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Type: Journal article
Title: Ethical and regulatory implications of the COVID-19 pandemic for the medical devices industry and its representatives
Author: Blakely, B.
Rogers, W.
Johnson, J.
Grundy, Q.
Hutchison, K.
Clay-Williams, R.
Richards, B.
Maddern, G.
Citation: BMC Medical Ethics, 2022; 23(1):31-1-31-7
Publisher: Springer Nature
Issue Date: 2022
ISSN: 1472-6939
Statement of
Brette Blakely, Wendy Rogers, Jane Johnson, Quinn Grundy, Katrina Hutchison, Robyn Clay, Williams, Bernadette Richards, and Guy Maddern
Abstract: The development and deployment of medical devices, along with most areas of healthcare, has been signifcantly 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 trig‑ gers 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 indefnite reduction in standards raises serious ethical issues. Second, the pandemic has disrupted the usual operations of device representatives in hospi‑ tals, providing an opportunity to examine and refne 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 refnement 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.
Keywords: Device representatives; Device regulation; COVID-19; Ethics; Crisis
Rights: © The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit The Creative Commons Public Domain Dedication waiver (http://creativeco applies to the data made available in this article, unless otherwise stated in a credit line to the data.
DOI: 10.1186/s12910-022-00771-2
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