Best-Practice Surgical Safety & Governance for Core Procedures

1. Purpose

This policy sets strict, Thailand-compliant standards for surgical safety, ethics and governance for all core procedures at Contour Clinic International Thailand: silicone semi-open rhinoplasty, upper blepharoplasty / double-eyelid surgery, chin augmentation (silicone implant) and less-invasive lower facelift (Korean-style technique). ^{1 7}

It translates duties under the Medical Facility Act B.E. 2541 and (No.4) B.E. 2559, the Medical Profession Act B.E. 2525, Medical Council ethics regulations, the Medical Devices Act, Thai FDA rules and the Personal Data Protection Act B.E. 2562 (PDPA), plus WHO “Safe Surgery” guidance, into clinic-level procedures that protect patients and licence holders. ^{1 2}

2. Scope

This policy applies to:

• All Thai-licensed surgeons engaged by Contour Clinic International for the above procedures. ^{2 3}
  – All anaesthesia providers, theatre nurses, scrub and circulating nurses, recovery staff and clinical support personnel involved in assessment, consent, surgery, post-operative care and follow-up. ^{2 9}
  – All Contour Clinic International locations in Bangkok and Pattaya. ^{1 11}

Injectables and non-surgical procedures are covered by separate policies and are not governed by this document.

3. Governance & Regulatory Alignment

All processes described in this policy must:

• Comply with the Medical Facility (Sanatorium) Act B.E. 2541 (1998) and (No.4) B.E. 2559 (2016), which govern private clinics and hospitals, including standards, licensing, inspections and advertising controls. ^{1 7}
• Comply with the Medical Profession Act B.E. 2525, which requires Medical Council registration and adherence to professional standards for anyone practising medicine in Thailand. ^{3 2}
• Follow the Medical Council Regulations on Medical Ethics Preservation B.E. 2549 (2006), including rules on indications, delegation, informed consent and prohibition of illegal practice. ^{2 7}
• Comply with the Medical Devices Act B.E. 2551 and (No.2) B.E. 2562 and Thai FDA rules on classification, import, registration, listing and traceability of silicone implants and other devices. ^{4 3}
• Comply with the PDPA B.E. 2562 and PDPA guidance for collection, storage, use and disclosure of health and image data, including rights of access, correction and withdrawal of consent. ^{5 6}
• Implement the WHO Guidelines for Safe Surgery 2009 and the WHO Surgical Safety Checklist implementation manual adapted to the Thai clinic setting. ^{8 9}

Where Contour Clinic internal standards are stricter than Thai minimum requirements, the stricter internal standard always applies. ^{2 8}

4. Core Safety Principles

1. No surgery is performed without a clear medical or anatomical indication, appropriate patient selection and documented risk–benefit assessment for that individual. ^{2 8}
2. Only Thai-licensed doctors practising within their credentialed scope of practice may assess, indicate, consent and perform these operations. ^{2 3}
3. Non-physicians and foreign non-licensed persons are strictly prohibited from practising medicine or surgery in any form, even “under supervision”. ^{2 3}
4. No procedure may exceed the licensed anaesthesia level or facility capabilities authorised under the Medical Facility Act and MOPH licence. ^{1 8}
5. If safety is uncertain for any reason (medical, psychological, facility, staffing or device issues), surgery is postponed or cancelled, and the reasoning is documented. ^{2 8}
6. All complications, near-misses and serious complaints are recorded, analysed and escalated through clinical-governance channels; falsification or concealment is a disciplinary matter and may be reportable to authorities. ^{1 7}

5. Pre-Operative Safety & Governance

5.1 Patient Assessment & Selection

Every surgical candidate must undergo a structured assessment that includes:

• Full medical history: medications, allergies, bleeding history, prior surgeries and implants, systemic disease, smoking/vaping and relevant family history. ^{8 11}
• Focused examination of nose, eyelids, chin and lower face, including skin quality, scarring and keloid tendency. ^{8 7}
• Screening for psychological red flags, unrealistic expectations and suspected body dysmorphic disorder using the clinic’s Patient Selection & BDD Policy, with referral or refusal when risk is high. ^{7 8}

Surgery is declined or deferred where there are absolute or major relative contraindications, such as unstable disease, uncontrolled psychiatric illness, obvious coercion or inability to comply with aftercare. ^{7 8}

5.2 Legal Age, Consent Capacity & Vulnerable Patients

• Age and identity must be verified using official documents before consent is accepted. ^{1 2}
• Minors and legally dependent patients are managed strictly in line with Thai law and Medical Council ethics; purely cosmetic procedures in minors require extreme caution and are usually refused unless clear medical or functional benefit exists. ^{2 3}
• Extra caution is required for very young adults pursuing major cosmetic change, for patients under strong social or relationship pressure, and for short-stay medical tourists with limited follow-up capacity. ^{7 11}

5.3 Informed Consent (Procedure-Specific)

The operating surgeon, not a salesperson, must personally obtain informed consent in Thai (with translation as needed). ^{2 7}

Consent discussions must:

