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BMJ Qual Saf. 2018 Mar;27(3):190-198. doi: 10.1136/bmjqs-2017-006481. Epub 2017 Aug 2.

Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices.

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Toronto General Hospital Research Institute, University Health Network, Toronto, Canada.
Department of Sociology, University of Calgary, Calgary, Canada.
Département d'administration de la santé, Université de Montréal, Montreal, Canada.
Concordia Hip and Knee Institute, Concordia Hospital, Winnipeg, Canada.
Women & Children's Health Research Institute, University of Alberta, Edmonton, Canada.
Institute for Health Policy, Management & Evaluation, University of Toronto, Toronto, Canada.
Institute of Biomaterials & Biomedical Engineering, University of Toronto, Toronto, Canada.
Division of General Internal Medicine, Sinai Health System, Toronto, Canada.



Postmarket surveillance of medical devices is reliant on physician reporting of adverse medical device events (AMDEs). Little is known about factors that influence whether and how physicians report AMDEs, an essential step in developing behaviour change interventions. This study explored factors that influence AMDE reporting.


Qualitative interviews were conducted with physicians who differed by specialties that implant cardiovascular and orthopaedic devices prone to AMDEs, geography and years in practice. Participants were asked if and how they reported AMDEs, and the influencing factors. Themes were identified inductively using constant comparative technique, and reviewed and discussed by the research team on four occasions.


Twenty-two physicians of varying specialty, region, organisation and career stage perceived AMDE reporting as unnecessary, not possible or futile due to multiple factors. Physicians viewed AMDEs as an expected part of practice that they could manage by switching to different devices or developing work-around strategies for problematic devices. Physician beliefs and behaviour were reinforced by limited healthcare system capacity and industry responsiveness. The healthcare system lacked processes and infrastructure to detect, capture, share and act on information about AMDEs, and constrained device choice through purchasing contracts. The device industry did not respond to reports of AMDEs from physicians or improve their products based on such reports. As a result, participants said they used devices that were less than ideal for a given patient, leading to suboptimal patient outcomes.


There may be little point in solely educating or incentivising individual physicians to report AMDEs unless environmental conditions are conducive to doing so. Future research should explore policies that govern AMDEs and investigate how to design and implement postmarket surveillance systems.


Equipment and supplies; influencing factors; medical devices; physicians’ practice patterns; qualitative research

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