The Advanced Medical Technology Association (AdvaMed) code of ethics for interactions with healthcare professionals has been revised for 2020.1
“The updates reflect the evolving legal standards, business models, and best practices seen over the last decade,” says Nancy Travis, AdvaMed’s vice president of international compliance and governance.
Device reps giving technical support in the clinical setting is a key area of focus. “One of the ways that medical technology companies can serve the interests of patients is through beneficial collaborations with healthcare professionals,” Travis says.
Collaborative relationships help develop new medical technologies, and ensure they are used safely and effectively, according to Travis. The code of ethics clarifies socially responsible conduct related to these interactions. “This ensures healthcare decisions are always in patients’ best interests,” Travis says.
Device reps’ training and credentialing is “a great concern,” says Lisa Spruce, RN, director of evidence-based perioperative practice at the Association of periOperative Registered Nurses (AORN). This group recently released an education and credentialing tool, RepDirect, that incorporates AdvaMed’s code of ethics.2 “This assures perioperative nurses that healthcare industry representatives have undergone training and have demonstrated competency and ethical practices,” Spruce says. What are the specific ethical concerns regarding the relationship between clinicians and device reps?
• Some clinicians rely too heavily on the expertise of reps during surgical procedures. Some reps (and even clinicians) may not have received adequate training to speak as experts on the subject.
• Device reps may be performing functions outside their scope of responsibility. “Credentialing processes for personnel who will have patient contact are different than for industry representatives,” Spruce explains.
Many organizations have instituted policies that prohibit device reps from opening sterile supplies, as this task carries infection risk to the patient. There also could be a conflict of interest if reps are opening their own company’s supplies or implants. “Clinicians and reps must work together to avoid crossovers that are outside their respective roles, training, and education,” Spruce stresses.
• Clinicians may lack training on commercial bias and marketing efforts. “Clinicians are ethically bound to act in the best interest of the patient and are licensed to do so, whereas reps are representing the manufacturer,” Spruce observes.
• Patients often lack knowledge of the rep’s presence during surgery and/or their role. Patients should be fully informed of these things, according to Spruce. Clinicians should obtain informed consent (to the extent possible). “In some cases, it is unfeasible or unsafe for patients to refuse the presence of an industry rep,” Spruce acknowledges.
The rep’s presence might be necessary to ensure a surgical device is used safely. Regardless, says Spruce, “facilities should have policies that clearly delineate the role of the rep when they are in the clinical space.”
The obvious ethical concern with industry relationships is clinicians can make choices that do not benefit their patients. Decisions are made, often under pressure, in the OR. “These relate to device choices that are profitable for firms but may not improve patient outcomes,” says Genevieve P. Kanter, PhD, assistant professor of medical ethics and health policy at Perelman School of Medicine at the University of Pennsylvania.
The latest, most expensive device is lucrative for the manufacturer, but sometimes of no additional value to the patient on the operating table. The device rep should not be the clinician’s sole source of information on this. “Clinicians need to be independently informed about the range of choices and consider only their value to the patient,” Kanter cautions.
Reps can influence various types of financial benefits for physicians. It does not mean cash is exchanged directly. Sometimes, the rep arranges for a lucrative consulting role or offers perks like travel to meetings. “There may be some kind of quid pro quo in that relationship,” Kanter observes.
Other times, the clinician is not really providing legitimate services to the device manufacturer. It is more a case of a company providing compensation to the clinician for using the manufacturer’s devices.
“A common unethical practice relates to misleading or biased information provided to the clinician,” Kanter says, listing some examples:
- Reps may overstate the evidence associated with a particular device by talking about poorly designed clinical trials;
- Reps may not be comprehensive about complications or adverse events reported to be associated with a device unless they are asked about them directly;
- Reps may talk inappropriately about off-label uses, especially with a weak evidence base. “It is difficult to police those one-on-one interactions,” Kanter acknowledges.
She suggests clinicians rigorously challenge claims made by the reps and mention the claims made by one firm to a rep in a competing firm. “The competing firm will be more than happy to point out weaknesses in what is presented, and to report violations in the code of ethics made by their competitors,” Kanter says.