Who is that performing surgery in the OR? A doctor or a sales rep?
Visitors in OR require strict policies to avoid tragedy, liability
As you’re passing through the surgical suite one day, you peek into an operating room where a joint replacement is under way. You know only one surgeon is in the room, but that’s not him manipulating the patient’s implant. And it’s not an assistant or a nurse, either.
So who is that working on the patient? It might be the person who sold you the implant.
Most hospitals allow sales representatives in the operating room during procedures, but many risk serious liability by allowing the visitor too much leeway and by not explicitly prohibiting certain activities including those that are so obviously wrong, their prohibition shouldn’t have to be spelled out.
Like allowing a sales representative to operate on a patient. If you do not specifically prohibit that absurdity, it could happen in your hospital as it did in a New York hospital in 1979. (For details, see story, p. 14.) Though the surgeons should have known better even without a policy in place, such a policy could have encouraged other OR staff to protest, explains Sharon Bayless, manager of risk management services for ECRI, a nonprofit health device research agency in Plymouth Meeting, PA. Without a policy prohibiting any hands-on contact by the sales representative, the OR team was left to assume that the surgeons knew best. Obviously, they did not.
Another less serious case shows how a fairly simple goof by a sales representative can nonetheless threaten the patient. A sales representative passed a nonsterile hip component across the sterile field, thereby contaminating the field and compromising the patient’s safety.1 The OR staff allowed the error to occur because they mistakenly assumed the sales representative understood the basics of OR behavior and maintaining a sterile field.
Any visitor in the OR can threaten the patient’s safety, Bayless explains, but visits by sales representatives are common, and the representatives have more motivation to get involved in the procedure, at least to the extent of handling equipment and making suggestions to the surgeon.
"If you don’t have the right kind of policies in place to address this issue, you are opening yourself up to some potentially large exposure," she notes.
ECRI survey shows practice is widespread
Sales people in the OR are just an unfortunate necessity, according to the experts at ECRI. They recently studied the issue and surveyed 180 hospitals on how they handled the problem, finding that almost all allow them in the OR, and most have policies addressing the issue. The agency found that 95% allow "outsiders" in the OR during surgery.2 While outsiders could include other observers, salespeople make up most of the visitors.
Of those that allow visitors, 86% have a policy in place to protect patients. More than three-quarters specify what the sales representative can and cannot do in the OR, and more than half require that the patient consent to the presence of visitors during the procedure. Sixty-seven percent require that hospital administrators approve the presence of the visitor in writing, and another 13% said verbal approval was acceptable.
Those most likely to be authorized to grant the request are the chief of surgery, surgeon, perioperative nurse manager, OR manager, head nurse, OR supervisor, charge nurse, OR committee, materials manager, and director of purchasing.
Don’t underestimate the risk
Although sales representatives in the OR are extremely common, the risk they pose should not be underestimated, says Joan Hajny-Leeds, RN, FASHRM, BSN, director of risk management at Cedars-Sinai Medical Center in Los Angeles. To adequately understand the risk, the risk manager must keep in mind the unique relationship between surgeons and sales representatives. Out of necessity, the two parties often develop very close and informal relationships. They share unique knowledge about the most advanced medical equipment, and they depend heavily on each other for information, access to patients, and new equipment. The surgeon often relies on the salesperson for advice on how to use the new equipment, perhaps more so than he or she would be willing to admit outside the OR. That can lead to situations that would seem outrageous to people who just see the sales representative as any other vendor.
Hajny-Leeds previously was an OR nurse, and she attests to the fact that surgeons rely heavily on sales representatives for guidance on how to use new and complex instrumentation. That is a necessity in surgery, she says, especially as techniques become more complicated and new devices are developed every day. But she says the practice is "borderline" improper when the salesperson is actually looking over the doctor’s shoulder and giving step-by-step instructions. She suspects that would greatly upset most patients who learned about it afterward, but she concedes that it is necessary in some cases.
