Since the 1990s, the Food and Drug Administration has been using an electronic system known as MAUDE to track complaints about medical devices. The Manufacturer and User Facility Device Experience is a repository of reports about device malfunctions, patient injuries and deaths. To date, more than 17 million reports have been submitted. Yet the system isn’t working the way it should to warn the public about emerging dangers. Here’s how it’s supposed to work and why the system is failing to live up to its mission.
What the reporting requirements are
Under federal law, device makers are required to submit information about reported malfunctions, injuries and deaths within 30 days. Patients, their family members and others can also voluntarily submit reports. The tracking system is publicly available and includes information such as the type of device involved, the date the manufacturer became aware of the problem, the date the report was submitted to the FDA and a description of any patient symptoms and injuries.
How the system is supposed to work
The FDA is supposed to read the reports and look for patterns — or “emerging signals” — about device breakdowns that can harm the public. Though the FDA uses other sources to pick up on patterns, experts say the MAUDE system remains the cornerstone of the agency’s ability to track dangerous devices, an early-warning system meant to save lives. Two-thirds of all recalls and FDA regulatory actions begin with a MAUDE report, according to former FDA analyst Madris Kinard, who spent four years working with MAUDE before leaving the agency. She has since developed a database to better sort and examine the reports.
How the system actually works
An investigation by the Pittsburgh Post-Gazette and ProPublica found device makers have repeatedly submitted reports after the 30-day deadline, in some cases waiting months or years before forwarding them to the FDA. Reporters also discovered that the FDA directs device makers to update the dates they first became aware of a defect when submitting follow-up information to the government. The new dates are put into the agency’s public tracking system, overriding original dates and obscuring how long companies had the warnings in hand before turning them over to the government.