A viewpoint piece published in BMJ Ethics addressed the ethical features of the medical device industry and the concern that practitioners may be inappropriately influenced by commercial incentives.
Technical product specialists and other representatives of medical devices are typically available in-house to provide guidance to health professionals. However, the duality of the role of these representatives with regard to both commission sales and providing medical advice raises concerns about the potential for commercial influence on physician decision-making. Authors identified 3 primary ethical challenges with the medical device industry: increasing healthcare costs, the outsourcing of expertise, and issues with informed consent.
Per study data from 2013, about 50% of all active surgeons in the United States received “non-research-related payments from industry.” Funding of this nature is typically associated with “increased use of the sponsor’s product.” Authors argue that the medical device industry is therefore associated with inappropriate financial incentives for clinicians and the increased cost of medical care in the United States, as representatives are typically encouraged to market more expensive devices. As an additional concern, the article addressed the outsourcing of expertise, or increasing physician dependence on technical representatives for guidance during procedures. Relying too heavily on device representatives can allow physicians to become incompetent in using the equipment, which is a liability during procedures. As a final point, authors noted that full informed consent cannot be obtained when the patient is unaware of the dynamics between the representatives and physicians on their care team.
Authors called for the separate contracting of industry representatives, such that service costs are kept from physicians and are unable to influence clinical decision-making. Further, hospitals should “invest in experts who can provide…product support” independent of sales initiatives. Alternatively, hospitals could invest in the training of their own personnel, such that physicians need not rely on in-house technical experts. Authors also suggested a registry to collect data related to device use, thus allowing for hospitals to track adverse events and lessening dependence on manufacturers for device efficacy information. Such a registry would also allow clinicians to make informed decisions on device use independent of influence from technical representatives.
Authors argued that “[decreased] reliance” on device representatives is essential to eliminating commercial influences on physician decision-making. Hospitals must clarify the respective roles of device representatives and healthcare professionals to eliminate commercial influences on clinical decision-making.
Grundy Q, Hutchinson K, Johnson J, et al. Device representatives in hospitals: are commercial imperatives driving clinical decision-making? [published online July 4, 2018]. BMJ Ethics. doi: 10.1136/medethics-2018-104804