Study Questions Company Rep Roles in Surgery

A study focused on medical device company representatives in surgical suites says there are “ethical questions about the reliance of surgeons on device reps and device companies for education and surgical assistance and practical concerns regarding existing levels of competence among OR personnel.” The research was reported in the open-access journal PLoS One. The authors say that while industry payments to surgeons have received public attention, little is known about the relationships between surgeons and medical device company representatives. “Medical device reps have become an integral part of operating room personnel,” they say. “The effect of their presence on patient care deserves discussion.”

Through interviewing surgeons, medical device reps, an academic medical center surgical residency program director, and a medical assistant for a multi-doctor orthopedic practice, the researchers found that device reps “work hard to make themselves unobtrusively indispensable to establish and maintain influence and to imbue the products they provide with personalized services that foster a surgeon’s loyalty to the reps and their companies. Surgeons view industry-funded training opportunities as a necessary service. Device reps and some surgeons believe that reps benefit patient care by increasing efficiency and mitigating deficiencies among operating room personnel (including the surgeons themselves).”

The report says that while it is clear that surgeons benefit from relationships with device reps, benefits to patients arising from the relationships are ambiguous. Impact on patient care must be viewed, the authors say, in the context of: 

•          the FDA approval process, which forgoes clinical trial requirements for devices deemed substantially equivalent to already marketed products;
•          the practice among manufacturers of crafting minor modifications to their implantable products, which arrive relatively quickly on the market accompanies by as yet unproved claims of superior clinical performance and higher prices;
•          the financial interest of the parent company and individual device reps in selling the most expansive implants, which may not necessarily be the best choice for individual patients;
•         the paucity of independent peer-reviewed outcomes data to fortify a choice to switch to the newer model;
•          the dominance of company representatives and surgeon consultants on their payrolls in the dissemination of early information on their new products and training sessions for surgeons; and
•          the time lag between widespread adoption of a new technology and the emergence of peer-reviewed evidence-based reports of its benefit or, conversely, its unfitness.

The authors conclude that the issues and potential pitfalls of excessive industry influence in medical care and doctors’ treatment decision making are at least as urgent for implantable medical devices as they are for drugs and prescribing practices, but to date they are far less well studied, debated, or systematically subjected to comparative effectiveness trials. “We call upon professional societies, hospital systems, individual hospitals, collaborative private practices, and regulatory bodies to develop real-time, workable methods to systematically collect, analyze, and disseminate data on implant surgeries and their short- and long-term outcomes to the professions and the public,” they say. “Finally, academic medical center and healthcare systems must develop means to provide neutral financial support for educational conferences and device training for their surgeons and trainees.”