A Framework for Minimally Invasive Remote Robotic‐Assisted Surgery: Bridging Innovation and Patient Safety

摘要

The development of scalable remote robotic-assisted surgery is a potentially transformative milestone in the delivery of surgical care. Remote robotic surgery offers care networks the opportunity to optimize deployment of high-quality surgical expertise, to minimize patient travel and inconvenience, and to maintain best outcome. It also holds promise as a means of reducing healthcare disparities globally [1]. Using modern advances in robotic and tele-communication technologies, investigators have established the feasibility of remote robotic-assisted surgery (RAS) in which the surgeon is not physically in the same location as the patient [2-5]. These pre-clinical and clinical studies underscore the need for a framework to guide healthcare stakeholders and medical societies in the development of clinical practice guidelines, with the overarching aim of ensuring the safe and effective integration of remote RAS into routine patient care [5-10]. Key clinical and operational issues are outlined below for consideration. Relevant terms and definitions are provided in the Appendix A. Several distinct operating models are defined by the level of responsibility assigned to the surgeon(s) and other credentialed practitioners involved in the remote RAS procedure [8, 11, 12]. The primary surgeon must be clearly designated prior to engaging in patient care. These operating models include: Telementoring/Teleprecepting without instrument control—A fully trained and credentialed remote surgeon observes and mentors a patient site credentialed practitioner by providing verbal/visual guidance, including telestration. The telementor has no control of the robotic instruments. Telementoring/Teleprecepting with instrument control—A fully trained and credentialed remote surgeon provides a patient site credentialed practitioner with (1) supervisory and educational verbal–visual guidance, including telestration, and/or (2) by taking control of the tools to demonstrate and/or complete a segment of the RAS procedure. Remote teleproctoring—A qualified remote surgeon observes, evaluates, and reports on the skills and performance of a patient site practitioner. Remote robotic-assisted co-surgery—A fully trained and credentialed remote surgeon collaborates with a fully trained patient site credentialed practitioner to complete a remote-enabled robotic procedure. Each surgeon/practitioner completes the part of the procedure for which they are credentialed. Full remote robotic-assisted surgery—A fully trained and credentialed remote surgeon performs remote RAS as the primary surgeon with a credentialed practitioner as the bedside assistant. In this configuration, the remote surgeon retains primary responsibility for the patient's surgical care. The remote RAS care team must be similar to a typical RAS team, with at least one surgeon remote from the patient site. The team at the patient site should include at least one site credentialed practitioner, a circulating nurse, a scrub nurse/technician, and an anesthesiologist/credentialed nurse anesthetist (CRNA). Depending on the operating model, the patient site practitioner could be the primary surgeon (and mentee), co-surgeon, or bedside assistant. Appropriate credentialing is required for each role. Each team member must have foundational expertise in RAS procedures and specialized training in remote surgery, with an emphasis on team coordination and the management of crises unique to remote RAS [7, 8, 12]. Appropriate patient selection is critical to ensuring both patient safety and the success of a remote RAS program. Consistent with current practice, patient selection for remote RAS should be guided by comprehensive risk assessment that accounts for both patient-specific factors and the capabilities of available resources. The surgeon with primary operative responsibility for the patient must conduct a pre-operative consultation, either in person or virtually. This discussion should include the options of nons