I want to start out this post by pointing out an important paper from the American Medical Association dated September 2021. It concerns the subject of medical device salespeople in operating rooms. The AMA Journal of Ethics makes several observations in its presentation including that a particular case:
“(S)uggests a possible disconnect between the device manufacturers and the health care organization’s training requirements for new technology use, especially at the point of care, and how those requirements are communicated.”
I have intentionally retained the link from the paper to allow a wider expansion of the article research.
The paper draws the conclusion that the days of sales reps in OR’s might and/or should be eliminated in favor of another model; a highly trained consultant who serves as a liaison between the sales organization and the surgical team.
At heart here, aside from an overstepping of bounds (an ethical issue) and the outcomes of what occurs when the medical device sales representative is ill-informed, and the surgical team is unfamiliar with the technology. The results can be catastrophic, and has led to major lawsuits.
Lately, there has been a rash of lawsuits and reports (Modern Healthcare, August 2021) that are rather disturbing in regard to what has been termed a “cozying up” of medical device sales reps and surgical personnel.
When a medical device sales rep and/or their sales team, assumes knowledge that he or she lacks, even if it seems innocuous – testing equipment for example, as opposed to a surgical implant, the lawsuits can be staggering. As an ethics consultant and speaker, I expect the lawsuits will get worse. This year has seen an aggressive stance on the part of the Department of Justice and other agencies to go after device companies. I would not be shocked to see additional penalties on top of fines.
Why is this Occurring?
We need to step back from the world of medicine and surgery and delve into the ethical universe. All fraud rests on three pillars despite the industry, size of the company, location or technology.
The pillars are a lack of oversite, need and rationalization. We usually don’t think of medical device sales reps (and their organizations) of falling into these areas, but unfortunately, they do.
Every time an unqualified sales rep has entered an operating room or misrepresented the capabilities of a product (or both), and is conferring with a healthcare provider who is “inexperienced,” the lack of oversite has often led to poor outcomes.
If the surgeon, for example, needs help with a new orthopedic device, and the sales rep – at best – is playing “junior doctor,” unethical behavior is clearly in play. This is why the AMA more than suggests that instead of an unqualified sales rep, there should be an improved dynamic where a surgical consultant extremely familiar with the technology should be brought in who has a documentable set of qualifications.
Why do these failures occur? Often it is based on a strong need to get the sale done because it means money, quotas and such. Then there is another need not often mentioned (and I have heard it many times): the need for power, where a rather unqualified dynamic occurs of “I know more than the doctor.” Unfortunately, when ego, greed and lack of training come together, the patient suffers.
The biggest “why” of this scenario rests on rationalization. The standard line is often one of, “Well, everyone does it.” The justification is both unethical and indefensible. Everyone does not do it, and it must be pointed out that all of us – at one time or another – will go from wellness to patients. Would anyone of us favor a surgery on ourselves where neither surgeon nor company representative knows what to do? I clearly think not.
Medical device salespeople do have a unique obligation, as do their organizations. It is not based on money or science first, but ethical behavior.
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