What is a MDR®?

From all accounts, device reps perform a myriad of tasks related to their OR assignments. Our interviewees reported attending at least one surgery daily and having to be available, at least by phone, 24 hours a day, seven days a week.

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The reps are responsible for ensuring that all the instruments and components needed for each surgery on their schedule are on hand and ready for use. That may entail assessing and accessing hospital stocks, as well as bringing their own implant systems. They also anticipate the need for alternative sizes, instruments, and components, and they bring these additional items with them. One rep reported helping hospital personnel sterilize and rewrap instruments after each surgery.

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The orthopedists estimated that they used about 100 implantable devices, not including the other tools used during any given surgery. Device Rep 1 estimated that for a total knee replacement, there are “typically eight trays of instruments, each with between 30 and 60 pieces of metal,” with all of which he was singularly familiar.

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“This is one of the reasons why, currently, you need a rep in the operating room. . . . Who’s to say who else will know when we get to surgery in the morning whether you're opening the right implants, or whether you're opening the right trays?…[I]t's useful to have somebody else in the room whose specific job is to have that information on hand always.” [DR1]

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“When the doctor comes into the room, [I can say], ‘We're ready to go with the instrumentation.’ That's one less thing he has to think about or worry about. And he has to be able to trust that I can say that with confidence.” [DR3]

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The device rep wears scrubs and authorizing badges in the OR, but does not scrub in and is not allowed to touch anything. He* [our three interviewees were males, as are most device reps][16] uses a laser pointer to indicate to the scrub tech(s) the items to be handed to the surgeon, in the appropriate order.

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“I like to say that the surgeon never has to put his hand out and ask for a scalpel; he just puts his hand out and gets what he needs.” [DR3]

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Throughout the surgery, the device rep is there to guide the scrub techs as needed, to answer any questions the surgeon may have, and to suggest or provide alternatives should a problem arise.

The extent of direct exchanges with the surgeon during the course of the surgery varies considerably. The rep takes his cue from the surgeon in a speak-when-spoken-to-manner, answering any questions posed to him but otherwise maintaining silence and a fit distance from the surgeon’s activity. To do otherwise, said one ENT, could get him removed from the OR and not invited back.

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“There was a big range of what you did. There were surgeons where, literally, all you did was open a box. They didn't need your help; they didn't want your help. They knew the sizing perfectly. . . . And there [were] other surgeons who would…ask for step-by-step instructions at times.” [DR1]

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Their auxiliary role in the surgical suite notwithstanding, each device rep recounted instances of having saved the day by dint of having a more thorough familiarity with the equipment and/or possible maneuvers than the surgeon had.

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“I have seen a doctor fracture a trochanter while putting in a hip replacement and look up at me and say, "Hey, do you happen to have your cables?" He had not ordered cables. . . . [But] we made it standard practice to always bring it with us. So this is one of those situations where I get to be the hero. He's never fractured a femur before. . . . So, I run out and I get [the cables, which are wrapped and sterile and outside the room] and I hand it to the circulating nurse, who will open the tray and put it on the table, and [the surgeon says], ‘Okay, walk me through this, I don't know how to do this.’ I'm the person in the room with the most knowledge about that device at this point. I know how to thread the wire through the jig. I know how it goes into the plate. I know how much you have to tighten it…” [DR1]