EXECUTIVE SUMMARY

Surgeons rely on device representatives’ presence, yet are concerned about conflicts of interest and patient safety. Some possible solutions include:

• hospitals, rather than surgeons, determining which companies get their business;

• physicians being informed of competitors’ products;

• surgeons actively seeking alternatives to the device they’re currently using.


Surgeons are concerned about conflicts of interest and patient safety due to the increasing presence of device representatives in operating rooms. However, the surgeons also rely on those reps, found a recent study.1

“This is certainly a topic that is fraught with ethical issues,” says Sue Ross, PhD, one of the study’s authors. “I suppose this will always be the case at the interface of medicine and industry.”

Researchers surveyed 22 physicians about their relationships with device industry representatives. “We chose to interview cardiovascular and orthopedic surgeons, because the devices they use tend to be in the higher-risk category,” says Ross, professor and Cavarzan chair of mature women’s health research at the University of Alberta in Canada.

Participants described:

• a tension between physicians and representatives that required physicians to be vigilant about conflicts of interest and patient safety;

• representatives varying regarding disclosure of device defects;

• tension between hospitals, whose policies and business practices were focused on cost control, and physicians who were required to use particular devices despite concerns about their safety and effectiveness.

“We were surprised that the role of device industry representatives was deemed to be crucial by many of the surgeons in assisting with their surgical practice,” says Ross. The reps were not involved with the actual surgery. Rather, they used their knowledge about their own specific products, and their skill in assembling devices, to advise surgeons on practical aspects of their use.

“The devices are now so complex and may involve a number of interchangeable parts, and the choice of individual components is patient-specific,” notes Ross.

Safer, Quicker Surgery

As employees of the device companies, the reps are obliged to represent that company. “The surgeons are, in a sense, their clients,” says Ross. Additionally, the reps have specific technical skills that can assist with patients’ surgical care.

“The surgeons need those skills,” says Ross. “Some surgeons believe that the reps make the surgery safer and quicker in most instances.”

The problem is that the reps can have conflicts of interest in terms of selling more product versus making the best choice for an individual patient, says Ross. Some ethical concerns include:

• Hospitals may be conflicted by making decisions based on financial considerations instead of purchasing the ideal devices for individual patients.

“Surgeons and hospitals may have a goal of quick surgery, so that more cases can be treated,” adds Ross.

• The relationship between rep and surgeon gives the company a competitive advantage to maintain the hospital’s business.

“Where the conflicts of interest come into play are when device manufacturers are in competition with each other — which is often the case,” says Ross.

• Physicians and surgeons may choose products that are not the best match for their patients’ needs.

If they rely on only one firm’s representatives, doctors can typically only choose from among the range of products offered by that firm.

“What the firm is good at manufacturing may not be optimal for any one particular patient,” says Genevieve P. Kanter, PhD, assistant professor in the division of general internal medicine and division of medical ethics and health policy at the University of Pennsylvania Perelman School of Medicine in Philadelphia.

• Physicians may value whatever perks they get from their relationship with the device firm.

These aren’t necessarily financial perks. “It may be social connection or friendship with a particular rep with whom they work closely — or with the goodies that the firm can offer,” says Kanter. Either way, it can lead physicians to favor one firm or device over another, separate from the device’s merits.

Having comfortable relationships with specific reps can cause conflicts by limiting the surgeon’s choices, says Ross: “The company may or may not have the best device for a particular patient.”

Open to Alternatives

Surgeons interviewed by the researchers offered various solutions to reduce conflicts. For example, some hospitals determined which companies would have their business, reducing surgeons’ choice in the matter.

To minimize conflicts of interest, physicians must be open to the products offered by firms other than the firm producing the device they’re currently using, says Kanter. Doctors often get used to working with a particular device or firm, so seeking out competitors doesn’t come naturally.

“But doctors periodically seeking out alternatives is the best way to not get locked in to a single relationship that may or may not be in the best interest of all their patients,” says Kanter.

The drive toward precision medicine is likely to affect the situation one way or another. Medical device companies may respond by developing more versatile products — or by driving up prices. “Doctors should keep their eyes open for these developments,” says Kanter.

REFERENCE

1. Gagliardi AR, Lehoux P, Ducey A, et al. “We can’t get along without each other:” Qualitative interviews with physicians about device industry representatives, conflict of interest and patient safety. PLoS One 2017;12(3):e0174934.

SOURCES

• Genevieve P. Kanter, PhD, Assistant Professor, Division of General Internal Medicine/Division of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia. Phone: (215) 898-2703. Email: gpkanter@pennmedicine.upenn.edu.

• Sue Ross, PhD, Professor and Cavarzan Chair in Mature Women’s Health Research, Department of Obstetrics and Gynecology, University of Alberta, Canada. Phone: (780) 735-6490. Email: sjross@ualberta.ca.