FDA looks to upgrade medical device reporting systems

The Food and Drug Administration has plans to make the database that houses medical device reports submitted to the agency more user friendly.

The Food and Drug Administration has plans to make the database that houses medical device reports submitted to the agency more user friendly.

As part of FDA’s efforts to modernize its information technology systems, the Manufacturer and User Facility Device Experience (MAUDE) database will be getting an overhaul, according to the agency.

Each year, the FDA receives hundreds of thousands of medical device reports (MDR) of suspected device-associated deaths, serious injuries, and malfunctions, which are made publicly available in the MAUDE database.

“Our goal is to make MDR data more usable and easier to find, furthering our efforts to increase transparency in medical device reporting,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in a written statement. “In Fiscal Year 2019, Congress provided funding that enabled us to begin implementation of the new systems. The President’s FY 2020 budget includes a request for additional funding for this Digital Transformation Initiative.”

At the same time, Shuren emphasized that medical device reports submitted to the FDA are just one source of information the agency leverages to monitor marketed medical devices.

“While such reports are a valuable source of information, this type of reporting system has limitations, including the potential submission of incomplete, inaccurate, untimely, duplicative, unverified or biased data,” said Shuren. “Modernized, active surveillance that utilizes real-world data is the future of medical device safety signal detection, and is a primary focus for the FDA.”

As a result, the agency continues to develop its active post-market data monitoring system to gather real-world evidence for medical devices.

The National Evaluation System for health Technology (NEST), which uses data from patient registries, Medicare claims, and electronic health records, is meant to provide critical information for assessing the safety and effectiveness of medical devices using real-world evidence.

Also See: FDA looks to bolster regulatory decisions using real-world data

“Active medical device surveillance will better protect patients by, for example, continuously using analytical software algorithms to evaluate large data sets on device performance and patient safety associated with device use in routine clinical practice,” according to Shuren, who noted that in FY 2019, Congress provided funding to begin to develop active surveillance capabilities for NEST.

While implementing a national surveillance system that allows the FDA to actively monitor device performance and patient safety is a critical step, Shuren made the case that it would not be possible without the agency’s establishment of a unique device identification (UDI) system and an international effort to create a global approach to the adoption of UDIs.

As part of that effort, medical devices are marked on their labels with a unique code that can be used to identify the device through its distribution and use in patients. The Global Unique Device Identification Database (GUDID), which is publicly available, contains key device identification information submitted to the FDA about medical devices that have UDIs.

So far, the GUDID database contains more than 2 million device records and enables patients and healthcare providers to download information about their devices.

“Taken together, we believe these steps will improve our ability to identify and address device safety signals and provide patients and healthcare professionals with important information they can use to make better informed healthcare decisions,” concluded Shuren.

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