Unknown to most hospital patients, it is common practice in surgeries requiring device implants for the device manufacturer's sales representative to be present during the operation. Sales reps can help doctors practice using new technology for the first time on a patient. Reps tell doctors which implant to use. They arrive early at the surgery suite and then set up all of the equipment needed to implant the device. Orthopedic surgeries can require sales reps to bring in eight trays or more, each with 20-60 different instruments per tray. Only the sales reps know what most of the instruments and hardware are for, including how and in what order to use them.
Technically, the sales rep cannot touch either the patient or any equipment that will contact the patient. Instead, the rep uses a laser pen to point out each instrument, screw, pin or piece of metal to the doctor. If the surgeon is hesitant, the rep points out where to install the piece. The sales rep explains to the surgeon how to perform the implant part of the surgery.
What defines the doctor-sales representative relationship?
A surgeon and sales rep may become close friends over the years. Many surgeons claim they trust their sales rep—a nonmedical person who usually has only a business school degree—more than they do any other medical personnel in the operating theatre.
How does this symbiosis create a conflict of interest?
The sales rep's job is to supply the most expensive implant in the company's product line, even if the company knows the new implant is not as effective as an older model. Medical device companies quickly produce and release new devices and new technology. Consequently, surgeons cannot realistically keep up with all the training to become proficient in their use; thus, they rely heavily on the sales rep's knowledge and direction.
Why is a sales rep in the operating room without patent consent?
Doctors generally do not inform patients about the nonmedical guest in the room. Company reps stay in the operating room for nearly every device implant operation. Sales reps may watch when doctors perform intimate mesh surgery on female patients, without the patient's consent.
In one case, a sales rep prepped two halves of a hip joint ball and accidentally mismatched them. The hospital had to tell the patient that the joint probably would not work as well and could fail significantly earlier than usual. In another case, a sales rep told a brain surgeon to use a particular bone cement to reseal a portion of the skull. The sales rep recommended the wrong cement, and the patient's outcome was poor.
In the case of a bad surgical outcome, the patient deserves a full written explanation from the doctor, the sales rep and their company, and the hospital. The patient has the right to make sure that any damage is compensated, including pain, suffering, loss of function, loss of employment earnings and expenses associated with any future corrective surgeries.