While actual patient contact by sales representatives is way over the line, Hajny-Leeds warns that it probably does happen at some facilities. She said she believes it is more likely to happen at smaller facilities where protocols are more relaxed and the community is less litigious.
"It would scare me silly to know that a sales rep ever gowned, gloved, and assisted in the procedure," she says. "I absolutely do see the potential for physicians to allow sales reps to manipulate equipment and do hands-on work because they have such a close, informal relationship. I’m sure it happens at some hospitals."
Touching the patient always forbidden
Most of the hospitals surveyed by ECRI report that sales representatives are restricted to observing only, with no patient contact. Some facilities go further to specify that the representative is not allowed to scrub, enter the sterile field, or open sterile products. Many facilities require the visitor to sign in and out and wear a name tag. Policies often specifically state that a sales representative is "not considered an appropriate assistant." The policy at Cedars-Sinai specifies that sales representatives are not allowed to scrub in and may not open sterile packages.
Policies also might require that the sales representative be in good health, without even a cold or runny nose, and some hospitals require proof of tuberculosis and hepatitis immunity. Once accepted to visit the OR, ECRI advises having a nurse manager orient the visitor to the basics of proper OR procedure and safety precautions.
More than half of the facilities surveyed by ECRI report they require the patient’s consent for visitors in the OR. That consent usually is of a general nature, most commonly a statement in the operative consent form that the surgeon and facility may allow observers during the procedure. ECRI advises going a step further and obtains consent for specific visitors during the procedure.
Disclosure of a sales representative’s presence may not technically be required for informed consent, the ECRI researchers conclude, but the patient could allege invasion of privacy. Any physical contact from the sales representative is particularly dangerous because it could be considered battery, and the hospital could be partly liable if a jury decides it allowed the battery to happen.
Any visitor should be documented in the intraoperative record, Bayless points out.
Watch out for breaks in procedure
Hajny-Leeds warns of a risk from sales representatives that might not be readily apparent. Even if the sales person does not touch the patient or otherwise violate hospital policy, the convivial relationship between the surgeon and sales person might lead to a loss of material after the surgery. If the surgeon removes a defective pacemaker or replaces a hip prosthesis, for example, the sales representative might want to take it back to the manufacturer.
The motive may be pure, or it could be an effort to hide a defective product. But either way, the hospital has lost material that could be important if a lawsuit arose from the case. In most hospitals, the proper procedure involves a pathological examination of any item removed from a patient, followed by cataloging and documentation. At that point, the item can be released to the manufacturer or another party.
"The surgeon often doesn’t hesitate to just hand it to the sales rep and let him take it away," Hajny-Leeds says. "It just goes away, and if we get a lawsuit, we have lost a piece of our material in a way that should not have happened."
A strong, formal policy on sales representatives in the OR can be the safety net for avoiding such lapses. All hospital staff, especially nurses, should be encouraged to protest inappropriate conduct by sales representatives, Hajny-Leeds says. Having a written policy that lays out the visitor prohibitions can give nurses the confidence to protest the behavior immediately, or at least report it to the proper supervisors afterward.
She points out that the facility’s risk manager should be considered a proper authority for reporting inappropriate behavior in the OR. If the nurse or other staff have gone through the OR supervisor and others in the chain of command, seeking help from the risk manager might be the next appropriate step. While Cedars-Sinai has had no reports of inappropriate activity by sales representatives, Hajny-Leeds says her office has intervened directly in other problems in the OR.
"We’ve had instances where nurses reported that something was wrong, and we went right down to the OR and just stopped the surgery dead," she recalls. "If the problem is serious, we shouldn’t be afraid to step in."
For more information, contact Sharon Bayless, ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462-1298. Telephone: (610) 825-6000. Fax: (610) 834-1275. Or contact Joan Hajny-Leeds, Director of Risk Management, Cedars-Sinai Medical Center, 8700 Beverly Blvd., Room 2806, Los Angeles, CA 90048. Telephone: (310) 855-5935.