Maybe guests have come at a bad time

Two groups representing surgeons and operating room nurses have issued guidelines that discourage visitors in the operating room and suggest that patients give consent for any visitor. The guidelines could help risk managers tighten their policies on OR visitors by showing that the clinicians’ own societies advocate a strong stance.

Risk managers have long sensed that surgeons are too lax about allowing visitors in the OR, usually salespeople who want to demonstrate a new device or others admitted for educational reasons. While many of those visits can be justified, some risk managers say hospitals run a risk by not obtaining consent from the patient and carefully policing all visitors.

The most recent development comes from the American College of Surgeons (ACS), which released a formal statement saying that any visitor should be allowed in the OR only under strict conditions.

The ACS says health care organizations should establish written policies defining requirements and procedures for manufacturers’ representatives to be present in the OR, and restrictions to govern representatives’ activities in the OR. The group also says the hospital should have a specific procedure for obtaining approval within the institution, and then a policy for orientation, training, and credentialing of the visitor.

But in the most significant guideline for risk managers, the ACS says "the patient should be notified of the presence and purpose of the representative in the OR and give written, informed consent." While risk managers and others have advocated consent from the patient, the ACS statement is a substantial step forward in reaching that goal, says R. Stephen Trosty, JD, MA, director of risk management at Mutual Insurance Corp. of America in East Lansing, MI. "There’s already been a reason to get informed consent, but the ACS guidelines kick that up a bit. It’s moving from just a good idea to something more."

Trosty says the increasing emphasis on the issue should prompt risk managers to seek more informed consent for OR visitors. Nearly every hospital allows such visitors at some time, according to ECRI, the nonprofit health research agency in Plymouth Meeting, PA. ECRI conducted a survey of 180 hospitals and found that 95% allow "outsiders" in the OR during surgery.1 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.

More than half of the facilities surveyed by ECRI report that they require the patient’s consent for visitors in the OR, but that consent is usually in the form of a general statement in the operative consent form, stating that the surgeon and facility may allow observers for professional reasons. That may be sufficient in most cases, though ECRI advises playing it safe and obtaining specific consent for visitors during the procedure.

Trosty agrees. Such a blanket consent may be sufficient in teaching hospitals, but not in any other case, he says. "If the visitor is not directly related to health care, like another physician or a medical student, it’s probably best to get specific consent by name or at least by the person’s function. If it’s a salesperson, say so and explain why that person needs to be there. The blanket consent for visitors works sometimes, but I think the ACS is looking for something more."

Question appropriateness of visitors

Trosty points out one complication. If the surgeon offers full disclosure that a salesperson will be in the OR, the patient is likely to ask why. And if the surgeon answers truthfully by saying, "This is the first time I’ve used this gadget, and the salesperson will be talking me through it," don’t expect the patient to be pleased.

"That gets you into the whole question of what true informed consent is," he says. "If you aren’t experienced with the item, maybe the patient should know that. It can get difficult, but I think the patient has a right to know."

The fact that the ACS has advised getting patient consent can be a powerful tool for risk managers, Trosty says. The ACS statement comes on the heels of a similar one by the Association of PeriOperating Registered Nurses (AORN); risk managers no longer have to seem like the bad guy when advocating stricter control. "In many cases, it is the surgeon or anesthesiologist who is bringing these people in, so these guidelines may give the risk manager some real ammunition to use with the surgeon resisting this type of consent," he says. "You can say, It’s your own professional group that says you should do it.’"

Similarly, the AORN Position Statement on the Role of the Health Care Industry Representative in the Operating Room emphasizes that the presence of an industry representative must not compromise patient safety in any way. AORN advises making the patient aware of the visitor’s presence, and says that "as the patient’s advocate, the RN responsible for the patient’s care during the procedure is accountable for maintaining the patient’s safety, privacy, dignity, and confidentiality."

Trosty says the trend in past years is clear. The health care community is recognizing the risk to both patients and the institution from letting people in the OR too casually. With every new guideline that advocates a strict policy and patient consent, the risk grows greater for hospitals with a lax policy, he says. "With this enhanced focus on privacy, people should be asking why we’re having those folks in there. Does the patient have the right to assume that only necessary medical professionals will be there in the OR? I think the answer is yes."


1. ECRI. Managing the risk of sales representatives in the operating room: An HRC survey. The Risk Management Reporter 1996; 15:1-7.