OrthoBuzz occasionally receives posts from guest bloggers. The following commentary comes from David Kovacevic, MD in response to a November 14, 2016 article in The Washington Post.
Sandra G. Boodman’s recent column in The Washington Post, ”Why is that salesman in the operating room?… sheds light on the potential for conflicts of interest and other possible pitfalls of having device reps in the OR. Currently, device reps are required to abide by the ethical standards set forth by AdvaMed, a medical device trade association. In addition, the American Academy of Orthopaedic Surgeons has adopted standards of professionalism regarding orthopaedist-industry conflicts of interest.
Both device rep and surgeon should have one common goal—to do what is in the best interest of the patient. Ultimately, though, the surgeon is responsible for patient welfare and safety. This includes thorough pre-surgical planning; expertise in surgical anatomy, approach, and technique; complete knowledge about surgical instrumentation and implantable devices; and total transparency in the doctor-patient relationship. The competent surgeon also manages the surgical team, collaborates with the anesthesia team, and recognizes the device rep’s adjunct role.
The presence of device reps in the operating room should be limited to answering implant-specific questions for the surgical team. Patient-care problems can arise when the surgical team leader (i.e., the attending surgeon) and surgical team rely too heavily on device reps for technical expertise and assistance. This can lead to questions as to who really is in charge and accountable.
Several solutions exist for sidestepping such ambiguity. The consent-for-surgery form should state explicitly that a device rep may be present in the procedure room, and the device rep should wear scrubs or a disposable head cover that is a different color from the OR attire worn by surgical and anesthesia teams. The most effective solution, though, lies in building, developing, and sustaining surgical teams focused on improving operating room efficiency and consistency. That’s a large undertaking, and the culture change needed for it requires buy-in from multiple stakeholders, such as the medical director of perioperative services, departments in the supply chain, and leaders in anesthesia, surgery, and nursing.
One rationale for a rep-less model is to reduce the cost of implants by working directly with and purchasing from the implant manufacturer and bypassing the group purchasing organization, sales reps, and distributors. As Boodman’s article explains, for Loma Linda University Medical Center this meant obtaining device inventory directly from the implant manufacturer and training one of its surgical technicians as a de facto rep. The result was at least a 54% reduction in total case costs for primary total hip and total knee replacement procedures and empowering surgical technicians with additional knowledge about implants. It is too early to tell whether this model enhances consistency in the operating room, decreases operative time, or reduces length of stay and 30-day hospital readmission rates.
We should expect ongoing scrutiny of the device rep’s role in the operating room. With help from surgeons, hospitals and health systems should consider developing more effective surgical teams, including surgical techs specially trained about implants, to improve patient outcomes and consistency.
David Kovacevic, MD is associate fellowship director of shoulder and elbow surgery and assistant professor in the Department of Orthopaedics & Rehabilitation at Yale University School of Medicine. He can be reached at firstname.lastname@example.org or @KovacevicMD.
What happens when hospital-specified, -purchased, and -owned equipment fails? How is information about such failures distributed within the hospital and to the orthopaedic community at large? Which parties—doctors, OR staff, manufacturers, or hospital administrators—should assume responsibility for reporting these failures to the FDA to prevent patient harm?