Device Reps Should Limit Their Role In The Operating Room, Says Surgeon

Full article reprinted from "The Gray Sheet" - December 8, 2008

Find out how device company representatives have a legitimate role in the surgical suite, but many overstep, according to surgeons speaking at a meeting in Washington, D.C., Dec. 3.

Device Reps Should Limit Their Role In The Operating Room, Says Surgeon

Full article reprinted from "The Gray Sheet" - December 8, 2008

"It takes leadership to figure out how to work together, to have physicians, the hospital and the device company on the same page," said Kevin Bozic, University of California, San Francisco, at an ECRI Institute conference on value-based purchasing.

Bozic, a practicing orthopedic surgeon and chair of the Healthcare Technology Assessment Program at UCSF Medical Center, said device reps have two important roles within his OR: to help with inventory management and to provide technical assistance for the nursing staff.

"His role is not to upsell me on the technology," Bozic said, although he acknowledged that the problem "happens in orthopedics every day."

From the audience, another physician raised concerns about the "latest and greatest technology" being chosen for implants because a device rep pulls it out of the trunk, "as opposed to thoughtful consideration as to whether the patient should get the device."

Hospitals Push Back With Attempts To Deny Access

In extreme cases, device representatives can put patients, hospitals, physicians and employers at risk if unwarranted advice in the OR leads to poor patient outcomes.

Stories about such cases in the mainstream media have put pressure on stakeholders to reduce any appearance of conflict of interest or compromise in patient care.

Liability issues have led some hospitals to require vendor credentialing - covering anything from background checks to vaccinations - for device reps to gain access to facilities or physicians (¹"The Gray Sheet" March 24, 2008, p. 14.)

Bozic is concerned that hospital backlash against device reps can get heavy-handed.

"The relatively short-sighted response of most hospitals unfortunately has been to develop policies to try to keep these people out," said Bozic, who also serves on the board of the American Academy of Orthopaedic Surgeons.

"In my hospital, they wear red stripes; they look like prisoners."

In discussions with colleagues around the country, Bozic has heard others joke that "we make them stand out in the cold for an hour in the freezing cold in Chicago, and get a badge."

Manufacturer Focus Is On Training And Testing

Device maker Medtronic would be "happy not to have our reps in operating rooms," as long as hospital staff were well-trained in using the technology in the company's implantable devices, according to David Steinhaus, medical director and vice president for strategy and professional relations for the firm's cardiac rhythm disease management division.

When it comes to complex devices such as implantable cardioverter defibrillators, "our devices have to be tested in the operating room," Steinhaus said. He said that especially for cardiac devices, Medtronic's reps are "highly trained."

Training hospital personnel becomes more of a challenge when nurses support multiple doctors who choose a variety of devices from multiple vendors.

"If you are doing surgeries in an operating room and you have different surgeons doing different implants, it's hard to train nurses to understand how to do this, which makes us more dependent on the role of the rep," said Bozic. "And there is a lot of inventory management. It is a huge problem."

A private payer attending the conference said hospitals and industry should not consider the issue of device reps in the OR an "all or none" proposition.

She added that insurers are interested in understanding more about the kinds of incentives device reps receive from their employers for their work within the operating room.

- Monica Hogan

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