FDA sponsors proposal for medical device surveillance plan

The FDA helped to fund a report on possible oversight for future medical device surveillance.

Improvements in medical technology could be paralleled with new policies that enforce data monitoring and effective surveillance for device safety. With funding from the FDA, the Brookings Institution's Engelberg Center for Health Care Reform (ECHCR) has created a report that looks over the possibilities of a "postmarket surveillance system" for medical devices, which would attempt to keep both patients and providers better informed about the efficacy of these devices.

Some of the "overarching principles" listed in this report concern working with multiple stakeholders, supporting further advancements in health technology and staying consistent with government privacy and security rules.

With these and other guiding thoughts in place, the document advocates for a National Medical Device Postmarket Surveillance System (MDS), that would work in concert with different existing programs to gather important device information.

The plan projects ahead seven years and breaks down specific goals for different stages: The first two years would be used to sustain an "incubator project" that would transition into the more long-term initiative later. One of the "data infrastructure challenges" that the report acknowledges concerns the problems that inaccurate data reporting could have.

"It is critical that the data entry requirements be minimized to the greatest extent possible if it is to be sustainable and supported by physicians and hospitals whose buy-in is critical to this national effort," the report states. "The goal should be to capture data accurately and efficiently once, and use it for multiple purposes."

Healthcare IT consulting services help practices create their own plans for responding to important trends within the industry and launch major projects correctly with minimum error. Learning more from device use and putting that information to good purposes could be critical for the growth of a more technologically advanced health system.

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