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

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.

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

add to favorites email to friend print save as pdf

Related Stories

FDA issues final rule for device identification system

Sep 24, 2013

(HealthDay)—The U.S. Food and Drug Administration has released a final rule for the unique device identification system (UDI) that, when implemented, will improve patient safety by providing a consistent ...

AMA awards grants for medical education innovation

Jun 22, 2013

(HealthDay)—The American Medical Association (AMA) has awarded funding to 11 U.S. medical schools in response to their proposals regarding educational innovations aimed at transforming how future physicians ...

FDA requires tracking codes on medical implants

Sep 20, 2013

Federal health regulators will begin tracking millions of medical devices, from pacemakers to hip replacements, using a new electronic system designed to protect patients by catching problematic implants earlier.

Recommended for you

US must respond to global health outbreaks, say bioethicists

10 hours ago

Last summer, West Africa fell into the grip of a deadly outbreak of Ebola that has thus far taken the lives of more than 9,500 people. The fear swept up by the epidemic quickly jumped across the Atlantic and landed in the ...

Uganda on defensive over medical 'brain drain' uproar

Mar 03, 2015

Uganda's government on Tuesday hit back at mounting criticism of plans to 'export' over 200 health workers to the Caribbean, insisting it was only seeking to regulate an existing labour market and prevent abuses.

Seth Mnookin on vaccination and public health

Mar 02, 2015

Seth Mnookin, an assistant professor of science writing and associate director of MIT's Graduate Program in Science Writing, is the author of "The Panic Virus: The True Story Behind the Vaccine-Autism Controversy" ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.