By Kezia Windham, RN, BSN, CNOR, CPHRM

Robotic-assisted surgery (RAS) has grown significantly since its introduction in 2000. This trend will likely continue across almost all surgical specialties and procedures. The increased use of this surgical modality has associated benefits and risks.

Potential short term benefits of RAS may include superior outcomes, reduced blood loss, smaller incisions, and less postoperative pain resulting in decreased pain medication use and shorter hospital stays. Data about the long-term benefits compared to laparoscopic or open procedures is limited. Practitioners report enhanced visualization and articulation, improved structures preservation, and increased surgeon comfort during the procedure.

Disadvantages of RAS for patients may include increased risk of nerve injuries secondary to the extreme positioning for some procedures, increased cost, and limited availability. Disadvantages for facilities and practitioners may include a steep practitioner learning curve, increased staff training and competency requirements, and increased operating room (OR) set-up and turnover time. Additional risks unique to RAS are related to equipment with multiple points of robotic technology error or failure.

Malpractice Claims Data

Regardless of the risks and benefits, patients, practitioners, and payers alike find RAS appealing, and more patients are specifically requesting robotic surgery. With increased demand and utilization, the number of claims related to RAS is expected to rise. An analysis of Coverys closed claims from 2017 to 2021 reveals that claims arising out of RAS typically involve allegations of poor technical performance (39%) and clinical decision-making (28%) resulting in procedural complications. Average indemnity for cases involving RAS during that same period is $267,000 and rising.

In order to mitigate RAS risks, it is essential to carefully evaluate key program components in the context of well-designed policies and procedures. Consider the following when initiating or evaluating an RAS program:

Patient Selection and Education

  • Establish well-defined patient selection criteria. While patients may specifically request RAS, it may not be the best option in all cases. Patient selection criteria that are carefully drafted, evidence-based, and procedure-specific can enhance patient safety and increase the likelihood of good outcomes.
  • Obtain informed consent. Inadequate informed consent is a frequent allegation in medical malpractice cases. Ensuring the patient understands not only the risks and benefits of RAS but also its alternatives is essential. Regardless of whether the patient requests RAS, consider if it is the right approach for both the patient and surgical team. A surgeon’s comfort and experience with the robot is important in that operator experience tends to correlate to outcomes. Consider utilizing plain language informed consents as well as adjunct aids like brochures or videos. Documentation of the informed consent or informed refusal process is crucial.
  • Determine whether the Food and Drug Administration (FDA) has approved a particular surgery. Robotic surgery is not approved for all patient diagnoses. For example, in August 2021, the FDA issued a safety communication to remind patients, practitioners, and facilities alike that it still considers the robotically assisted surgical device to be an investigational device for mastectomies. Carefully monitor FDA medical device alerts to remain current on device recommendations.

Credentialing and Competency

  • Determine initial credentialing requirements. A well-designed proctoring and orientation process can guide the novice robotic surgeon and protect the facility. A progressive training structure starting with easier cases and ideal patients may help the surgeon gain confidence and experience before progressing to complex cases. While robot manufacturers offer initial training courses and resources, they are no substitute for organizational credentialing.
  • Establish a clear process for establishing and maintaining competency. RAS has a steep learning curve, and it can be a challenge to maintain competency. A strong RAS program has clear, defined parameters for proctoring, initial credentialing, and maintaining competency that include technical skills, performance, and quality oversight. Some specialty-specific organizations, such as the American College of Obstetricians and Gynecologists, offer recommendations for organizations when developing credentialing and privileging guidelines.
  • Perform ongoing skills assessment. After completing the initial credentialing, it is important to establish ongoing focused professional performance assessment. Review and maintain detailed records of robotic surgery procedures and outcomes for ongoing credentialing considerations. Ensure that credentialing processes address parameters for a minimum frequency of robotic surgery performance and patient quality outcomes.

Perform Quality Review

  • Form an oversight committee. Implement and maintain a robotic surgery team/committee to oversee the unique aspects of this surgical delivery modality, including training, credentialing, equipment maintenance, and quality oversight. Committee membership may include a perioperative robotics coordinator, risk and quality personnel, representation from the sterile processing department, surgeons, anesthesiologists, and perioperative leadership. Robotics committees are often sanctioned by the medical board and are accountable to the governing body.
  • Provide training oversight. Enhanced training and best practices sharing may help avoid poor outcomes. Training should be intentional and outcomes-oriented and include basic procedure training modules, precepting, and simulation training. Establish specific criteria regarding the number of proctored surgeries required before being credentialed for unproctored surgery.
  • Monitor and maintain equipment: Improperly maintained or operated equipment can injure patients. Accordingly, the committee must ensure that proper policies and procedures are in place for staff training, medical devices/equipment maintenance, and device-related event reporting. The FDA Safe Medical Device Act provides guidance for voluntary and mandatory reporting requirements.
  • Develop and revise policies and clinical guidelines for procedures. As with any other specialized surgical area, develop specific policies, procedures, and guidelines. For example, a facility may want to consider specific pathways for patient safety, such as the AORN Robotic Surgery Emergency Checklist.
  • Review quality outcomes. Diligently monitor quality indicators, such as frequency of return to OR, blood loss, conversion to open procedures, and procedure length. Quality data may indicate that a surgeon needs additional mentoring, proctoring, or training. Risk management personnel should be prepared to provide the committee with data regarding patient complaints and claims related to RAS.
  • Provide guidance for block time and robotic utilization. This OR-specific challenge can often be a source of argument among surgeons. A clear block schedule process can prevent conflict and optimize robot utilization.
Providing a safe environment of care for successful robotics programs is multifactorial. Safe, efficient patient care is a priority that requires clear patient selection criteria and patient education. A robotics committee coupled with policies and procedures for credentialing, training, and competency will augment facilities’ surgical offerings while mitigating their risk exposures.
 
 
Copyrighted. No legal or medical advice intended. This post includes general risk management guidelines. Such materials are for informational purposes only and may not reflect the most current legal or medical developments. These informational materials are not intended, and must not be taken, as legal or medical advice on any particular set of facts or circumstances.