Preventing and managing adverse medical device events


Medical devices (i.e. cardiovascular, orthopedic) extend life and improve quality of life; however, adverse medical device events (AMDEs) constitute approximately 10% of hospital incidents. We generated insight on how to prevent and manage AMDEs.

Key Findings

  • Consulted with multi-sector professionals from the United States and Canada to generate a research agenda [BMJ Qual Saf 2013;22:210-8].
  • During a 10-year period in Canada, 24,849 new device licenses were issued. Of 7,226 recalls among those devices, 5.0% were judged to have a reasonable probability of serious consequences or death, and 60.0% were judged to potentially cause temporary adverse health effects [Int J Technol Assess Health Care 2017;18:1-7].
  • Physicians choose devices for individual patients based on personal preference, availability in local inventory or purchasing contracts, and tacit knowledge from trusted colleagues and less-trusted industry representatives such that choice of device most suitable for a given patient was perceived to be sometimes compromised, possibly leading to sub-optimal clinical outcomes [BMC Med Inform Dec Mak 2017;17:178].
  • Patient engagement in discussions and decisions about devices was said to be constrained by patient (demographic/clinical characteristics), physician (preferences), health system (purchasing contracts) and device factors (availability, affordability, advantage) [Int J Qual Health Care 2017;13:1-7].
  • AMDE reporting was limited by physician beliefs (AMDEs expected) and behaviour (work-around strategies), and reinforced by hospital (lack of processes and infrastructure to detect, capture, share and act on information about AMDEs) and device industry (little to no response to physician reports of AMDEs) factors [BMJ Qual Saf 2018;27:190-8].
  • Physicians described the relationship with industry representatives as “symbiotic” but recognized the potential for conflict of interest; and a concurrent tension with hospitals: they were required to comply with purchasing contracts despite concerns about device safety and effectiveness [PLoS One 2017;12:e0174934].
  • Analysis of 106 documents (e.g. guidance, forms) used by manufacturers or Health Canada staff, or aimed at the healthcare professionals or the public revealed that few included explicit details about sex, gender or intersectional factors identified more than 340 ways that Health Canada can strengthen those documents and related policies. In future, greater reporting of these details may result in the development and use of devices that are safe for everyone. PDF


This research contributed to new Health Canada policy requiring that: (1) hospitals across Canada capture and submit information about AMDEs; and (2) Manufacturers and Health Canada staff explicitly consider sex, gender and intersectional factors across the medical device lifecycle.