Applies to: All clinical, administrative and marketing staff at Newcastle Cosmetic Doctor (NCD)

1. Purpose & Scope

This master policy establishes the governance, safety and operational framework for all cosmetic services delivered by NCD, including anti‑wrinkle injections, dermal fillers, bio‑stimulators, PDO/PLLA threads, prescription and non‑prescription topicals, and all energy‑based devices (laser, IPL/BBL, RF, HIFU/ultrasound, LED, body contouring). It integrates risk management, clinical standards, and consumer protections applicable in Australia, ensuring consistent care and defensible clinical decision‑making.^{1 2 3 4 5 6 7}

2. Regulatory & Ethical Framework

NCD operates under AHPRA/Medical Board cosmetic procedure guidance, the TGA's medicines and medical device regulations, and the NSQHS Standards for clinical governance, infection control, medication safety and recognition of deterioration. NSW Health policies inform skin penetration and pharmaceutical controls; OAIC's Australian Privacy Principles govern data and images. Advertising and claims comply with AHPRA and Australian Consumer Law.^{1 2 3 4 5 6 20}

3. Clinical Governance & Medical Oversight

The Responsible Medical Practitioner (RMP) provides clinical governance, approves protocols, and oversees incident review and credentialing. Multidisciplinary meetings review complications, audit trends and CAPA outcomes. Policies mandate risk assessments for new services, device commissioning, and formulary decisions, with escalation pathways for clinical deterioration and device malfunction.^{4 8}

4. Practitioner Credentialing, Scope of Practice & CPD

All practitioners maintain current AHPRA registration within scope; device and product‑specific credentialing is required prior to independent practice. Ongoing CPD is documented, including emergency response (anaphylaxis, airway, vascular occlusion drills) and periodic peer review. Delegation to nurses follows written protocols with clear supervision and escalation criteria.^{1 4}

5. Patient Assessment, Informed Consent & Documentation

Comprehensive assessment includes medical history, medications, allergies, pregnancy/lactation status, psychosocial context, Fitzpatrick type, and risk factors for scarring or PIH. Informed consent is staged with written PIS, discussion of risks/benefits/alternatives and costs, cooling‑off where appropriate, and teach‑back for comprehension. Clinical records include indication, product/device parameters, batch/lot numbers, photos, and aftercare; privacy notices are provided and signed.^{1 4 6 9}

6. Medication Management & Prescribing

All prescription medicines (e.g., botulinum toxin, lidocaine, hyaluronidase, antibiotics) are prescribed by an authorised prescriber with clear dosing, indications and repeats. Storage, access control, expiry checks and temperature monitoring are enforced. Compounded topicals follow Pharmacy Board standards and TGA guidance; PBS supply and off‑label use are documented with risk–benefit justification and consent.^{3 10 11 12}

7. Injectables — Anti‑Wrinkle & Dermal Fillers

Injection procedures require aseptic technique, patient positioning, anatomical mapping, and dose recording. For botulinum toxin, units, dilution, injection depth and patterns are recorded; contraindications such as neuromuscular disorders and pregnancy are considered. Dermal filler care includes aspiration where appropriate, conservative volumes, and readiness for vascular occlusion response with protocols for hyaluronidase use, escalation, and documentation.^{1 4 14 13}

8. Threads & Bio‑Stimulators

Threads and bio‑stimulators are restricted to credentialed practitioners after dedicated training. Pre‑procedure screening identifies coagulation risks, autoimmune disease, active infection or acne, and unrealistic expectations. Procedural technique follows manufacturer IFU with sterile field setup, safe vector planning, and immediate complication recognition; aftercare outlines bruising, swelling, and infection warnings with contact pathways.^{1 4 15}

9. Lasers, RF, HIFU/Ultrasound, IPL/BBL & LED — Governance Integration

All energy‑based treatments operate within controlled areas, eyewear compliance, signage, and plume management where relevant. Device parameters reflect manufacturer IFU, skin type, indication, and test‑spot outcomes. ARPANSA‑aligned standards (AS/NZS IEC 60825; AS/NZS 4173) and device risk management (ISO 14971; IEC 60601) inform commissioning, maintenance and adverse event escalation to the TGA when indicated.^{3 14 15 16 17}

10. Infection Prevention, Asepsis & Skin Penetration

Aseptic technique includes hand hygiene, gloves, sterile or single-use devices, and sterile fields where appropriate. All reusable instruments follow TGA‑compliant reprocessing standards (cleaning, disinfection, sterilisation, storage) with cycle validation and biological indicators. Injection sites are prepared per manufacturer IFU and NHMRC guidelines; topical anaesthetics are assessed for occlusion duration and allergy risks. Standard precautions apply to all patient encounters.^{4 5}

11. Sharps Safety, Waste & Environmental Management

Sharps handling follows point‑of‑use disposal, approved containers, and incident reporting for needlestick exposure with post‑exposure prophylaxis pathways. Waste management adheres to local clinical waste contracts and environmental considerations, including safe disposal of expired medicines and contaminated consumables.^{4 5}

12. Emergency Preparedness & Deterioration Response

Emergency kits include anaphylaxis medications, oxygen, and resuscitation equipment with staff trained in BLS. Escalation follows NSQHS Standard 8 with defined responders and transfer procedures. For filler‑related vascular events, hyaluronidase protocols, warming, massage and urgent specialist referral pathways are rehearsed and documented.^{4 7}

