Improved strategies are needed to assess of postmarket safety and effectiveness of medical devices

September 24, 2013

In this week's PLOS Medicine, Daniel Kramer and colleagues from Harvard Medical School, Boston, US, compare current practices in the EU, the US, China, and Japan for monitoring the safety and effectiveness of medical devices already on the market, to identify strategies that might improve postmarket surveillance of medical devices.

Based on their comparison of current practices in the EU, the US, China, and Japan, the authors call for greater system , regular reexamination of the safety and effectiveness of select devices, and improved balance of central and .

The authors say: "Broader use of these strategies could preserve patients' access to new technologies while protecting them as well as possible from devices that later turn out to be unsafe or ineffective."

Funding: This study was supported by funding from the Medical Device Initiative from the Pew Charitable Trusts. DBK is the Lois Green Scholar at the Hebrew Senior Life Institute for Aging Research and is supported in part by a career development award from the Harvard Catalyst Clinical and Translational Research Center. DBK reports serving as a consultant to the US FDA's Circulatory Systems Advisory Panel. ASK is also supported by a career development award from the Agency for Healthcare Research & Quality (K08HS18465-01), and a Robert Wood Johnson Foundation Investigator Award in Health Policy Research. The funders had no role in the decision to publish or preparation of the manuscript.

Competing Interests: ASK is a member of the Editorial Board of PLOS Medicine. DBK and ASK previously were awarded a research contract by the US FDA/CDRH to conduct an independent research project (one piece of which was published in PLOS Medicine). DBK reports serving as a consultant to Circulatory Systems Advisory Panel of the US FDA. DBK and ASK previously published research funded by US FDA on comparative medical device regulation. DBK and ASK are also supported in part by US NIH career development awards. CS is a member for the OECD Advisory Panel of Experts in Health Information Infrastructure, 2013-14, without any payment. YTT has declared that no competing interests exist.

Explore further: FDA issues final rule for device identification system

More information: Kramer DB, Tan YT, Sato C, Kesselheim AS (2013) Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China. PLoS Med 10(9): e1001519. DOI: 10.1371/journal.pmed.1001519

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