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Should medical device sales reps be in the operating room?

If you or a loved one is preparing to undergo surgery, you might assume that the only people in the operating room will be medical professionals. However, if you're having hip or knee replacement surgery or a cardiac procedure that involves implementation of a medical device like a pacemaker or stent, a sales representative from the company that made that device might be there as well.

This isn't a new practice. Device reps have been in operating rooms for a long time. However, as baby boomers are wearing out their joints — not to mention their hearts — and artificial joints and other hardware are becoming more common, the involvement of these sales reps in surgical procedures has gained new scrutiny and criticism.

The reps, as well as many surgeons, contend that their help is crucial because of their knowledge of their products. Many have numerous tiny components, and the reps may be more familiar with the tools needed to insert and remove them than the surgeons are — particularly if the device is a new model. These reps undergo extensive training that often involves cadavers, so they're not unfamiliar with what goes on in a surgical suite.

Medical device reps can help ensure that the components of a device are properly laid out for the surgeon for efficient access. They also save hospitals money, because if reps are banned from operating rooms during surgery, hospitals must replace them with additional hospital personnel to assist with insertion or removal of the devices.

Critics say that reps are there only to build their relationships with doctors and gain an advantage over competitors. However, surgeons often prefer having reps there, making hospitals reluctant to limit or forbid their presence.

Hospitals and some medical device companies have rules about what reps can and can't do. For example, they can't touch patients or any sterile instruments or objects.

With all the advantages that medical device reps offer to surgeons, it may be in a patient's best interests to have one in the operating room if they're getting a new knee or having their pacemaker replaced. However, if something goes wrong, it's wise to find out precisely who was in the room and what role they may have played in a surgical error.

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