Device Industry employees in the clinic: ethical issues

Katrina Hutchison ()

When you’re under the knife in the operating suite having a device implanted, would you expect a device industry employee with a laser pointer to be walking the surgeon through the finer points of implantation? When I recently interviewed surgeons, nurses and hospital managers about innovative surgery many talked about the involvement of device industry employees in clinical care. In this paper my aim is to describe a set of neglected but important ethical issues associated with this, and to offer some preliminary thoughts on how these problems might be addressed. Device industry employees are in many ways well-placed to provide technical support in the operating theatre when their devices are being implanted, and in clinical contexts involving device maintenance. They have both the requisite familiarity with the device, and an interest in ensuring that clinicians and nursing staff use it safely and effectively. Nevertheless, there are reasons to be wary. These include risks of harm to patients when reliance on industry-employed technicians leads to treatment delays, risks of harm that may be associated with patient misconceptions about the roles of these individuals, risks of harm associated with industry employee involvement in end-of-life care (e.g. device de-activation), ethical issues generated by role ambiguities such as when clinicians and nurses seek clinical advice from industry employees that takes them beyond their designated role, and the potential for conflicts of interest. The discussion is partly motivated by a concern about how these issues will play out in the future, with increasing uptake of complex implanted medical devices and prospects for implantable artificial organs, upon which patients will be highly dependent and for which technical support is time-critical.