FDA unveils plan for device surveillance

The FDA released a report on its proposed changes to medical device post-market surveillance, including this chart (click to expand)--courtesy of the FDA

The FDA wants industry feedback on a host of new post-market surveillance initiatives, designed to better track, analyze and report the performance of medical devices.

In a report released Thursday, the agency proposes a four-point plan to improve its post-market system, including the previously announced unique ID program and a modernization of MedWatch. The agency is taking any and all opinions from devicemakers and members of the healthcare community through its website, and the FDA plans to host public meetings on the plan this month.

Here's a summary of the four points:

  • Establish a unique device ID system: In keeping with its July announcement, the FDA wants to require devicemakers to tag their products with an alphanumeric code, disclosing the device's production information, serial number, manufacturing date and expiration date. The goal is to help the FDA and healthcare community to more accurately track and analyze device-related adverse events. Once rolled out, the ID system will cost the industry $65 million, the FDA has said.
  • Promote international device registries: The agency isn't looking to found a huge, centralized registry, housing data on device uses and reactions. Instead, the FDA wants to help governments and private outfits set up and operationalize smaller registries, sharing data with one another to keep tabs on device performance. The agency plans to host a series of public workshops to educate would-be registry founders on the best way to move forward.
  • Modernize adverse event reporting: Currently, the FDA relies on spontaneous reporting for when devices go awry, primarily using its voluntary MedWatch system. That model is inherently limited, the agency says, and it wants to institute automated reporting systems in hospitals, encourage more electronic reporting, develop a mobile app for MedWatch and update the MAUDE adverse event database, which the FDA says is technologically outdated.
  • Develop new tools and methods for post-market surveillance: This is the catch-all part of the FDA's plan, in which the agency discusses future innovations that could generate, synthesize and interpret post-market data to drive decision-making. For instance, the FDA wants to automate data analysis to identify spikes in adverse events across disparate data sources. The agency also proposes instituting quantitative decision analysis in its post-market deliberations, aiming to better standardize its methods.

- read the FDA's report (PDF)
- weigh in on the agency's website

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