Regulatory Focus™ > News Articles > So Long, MAUDE: CDRH Selects PRIMO as Adverse Event Reporting Replacement System

So Long, MAUDE: CDRH Selects PRIMO as Adverse Event Reporting Replacement System

Posted 18 September 2013 | By Alexander Gaffney, RAC

Medical device manufacturers will soon have a new five-letter product vigilance acronym to know, and one to forget. Goodbye, MAUDE; Hello, PRIMO.


MAUDE-the Manufacturer and User Facility Device Experiences system-has long been a fixture of the US Food and Drug Administration's (FDA) postmarketing vigilance efforts. The agency's Center for Devices and Radiological Health (CDRH) receives "several hundred thousand" medical device reports (MDRs) each year, including reports of adverse events, deaths and product malfunctions.

"The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products," FDA explains on its website. "The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers."

There's just one problem: MAUDE is old-really old. "If you go to the Natural History Museum, you will see a display of MAUDE there," Jeffery Shuren, director of CDRH, joked at a conference earlier this year. "It sounds like someone's grandmother," quipped Ross Jaffe, a venture capitalist at the same conference.

As a result, CDRH has been looking to replace the system for quite some time. 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.

FDA explained that the MAUDE adverse event report database is nearly obsolete, both nearing the limits of its design capacity and 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."

At present, FDA is unable to leverage MAUDE's capabilities to conduct real-time reporting and analysis, slowing any attempts to discover unknown adverse events. This, in turn, affects its ability to generate and evaluate evidence.

FDA said it is aware of studies that showed when the reports were conducted automatically, adverse event reporting increased as the public and physicians felt their concerns would actually be evaluated appropriately.

Another feature, mobile adverse event reporting through the use of mobile apps, was also called for in the report, and has since been launched as the MedWatcher app.

The new reporting system was envisioned as one with an expanded capacity to receive reports, modern analytical capabilities, and will be able to present information report in a variety of formats for end users.

Hello, PRIMO

But since then, details on what that system would look like have been sparse. That is, until now.

In a press statement released on 17 September 2013, November Research Group said it had won an FDA contract to have its Pharmacovigilance Report Intake and Managed Output (PRIMO) software system eventually replace MAUDE.

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," the group said.

"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."

Focus has reached out to CDRH for more information, and will update this space when we hear back.

NRG Statement on PRIMO

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