1. Purpose & Scope

This policy standardises how Newcastle Cosmetic Doctor (NCD) classifies, reports, and manages adverse events related to injectables, threads, and energy-based devices. It aligns with national and international frameworks including the ACSQHC NSQHS Standards, AHPRA cosmetic practice guidelines, TGA pharmacovigilance requirements, and WHO patient safety taxonomies. ^{1 2 3 4 5}

2. Definitions

Adverse Event (AE): Any unintended medical occurrence in a patient undergoing cosmetic treatment, not necessarily causally related. Serious Adverse Event (SAE): Results in hospitalisation, disability, or requires urgent medical intervention. Near Miss: An event that could have caused harm but was prevented before occurring. ^{3 5 6}

3. Event Grading Matrix (Severity Levels)

NCD adopts a 5-level grading system:

• Grade 1 (Minor): Mild erythema, transient swelling or bruising resolving without intervention.
• Grade 2 (Moderate): Prolonged oedema, infection requiring oral medication, small laser burns resolving with conservative care.
• Grade 3 (Major): Significant injury, vascular occlusion, abscess, or delayed nodule needing medical/surgical intervention.
• Grade 4 (Severe): Permanent injury, vision loss, necrosis, or systemic reaction requiring hospitalisation.
• Grade 5 (Sentinel): Death, permanent disability, or major regulatory reportable event. ^{1 4 7}

4. Classification Criteria

Each AE is classified based on clinical severity, causality, and preventability. Documentation includes date, procedure, device/product, operator, and contributing factors (patient risk, technique, product). Causality follows WHO–UMC or CIOMS principles. ^{4 5 8}

5. Immediate Response & Containment

Clinicians must provide prompt care according to NCD emergency SOPs (vascular occlusion, anaphylaxis, infection). Document and photograph all findings, provide patient communication, and notify the Medical Director within 24 hours for Grade 3–5 events. ^{2 6 9}

6. Notification & Reporting Pathways

All Grade 3–5 events trigger internal governance review and may require external notification to the TGA (device or medicine), AHPRA (practitioner impairment or breach), or HCCC NSW (consumer complaint). Reporting complies with legislative timelines. ^{1 3 9}

7. Root Cause Analysis (RCA) & CAPA

A structured RCA identifies system, human, and equipment factors. Corrective and Preventive Actions (CAPA) are assigned to prevent recurrence. Learnings are reviewed during CQI meetings and feed into training, protocols, and audit cycles. ^{2 10}

8. Continuous Improvement & CQI Integration

Incident data are trended across services (injectables, threads, laser) to detect patterns. Quarterly CQI meetings assess RCA outcomes, update policies, and benchmark against ACSQHC and international safety indicators. ^{2 5 10}

Sources

1. Ahpra/Medical Board of Australia, Guidelines for practitioners who perform cosmetic medical and surgical procedures (2025)., viewed 28 October 2025, https://www.ahpra.gov.au/Resources/Cosmetic-surgery-hub/Cosmetic-procedure-guidelines.aspx ↩
2. ACSQHC, National Safety and Quality Health Service (NSQHS) Standards (2nd ed.)., viewed 28 October 2025, https://www.safetyandquality.gov.au/standards ↩
3. Therapeutic Goods Administration (TGA),Database of Adverse Event Notifications (DAEN)., viewed 28 October 2025, https://www.tga.gov.au/safety-and-shortages/database-adverse-event-notifications-daen ↩
4. World Health Organization (WHO), Patient Safety Incident Reporting and Learning Systems., viewed 28 October 2025, https://www.who.int/publications/i/item/9789241511636 ↩
5. ISO, ISO 14155:2020 – Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice., viewed 28 October 2025, https://www.iso.org/standard/71690.html ↩
6. NHMRC, Australian Guidelines for the Prevention and Control of Infection in Healthcare (2019)., viewed 28 October 2025, https://www.nhmrc.gov.au/about-us/publications/australian-guidelines-prevention-and-control-infection-healthcare-2019 ↩
7. NSW Health, Clinical Governance and Patient Safety Framework (PD2017_043)., viewed 28 October 2025, https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2017_043.pdf ↩
8. CIOMS/WHO (2018), Causality assessment of an adverse event following immunization (AEFI): User manual for the revised WHO classification (2nd ed.), viewed 28 October 2025, https://www.who.int/publications/i/item/9789241516990 ↩
9. Health Care Complaints Commission (HCCC) NSW, Complaints and Notifications., viewed 28 October 2025, https://www.hccc.nsw.gov.au/ ↩
10. Institute for Healthcare Improvement (IHI) (2015), RCA²: Improving Root Cause Analyses and Actions to Prevent Harm, viewed 28 October 2025, https://www.ihi.org/library/tools/rca2-improving-root-cause-analyses-and-actions-prevent-harm ↩