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Identifying optimal postmarket surveillance strategies for medical and surgical devices: implications for policy, practice and research
  1. Anna R Gagliardi1,
  2. Muriah Umoquit1,
  3. Pascale Lehoux2,
  4. Sue Ross3,
  5. Ariel Ducey4,
  6. David R Urbach1
  1. 1Toronto General Research Institute, University Health Network, Toronto, Ontario, Canada
  2. 2Department of Health Administration, University of Montreal, Montreal, Quebec, Canada
  3. 3Department of Obstetrics and Gynecology, University of Alberta, Edmonton, Alberta, Canada
  4. 4Department of Sociology, University of Calgary, Calgary, Alberta, Canada
  1. Correspondence to Dr Anna R Gagliardi, Toronto General Research Institute, University Health Network, 200 Elizabeth Street, Toronto, Ontario, Canada M5G2C4; anna.gagliardi{at}uhnresearch.ca

Abstract

Background Non-drug technologies offer many benefits, but have been associated with adverse events, prompting calls for improved postmarket surveillance. There is little empirical research to guide the development of such a system. The purpose of this study was to identify optimal postmarket surveillance strategies for medical and surgical devices.

Methods Qualitative methods were used for sampling, data collection and analysis. Stakeholders from Canada and the USA representing different roles and perspectives were first interviewed to identify examples and characteristics of different surveillance strategies. These stakeholders and others they recommended were then assembled at a 1-day nominal group meeting to discuss and prioritise the components of a postmarket device surveillance system, and research needed to achieve such a system.

Results Consultations were held with 37 participants, and 47 participants attended the 1-day meeting. They recommended a multicomponent system including reporting by facilities, clinicians and patients, supported with some external surveillance for validation and real-time trials for high-risk devices. Many considerations were identified that constitute desirable characteristics of, and means by which to implement such a system. An overarching network was envisioned to broker linkages, establish a shared minimum dataset, and support communication and decision making. Numerous research questions were identified, which could be pursued in tandem with phased implementation of the system.

Discussion These findings provide unique guidance for establishing a device safety network that is based on existing initiatives, and could be expanded and evaluated in a prospective, phased fashion as it was developed.

  • Healthcare quality improvement
  • Incident reporting
  • Qualitative research

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