In the operating room, surgical masks andmatching scrubs can make it hard to tell who’s who — at least for outsiders.

Patients getting wheeled in might not realizethat salespeople working on commission are frequently present and sometimeseven advise the clinical team during surgery.

Who are these salespeople, and why are theythere?

The answer to the first question is prettyeasy. These sales reps typically work for medical device companies, such asStryker, Medtronic or DePuy Synthes. Many surgeries, especially orthopedictrauma and cardiac procedures, require insertion of artificial joints or otherhardware manufactured by these companies.

But as to why they’re present in theoperating room, the answer depends on whom you ask.

Critics of the practice say that device repsattend surgeries to strengthen their relationships with particular surgeons andthereby persuade them to choose one brand of artificial hip joint or stent orpacemaker over a competitor’s.

The device reps say they observe surgeriesbecause they are experts on particular devices and their accompanying toolkits,which often include hundreds of wrenches, screws and other hardware to aid ininstallation.

Sometimes, the device reps have observed moresurgeries with a particular device than any one surgeon. That depth ofexperience can be helpful, the reps say, especially with the newest devicemodel or upgrade.

“I can’t keep my socks together through thedryer. You can imagine trying to get 100 pans or 300 pans of instruments allset up correctly,” said Dr. Michael Christie of Nashville, an orthopedicsurgeon who specializes in new hips.

Device reps have been attending surgeries foryears, but that practice is coming under new scrutiny. As baby boomers age,there has been exponential growth indevice-dependent procedures like total joint replacements. In addition,insurers are starting to crack down on health care costs, telling hospitalsthat they’ll pay only a fixed price, known as a “bundled payment,” for certainsurgical procedures, such as hip or knee replacements.

That approach has forced hospitals to take ahard look at the price tags of the devices and the salespeople who are pushingthe latest models. Hospitals are “starting to figure out what these reps makefor a living. They feel like they’re making too much money, and I think that’swhy they want them out,” said Brent Ford, a former sales rep who now works forNashville-based HealthTrust, a firm that handles contracting and purchasing ofsupplies like hip implants for more than 1,600 U.S. hospitals.

Medical device reps are more often businessmajors than biology buffs, but they train for the job as if they might have toconduct surgery themselves. At an educational center in Colorado, futurereps learn how to saw off a hip bone andimplant an artificial hip.

Their corporate training frequently involvescadavers, which helps reps develop the steel stomach required for theunsettling sights and sounds of an orthopedic operating room — like a surgeonloudly hammering a spike into a bone.

“Before we’re allowed to sell our products tosurgeons, we have to know the anatomy of the body, go through tests of whyphysicians use these types of products and how we can assist in surgery,” saysChris Stewart, a former rep for Stryker, one of the largest devicemanufacturers.

Stewart now works for Ortho Sales Partners, a company that helpsdevice manufacturers navigate relationships with hospitals.

Keeping those relationships strong iscrucial, because hospitals don’t have to allow reps into their operating rooms.But if reps are allowed, there are rules: Reps can’t touch the patient oranything that’s sterile.

Big companies like Stryker have developed detailed policies for theirown reps about how to behave in the operating room. And some hospitals, likehospital chain HCA’s flagship medical center in Nashville, have instituted evenstricter rules — selling is banned in the OR and reps are only allowed toprovide support for surgical cases.

But Stewart maintains reps still can beuseful. Some help surgical assistants find a particular tiny component amongthe trays of ancillary tools. Some reps even deliver the tool trays to thehospital themselves, prior to the surgery. They want the procedure to run assmoothly as possible so that a busy surgeon will become a steady customer.

“Obviously, there’s a patient on the tablebeing operated on, so that’s where the sense of urgency is,” Stewart said. “Youhave to become an expert in understanding how to be efficient with helpingeveryone in the OR making sure your implants are being utilized correctly.”

Keeping Up With Technology

It has become difficult for hospital staffsto keep pace with constant design changes for artificial joints or spinal rodsystems, Stewart said.

The speed of innovation concerns someresearchers, including Dr. Adriane Fugh-Berman, a Georgetown University medicaldoctor who studies the relationships between industry and physicians.

“What we need are skilled helpers in theoperating room who are not making money off of the choices of the surgeons,”she said.

Fugh-Berman said she has come to believe thatreps should be banned from operating rooms. Her biggest concern is safety,including the occasional violations ofsterile protocol. As part of her research, she anonymously interviewed reps whosaid they’re instructed to always push the latest, most expensive products,even when the old version is more proven.

