As robotic surgery continues to become increasingly popular for use in certain types of operations, surgeons need to be aware of what steps they can take to reduce the risks associated with these procedures. The Joint Commission urged surgeons and health care organizations to focus additional attention on the unique risks of robotic procedures in the June 2014 issue of its Quick Safety newsletter.*
The additional caution measures are a result of a general increase annually in the number of robotic surgery-related reports to The Joint Commission’s Sentinel Event Database over the past seven years. From 2006 to 2013, the database received 34 reports of sentinel events related to robotic surgery that affected 36 patients.* (A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof.)
Of the 34 reports, 27 were related to unintended retention of foreign objects, and seven to operative or postoperative complications. The complications were usually due to hemorrhage caused by laceration. Other complications included injury to surrounding tissue and serious injury, including blindness, related to prolonged surgery. Of the seven operative or postoperative complication reports, two resulted in death from excessive blood loss and one was related to a delay in treatment.*
The reporting of most sentinel events to The Joint Commission is voluntary and represents only a small proportion of actual events. These data are not an epidemiologic data set and no conclusions should be drawn about the actual relative frequency of events or trends in events over time. Therefore, it is questionable whether the increase in robotic surgery-related reports stems from the more frequent occurrence of sentinel events or simply from more reporting.
The reports in the Sentinel Event Database are consistent with current literature for the most serious events involving robotic surgery. These events are generally categorized as directly related to the use of a robotic system and the general risks of the operative procedure. Surgeons should consider the unique risks of robotic surgery within both types of events.
For example, surgeons may be located at some distance from patients during robotic surgery, and precise control of the robot can depend on the quality of the data connection between the surgeon’s console and the operating room robot. Although current robotic systems are designed to minimize potential patient harm with features such as redundant safety mechanisms to minimize human error, fault tolerance, just-in-time maintenance, and system alerting, all mechanic and electronic devices are subject to failure.
Another risk is associated with training and credentialing. Robotic surgery is a relatively new technology and requires advanced operator skills typically not taught during residency. Surgeons should be adequately trained in the use of surgical robots. According to an article in the April 2011 issue of the Journal of Urology, “credentialing should involve the demonstration of proficiency and safety in executing basic robotic skills and procedural tasks.”†
Safety actions to consider
Surgeons and health care institutions that use surgical robots should consider the following safety actions:
- Develop and follow credentialing guidelines. A period of focused professional practice evaluation for any newly granted privilege needs to be implemented. Once a confidence level is achieved with the practitioner’s practice related to robotic surgery, a transition to ongoing professional practice evaluation should begin.
- Provide patient assessments to ensure the planned robotic procedure is appropriate for the individual patient.
- Improve operating room team communication. During robotic surgery, the team must communicate in different ways because the surgeon is typically positioned at a console away from the operating table, and the other team members cannot see what the surgeon sees.
- Standardize processes in the operating room, including the count process, by taking into account sponges, needles, and other supplies, as well as checking tools and tool tips to ensure they are secure and in working order.
Should a robotic surgery become a sentinel event, The Joint Commission encourages its accredited health care organizations to report the case in an effort to improve patient safety and quality of care. For more information, go to www.jointcommission.org.
*The Joint Commission. Potential risks of robotic surgery. Quick Safety: An Advisory on Safety and Quality Issues. June 2014. Accessed August 25, 2014.
†Lee JY, Mucksavage P, Sundaram CP, McDougall EM. Best practices for robotic surgery training and credentialing. J Urol. 2011;185(4):1191-1197.