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Should medical device sales reps be 'surgery consultants?'

Some hospitals have pulled the plug on this legal and ethical dilemma.

It's normal to have numerous doctors in the operating room assisting or observing a hip or knee replacement. But many patients don't realize their surgical team includes an extra person who has no medical training. Sales representatives for implanted medical devices are often in the OR, not merely watching but actively guiding the surgeon.

While manufacturer reps have product insights and practical understanding of medical issues, they are not doctors. The situation is fraught with potential for harm to patients. It has come into play in medical malpractice lawsuits over botched implants, as well as product liability lawsuits over defective implanted devices. If someone has suffered complications from a hip replacement or knee reconstruction, a savvy malpractice attorney will investigate the nature and extent of the sales rep's involvement.


Device reps may be involved in your surgery

Normally "civilians" are not allowed in the operating room, not even family members or hospital administrators. Medical personnel only. Likewise, a doctor would never invite a pharmaceutical company rep into a patient conversation about a particular drug.

But an exception is made for representatives of implanted medical devices such as hip joints, pacemakers or stents. They are product experts and frequently allowed to attend the surgery in a consultant role.

A recent Washington Post article examined the troubling trend of device reps in the OR. Some view it as a conflict of interest -- direct corporate influence over medical decisions - especially when patients are not aware of the rep's involvement. Some are aghast at the medical ethics of "Sales Guy" calling the shots during an operation. On the other hand, manufacturer reps do have intimate knowledge of the technical aspects of the device, which may be invaluable during implantation. Often, they have more experience than the surgeon with the specific implant surgery techniques and complications.

The sticky wicket of industry reps

There are numerous class action lawsuits - pending and settled - over hip and knee implants. Many devices turned out to be mechanically defective or caused metallosis (illness and bone deterioration). Device reps may be implicated if an artificial knee joint or hip replacement fails, especially if it is improperly implanted based on real-time input from the rep.

Device reps may have undue influence over choosing a certain model or the decision to have a partial replacement versus a replacement "system." Long before a recall was announced, account reps were probably aware of the high failure rate of various models. Did they knowingly sell a flawed product?

The surgeon and hospital may be implicated for allowing the device rep to be too heavily involved in the operation. In one of the earliest and most egregious cases (in the 1970s) a surgeon left the OR for several hours while a manufacturer's rep performed hands-on troubleshooting. More recently, device reps are not performing surgery but some are giving step-by-step instructions to surgeons who are not well-versed with the device and the surgery.

Do you think there is a role for sales representatives in medical device surgery? At a minimum, patients should be informed of the rep's involvement. Some hospitals have banned device reps from the OR altogether. Others have implemented rules and transparency for their involvement.

Source: Washington Post article Nov. 14, 2016

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