“The newest device is not necessarily thebest device,” she said. “In fact, it may be the worst device.”

Cost Concerns

Yet safety issues are not what has worn outthe welcome for some reps — it’s their potential influence on surgical costs.Their precise impact remains hard for hospitals to quantify, but hospitalexecutives now have a new incentive to push back on the role of the rep becauseinsurance reimbursement formulas have changed.

For example, in 2016 the government-runMedicare program began changing how it pays hospitals for a joint replacement —from a traditional billing-for-costs model to a fixed-dollar amount for eachsurgery. It’s a cost-control move, because joint replacement has become one ofthe most common reasonsfor inpatient hospitalization for Medicarepatients.

Increasingly, hospitals are feeling thesqueeze of these new payment caps.

“They’re looking at costs and saying, ‘Iwant to understand everything that drives cost in my OR,'” said Doug Jones, aformer rep with DePuy who now works for HealthTrust to control surgicalspending. “I think they’re becoming more aware that that rep is in there andsaying, ‘Is there a cost associated with it?'”

HealthTrust hasn’t been tellingadministrators to kick out sales reps. But it has been suggestinghospitals reassesstheir role. The company, which is a subsidiary of for-profithospital chain HCA, has studied particular devices, like pediclescrews, often used in spine procedures. They cost anywhere from $50 to $100 tomanufacture, but a hospital might pay a thousand dollars apiece to keep them instock. One basic spine procedure can involve several screws and rods, with the salesrep standing to make a 10 percent to 25 percent commission on the equipmentused, according to HealthTrust’s market research.

And in many places, upselling occurs inthe room, said HealthTrust’s Ford. He recalled seeing reps encouraging asurgeon preparing for a procedure to use a fancier device that wasn’t on thehospital’s discounted list.

Other HealthTrust clients are startingpilot projects on running operating rooms without company-sponsored reps andbuying equipment directly from smaller firms, which often have devices that arenearly identical to the brand names.

But getting rid of the rep may havehidden costs, too.

Surgeon-Rep Relationships

Joint replacements have become soroutine that an experienced surgical team can nearly operate in silence. Whenthe surgeon says “neck” and reaches out his hand, an assistant places the piecein his hand without a moment’s delay.

The array of tools and components areoften in the right place because a device rep made sure of it. Logistics is abig part of the job — delivering trays of instruments in the pre-dawn hours tobe sterilized by the hospital, the “non-glorious side of being a rep,” Fordsaid.

The logistical role has essentially beenfilled by the manufacturers instead of hospitals in recent decades. And nowsurgeons may trust their reps more than anyone else in the room.They’re often the first call he or she makes when scheduling a case, to makesure the device will be ready to go.

“If that widget isn’t there the next daywhen I’m doing a case and I need the widget, we’re kind of at an impasse,” saidChristie, the Nashville-based joint replacement surgeon.

Many experienced surgeons, likeChristie, also have financial ties to manufacturers, collecting substantialroyalties for helping design new implants. As of 2013, these payments are nowdisclosed publicly. Christie,for example, was paid $123,000 by DePuy in 2017.

An industry trade group spokesmandefends the close relationship as a way to improve their products and providehands-on training to surgeons. “Those are two areas where it’s key to maintaina close, collaborative relationship, with the appropriate ethical limitations,”said Dr. Terry Chang, associate general counsel for AdvaMed.

Filling A Personnel Gap

The overall result is that manyclinicians are happy to have reps in the room.

“You say ‘sales rep,'” said Marley Duff,an operating room manager at TriStarCentennial Medical Center. “I look at them more being somebody that’s expertlytrained in their field to provide support for the implants that they happen tosell.”

Reps can be especially helpful when afailing artificial joint needs to be removed and replaced, Duff said.

Hospitals are reluctant to remove reps,for fear of irritating surgeons, who typically don’t work directly for aparticular hospital and could move their cases to another institution. Thosehospitals experimenting with going “rep-less” have done so quietly and have hadto hireadditional staff to pick up the slack.

One of the first in the country to try,Loma Linda University Health in Loma Linda, Calif.,boastedin 2015 of reducing costs for total knee and hip replacements by more than50 percent by going rep-less.

But a hospital spokeswoman now says thatthe medical center has abandoned the effort, though she refused to discuss why.

This story is part of a partnership thatincludes WPLN, NPR and Kaiser Health News.