Clinical practice guidelines for telesurgery, 2nd Edition : Committee for the Promotion of Remote Surgery Implementation, Japan Surgical Society.

2.1.1.1.1. Remote surgeon

• REC-2.1.1.1.1

  A remote surgeon must possess sufficient technical skills to safely perform telesurgery while supporting a local surgeon, hold certification as a robot-assisted surgery instructor/proctor or an equivalent qualification corresponding to the specific surgical robot model, and complete the Training Program for Remote Surgery managed by the Japan Surgical Society [1].

  Provider Requirement

2.1.1.1.2. Local surgeon

• REC-2.1.1.1.2

  The local surgeon must complete the robot manufacturer's training, obtain an operator certificate, complete the Training Program for Remote Surgery, hold board certification in their field, and have experience with the planned procedure or prior direct instruction from a certified instructor [2].

  Provider Requirement

2.1.1.2.3. Clinical engineers

• REC-2.1.1.2.3

  Clinical engineers experienced in surgical robot maintenance and management must be assigned to both local and remote facilities, and must complete the manufacturer's training program and the Training Program for Remote Surgery [3].

  Staff Requirement

2.1.2.2.3. Local facility alternative approaches

• REC-2.1.2.2.3

  The local facility must possess the equipment and staff necessary to complete robotic surgical procedures planned for telesurgical support through alternative approaches, such as endoscopic surgery or open surgery, in case telesurgical support cannot continue [4].

  Facility Requirement

2.1.3.3. Delay limits

• REC-2.1.3.3

  The sum of the round-trip communication network transmission delay time and information processing delay time newly generated in the telesurgery environment should be within 100 ms (0.1 s) at the maximum [5].

  Technical Standard

2.1.6.1.1. Line security

• REC-2.1.6.1.1

  A closed communication network, such as a layer-3/layer-2 virtual private network (L3/L2VPN), that is physically or logically separated from the Internet is desirable [6]. If open lines are unavoidable, highly secure IPSec+IKE (version 2) connections are recommended with strict source/destination IP and port firewall limits [6].

  Security Standard

2.2.3.2. Preoperative review of cases

• REC-2.2.3.2

  The local surgeon, local surgical staff, and remote surgeon must hold a conference in advance to discuss the appropriateness of telesurgical support, division of roles, potential surgical procedure changes, and response plans if telesurgery becomes unfeasible, and document this in the medical record [7].

  Clinical Workflow

2.3. Apportionment of responsibility

• REC-2.3

  In principle, the local surgeon and local facility administrator bear responsibility for telesurgical support outcomes, and must discuss responsibility sharing with the remote surgeon and remote facility administrator for each case and create a written agreement in advance [8, 9].

  Legal Responsibility

3.1.6. Communication delay in telementoring

• REC-3.1.6

  Telementoring does not require strict delay time management like telesurgical support, but perceived delay must be evaluated in advance [10]. A total delay time of <= 450 ms is recommended as a reference [10].

  Technical Standard

Therapeutic Area

Guideline Scope

Inclusion Criteria

• Robotic surgery procedures covered by national insurance
• Surgeries utilizing approved surgical robot models

Exclusion Criteria

• Full telesurgery (currently difficult to implement in Japan due to legal, ethical, and safety concerns)

Care Settings

Special Populations

Related

• Guidelines for the Appropriate Implementation of Online Clinical Practice
• Guidelines on Safety Management of Healthcare Information Systems
• Safety Management Guidelines for Providers of Information Systems and Services that Handle Medical Information

Comparable guidelines from other societies

• Guidelines for the Appropriate Implementation of Online Clinical Practice (Japan) [23]
• Guidelines on Safety Management of Healthcare Information Systems (Japan) [24]
• Safety Management Guidelines for Providers of Information Systems and Services that Handle Medical Information (Japan) [25]
• SAGES Technology for Surgical Telementoring White Paper (Society of American Gastrointestinal and Endoscopic Surgeons) [10, 26]