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FDA offers four-pronged plan to strengthen postmarket device surveillance

In a report released Thursday, the FDA outlined a four-step plan to intensify its postmarket medical device surveillance system.

According to the report, “Strengthening our National System for Medical Device Postmarket Surveillance,” the plan is designed to bolster the agency’s efforts to better monitor and report on the effectiveness and safety of medical devices.

“Although the United States has a robust postmarket medical device surveillance system, we believe our system can be strengthened by implementing four key changes to our existing program. It bears emphasizing that modernizing medical device postmarket surveillance is a long-term effort. Our proposed strategic changes are intended to complement our existing programs,” FDA officials said in the report.

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The four recommended changes are:

  1. Establish a unique device identification system and promote its incorporation into electronic health information. The FDA issued a proposed rule for a UDI system in July and is currently accepting comments. A final rule is expected in November.
  2. Promote the development of national and international device registries for selected products. This system would maintain records on a specific disease or condition and of patients who had been exposed to a specific medical device, biologic or drug product.
  3. Modernize adverse event reporting and analysis. The FDA proposes to improve its ability to report adverse events through the use of digital records and a mobile app. 
  4. Develop and use new methods for evidence generation, synthesis and appraisal. The FDA proposes to be forward looking in its development of “innovative methodological approaches for evidence generation, synthesis and appraisal” of devices.

The agency is currently accepting comments on the new plan via its website FDA.gov.

In an interview with Healthcare Finance News in July, Joe Pleasant, CIO of Charlotte, N.C.-based Premier healthcare alliance said the FDA’s UDI rule will result in supply chain efficiencies for providers.

“If (providers) can depend upon the coding on the package, they can begin to eliminate internal barcoding and labeling and the costs associated with them,” he said.

Dan Sweeney, senior vice president of information and data services at Irving, Texas-based supply contracting firm Novation, told Healthcare Finance News that the UDI system is also likely to improve patient safety.

“It’s extraordinarily difficult today to communicate to a patient that they may have been exposed to a recalled product,” he said, adding that new levels of information management would positively impact patient safety after a procedure has been done.
 

[See also: FDA releases proposed UDI rule; reaction generally positive]