Identification and Market Removal of Risky Medical Devices

“Reporting of adverse events to the US Food and Drug Administration (FDA) has long been the primary mechanism of identifying safety issues with medical devices—ranging from nasal swabs to cardiac defibrillators to in vitro diagnostic test kits. Each day, approximately 3500 adverse event reports are collected in the agency’s Manufacturer and User Facility Device Experience (MAUDE) database. As anyone who has tried to use it will attest, the database provides a difficult-to-use interface to search these reports.

[..] The agency’s Sentinel System has successfully identified issues with drugs using a combination of claims and electronic health record data, but unlike MAUDE, the Sentinel System data are not publicly available, and the wait time for data requests can be several months. Drug-related adverse events are easier to link to Sentinel System data because of the National Drug Code, which uniquely identifies a drug so it can be linked directly to the report. In 2019, less than 2% of the 1.3 million adverse event reports for devices contained a Unique Device Identifier (UDI), and the UDI is often redacted by the FDA in whole or in part because the agency’s Freedom of Information Act team is unsure of which portions of the UDI are protected health information, even though only the serial number should be redacted. This redaction is important because all other methods of postmarket surveillance for medical devices in development by government agencies, hospitals, device registries, and insurance companies rely on the UDI. In addition, until all devices contain a UDI, the use of the Sentinel System for medical device surveillance is not feasible.

[..] The FDA should require immediately (and enforce) the listing of the UDI on every adverse event report and discontinue all redactions of the identifier to decrease chances that patients are not unknowingly receiving harmful devices.

The FDA could also improve medical device reporting by requiring that physicians submit reports directly to the FDA instead of the current system in which almost all these reports are first submitted to the manufacturer (often to get a replacement device or report an event). Under current law, only hospitals and manufacturers, not physicians, are mandated to report to the FDA. The Medical Device Guardians Act, a bipartisan bill introduced in the US House of Representatives in 2019, would provide the FDA with a mechanism to require that physicians report adverse events directly to the agency. Direct reporting with the UDI would greatly speed the time to identify signals and improve the chances that all the relevant details of the event are submitted. A copy of the report could be sent to the manufacturer simultaneously.

Data from the MAUDE database can be improved on, and even more can be done without waiting for the components of National Evaluation System for Health Technology to be implemented. For example, the FDA should reinstate the acceptance of adverse events via the Medwatcher, a third-party iPhone and Android application that allows submission of adverse events directly via smartphone and facilitates reporting by patients and physicians.”

Full article, Tomes M. JAMA Internal Medicine 2020.9.28