Mar 2, 2015
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:
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.
The US Food and Drug Administration has published new training material to help medical device manufacturers comply with new Unique Device Identification (UDI) requirements in the country.
The FDA UDI system requires US medical device market registrants to set up and maintain accounts with a Global Unique Device Identification Database (GUDID). Once registrants have opened accounts, they can submit device identification information into the database according to FDA rules. UDI data entered into GUDID is publicly searchable.
The US Food and Drug Administration has published draft technical specifications related to its Unique Device Identification (UDI) rule finalized earlier this year.