By Quinn Grundy, Katrina Hutchison, Jane Johnson, Brette Blakely, Robyn Clay-Wlliams, Bernadette Richards, Wendy A Rogers
Imagine that your elderly mother undergoes a hip replacement. During the post-operative appointment, the surgeon informs your mother that an error has been made: the two parts of the joint implant, a ball and socket, are mismatched. He explains that a device company representative, who was present during the case to provide technical support, had prepared the wrong components. The error was identified after the case, when the mismatched serial numbers were entered into the medical record.
You and your family have two options: remedy the error through another surgery, or live with an artificial joint that might not function optimally or may fail earlier than anticipated. While working through your options, one question remains: who was this person who prepared your mother’s implant and what were they doing in the operating theatre?
The presence of a company ‘technician’ is surprising to both you and your mother. When she was being prepared for surgery your mother had been introduced to the surgeon, anaesthetist, nurses and other members of the clinical team. At no point was she made aware that someone else would be involved in her surgery, she was not asked permission for them to be there and now, you all want to know what someone, best characterised as a ‘salesman’ was doing in the room and taking responsibility for preparation of a surgical implant.
This scenario is not hypothetical. It is common practice for device industry representatives, who are technical product specialists, to be present in hospitals on a day-to-day basis. Device representatives provide support for the use of products manufactured by the companies for whom they work. Activities of device representatives include being on call and/or present in operating theatres to provide technical guidance to surgeons and nursing staff; ‘trouble shooting’ equipment problems on the wards; and providing in-house training to staff using new devices and technologies. They may also buy lunch for staff, attend staff holiday parties, sponsor conference travel and form long-term, personal relationships with clinicians to foster friendship and loyalty. Regardless of their utility, there are many unanswered questions about the roles and responsibilities of reps, and their relationships with medical and nursing staff, and patients.
Our recent paper, Device representatives in hospitals: Are commercial imperatives driving clinical decision-making? explores this question. Our concern arises from the fact that while device representatives are technical experts, they are not necessarily medically trained and most work on sales commission. Thus, device representatives are incentivized to increase the volume of sales and the use of more expensive products. They do so by providing ‘service’ for the device. At times this service expands to include: remedying staffing shortages, helping to prepare sterile implements, explaining procedures to patients, and treating clinicians to lunch. Their dual function as support and sales person creates a clear conflict between commercial and clinical goals.
When activities such as training or guidance on the use of a device are outsourced to device representatives a conflict arises between commercial and public interests, potentially compromising safe, cost-effective care. The potential for poor outcomes is illustrated by the vaginal mesh case. This story is unfolding in many courtrooms around the world, where plaintiffs are asserting they were harmed, and in some circumstances, permanently disabled by their implants. Internal company documents that have become public through these legal proceedings suggest the device was aggressively marketed to unqualified surgeons who relied on device representatives for training. Commercial imperatives led to poor clinical outcomes.
Recent headlines also highlight the issue of informed consent. The practice of relying on device representatives during surgeries elicited the headline: “Patients in disbelief as mesh company sales reps were allowed in theatre while surgeons carried out intimate operations.” The same practice taking place in Australia resulted in an investigation as to how a male company rep attended a woman’s surgery without a patient’s knowledge.
Our paper explores this issue in depth and represents the beginning of important research into the ethical and legal implications of involving sales representatives in clinical procedures. We are a multi-disciplinary team examining the complex questions around consent, liability, ethics, respect and patient care that arise in this context. Importantly, we recognise the need for specialist advice and training when there are new devices or procedures, but caution against the outsourcing of expertise and unfettered access to patients (especially without their knowledge). However, in our view the place of device representatives in the treatment chain is open to challenge. We are beginning a dialogue that many have avoided – clinicians, hospitals and device companies all benefit from the relationships that currently exist. Patients can also benefit from access to the latest medical technology. But what are the risks and where are the boundaries?
Authors: Quinn Grundy1,2, Katrina Hutchison3, Jane Johnson3, Brette Blakely4, Robyn Clay-Wlliams4, Bernadette Richards5, Wendy A Rogers3,6
1 School of Pharmacy, The University of Sydney, Sydney, NSW, Australia
2 Charles Perkins Centre, The University of Sydney, Sydney, NSW, Australia
3 Department of Philosophy, Macquarie University, Sydney, NSW, Australia
4 Australian Institute of Health Innovation, Macquarie University, Sydney, NSW, Australia
5 Adelaide Law School, University of Adelaide, Adelaide, SA, Australia
6 Department of Clinical Medicine, Macquarie University, Sydney, NSW, Australia
Acknowledgments: We would like to thank Chrissy Clay, Research Assistant at the Australian Institute for Health Innovation, Macquarie University, for her comments on this post.
Funding: Dr Grundy is supported by a Postdoctoral Fellowship from the Canadian Institutes of Health Research. This work received no specific funding.
Competing interests: None.