Cosmetic Device Governance Policy & Procedure (All Energy-Based Devices)

Applies to: All Newcastle Cosmetic Doctor (NCD) clinical, technical and administrative staff
Responsible Officer: Dr Bart Scanlon

1. Purpose & Scope

This policy provides a unified governance framework for the safe procurement, operation, maintenance, documentation and decommissioning of all cosmetic energy-based devices used at NCD, including lasers, IPL/BBL, radiofrequency, HIFU/ultrasound, LED phototherapy, cryolipolysis and fractional/ablative platforms. It aligns with Australian legislation and standards while benchmarking international safety principles.^{1 2 3}

2. Regulatory & Legislative Framework

All devices must be lawfully supplied and compliant with TGA medical device regulations; significant incidents are reportable to the TGA. Optical radiation sources are controlled under ARPANSA-aligned standards (AS/NZS IEC 60825; AS/NZS 4173). Clinical governance is maintained under NSQHS standards, with infection control and skin penetration obligations under NSW Health. Workplace risk controls follow SafeWork NSW requirements. Advertising must comply with TGA and AHPRA rules.^{1 2 4 5 6 6 7 8 9}

3. Device Classification & Registration

Prior to clinical use, each device is verified for ARTG status (where applicable), intended purpose, and class. Documentation includes manufacturer IFU, conformity evidence, software version, and accessories. Risk evaluation follows ISO 14971; photobiological and electrical safety are considered with IEC 62471 and IEC 60601 as relevant.^{1 10 11 12}

4. Procurement, Installation & Commissioning

Procurement requires supplier due diligence, installation by qualified personnel, and commissioning checks that confirm calibration, interlocks, emergency stops, eyewear compatibility, plume evacuation (for lasers), and electrical safety. Baseline test shots are recorded, and a controlled area is designated with signage and SOPs prior to first patient use.^{1 2 3 4 8}

5. Operator Credentialing & Laser Safety Officer Responsibilities

Only credentialed operators may use devices within their scope of practice. A Laser Safety Officer oversees laser/optical hazards, eyewear inventories with optical density ratings, room audits, and incident logs. Competency is maintained via device-specific training, annual updates, and emergency drills in accordance with NSQHS governance.^{2 3 4 6}

6. Patient Assessment & Informed Consent

Assessment documents indications, alternatives, expectations, Fitzpatrick skin type, sun exposure, medications, and contraindications. Informed consent is a staged process with written PIS, discussion of benefits/risks, cooling-off where applicable, and consent storage per privacy law. Clinical photography uses explicit consent with clear clinical or marketing purpose.^{13 6 14 12}

7. Pre-Treatment Preparation & Patch Testing

Pre-treatment steps include skin inspection, cleansing, and where indicated, patch test/test-spot based on skin type and device modality. Patch results guide parameter selection for lasers/IPL and sensitivity to RF/HIFU or cryolipolysis. Infection prevention measures and PPE are applied consistently.^{6 7 15}

8. Treatment Delivery – Lasers & Light (Laser, IPL/BBL, LED)

For lasers and IPL/BBL, establish a controlled area with appropriate wavelength-specific eyewear, non-reflective surfaces, and warning signage. Parameters are selected per manufacturer IFU and patient factors; plume evacuation is used for ablative or pigment-targeting systems. LED phototherapy follows photobiological safety and eye protection requirements. Immediate endpoints and skin response are documented.^{2 3 4 11 17}

9. Treatment Delivery – RF & HIFU/Ultrasound

RF and HIFU devices require attention to coupling media, contact pressure, and real-time feedback indicators. Operators avoid bony prominences and protect nerves and sensitive structures; energy, depth and passes are tailored to anatomical zones and skin type. Device handpieces are maintained per IFU to prevent thermal injury.^{6 13}

10. Treatment Delivery – Body Contouring (e.g., Cryolipolysis)

Cryolipolysis requires applicator fit assessment, skin protection membranes, monitoring for pain or numbness, and post-treatment massage as per IFU. Patients are counselled on delayed onset of results and rare risks such as paradoxical adipose hyperplasia. Any suspected device malfunction or serious adverse event is escalated per TGA vigilance procedures.^{1 6}

11. Infection Control & Environmental Safety

Standard precautions apply to all treatments, with surface disinfection between patients, hand hygiene, and sterile single-use disposables where indicated. Eye shields are disinfected or disposed per manufacturer guidance. Environmental controls include ventilation and fume extraction, especially during ablative procedures generating plume.^{6 7}

