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)

Increasingly, policymakers within biomedicine argue that “non-financial” interests should be given equal scrutiny to individuals’ financial relationships with industry. Problematized as “non-financial conflicts of interest,” interests, ranging from intellectual commitments to personal beliefs, are managed through disclosure, restrictions on participation, and recusal where necessary. “Non-financial” interests, though vaguely and variably defined, are characterized as important influences on judgment and thus, are considered risks to scientific objectivity. This article explores the ways that “non-financial interests” have been constructed as an ethical problem (...) and the implications for research integrity. I conducted an interpretive, qualitative study, which triangulated two data sources: documents (including published accounts of identifying and managing “non-financial” interests and conflict of interest policies) and in-depth interviews with 16 leaders within evidence-based medicine, responsible for contributing to, directing, or overseeing conflict of interest policy development and implementation. This article outlines how evolutions in the definition of conflict of interest have opened the door to include myriad “non-financial” interests, resulting in the generalisation of a statistical concept—risk of bias—to social contexts. Consequently, biases appear equally pervasive among participants while in reality, a politics of objectivity is at play, with allegations of conflict of interest used as a means to undermine others’ credibility, or even participation. Iterations of the concept of conflict of interest within biomedicine have thus consistently failed to articulate or address questions of accountability including whose interests are able to dominate or distort evidence-led processes and why. Consequently, current policy solutions meant to mitigate bias may instead serve exclusionary purposes under the guise of impartiality while remaining vulnerable to interference from powerful stakeholders. (shrink)

Conflicts of interest, stemming from relationships between health professionals and the pharmaceutical industry, remain a highly divisive and inflammatory issue in healthcare. Given that most jurisdictions rely on industry to self-regulate with respect to its interactions with health professionals, it is surprising that little research has explored industry leaders’ understandings of conflicts of interest. Drawing from in-depth interviews with ten pharmaceutical industry leaders based in Australia, we explore the normalized and structural management of conflicts of interest within pharmaceutical companies. We (...) contrast this with participants’ unanimous belief that the antidote to conflicts of interest with health professionals were “informed consumers.” It is, thus, unlikely that a self-regulatory approach will be successful in ensuring ethical interactions with health professionals. However, the pharmaceutical industry’s routine and accepted practices for disclosing and managing employees’ conflicts of interest could, paradoxically, serve as an excellent model for healthcare. (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)