ECRI survey shows practice is widespread
Sales representatives in the OR are an unfortunate necessity, according to the experts at ECRI, a nonprofit health devices research agency in Plymouth Meeting, PA. They recently surveyed 180 hospitals on how they handled the situation, finding that almost all allow salespeople in the OR and most have policies addressing the issue. The agency found that 95% allow "outsiders" in the OR during surgery.1 While outsiders could include other observers, most of them are salespeople.
Of the hospitals that allow visitors, 86% have a policy to protect patients. More than three-quarters specify what sales representatives can and cannot do in the OR, and more than half require that patients consent to the presence of visitors during procedures. Sixty-seven percent require that hospital administrators approve the presence of the visitor in writing, and another 13% said verbal approval was acceptable.
Personnel most likely to be authorized to grant requests are the chief of surgery, surgeon, perioperative nurse manager, OR manager, head nurse, OR supervisor, charge nurse, OR committee, materials manager, and purchasing director.
In the survey, most hospitals reported 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 visitors to sign in and out and wear name tags.
Policies often specify that a sales representative is "not considered an appropriate assistant." 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 visitors are approved to enter the OR, ECRI advises having a nurse manager orient them to the basics of proper OR procedure and safety precautions.
More than half of the facilities surveyed by ECRI report that 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 patient consent form that the surgeon and facility may allow observers during the procedure. ECRI advises going a step further and obtaining 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 facility could be partly liable if a jury decides it allowed the battery to happen. All visitors should be documented in the intraoperative record.
Reference:
1. ECRI. Managing the risk of sales representatives in the operating room: an HRC survey. The Risk Management Reporter 1996; 15:1-7.
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