Ethical and regulatory implications of the COVID-19 pandemic for the medical devices industry and its representatives

Brette Blakely, Wendy Rogers, Jane Johnson, Quinn Grundy, Katrina Hutchison, Robyn Clay-Williams, Bernadette Richards, Guy Maddern

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)
24 Downloads (Pure)

Abstract

The development and deployment of medical devices, along with most areas of healthcare, has been significantly impacted by the COVID-19 pandemic. This has had variable ethical implications, two of which we will focus on here. First, medical device regulations have been rapidly amended to expedite approvals of devices ranging from face masks to ventilators. Although some regulators have issued cessation dates, there is inadequate discussion of triggers for exiting these crisis standards, and evidence that this may not be feasible. Given the relatively low evidence standards currently required for regulatory approval of devices, this further indefinite reduction in standards raises serious ethical issues. Second, the pandemic has disrupted the usual operations of device representatives in hospitals, providing an opportunity to examine and refine this potentially ethically problematic practice. In this paper we explain and critically analyse the ethical implications of these two pandemic-related impacts on medical devices and propose suggestions for their management. These include an endpoint for pandemic-related adjustments to device regulation or a mechanism for continued refinement over time, together with a review of device research conducted under crisis conditions, support for the removal and replacement of emergency approved devices, and a review of device representative credentialling.

Original languageEnglish
Article number31
Pages (from-to)1-7
Number of pages7
JournalBMC Medical Ethics
Volume23
Issue number1
DOIs
Publication statusPublished - 23 Mar 2022

Bibliographical note

Copyright the Author(s) 2022. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

  • Device representatives
  • Device regulation
  • COVID-19
  • Ethics
  • Crisis

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