Medical Device blog by Phil Englert, Health-ISAC VP of Medical Device Security
Medical device owners are increasingly frustrated by the limited information medical device manufacturers share about known but undisclosed vulnerabilities in medical technologies and the speed at which they patch known vulnerabilities. Leveraging the Food and Drug Administration’s MAUDE may be a way to drive expediency.
The FDA’s MAUDE database – short for Manufacturer and User Facility Device Experience – is a public repository of adverse event reports involving medical devices and is part of the FDA’s postmarket surveillance strategy. Its primary purpose is to help the FDA monitor device performance, detect potential safety issues, and support benefit-risk assessments after devices are on the market. Mandatory reporters (like manufacturers, importers, and healthcare facilities) must submit reports when a device may have caused or contributed to a death, serious injury, or malfunction. Voluntary reporters (such as healthcare professionals, patients, or caregivers) can also submit reports if they observe or experience a device-related issue.
Read more about MAUDE, including an example of a cyber-related MAUDE report narrative, in TechNation.
