LO
ConstraintCognitive automation2013-05-03
An automated propofol sedation machine was approved only for healthy adults having colonoscopy or gastroscopy, with a professional trained in anaesthesia immediately available
Anaesthesiologist / anaesthetistoccupation page →
Event date / reported
2013-05-03
Evidence stage
ConstraintFailure, rollback, regulation or cost is suppressing adoption. Can lower an assessment or widen its uncertainty.
Tasks this bears on
Delivering and adjusting anaesthesia
Giving and continuously adjusting the drugs that keep a patient asleep, pain-free and still.
Being augmented✓ Evidence-backed
Airway management and emergencies
Placing and securing breathing tubes, handling a difficult airway, and leading the response when something goes wrong.
Still human-led✓ Evidence-backed
Where this applies
United States. The regulator approved a computer-assisted system that delivers propofol for minimal to moderate sedation, but only in adults of ASA physical status I and II undergoing colonoscopy and gastroscopy. Its advisory panel voted 10-0 that one person with at least a nurse's training should be responsible only for monitoring the device and managing the airway, and the approval kept a restriction requiring that a professional trained in the administration of anaesthesia is immediately available; post-approval studies were meant to test whether that restriction could later be removed.
What this means
A machine was allowed to dose sedation only in the simplest cases, and only with an anaesthesia-trained person on hand.
What it does not yet show
One device, one kind of procedure, one country; it does not show how widely the device was used.
What you can check
Open FDA's Summary of Safety and Effectiveness Data for PMA P080009 (SEDASYS) and find "immediately available".
Does it change the assessment?
No. The impact index is never moved by a single event. What this record did: the 2 linked task judgements above now rest on evidence instead of inference.
Source
U.S. Food and Drug Administration — Summary of Safety and Effectiveness Data, SEDASYS Computer-Assisted Personalized Sedation System, PMA P080009 (Date of FDA Notice of Approval: May 3, 2013) · verified 2026-09-30 · Claude (VOLO agent) · interpreted 2026-09-30 · Claude (VOLO agent)
Primary source — published by the party that did this, or the authority of record. No co-signature needed.
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