12. Analgesia, Medicines & Emergency Preparedness

Topical anaesthetics and analgesia are used within state poisons legislation and clinic medication policies, with dose calculations and monitoring. Emergency equipment (oxygen, AED, anaphylaxis kit) is available and staff are trained to respond to acute deterioration consistent with NSQHS Standard 8.^{6 16}

13. Adverse Events, Incident Response & TGA Reporting

Adverse events—from burns and blistering to pigmentary changes or ocular exposure—are documented, triaged, and managed according to severity. Serious incidents trigger device quarantine, internal investigation, and consideration of TGA adverse event reporting. Trends inform preventive actions and parameter adjustments.^{1 6}

14. Device Maintenance, Calibration & Servicing

Each device has a maintenance schedule covering calibration, software updates, handpiece lifecycle, and safety system checks. Service documentation is retained and reviewed before returning devices to service after repair. Faults or near-misses are logged and investigated.^{1 16}

15. Documentation, Advertising & Privacy

Clinical records include indication, parameters, consumables, batch/lot numbers where relevant, endpoints, adverse events, and aftercare given. Advertising and digital claims distinguish cosmetic from therapeutic claims and avoid testimonials. Images and health information are stored with access controls and retained per legal timelines.^{9 11 12 17}

16. Training, Competency & Continuous Improvement

Orientation covers device physics, hazards, parameter setting, skin typing, and emergency actions. Competency is signed off by the Responsible Medical Practitioner and refreshed annually. Case reviews, morbidity meetings, and updates from regulators inform practice improvements.^{5 6}

17. Audit, Review & Quality Governance

Quarterly audits evaluate documentation completeness, incident handling, maintenance compliance, and consent quality. Findings feed into governance meetings, CAPA actions, and policy updates. The SOP is reviewed annually or earlier after key regulatory or device updates.^{6 1}

Sources

1. Therapeutic Goods Administration (TGA) (2025), Medical devices regulation & adverse event reporting, viewed 22 October 2025, https://www.tga.gov.au/ ↩
2. ARPANSA (2025), Laser/optical radiation safety; alignment with AS/NZS IEC 60825 series, viewed 22 October 2025, https://www.arpansa.gov.au/ ↩
3. Standards Australia (2025), AS/NZS IEC 60825 series – Safety of laser products, viewed 22 October 2025, https://www.standards.org.au/ ↩
4. Standards Australia (2025), AS/NZS 4173: Safe use of lasers in health care, viewed 22 October 2025, https://www.standards.org.au/ ↩
5. AHPRA / Medical Board of Australia (2025), Cosmetic procedures guidelines, viewed 22 October 2025, https://www.medicalboard.gov.au/ ↩
6. ACSQHC (2025), NSQHS Standards (Std 1 Clinical Governance; Std 3 Infection Prevention; Std 4 Medication Safety; Std 8 Acute Deterioration), viewed 22 October 2025, https://www.safetyandquality.gov.au/ ↩
7. NSW Health (2025), Skin penetration & infection control requirements (Public Health Act/Regs), viewed 22 October 2025, https://www.health.nsw.gov.au/ ↩
8. SafeWork NSW (2025), Managing risks of lasers and plant in the workplace, viewed 22 October 2025, https://www.safework.nsw.gov.au/ ↩
9. OAIC (2025), Australian Privacy Principles – health information & images, viewed 22 October 2025, https://www.oaic.gov.au/ ↩
10. TGA (2025), Advertising therapeutic goods & social media guidance, viewed 22 October 2025, https://www.tga.gov.au/ ↩
11. 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 ↩
12. Australasian College of Dermatologists (ACD) (2025), Laser/RF/IPL clinical resources, viewed 22 October 2025, https://www.dermcoll.edu.au/ ↩
13. ISO (2025), ISO 14971: Medical devices – Application of risk management to medical devices, viewed 22 October 2025, https://www.iso.org/ ↩
14. IEC (2025), IEC 60601 series: Medical electrical equipment safety and essential performance, viewed 22 October 2025, https://www.iec.ch/ ↩
15. IEC (2025), IEC 62471: Photobiological safety of lamps and lamp systems, viewed 22 October 2025, https://www.iec.ch/ ↩
16. NSW Health (2025), Poisons & Therapeutic Goods – topical anaesthetics and medicines handling, viewed 22 October 2025, https://www.health.nsw.gov.au/pharmaceutical/Pages/default.aspx ↩
17. ACCC (2025), Australian Consumer Law – misleading or deceptive conduct in advertising, viewed 22 October 2025, https://www.accc.gov.au/ ↩