Device reps in theatre: blurred boundaries or regulatory gaps?

There has been a shift of dynamic in the relationship between technology and healthcare, with technological advancements progressively driving change in the delivery of care and, at times, causing disruption to the traditional doctor/patient partnership. This shift is significant in the context of medical devices. Increasingly complex devices are being introduced which require a level of technical expertise outside of the scope of the traditional training of doctors, with this knowledge gap progressively filled by medical device representatives (MDRs), a role that began as devoted to sales and has now expanded to that of adviser and trainer. This change in role represents a blurring of lines between sales and support and has potentially flourished within a regulatory gap. This paper addresses the challenge of the evolving relationship between MDRs, surgeons and patients and is based on the findings of a broader project "Support or Sales? Medical device representatives in Australian hospitals". It provides an overview of the outcomes of a series of interviews with stakeholders highlighting their perceptions and experiences at this point of intersection between care and sales. It then examines the existing regulatory framework and considers whether there is a real or perceived regulatory gap. This analysis of current regulatory measures in areas such as hospital safety, privacy and professional regulation and conflicts of interests, leads to a conclusion that the evolving relationship between MDRs and surgeons has not taken place in a regulatory vacuum and sufficient frameworks are in place to protect the public. However, they rely heavily on translation into local policies and concurrent adaptations to best practice behaviour which does appear to be lagging, resulting in insufficient transparency and recognition of emerging contexts requiring novel applications. This lag could threaten patient safety and patient trust in the healthcare system.