The popularity of robotic surgery systems continues to grow as an adjunct to conventional open surgery and minimally invasive surgery techniques for certain types of procedures, such as hysterectomy and prostatectomy. The robotic system adds new complexities to operating room (OR) procedures with the preoperative device setup, perioperative system use, and ongoing inspection and preventive maintenance. ECRI Institute's Accident Forensic Investigation (AFI) Group warns that the presence of these systems in the OR must not diminish the OR team's need to adhere to established patient safety practices with existing technologies that have long been in place to reduce risks to the patient. These practices include measures to ensure electrosurgical safety, proper patient positioning, and laparoscopic insufflation safety.
Simply put, robots change the dynamic of an otherwise typical environment in the OR.
Don't overlook patient safety measures
"It is critical to be vigilant in applying existing patient safety techniques with all of the medical devices associated with robotic surgery, not just the robotic system," says Scott R. Lucas, PhD, PE, program manager, engineering, of the AFI Group. The group has investigated injuries occurring during robotic surgery that were not directly related to the presence of the robotic system. Instead, standard patient safety measures were overlooked.
Since it was cleared by the U.S. Food and Drug Administration (FDA) for marketing in 2000, the robotic surgical system has gained FDA's go-ahead to be used for a growing number of endoscopic surgical procedures, including cholecystectomy, mitral valve repair, radical prostatectomy, and hysterectomy. The system consists of a surgeon console, a patient cart, and a vision cart. The patient cart is positioned beside the OR table so that its two to four instrument arms can hold robot-specific endoscopic instruments and an endoscopic camera. The surgeon sits at the console positioned several feet from the patient to view the surgical site with 3-D video and uses hand and foot controls to manipulate the arms, instruments, and camera. Ancillary devices may include electrosurgical generators, insufflators, and robotic or accessory endoscopic instruments.
Electrosurgical safety. As with any procedure involving electrosurgery, patient harm can occur if an electrosurgical unit is used improperly during robotic surgery. "Alternate-site electrosurgical burns can occur if the OR team fails to follow established safety practices for electrosurgical safety advocated by ECRI Institute for decades," says Lucas. During any root-cause analysis of an event that involves robotic surgery, Lucas cautions against making the robotic system the only focus of the analysis. "We regularly identify human factors issues in these investigations. Electrosurgical burns in laparoscopic procedures are often related to equipment setup and technique of use. This is no different with robotic surgery."
The AFI Group also warns of electrosurgical equipment-related issues that can occur during robotic surgery, including electrode insulation failures and the unintentional retention of a broken piece from an electrosurgical instrument in the patient. "A perioperative electrosurgery checklist is a useful tool to help mitigate these and other risks and can be complemented by periodic facility-level electrosurgical safety audits," says Lucas.
Retained foreign objects. "Although retained foreign objects might be considered less likely during a robotically assisted procedure, lack of diligence during robotically assisted surgical procedures can be associated with the unintentional retention of a foreign object," says Mark E. Bruley, CCE, vice president, AFI Group. Perioperative instrument safety procedures—namely, instrument counts before, during, and after the procedure; open communication among the surgical team throughout the entire process; and ensuring instrument integrity upon removal from the patient—must be implemented during robotically assisted surgeries.
Patient positioning and insufflation. "The need for peritoneal insufflation and steep Trendelenburg positioning for many robotic surgeries increases the potential for complications related to perfusion and ventilation," says Bruce C. Hansel, Ph.D., CCE, executive director of the AFI Group. The intraperitoneal pressure from insufflation can reduce venous return to the heart from the lower extremities and abdominal organs. Tilting the patient steeply head down causes the abdominal organs to slide against the diaphragm, which can further compress the great vessels in the abdomen, resulting in even poorer venous return. Severe hypotension and dangerously low cardiac output can manifest simply due to insufficient venous return to the heart caused by intra-abdominal gas pressure and the weight of the organs bearing on the great vessels. The weight of the organs resting against the diaphragm also reduces the lung volume and increases the pressure needed to deliver the respiratory and anesthetic gases to the lungs. "The combination of poor lung perfusion with underventilation is a recipe for cardiopulmonary collapse," says Hansel. During robotic procedures, anesthesiologists must be ready to recognize these complications and respond appropriately.
Complicating matters in robotic surgery, the OR table should not be moved once the robotic system instruments are connected to the patient (i.e., once the surgical system patient cart is docked next to the OR table). If during the procedure, repositioning the patient is necessary, the OR team must undock the cart, which may prolong the procedure. As a result, the OR team may be inclined to initially move a patient into a more extreme Trendelenburg position—up to a tilt of 45° with the OR table—to avoid having to reposition during the procedure.
Lucas advises, "With the gaining popularity of the robotic system, we want to remind healthcare organizations that attention to the robotic system's requirements should not overshadow the OR team's attention to the safe use of existing technologies."
Finally, if an adverse incident does occur, all devices and accessories used in the incident procedure should be considered in the initial equipment sequestration and in a root-cause analysis.
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