AORN says operating room visitors OK with guidelines
August 1, 2000 6 minutes read
AORN says operating room visitors OK with guidelines
But hospital must take precautions
The Association of periOperating Room Nurses (AORN) in Denver recently announced two policy initiatives with bearing on risk management, addressing the risk of having salespeople in the operating room and endorsing the use of active electrode monitoring to reduce electrosurgery accidents.
At the recent AORN 2000 National Congress in New Orleans, the group announced a new position statement that says industry salespeople and other visitors are acceptable in the operating room as long as the hospital takes precautions to protect the patient. Facilities should enact strict policies on how visitors are allowed, AORN says.
The position statement came as the result of concern in the health care industry about the way OR visitors have become commonplace. Nearly every hospital allows such visitors at some time, says ECRI, the nonprofit health research agency in Plymouth Meeting, PA. Visitors can threaten both patients and the hospital if the practice is not closely supervised, ECRI says.
Who makes authorizations?
ECRI recently 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 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, and another 13% said verbal approval was acceptable. Those most likely to be authorized to grant the request were the chief of surgery, surgeon, perioperative nurse manager, OR manager, head nurse, OR supervisor, charge nurse, OR committee, materials manager, and director of purchasing.
Like AORN, ECRI recommends close supervision of any OR visitors. There have been reports of salespeople participating in surgery, ostensibly to show the surgeon how to use equipment, and incidents of visitors compromising patient safety by violating the sterile field, for instance.
More than half of the facilities surveyed by ECRI report that they require the patient’s consent for visitors in the OR, usually with a general statement in the operative consent form 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.
In its "Position Statement on the Role of the Health Care Industry Representative in the Operating Room," AORN emphasizes that patient safety must be the top priority. AORN also advises making the patient aware of the visitor’s presence.
AORN’s position
These are excerpts from the AORN position statement:
• "In defined conditions, AORN believes that health care industry representatives, by virtue of their training, knowledge and expertise, can provide technical assistance to the surgical team, which expedites the procedure and facilitates desired patient outcomes. The purpose of this statement is to affirm the valuable role health care industry representatives play in the care of surgical patients and to assist the perioperative team in maintaining the patient’s safety, right to privacy, and confidentiality when a health care industry representative is present during a surgical procedure.
• "A health care industry representative may be present during a surgical procedure under conditions prescribed by the facility. AORN recognizes there is a wide range of geographic and regional variations regarding the activities of the health care industry representative in the operating room. This statement provides general guidelines to assist the individual facility in developing policies best suited to its community standards.
• "The policy should be developed in collaboration with the facility’s risk management and/or legal counsel to ensure compliance with applicable laws. Each facility should develop a system that addresses informed patient consent regarding the presence and role of a health care industry representative in the operating room during a surgical procedure in both routine and emergency situations. This system should include documentation in medical records.
• "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. To achieve this, the RN should monitor the health care industry representative’s activities whenever possible and facilitate the representative’s service to the patient and the perioperative team. The RN should be informed prior to the procedure that a health care industry representative will be present and about his/her purpose for being there.
• "Perioperative team members are responsible for acquiring instruction on new procedures, techniques, technology, and equipment with which they are not familiar prior to their use in a surgical procedure. This instruction may be provided by the health care industry representative. The facility should maintain evidence of documented competencies for health care professionals, especially when introducing new procedures, techniques, technology, and equipment as required by the Joint Commission on Accreditation of Healthcare Organizations.
• "Each facility should develop a system that documents that the health care industry representative has completed instruction in the principles of asepsis, fire and safety protocols, infection control practices, bloodborne pathogens, and patient’s rights. Based on community standards, this may range from maintaining up-to-date documentation provided by the health care industry representative’s employing company to providing facility-specific instruction and training.
• "The health care industry representative’s presence and purpose should be pre-scheduled with the designated operating room management authority and the surgeon in accordance with the facility policy.
• "The health care industry representative should wear identification while in the facility.
• "Each facility should develop a system that clearly delineates limits on the health care industry representative activities in the operating room based on community standards. The health care industry representative should not scrub in.
• "The health care industry representative with specialized training may perform remote calibration to adjust devices to the surgeon’s specification (e.g., pacemakers, laser technicians)."
It’s now the standard
AORN recognized active electrode monitoring technology as an "AORN Recommended Practice" for minimally invasive surgery, a major endorsement of a tool that the manufacturer says can prevent many electrosurgery injuries. Electrosurgery injuries are a leading cause of malpractice claims in minimally invasive surgery.
A panel consisting of operating room directors and managers concluded that the technology is becoming the standard of care in minimally invasive surgery. The panel advocated integrating it into their practice as they had with previous technical innovations in electrosurgery. The system is manufactured by Electroscope in Boulder, CO.
Active electrode monitoring technology helps minimize accidental electrosurgical burns during minimally invasive surgery. Two years ago, active electrode monitoring was recommended by legal experts involved in laparoscopy litigation and by an independent testing organization. Antonios Tsarouhas, JD, an attorney with Perantinides & Nolan in Akron, OH, and vice chairman of the Laparoscopic Surgery Litigation Group, a subgroup of the Association of Trial Lawyers of America, says electrosurgery injuries are among the biggest malpractice risks in minimally invasive surgery.
A group’s recommendations
The litigation group is made up of plaintiffs’ attorneys who have a special interest in pursuing cases related to laparoscopy. A significant number of the malpractice cases that already have been litigated involve the accidental injury of nontarget tissue by stray electricity emanating from the laparoscopic monopolar electrosurgical instruments, usually traced to long-term degradation of electrical insulation or capacitive coupling.
The laparoscopic litigation group recommends the use of active electrode monitoring systems to avoid stray current injuries. That recommendation was echoed by ECRI. The agency’s independent evaluation of the Electroshield system convinced the researchers that the product performs as it should and can prevent many injuries in laparoscopy.1
ECRI concludes that "we therefore encourage use of electrode shielding, such as that offered by the evaluated Electroscope Electroshield System . . . during laparoscopic monopolar electrosurgery." ECRI calls it "the most effective means currently available of minimizing the potential for patient injuries" from certain kinds of electrosurgery accidents.2
Electroshield in detail
In addition, several medical malpractice insurers have recommended the Electroshield system. Recommendations to consider the system have appeared in publications of American Physicians Insurance, Mutual Insurance Company of Arizona, and Copic. The Electroshield system has a list price of more than $3,000, with the exact costs depending on how many accessories are purchased, according to information from the manufacturer.
The Electroscope product conducts potentially dangerous current leakage from the laparoscopic electrosurgical active electrode shaft away from the patient and alerts the surgical team to a problem with the monopolar electrosurgery equipment. A standard electrode is inserted through the Electroshield’s cylindrical conductive shield, and the electrode and shield then are introduced through a cannula.
When the conductive shield is connected to a monitoring unit and the return electrode, stray current from the electrode has a safe return path, so it does not travel through the patient. The monitoring unit also issues an alarm and deactivates the monopolar electrosurgery unit if the stray current exceeds a preset level, the manufacturer reports.
References
1. ECRI. Managing the risk of sales representatives in the operating room: An HRC survey. The Risk Management Reporter 1996; 15:1-7.
2. ECRI. Monopolar electrosurgical safety during laparoscopy. Health Devices 1995; 24:11-17.
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