Projects per year
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 language | English |
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Article number | 31 |
Pages (from-to) | 1-7 |
Number of pages | 7 |
Journal | BMC Medical Ethics |
Volume | 23 |
Issue number | 1 |
DOIs | |
Publication status | Published - 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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Dive into the research topics of 'Ethical and regulatory implications of the COVID-19 pandemic for the medical devices industry and its representatives'. Together they form a unique fingerprint.Projects
- 1 Finished
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DP200100883: Support or sales? Medical device representatives in Australian hospitals
Johnson, J., Rogers, W., Richards, B., Hutchison, K., Clay-Williams, R., Maddern, G. J. & Grundy, Q.
1/01/20 → 31/12/22
Project: Research