Top officials at the Food and Drug Administration say that medical devices need to be more closely and efficiently tracked from the point they undergo clinical trials to when they are used in the real world.
In a JAMA editorial published Monday, Commissioner Dr. Robert Califf and Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health wrote that an “ideal approach” to determining the safety and efficacy of devices would be to match the level of scrutiny in premarket evaluation to the product's potential risk and benefit. Devices would also undergo “rigorous” post market evaluation.
The two write that gathering data from registries, electronic health records, insurance claims and incorporating unique device identifiers would help monitor the products. They say the agency's National Evaluation System for Healthcare Technology, the agency's forthcoming evaluation plan, calls for an independent entity governed by patients, providers, insurers, health care organizations, medical device manufacturers and the government.
The FDA has faced scrutiny for approving devices that turn out to be problematic and sometimes deadly. Critics say the products aren't properly vetted before they are widely used in patients. Meanwhile, the agency is also under increased pressure to more quickly vet and approve innovative drugs and devices.
In 2012, the FDA established the current system to identify issues with devices, inform clinicians about their performance and better generate data to speed up the approval process. Congress has mandated that by 2020, all medical devices such as pacemakers and heart valves carry unique device identifiers. The labels currently being implemented would help the FDA and providers more easily locate recalled devices already implanted in patients.
Most recently, the largely bipartisan 21st Century Cures Act, a House bill aimed at sparking healthcare innovations, was expected to speed up the device approval process. But the bill has stalled in the Senate.
Calliff and Shuren note the FDA faces challenges ensuring “timely access while also providing evidence to guide safe and appropriate use.” They worry the U.S. might be delaying some innovations because of regulatory delays.
It's necessary to conduct post-market surveillance on devices to identify real-world risks, they say, but current approaches to surveillance aren't fully effective. The FDA has estimated that approximately 50,000 serious adverse events related to medical devices are reported each year, resulting in some 3,000 deaths.
“Even though the FDA can require device makers to perform postmarket studies, patients have few incentives to enroll in a study once a device is marketed, and many FDA-mandated postmarket studies for devices have been delayed, scaled back, or never finished,” they write. “Generally, if the company makes a good-faith effort in performing post-market studies, there are no penalties.”
They also note that the current adverse event reporting process depends on clinicians identifying patterns, which can mean device issues aren't revealed until a significant number of patients are affected. By tying adverse event reports to specific device identifiers, the FDA could more quickly flag device problems that go unnoticed by physicians.
Returning to the idea that NEST be independent and accountable, the authors said that would "provide maximal value to stakeholders, including the critical data needed by the FDA to make decisions that currently must be made with less comprehensive information.”
One of the ways to do this is to add UDIs to the existing agency's postmarket surveillance system, which collects claims data on over 100 million patients, they write. Califf and Shuren also note that it is important for this information to be included in patients' electronic health records, but most vendors told Modern Healthcare this won't likely be available until 2018.
“Accelerating incorporation of UDIs could further enhance the utility of EHRs for this purpose because current EHRs often do not identify the specific device used,” they write.
The FDA chiefs say it will take not just new infrastructure but a new paradigm of data collection and sharing among providers and researchers alike to create an improved system for evaluating and monitoring devices.
“Ultimately, these changes could contribute to a much more efficient system that rewards innovation that leads to better health outcomes, creating powerful incentives for continuous improvement and accelerating access to technologies that patients and physicians can use with the assurance of safety, efficacy, and a well-characterized balance of benefit and risk.”
