Detect
Define alarms, plausibility checks, cross-checks and loss-of-function indicators.
Deployment evaluation · 16
Failure and conversion
Measure malfunctions, interruptions, aborted actions and time to a safe alternative pathway under realistic conditions.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
16
FUURAA thesis
Recovery is a clinical capability only when the patient remains protected throughout transition.
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.
Stabilise
Specify safe state, energy control, patient protection and communication.
Convert
Prepare staff, instruments, access, authority and time objective.
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
Which failures are not self-announcing?
- 02
Can conversion occur at every step?
- 03
What remains attached to the patient?
- 04
How are aborted cases counted?
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
Failure-mode and conversion map
- 02
Evidence package 2
Representative fault-injection drills
- 03
Evidence package 3
Time-to-safe-care and outcome ledger
Scope boundary
State what this evidence still cannot be generalised to.
- 01
An emergency stop protects against some hazards but is not a complete clinical conversion plan.
- 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
ISO · Published 2019-12 · current edition verified 2026-08-15
↗02ISO 14971:2019 — Medical-device risk management
Specifies a lifecycle process for identifying hazards, estimating and evaluating risk, controlling risk and monitoring control effectiveness.
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.
U.S. FDA · Updated 2022-06-21 · verified 2026-08-15
↗04Computer-Assisted Surgical Systems
Explains authorised uses, clinician control, training, credentialing, facility responsibilities and adverse-event reporting for computer-assisted surgery.
U.S. FDA · Database limitations verified 2026-08-15
↗MAUDE adverse-event database and reporting limitations
Provides device reports that can reveal failure modes, complaint patterns and questions requiring further investigation.