An article for physicians by CMPA General Counsel
Originally published December 2008
Before permitting persons not a part of the surgical team to be present in the operating room, it is important to consider many issues, among them patient privacy and confidentiality, consent, and safety.
Of interest to physicians doing procedures
Recent attention has been focused on the practice of allowing third parties who are not members of the surgical care team to be present in operating rooms (OR) while surgeries are being performed. Over time, the practice may have become generally accepted or even commonplace, particularly with reference to representatives of manufacturers of medical equipment. While medical professionals may be familiar with this practice, it would be fair to say that many patients are not. This is primarily because many patients are unaware of precisely who is observing the procedure. Recent media reports have drawn this practice into the public eye and commenced a debate over its appropriateness when the patient has not consented.
Why third parties are invited
There are a variety of circumstances in which a third party may request or be invited to be present in the OR. Whether it is appropriate will depend, in part, on the purpose of the individual's attendance. Perhaps the most common example is representatives of manufacturers of surgical equipment being used in the OR. In these circumstances, manufacturer representatives can play an important role in improving patient safety. These representatives often provide valuable assistance in the OR to the surgical team, including technical support and training, when new technologies or devices are being used.
In other circumstances, however, the presence of a layperson in the OR may not always be appropriate, particularly when it is done without the patient's consent and it does not relate to patient care or safety. For example, an individual may request to observe a surgical procedure for personal or other reasons unrelated to patient care or safety. In these circumstances, issues such as patient privacy and autonomy exist. Furthermore, patient safety concerns may arise if that person turns out to be a source of distraction or not properly instructed about the rules and procedures of the hospital and OR.
Possible medico-legal risks
Generally speaking, health care professionals are responsible for ensuring that adequate measures are taken to protect the safety, privacy and autonomy of their patients. Health care professionals who approve or request that a third party who is not a member of the medical team be present in the OR may be subject to legal proceedings or complaints. For example, where a patient feels that he or she should have been informed of and did not consent to the presence of such an individual in the OR, a physician involved in such an occurrence may be exposed to a complaint before his or her provincial/territorial regulatory authority (College) and/or the privacy commissioner. The physician may also be exposed to the risk of litigation if the presence of such an individual is suspected of having caused the patient harm during surgery.
To minimize such risks and avoid any misunderstandings, physicians should consider obtaining the patient's consent in appropriate cases before approving or requesting the presence of third parties in the OR, particularly those not considered members of the patient care team. For example, a surgeon aware that there will be a third party observing the surgery may want to raise the issue in advance with the patient. A note should be made of the discussion and the patient's consent or refusal documented in the medical record. The surgical consent form may also be amended to make reference to the possible presence of third parties during surgery for a stated purpose (e.g., technical support, demonstration of device or instrument, etc.).
Physicians working in institutions in which manufacturer representatives or other third parties are present in the OR may also wish to ensure that policies are in place at their institutions to regulate the conduct of those individuals and address the important legal and medical issues that may arise. Such policies could include:
Establishing a procedure for approval by the surgeon prior to the attendance of a third party in the OR who is not a necessary member of the care team;
Requiring the proper identification of the representative (e.g., badge, signing-in at a designated location, etc.);
Delineating the limits of their involvement in the procedure (e.g., no "scrubbing in," no touching patients, etc.);
Establishing a procedure for obtaining informed patient consent to the presence of a third party in the OR where appropriate;
Requiring proof of training in their technical field as well as in matters relevant to the OR, such as aseptic principles, sterile techniques, roles of the various members of the surgical team, traffic patterns and proper conduct in the OR, and fire and safety protocols;
Specifying that the third party be instructed not to interfere with the surgical team;
Training in respect of patient privacy and confidentiality and clarifying what information the representative should not be privy to; and
Requiring evidence of adequate professional liability protection concerning their actions inside the OR.
Above all else, physicians should assess whether having a third party in the OR is expected to improve the safety of the patient, and whether, on balance, it is in the patient's best interests. If so, the patient's consent should be obtained, where possible. If not, admission into the OR should not be permitted.
By taking the above precautions and having appropriate policies in place that are rigorously followed, a physician's potential exposure to legal action and/or patient complaints can be appropriately managed.