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Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices
  1. Anna R Gagliardi1,
  2. Ariel Ducey2,
  3. Pascale Lehoux3,
  4. Thomas Turgeon4,
  5. Sue Ross5,
  6. Patricia Trbovich6,
  7. Anthony Easty7,
  8. Chaim Bell8,
  9. David Urbach1
  1. 1 Toronto General Hospital Research Institute, University Health Network, Toronto, Canada
  2. 2 Department of Sociology, University of Calgary, Calgary, Canada
  3. 3 Département d’administration de la santé, Université de Montréal, Montreal, Canada
  4. 4 Concordia Hip and Knee Institute, Concordia Hospital, Winnipeg, Canada
  5. 5 Women & Children’s Health Research Institute, University of Alberta, Edmonton, Canada
  6. 6 Institute for Health Policy, Management & Evaluation, University of Toronto, Toronto, Canada
  7. 7 Institute of Biomaterials & Biomedical Engineering, University of Toronto, Toronto, Canada
  8. 8 Division of General Internal Medicine, Sinai Health System, Toronto, Canada
  1. Correspondence to Dr Anna R Gagliardi, Toronto General Research Institute, University Health Network, Toronto, Canada; anna.gagliardi{at}uhnresearch.ca

Abstract

Background 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.

Methods 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.

Results 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.

Conclusions 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
  • medical devices
  • physicians’ practice patterns
  • influencing factors
  • qualitative research

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors ARG and DU conceptualised the study and acquired funding. All authors designed the study, collected and analysed data, drafted the manuscript, and gave final approval of the version to be published.

  • Funding This study was funded by the Canadian Institutes for Health Research.

  • Competing interests None declared.

  • Ethics approval University Health Network Research Ethics Board.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement All data are available in the article or online supplementary files.

  • Correction notice This article has been corrected since it published Online First. The author Patricia Trbovich’s name has been corrected.

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