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Leading the Call for Reform of Medical Device Safety Surveillance

Leading the Call for Reform of Medical Device Safety Surveillance Opinion EDITORIAL James W. Salazar, MD, MAS; Rita F. Redberg, MD, MSc An ideal surveillance system for medical device safety would the iceberg in inadequate surveillance and inappropriate re- comprehensively collect data on adverse events across the life porting of medical device–related adverse events. A report span of a device. Preferably, the system would be integrated called the Implant Files published by the International Con- into electronic health records to allow seamless identifica- sortium of Investigative Journalists estimated that there were tion, tracking, and real-time nearly 2 million injuries and 80 000 deaths associated with reporting of device-associ- medical devices from 2008 through 2017. A Netflix documen- Related articles pages 198 ated adverse events. More- tary, The Bleeding Edge, released in 2018, is another example and 322 over, it would parse adverse showing the public concern and growing patient safety move- events to detect substantial safety signals and underperform- ment regarding the harms of medical devices. ing devices. Such a system would also allow implementation When there is a device safety signal or recall, it is appall- of corrective actions in a swift and commensurate manner. ing that the United States, unlike Iceland, lacks even a rudi- 1,2 In http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

Leading the Call for Reform of Medical Device Safety Surveillance

JAMA Internal Medicine , Volume 180 (2) – Feb 20, 2020

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Publisher
American Medical Association
Copyright
Copyright 2019 American Medical Association. All Rights Reserved.
ISSN
2168-6106
eISSN
2168-6114
DOI
10.1001/jamainternmed.2019.5170
Publisher site
See Article on Publisher Site

Abstract

Opinion EDITORIAL James W. Salazar, MD, MAS; Rita F. Redberg, MD, MSc An ideal surveillance system for medical device safety would the iceberg in inadequate surveillance and inappropriate re- comprehensively collect data on adverse events across the life porting of medical device–related adverse events. A report span of a device. Preferably, the system would be integrated called the Implant Files published by the International Con- into electronic health records to allow seamless identifica- sortium of Investigative Journalists estimated that there were tion, tracking, and real-time nearly 2 million injuries and 80 000 deaths associated with reporting of device-associ- medical devices from 2008 through 2017. A Netflix documen- Related articles pages 198 ated adverse events. More- tary, The Bleeding Edge, released in 2018, is another example and 322 over, it would parse adverse showing the public concern and growing patient safety move- events to detect substantial safety signals and underperform- ment regarding the harms of medical devices. ing devices. Such a system would also allow implementation When there is a device safety signal or recall, it is appall- of corrective actions in a swift and commensurate manner. ing that the United States, unlike Iceland, lacks even a rudi- 1,2 In

Journal

JAMA Internal MedicineAmerican Medical Association

Published: Feb 20, 2020

References