European Respiratory SocietySurgery2026advanced

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

Published by Committee for the Promotion of Remote Surgery Implementation, Japan Surgical Society

28References

1Tables

3Figures

Summary

AI-generated

This document outlines the clinical practice guidelines for telesurgery in Japan (2nd Edition). It details requirements for surgical teams, facilities, and communication networks for three types of telesurgery: telementoring, telesurgical support, and full telesurgery. It provides specific safety, information security, and legal accountability standards.

Remote surgeryTelesurgeryTelementoringSurgical robotsCybersecuritySurgical educationGuidelines

Key Takeaways

1
Telesurgery is categorized into telementoring, telesurgical support, and full telesurgery [16-18].
2
In telesurgical support, the sum of newly generated round-trip network transmission and information processing delay must not exceed 100 ms [5].
3
Both local and remote surgeons, assistants, nurses, and clinical engineers must complete specific academic society and robot manufacturer training, including the 'Training Program for Remote Surgery' [1-3, 19].
4
Clinical engineers must be stationed at both the local and remote facilities to advise and troubleshoot robotic systems during procedures [3].
5
A closed communication network (such as L3/L2 VPN) is highly desirable to isolate the remote surgical environment from other hospital networks [6, 20].
6
The local surgeon and local facility administrator bear primary clinical and legal responsibility for surgical outcomes, necessitating written agreements on liability distribution prior to procedures [8, 9, 21].
7
Full telesurgery is not legally approved for clinical implementation in Japan due to legal, ethical, and safety concerns [18, 22].

What's New in This Version

Compared to the first edition, the second edition updates and expands implementation-oriented guidance [27, 28]. Key changes include: 1) Concrete qualification requirements for surgeons and support staff [27, 28]; 2) Detailed institutional and network environment specifications [27, 28]; 3) Expanded cybersecurity standards [27, 28]; 4) Registry-based governance requiring performance reporting [29]; 5) Inclusion of representative informed consent templates and contractual frameworks [27, 28]; and 6) Separation of universally applicable technical/legal principles from Japan-specific regulatory systems to improve international applicability [27, 30].

Key Recommendations

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

Scope & Objectives

Clinical Topic

Telesurgery (Remote Surgery)

Objectives

To present appropriate standards for the systems through which telesurgery is provided and implemented, specifically when performed remotely by a supervising physician in a distant location using both surgical robots and information and communication technology.

Target Patient Population

Patients undergoing surgical procedures that can be performed remotely using robotic systems.

Target Providers

Surgeons (remote surgeons, local surgeons)Surgical assistantsNursesClinical engineersFacility administrators

Patient Criteria & Setting

Therapeutic Area

Surgery

Guideline Scope

Clinical practiceTechnical standardsLegal responsibilityEthical considerationsOrganizational frameworks

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

Local medical facilities (hospitals)Remote medical facilities (hospitals)

Special Populations

Elderly patients living in remote areas who have difficulty moving

Safety & Contraindications

Contraindications

Full telesurgery is currently not approved for implementation in Japan due to patient safety, ethical, and legal concerns.

Monitoring Guidance

Continuous monitoring of patient's vital signs (such as ECG and blood pressure) by the local surgeon and anesthesiologist is required, with remote surgeons/mentors recommended to continuously monitor this information via a separate communication line.

Authors & Contributors

Satoshi HiranoKenichi HakamadaEiji OkiTakayuki ItoShigeo UrushidaniIchiro UyamaMasatoshi EtoYuma EbiharaYukihide KanemitsuKenji KawashimaTakahiro KannoMasaru KitsuregawaYusuke KinugasaHiroaki KitatsujiToshihiko SatoFumiaki SatoTomoki ShimokawaHiroshi ShimamotoShuji TakiguchiIchiro TakemasaMasanori TokunagaMasaya NakauchiHirokazu NoshiroMasaki MandaiKoshi MimoriHajime MorohashiTomoharu YoshizumiGo WatanabeYoshiharu SakaiNorihiko IkedaAkinobu Taketomi

Guideline Features

Multidisciplinary

Learning Context

Difficulty

advanced

Learning Paths

Remote SurgeryRobotic SurgeryTelemedicine RegulationsSurgical EducationNetwork Security in HealthcareMedical Liability