-event reporting.
Journal editor Dr. Rita Redberg and Dr. James Salazar, both of Department of Medicine, University of California, San Francisco, note several instances in which information was withheld from the public or not reported in full detail.
The editorial also highlights two studies published in the Dec. 20, 2019 issue, one about nationwide experience in Iceland of adverse events related to St. Jude Medical’s Riata defibrillator lead, and the other about “the high burden of serious adverse events (including death)” with Medtronic’s InSync III model 8042 heart failure pacemaker.
The InSync II article notes the length of time the FDA took from the first notice of device failure (19 months) to a recall of the device, and the FDA’s decision to classify the recall as Class II, which denotes 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,” Redberg and Salazar wrote. “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 FDA has been working on developing a unique device identifier (UDI) for each medical device since 2007. The agency began requiring UDIs in 2014 for high-risk (Class III) devices and in 2016 for Class II devices. the labeling requirement went into effect in 2014 for class III (high-risk) devices and in 2016 for class II devices. The requirement for class I (low to moderate risk) devices is set to take effect September 24, 2020. A guidance published in November 2018 gave medtech manufacturers until Sept. 24, 2022 before they must comply with direct-mark requirements for these devices.
“The integration of UDIs into electronic health records, which is necessary for the identifier to be useful, is highly reliant on the vendors accommodating the FDA’s recommendations,” the authors said. “In addition, devices may have multiple UDIs, which has created challenges that medical centers are addressing.”
The agency has also been working on a National Evaluation System for Health Technology (NEST) for several years, including a funding boost in 2018. Meanwhile, media outlets including Kaiser Health News, the International Consortium of Investigative Journalists and Netflix have published scathing reports about the effects of medical device-related injuries and deaths and the FDA’s adverse-event reporting system.
“Progress on medical device safety will not be possible in the United States unless the FDA makes data collection and data transparency priorities and takes prompt and commensurate regulatory actions when safety issues are identified,” the JAMA editorial authors said. “There is no question that the current medical device surveillance system, which is based on the voluntary reporting of adverse events, requires substantial improvement to prevent avoidable serious illnesses and deaths. Patients deserve a robust medical device surveillance system that invariably puts patient safety first.”
In an email to MassDevice, the FDA said it does not generally comment on specific studies, “but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health. The FDA is reviewing the findings of the paper.”
“The FDA 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 added. “In our April 2018 Medical Device Safety Action Plan we described several of the key actions we had taken in the past and steps we planned to take in the future. Since then we have been implementing the plan and have continued to enhance postmarket surveillance capabilities generally through several efforts, including enforcement of adverse event reporting requirements, improved summary reporting with public transparency, reorganization to share expertise and responsibility across pre- and postmarket activities, and support for the establishment of a National Evaluation System for health Technology (NEST) led by the Medical Device Innovation Consortium (MDIC).
“We are also in the process of a digital transformation to build a modern platform that will allow us to make more information readily available and easier to access analyze by the public. FDA remains committed to these ongoing improvements to enhance device safety.”
