National US Postmarket Surveillance System Takes Further Shape

A new report commissioned by the US Food and Drug Administration recommends a seven-year, multi-step implementation project in order to establish a nationwide postmarket surveillance system for medical devices.

The Brookings Institution report proposes the formation of a National Medical Device Postmarket Surveillance System, or MDS, that would coordinate and build upon efforts of both public and private-sector programs such as the Sentinel Initiative originally developed for pharmaceuticals and the Patient-Centered Outcome Research Institute in order to perform nationwide device surveillance.

A seven-year implementation program

As described in the report, authors envisage a seven-year implementation program for MDS, managed by a public-private partnership. Specific recommendations and timeframes include:

• First and second years: Launching pilot programs overseen by the FDA to develop a full five-year MDS implementation plan
• Third through seventh years: Actual implementation of the MDS based on pilot program and fact-finding results

Successful MDS implementation is contingent upon several issues, however, according to the report. First and foremost, the FDA’s nascent Unique Device Identification (UDI) program must be widely adopted across the US in order for any viable postmarket surveillance system to properly function. Also, a full-blown MDS development and implementation effort will need adequate funding from Congress as well as active and consistent FDA involvement.

How MDS would work

MDS’s key purpose would be to coordinate and provide access to a nationwide data infrastructure, argue the report authors, based on information from patient complaint and administrative systems, electronic health records, device and clinical registries, and the FDA’s Global UDI Database.

The primary function of MDS would be supporting development of benefits and risks related to medical devices for purposes of active safety surveillance; a secondary function of the system would be collaborating with other organizations to boost product tracking, quality improvement and economic analysis.

By “active safety surveillance,” report authors refer to using electronic health information to identify and if possible head off potential safety issues related to devices instead of relying “passively” on adverse event reports.

Current surveillance tools too limited?

US regulators currently have some postmarket surveillance capabilities, including issuing device recalls, reclassification and withdrawal of device clearance or approvals. The FDA also uses the Medical Device Reporting (MDR) and Medical Product Safety Network (MedSun) programs for capturing adverse event reports, and relies on adverse event data provided by manufacturers, healthcare providers and patients.

However, such tools do not constitute a fully-fledged nationwide surveillance system; data backlogs and disparities, overwhelmed CDRH resources and voluntary rather than mandatory adverse event reporting from various sources keep the FDA’s current postmarket surveillance program from adequately keeping up with a market of the size and complexity of the US’s, argue the report authors.