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Adverse Events & Critical-Incident Management in Anaesthesia

Definitions

Term Working definition Key legal reference (SA)
Adverse Event (AE) Unintended injury or complication that results in disability, prolonged hospital stay or death and is caused by healthcare management rather than the patient’s underlying disease. DoH National Patient-Safety Incident (PSI) Guideline v2 (2022)
Serious Reportable Incident AE that leads to death, loss of function, or is likely to attract media/public attention. NHLS/NDoH PSI taxonomy
Procedure-related death Death occurring during or as a result of any diagnostic, therapeutic or palliative procedure, irrespective of time delay. Health Professions Amendment Act 29 of 2007 §48
Adverse Drug Reaction (ADR) A noxious, unintended response to a medicine that occurs at any dose, including errors, misuse or overdose. SAHPRA Vigilance Guideline v4 (2024)

Immediate Response Algorithm–“10 C’s”

C-step Actions
Call help Second anaesthetist, resus trolley, rapid-response team.
Care for patient Allocate primary clinician to airway/ventilation; secondary to drugs/lines.
Command (Incident Supervisor) Senior anaesthetist takes charge, allocates tasks, verifies critical steps (tube position, monitors, machine).
Close theatre Stop list; restrict entry; quarantine equipment.
Collect evidence Do not turn off monitors; print waveforms; photograph screens; bag/label syringes, ampoules, disposables.
Console relatives Joint surgeon–anaesthetist disclosure; honest facts, no blame, clear next steps.
Contact hospital risk & insurer Notify PSI officer, theatre matron; phone MPS/Ethiqal before formal statements.
Chart Contemporaneous narrative, exact times, team roster; attach print-outs.
Counsel team Hot debrief within two hours; psychological first aid; roster flexibility.
Continue review Follow patient post-event; update family; prepare for cold M&M, GW 7/24 etc.

Mandatory Forms & Reporting (Timeline) in South Africa

Timeframe Form Completed by Destination
Immediately PSI notification (electronic) Theatre unit manager National PSI system
< 24 h GW 7/24 Parts A–C (anaesthetic/procedure deaths) Anaesthetist / Surgeon / HoD Provincial Forensic Pathology Services
DHA-1663 death certificate Certifying doctor Dept. Home Affairs
FPS 100 body referral Theatre nurse Forensic mortuary
MDNF (maternal only) Obstetric clinician District MCH office
< 48 h GW 7/24 Part D (institutional review) HoD FPS & DoH
< 3 d Insurer report Responsible clinician MPS / Ethiqal

Analysis & Learning

Structured Methods

Tool Purpose Output
Root-Cause Analysis (RCA) Finds single most proximate cause. Fishbone diagram, action plan.
London Protocol Systems analysis: patient, task, team, workspace, org & culture. List of contributory factors + safety recommendations.
Human Factors–Swiss-Cheese model Differentiates latent vs active failures. Safety-barrier map.
Treat-&-Error (threat–error management) Prospective mapping of threats and human errors. Simulation scenarios, checklists.

Just-Culture Grid

Behaviour Response
Human error (slip, lapse) Console, support, systems fix.
At-risk behaviour (work-around) Coaching, education.
Reckless behaviour Disciplinary / regulatory action.

Adverse Drug Reactions & Medication Safety

ABCDEF Classification

Type Example (anaesthesia) Prevention / Response
A Augmented (dose-related) Hypotension with propofol bolus Titrate, adjust weight-based dose
B Bizarre (idiosyncratic) Anaphylaxis to rocuronium Avoid agent, prepare Kit A
C Chronic HPA suppression from prolonged steroids Limit dose, taper
D Delayed Post-op cognitive decline after anaesthesia Prevention techniques
E End-of-use Clonidine withdrawal hypertension Step-down patch strength
F Failure OCP failure with midazolam CYP3A induction Counsel, alter anaesthetic plan

High-impact Safety Recommendations (evidence graded)

Rank Intervention Evidence level
★★★ Read syringe/ampoule twice before draw-up Strong (RCT & observational)
★★★ Label every syringe immediately after drawing Strong
★★★ Colour-coded, pre-printed drug class labels (ISO 26825) Strong
★★ Double-check with second person or barcode Moderate
★★ Standardise tray layout (routine vs emergency) Moderate
Prefilled syringes for emergency drugs Emerging
Smart pumps with drug library & hard limits Emerging
  • (Adapted from ANZCA PS51 2022, ASA 2023 Safe Drug Administration statement.)

Debrief & Staff Well-being

  1. Hot debrief–within two hours, facilitator uses IF SPOTS mnemonic (Introduction, Facts, … Support).
  2. Cold debrief / M&M–within 7 days, use structured form; invite all disciplines.
  3. Second-victim support–confidential counselling, buddy system, phased return to work.

Links


Past Exam Questions

Prevention of Oxygen Cylinder Injury in the MRI Scanner

An adverse incident of oxygen cylinder injury to a patient in the MRI scanner has occurred in your hospital. The patient was transported from the intensive care unit.

Explain the different ways that the incident should be prevented in future (10)


References:

  1. Adyanthaya, S. S. and Patil, V. (2014). Never events: an anaesthetic perspective. Continuing Education in Anaesthesia Critical Care &Amp; Pain, 14(5), 197-201. https://doi.org/10.1093/bjaceaccp/mkt055
  2. Adapted from Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000;356:1255-9.
  3. South African Society of Anaesthesiologists. Adverse Event Reporting & Management Guidelines. 2024.
  4. Department of Health. National Patient Safety Incident Reporting & Learning Guideline v2. 2022.
  5. Health Professions Amendment Act 29 of 2007 (Section 48).
  6. ANZCA. Professional Document PS51: Safe Administration of Injectable Drugs in Anaesthesia. 2022.
  7. International Organization for Standardization. ISO 26825: User-applied Drug Labels in Anaesthesia. 2021.
  8. ASA Committee on Patient Safety. Statement on Medication Safety in the Operating Room. 2023.
  9. South African Health Products Regulatory Authority. Vigilance Guideline v4. 2024.
  10. Reason J. Human error: models and management. BMJ 2000;320:768-70.
  11. Kohn LT, Corrigan JM, Donaldson MS. To Err is Human: Building a Safer Health System. National Academies Press; 2000.

Summaries:



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