Keep a close rein on visitors in the OR
Sales reps need strict policies to avoid tragedy
Most same-day surgery programs allow sales representatives in the operating room during procedures, but many risk serious liability by allowing these visitors too much leeway and not prohibiting activities that seem so obviously wrong that a rule should be unnecessary.
For example? Allowing the sales representative to operate on the patient. If you do not specifically prohibit that absurdity, it could happen in your OR, just like it was reported to have happened in a New York hospital in 1979.1 One could argue the surgeons should know better even without a policy, but a policy could urge 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 a sales representative, the OR team is left to assume that the surgeons know best.
Even a fairly simple goof by a sales representative can threaten the patient. In one instance, a salesperson passed a nonsterile hip component across the sterile field, thereby contaminating the sterile field and compromising the patient’s safety.2 The OR staff mistakenly assumed the sales representative understood the basics of OR behavior and maintaining a sterile field.
Visits by sales representatives are common, and they tend to get involved in procedures, at least to the extent of handling equipment and making suggestions to the surgeons, Bayless says.
"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.
Don’t underestimate the risk
Surgeons rely heavily on sales representatives for guidance on how to use new and complex instrumentation, says Joan Hajny-Leeds, RN, FASHRM, BSN, director of risk management at Cedars-Sinai Medical Center in Los Angeles. Hajny-Leeds previously was an OR nurse.
That guidance is becoming more commonplace, says John Harries, MD, medical director of Same Day SurgiClinic in Fall River, MA.
"All ORs are experiencing this," Harries says. "The issue is that technology is moving along quickly."
Hajny-Leeds says the practice is "borderline" improper when the salesperson is looking over the doctor’s shoulder and giving step-by-step instructions.
Although actual patient contact by sales representatives is way over the line, Hajny-Leeds warns that it probably does happen at some facilities. She says 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."
Watch for breaks in procedure
Hajny-Leeds warns of a risk from sales representatives that might not be readily apparent. Even if the salesperson does not touch the patient or otherwise violate hospital policy, the convivial relationship between the surgeon and salesperson might lead to a loss of material after the surgery. If the surgeon has trouble with a new trocar, scope, or screw set, 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 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."
References
1. Salesman-surgeon case settled for $1 million. Hospital Risk Management 1980; 2:157.
2. Schultz M. Sales representatives in the OR. Are they prepared? AORN J 1994; 59:651-662.
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