Before
Map selection, imaging, consent, preparation and room readiness.
Reading method · 02
Map the complete care pathway
Follow the patient, staff, device, data and fallback route before, during and after the robotic intervention.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
02
FUURAA thesis
A technically successful robot step can still displace risk or delay elsewhere in care.
Engineering map
Turn the title into engineering objects that can be observed, measured and reviewed.
Each layer states the boundary to establish and the evidence needed for the next decision.
During
Map setup, registration, control, alarms, handoffs and conversion.
After
Map recovery, device cleaning, data review, follow-up and event reporting.
Verification questions
Write the questions first, then decide whether a demo, test, pilot or operating record can answer them.
Each question needs an object, conditions, denominator, threshold and accountable decision owner.
- 01
Where can delay or handoff error occur?
- 02
What is the non-robot fallback?
- 03
Who owns every transition?
- 04
Which outcome matters to the patient?
Evidence to preserve
Enable the next reader to reconstruct conditions, results, failures and the decision.
A conclusion alone loses reviewability; raw records, configuration and exclusions matter too.
- 01
Evidence package 1
End-to-end care-pathway map
- 02
Evidence package 2
Roles, timing and exception ledger
- 03
Evidence package 3
Fallback and transfer drill
Scope boundary
State what this evidence still cannot be generalised to.
- 01
Procedure duration or technical accuracy alone cannot establish pathway benefit.
- 02
This is an engineering reading and decision framework; it does not replace application-specific risk assessment, conformity work, procurement acceptance or professional advice.
Sources and evidence status
Read standards scope, measurement evidence and application conclusions separately.
Source dates and review status remain visible; external sources open in a new tab.
01
U.S. FDA · Updated 2022-06-21 · verified 2026-08-15
↗02Computer-Assisted Surgical Systems
Explains authorised uses, clinician control, training, credentialing, facility responsibilities and adverse-event reporting for computer-assisted surgery.
U.S. FDA · Updated 2026-08-03
↗03Applying Human Factors and Usability Engineering to Medical Devices
Frames safe and effective use around intended users, uses, environments, interfaces, critical tasks and validation of use-related risk controls.
ISO · Published 2019-12 · current edition verified 2026-08-15
↗ISO 14971:2019 — Medical-device risk management
Specifies a lifecycle process for identifying hazards, estimating and evaluating risk, controlling risk and monitoring control effectiveness.