Say goodnight MAUDE.
The November Research Group (NGR) announced on September 17, 2013 that it had won an FDA contract to have its Pharmacovigilance Report Intake and Managed Output (PRIMO) software system eventually replace the FDA’s Manufacturer and User Facility Device Experiences (MAUDE) system.
MAUDE is the primary tool used by the FDA to receive and track thousands of medical device reports (MDRs) of adverse events, deaths and product malfunctions each year. The agency uses MDRs to monitor device performance and detect potential device-related safety issues. MAUDE houses MDRs submitted by mandated reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
But MAUDE is getting old and tired.
“If you go to the Natural History Museum, you will see a display of MAUDE there, ” Jeffery Shuren, M.D., director of Center for Devices and Radiological Health (CDRH), reportedly joked at a conference earlier this year.
In 2012, FDA announced the release of a report entitled “Strengthening our National System for Medical Device Postmarket Surveillance, ” in which it called for a number of changes to the vigilance systems for monitoring medical devices.
The agency said the MAUDE adverse event report database is nearly obsolete. It’s nearing the limits of its design capacity and is limited by its age and inherent capabilities. “The database platform cannot be extended further, ” remarked FDA. “Therefore, a new adverse event reporting system is needed.”
The software, which NRG said should be rolled out within CDRH by the end of 2013, is a “unique web-based solution designed specifically to streamline the intake, review and triage of adverse event reports within the healthcare industry.”
“PRIMO’s open architecture allows regulatory authority users to capture, organize, and review a high volume of adverse event reports from a variety of electronic sources, ” NRG continued. “Additionally, PRIMO offers an ‘intelligent’ report review function and powerful correspondence tracking to support regulatory authority users in their decision-making and case management processes. The result is a rich user experience that drives efficiencies and assists in achieving the patient safety goals that underpin all product vigilance activities.”