13. Adverse Events, Incident Reporting & TGA/Regulator Notifications

All adverse events are triaged by severity and documented. Device malfunctions or serious outcomes are quarantined and considered for TGA reporting; medicine issues are assessed for pharmacovigilance reporting. Root cause analysis informs CAPA, and lessons are circulated through clinical governance meetings.^{3 4}

14. Clinical Photography, Records & Privacy

Photographs are obtained with separate consent stipulating clinical or marketing use. Images and records are stored securely with role‑based access and audit trails; de‑identification is applied for education. APP compliance is maintained for retention and disclosure; marketing materials avoid testimonials and misleading before‑after representations.^{6 11 2}

15. Advertising, Digital Claims & Social Media

All public-facing content avoids prohibited therapeutic claims for non‑therapeutic goods and complies with AHPRA/TGA/ACCC rules. Testimonials of clinical outcomes are not used, and influencer content is controlled to prevent misleading or deceptive conduct. Disclaimers clarify individual variability and the requirement for consultation for prescription products.^{2 3 20}

16. Quality Assurance — Devices & Facilities

Each device has a maintenance and calibration schedule with service records, safety checks, and software version control. Facilities maintain emergency power checks, environmental cleaning logs, and consumable batch traceability. Non‑conformances trigger quarantine and documented investigation before return to service.^{3 8 9 18}

17. Training, Competency & Supervision

All staff complete induction covering clinical risk, privacy, infection control, emergency procedures, and role-specific competencies. Device and product sign-offs precede independent practice; supervision levels are documented and periodically reviewed. CPD and competency reassessment occur annually or after scope changes.^{1 4}

18. Audit, Consumer Feedback & Continuous Improvement

Quarterly audits sample records for consent quality, parameter documentation, complication management, and advertising compliance. Consumer feedback and complaint trends are analysed for service improvements. Policies are reviewed annually or following regulatory updates, with changes communicated to staff and reflected in training.^{4 20}

19. Governance Documentation & Version Control

This policy is controlled under the clinic's governance framework with a version number, approval date, and next review date. Superseded copies are archived. Staff are notified of updates and must attest to having read and understood material changes before the effective date.^{4 6}

Sources

1. Medical Board of Australia / AHPRA (2025), Guidelines for practitioners who perform cosmetic medical and surgical procedures, viewed 22 October 2025, https://www.medicalboard.gov.au/ ↩︎
2. AHPRA (2024), Advertising a regulated health service – Guidelines, viewed 22 October 2025, https://www.ahpra.gov.au/Resources/Advertising-hub/Advertising-guidelines-and-other-guidance/Advertising-guidelines.aspx ↩︎
3. Therapeutic Goods Administration (TGA), Medical devices & medicines regulation; adverse event reporting, viewed 22 October 2025, https://www.tga.gov.au/ ↩︎
4. ACSQHC, National Safety and Quality Health Service (NSQHS) Standards, viewed 22 October 2025, https://www.safetyandquality.gov.au/ ↩︎
5. NSW Health, Infection prevention/skin penetration and pharmaceutical services policies, viewed 22 October 2025, https://www.health.nsw.gov.au/ ↩︎
6. OAIC, Australian Privacy Principles guidance for health service providers, viewed 22 October 2025, https://www.oaic.gov.au/ ↩︎
7. RACGP, Safe prescribing, clinical governance and emergency preparedness in primary care, viewed 22 October 2025, https://www.racgp.org.au/ ↩︎
8. ARPANSA, Laser and optical radiation safety aligned with AS/NZS standards, viewed 22 October 2025, https://www.arpansa.gov.au/ ↩︎
9. Standards Australia, AS/NZS IEC 60825; AS/NZS 4173 (laser safety in health care), viewed 22 October 2025, https://www.standards.org.au/ ↩︎
10. NHMRC, National Statement (consent ethics) and guidance on clinical photography, viewed 22 October 2025, https://www.nhmrc.gov.au/ ↩︎
11. PBS, Schedule of Pharmaceutical Benefits (medicines supply considerations), viewed 22 October 2025, https://www.pbs.gov.au/ ↩︎
12. Pharmacy Board of Australia, Guidelines on compounding of medicines, viewed 22 October 2025, https://www.pharmacyboard.gov.au/ ↩︎
13. Therapeutic Guidelines / AMH, Dermatology, antimicrobials, anaphylaxis, and analgesia counselling, viewed 22 October 2025, https://tgldcdp.tg.org.au/ ↩︎
14. Australasian College of Dermatologists, Clinical resources on lasers, dermatology and fillers, viewed 22 October 2025, https://www.dermcoll.edu.au/ ↩︎
15. IEC, 60601 series. Medical electrical equipment – safety and essential performance, viewed 22 October 2025, https://www.iec.ch/ ↩︎
16. ISO, 14971. Medical devices – application of risk management to medical devices, viewed 22 October 2025, https://www.iso.org/ ↩︎
17. ACCC, Australian Consumer Law – misleading or deceptive conduct, viewed 22 October 2025, https://www.accc.gov.au/ ↩︎