FDA Unveils Plan To Modernize Surveillance of Medical Devices


On Tuesday, FDA announced a plan to modernize its early warning system for high-risk medical devices through the use of a smartphone application and other health IT-related initiatives, the Wall Street Journal reports.

FDA's current early warning system requires medical device companies and hospitals to report certain adverse events associated with medical devices. Doctor can report such events on a voluntary basis.

FDA's Medical Device Surveillance Modernization Plan

The agency's modernization plan -- which is outlined in a new report -- calls for the creation of a smartphone application that would make it easier for health care providers to report medical device-related adverse events.

William Maisel -- deputy director for science at FDA's Center for Devices and Radiological Health -- said the app could help reduce medical device-related adverse events by giving federal officials "access to better data more quickly."

FDA's modernization plan also calls for the creation of an automated surveillance system that would leverage electronic health data, such as:

  • Patients' electronic health records;
  • Patients' bills;
  • Insurance databases; and
  • Medical device company data.

In addition, FDA this year is expected to release a final rule creating a unique device identification system (Burton, Wall Street Journal, 4/23).

FDA released a proposed rule to create a UDI system in July 2012. A UDI system would allow FDA officials to electronically track medical tools and promptly recall any devices that could jeopardize patient safety. Under the proposed rule, manufacturers would need to place UDI codes on each device identifying:

  • Make;
  • Manufacturer; and
  • Lot number.

Such codes would be stored in a public database so regulators, physicians and companies could monitor safety issues related to the devices (iHealthBeat, 11/15/12).

FDA Launches New Consumer-Focused Website

In related news, FDA has launched a new website -- called FDA Patient Network -- that aims to educate consumers on the drug and medical device approval process, the Los Angeles Times' "Booster Shots" reports.

FDA said the website will allow caregivers, patients and patient advocates to listen to live webinars and open meetings, including meetings of advisory panels that recommend whether FDA should approve a drug.

In addition, the website will let consumers email their views to FDA and sign up to participate in certain meetings (Healy, "Booster Shots," Los Angeles Times, 4/23).

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