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“I often felt like I’m driving up the costs of the healthcare system …We used to sell an implant that has 99% survivorship at 15 years, which is great, right? We were told to not ever market it to anybody … If a doctor asked for it by name, we would give it to him. We want to market the newer, the better technology. I’m not certain I ever thought the newer technology was better. There certainly wasn’t data on it … I was uncomfortable with those sorts of things.”
This statement was made by a medical device representative during a recent focus group held by researchers. “We believe that there is an inherent conflict of interest, and therefore an ethical problem, in having the surgical sales representatives present in advisory capacities in the OR,” says Bonnie B. O’Connor, PhD, the study’s lead author and professor emerita of pediatrics at Brown University’s Alpert Medical School in Providence, RI.
Researchers also held focus groups with ear, nose, and throat surgeons and hospital-based attending orthopedic surgeons. While most surgeons said that medical device representatives improved efficiency within the OR, some were uncomfortable with certain aspects of the representative’s role, researchers found.1
Device reps can make surgeries more “efficient” in terms of length of time spent completing the surgical procedure. “This, along with sales techniques that rely on sophisticated use of social psychology data, helps to create a sense of indebtedness on the part of physicians,” says O’Connor.
In the case of drug reps, this is well-demonstrated to affect physicians’ choices and prescribing practices. “We believe the same factors are at work in the selection of medical devices,” says O’Connor.
Adriane Fugh-Berman, MD, associate professor in the department of pharmacology and physiology at Georgetown University Medical Center in Washington, DC, is another of the study’s authors. She notes that some surgeons didn’t realize that devices did not have to be tested in humans before being approved.
“Newer devices not only cost more, but they are relatively untested,” says Fugh-Berman. “Untested devices have caused many problems.” In the U.S., devices can be approved based on “substantial equivalence;” many have never been tested in humans before being surgically implanted in patients.
“Add to that surgeons’ conflicts of interest with device companies, and the question of whether patients are aware that a device rep will attend their surgery, and the ethics issues increase exponentially,” says Fugh-Berman.
Close relationships develop when device reps provide services to individual surgeons. “They act as a part of the surgical team,” says Fugh-Berman. “However, these are not health professionals who have the patient’s best interests in mind.”
Rather, the reps are industry employees who make money from every device from their company that is implanted into a patient. “They should not be part of the surgical team. Everyone in an operating room should be there to benefit the patient,” says Fugh-Berman.
While device reps offer services that surgeons are grateful for, says Fugh-Berman, these services should be provided by the hospital — not someone who is profiting from surgeons’ choices.
O’Connor says, “Surgical sales representatives are understandably biased in favor of their companies’ proprietary devices, and so are trying to ‘convert’ surgeons to use them.” Commissions earned on sales can significantly increase the compensation of successful reps.
“This creates a powerful incentive for reps to persuade physicians to choose newer and more expensive devices, irrespective of how much benefit they confer for patients by comparison with established and less expensive devices,” says O’Connor.
The American College of Surgeons’ guidelines for informed consent of patients regarding the presence of device reps in the OR state the patients should be clearly informed, and their agreement or disagreement with having reps present documented and followed.
“The majority of the surgeons we interviewed were not aware that this is a recommended part of the pre-surgical informed consent content and process,” says O’Connor. The surgeons didn’t know if it was part of their hospital’s informed consent process.
“Some believed it was not necessary to inform patients, since the choice to have a rep present rested with the surgeon,” says O’Connor. Some believed patients would not be equipped to make the decision in an educated way. “One believed it would only confuse patients to be asked about it, at a time when they were already stressed enough,” says O’Connor.
Others expressed concern at informing patients about the practice because they believed that patients would refuse it if it were specifically pointed out. “Deciding not to inform patients of a practice because you believe they will say no if you tell them about it, is an obvious signal of an ethical problem,” says O’Connor.
Lydia Dugdale, MD, assistant professor of medicine and associate director of Yale School of Medicine’s Program for Biomedical Ethics, says that even if the devices pushed by reps are equivalent in efficacy to older options, they typically cost more — and the patient bears this cost.
“The relationships between doctors and medical device or pharmaceutical reps also raise questions of conflict of interest and informed consent,” says Dugdale.2
If a surgeon plans to use a brand-new device for a joint replacement, for example, should the patient be told that an older, cheaper, similarly efficacious device is available? “There has been a growing trend, among academic physicians, at least, to disclose financial conflicts of interest in publications or before a public lecture,” notes Dugdale.
Should the patient’s consent to surgery include the patient being privy to the surgeon’s relationship with the device company? “If we doctors are to be wholly consistent, we should consider making similar disclosures to our patients who might benefit, or not, from physician relationships to drug and device reps,” says Dugdale.
While there is growing awareness of the untoward influence of drug reps on physicians’ practice, notes Fugh-Berman, the same is not true of device reps. “A few places make them wear different colored surgical caps,” she notes.
A few device companies are trying out a “rep-less” approach, with hospital employees trained to provide the technical assistance instead. But, according to O’Connor, device reps “still aren’t getting even a tiny percentage of the push-back and refusal that drug reps have in recent years.”
Consulting Editor Arthur R. Derse, MD, JD, Nurse Planner Susan Solverson BSN, RN, CMSRN, Managing Editor Jill Drachenberg, Associate Managing Editor Dana Spector, and Contributing Editor Stacey Kusterbeck report no consultant, stockholder, speakers’ bureau, research, or other financial relationships with companies having ties to this field of study.