Assoc Prof Bernadette Richards1, Dr Susannah Sage Jacobson, Associate Professor Mianna Lotz, Distinguished Professor Wendy Rogers
1University Of Queensland
The introduction of new technologies in medical treatment has led to rapidly evolving innovations in medical devices. Medical device representatives (MDRs) are employed by device manufacturers to help healthcare providers to use new devices competently. While the relationship between MDRs and healthcare providers can be a positive one, it has evolved over time and is not independently regulated.
However, healthcare providers are not the only ones affected by MDRs. This presentation will discuss the problem of medical device representatives (MDRs) being physically present in clinical settings, where their role within the healthcare team is unclear, and the nature of their relationship with patients unspecified. Although patients may be advised about the technical nature of any medical device itself planned for use in their care, they may not be aware of the presence or active involvement of the MDR in their surgery. Significantly, they will have little insight into the nature of the relationship between the MDR and their healthcare team. It is this knowledge gap with regard to the role of MDRs that is the focus of this paper.
We argue that trust is at the heart of healthcare relationships and that MDRs may currently present a threat to both the interpersonal and the institutional trust of patients. We identify transparency and communication as the crucial characteristics of an appropriate regulatory and policy responses and recommend that a positive obligation to inform the patient of the role of MDRs in their clinical care be established.
Biography:
Bernadette is currently A/Prof of Ethics and Professionalism at University of Qld Medical School. Prior to that she was working on the Future Health Technologies Project at the Singapore ETH Centre, exploring trustworthy data governance. She is a member of the NHMRC’s Australian Health Ethics Committee and Embryo Research Licensing Committee and the South Australian Voluntary Assisted Dying Taskforce. She Chaired the Mitochondrial Donation Expert Working Committee and was involved in drafting of the new law. Bernadette is President of the Australasian Association of Bioethics and Health Law (AABHL), and has completed major projects on organ donation, consent to treatment and legal issues around innovative surgery. She is a chief investigator on three major grants, NHMRC Partnership Grant, “Strategies for the inclusion of vulnerable populations in developing complex and sensitive public policy: A case study in Advance Care Planning”, NHMRC Ideas Grant, ‘The algorithm will see you now: ethical, legal and social implications of adopting machine learning systems for diagnosis and screening’ and ARC Discovery Grant, ‘Support or Sales? Medical Device Representatives in Australian Hospitals’. Her co-authored book, ‘Technology, Innovation and Healthcare: An evolving relationship’ was published in February 2022 and has over 90 other scholarly publications.