Despite concerns about the relationships between health professionals and the medical device industry, the issue has received relatively little attention. Prevalence data are lacking; however, qualitative and survey research suggest device industry representatives, who are commonly present in clinical settings, play a key role in these relationships. Representatives, who are technical product specialists and not necessarily medically trained, may attend surgeries on a daily basis and be available to health professionals 24 hours a day, 7 days a week, to provide (...) advice. However, device representatives have a dual role: functioning as commissioned sales representatives at the same time as providing advice on approaches to treatment. This duality raises the concern that clinical decision-making may be unduly influenced by commercial imperatives. In this paper, we identify three key ethical concerns raised by the relationship between device representatives and health professionals: impacts on healthcare costs, the outsourcing of expertise and issues of accountability and informed consent. These ethical concerns can be addressed in part through clarifying the boundary between the support and sales aspects of the roles of device representatives and developing clear guidelines for device representatives providing support in clinical spaces. We suggest several policy options including hospital provision of expert support, formalising clinician conduct to eschew receipt of meals and payments from industry and establishing device registries. (shrink)

Social, political, and economic environments play an active role in nurturing professional virtue. Yet, these environments can also lead to the erosion of virtue. As such, professional virtue is fragile and vulnerable to environmental shifts. While physicians are often considered to be among the most virtuous of professional groups, concern has also always existed about the impact of commercial arrangements on physicians’ willingness and capacity to enact their professional virtues. This article examines the ways in which commercial arrangements have been (...) negotiated to secure medical virtue from real or perceived threats of erosion. In particular, we focus on the concern surrounding conflicts of interest arising from commercial arrangements that have developed as a result of neoliberal economic and social policies. The deregulation of medical markets and privatization of services have produced new commercial relationships that are often misunderstood by patients, publics, and physicians themselves. ‘Conflicts of interest’ policies have been introduced in an attempt to safeguard ethical conduct and medical practice. However, a number of virtue ethicists have critiqued these policies as inadequate for securing virtue. We examine the ways in which commercial arrangements have been seen to impact upon medical virtue, both historically and in the context of modern medicine. We then describe and critique current efforts to restore clinical virtue through both conflict of interest policies and through virtue ethics. Finally, we suggest some possible ways of addressing the corrosive effects of neoliberalism on medical virtue. (shrink)

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. (shrink)