• Explain the nature, purpose and limits of the planned surgery for that individual, including realistic outcomes and the option of no surgery. ^{2 8}
• Explain alternatives (e.g. cartilage graft, filler, no change) without disparaging other lawful techniques. ^{7 8}
• Describe material risks in plain language, including infection, scarring, need for revision, asymmetry, functional change and rare serious events, tailored to rhinoplasty, blepharoplasty, chin implant and lower facelift respectively. ^{8 11}
• Clarify expected recovery time, activity restrictions and support required after surgery. ^{8 11}

Surgeons must clearly document that no guarantee of cosmetic outcome was given, that before/after images are examples only, and that the patient was not pressured or offered improper inducements to consent. ^{2 7}

A cooling-off period between initial consent and surgery is strongly recommended, consistent with international ethical guidance for aesthetic surgery and Thai consumer-protection expectations. ^{7 8}

Consent forms must be procedure-specific, written, signed and dated by both patient and surgeon, with key risk phrases ideally written in the patient’s own handwriting. ^{2 7}

5.4 Pre-Operative Investigations & Optimisation

• Baseline clinical photographs are taken and stored under the PDPA-compliant imaging policy, with explicit separation between use for clinical care and any optional use for marketing or education. ^{5 13}
• Investigations (e.g. blood tests, ECG) are ordered based on age, co-morbidities and anaesthetic plan, and must be reviewed and documented before surgery proceeds. ^{8 9}
• Smoking and vaping cessation is strongly recommended; where risk is excessive, surgery may be deferred or refused. ^{8 10}
• Management of antiplatelet/anticoagulant drugs and other high-risk medications is documented in line with Thai prescribing standards and good surgical practice. ^{4 8}

5.5 Surgical Planning & Marking

• The operating surgeon performs planning and marking, ideally with the patient upright for nose, eyelid crease and chin vector planning. ^{8 2}
• Any pre-existing asymmetry, anatomical constraint or limitation of achievable change is explained and documented before the day of surgery. ^{7 8}

6. Intra-Operative Safety & Theatre Governance

6.1 Theatre & Facility Standards

• The clinic must meet the infrastructure and staffing requirements for a licensed medical facility under the Medical Facility Act and relevant MOPH ministerial regulations. ^{1 14}
• Licences and nameplates are displayed as required, and inspections or audits by the Department of Health Service Support are fully supported. ^{1 2}
• Sterilisation systems (autoclaves, instrument tracking, surface disinfection) follow national infection-control norms and are logged for inspection. ^{8 9}

6.2 Time-Out & Verification

For every case, a documented surgical time-out is completed before the first incision to confirm:

• Patient identity, procedure and site/side;
• Relevant allergies and key risks;
• Anaesthetic plan and monitoring;
• Implants/devices (type, size, side, lot numbers present and checked).

The time-out is based on the WHO Surgical Safety Checklist, locally adapted to Contour Clinic workflows. ^{8 9}

If any critical discrepancy is found, surgery is delayed until resolved. ^{8 9}

6.3 Anaesthesia & Monitoring

• The type and depth of anaesthesia (local, local with minimal or moderate sedation) must never exceed what is allowed under the clinic’s Health Facility Act licence. ^{1 14}
• General anaesthesia and deep sedation requiring airway control are not performed in the clinic and must only occur in a hospital-level facility with full critical-care capability. ^{1 8}
• Sedation may only be given by, or under direct supervision of, trained personnel who meet Thai professional and regulatory requirements for office-based sedation, with continuous monitoring of SpO2, heart rate, blood pressure and respiratory status. ^{8 9}
• IV access, oxygen, suction and emergency drugs must be present and checked before each list, with documented equipment checks. ^{8 9}
• A written escalation and transfer pathway to a designated hospital is maintained and drilled for emergencies beyond the clinic’s capability. ^{1 8}

6.4 Aseptic Technique & Implant Handling

• Hand hygiene, PPE, sterile field and environmental cleaning follow clinic infection-control SOPs aligned with Thai facility standards. ^{1 2}
• All silicone implants and other devices used in surgery must be appropriately classified and authorised under the Medical Devices Act and Thai FDA rules, in intact, in-date packaging. ^{4 3}
• Implants are opened immediately before use onto a sterile field and are never reused. ^{4 8}
• Implant details (manufacturer, model, size, batch/lot, side, date) are recorded in the Implant Registry and in the patient’s record. ^{4 8}

Thai enforcement actions against illegal implants and drugs illustrate that using unregistered devices can attract criminal penalties and licence sanctions, so strict compliance is mandatory. ^{4 7}

6.5 Operative Conduct (High-Level)

This policy intentionally avoids surgical “how-to” detail; surgeons must follow formal training, peer-reviewed techniques and internal procedure-specific SOPs. ^{2 8}

Core expectations are:

• Operative time is reasonable for the facility level and anaesthetic technique. ^{8 9}
• Haemostasis is maintained and blood loss is minimised. ^{8 9}
• Critical structures are protected and tissues handled gently. ^{8 9}
• If safety or conditions become unacceptable (e.g. bleeding, equipment failure, airway concern), the surgeon must pause, correct or, if necessary, terminate the procedure early and arrange staged or revision care. ^{8 10}

6.6 Intra-Operative Documentation

Immediately after surgery, the surgeon documents:

• The procedure actually performed and any deviation from the original plan. ^{2 8}
• Any intra-operative complications or concerns. ^{8 10}
• Implants used with batch/lot numbers. ^{4 8}
• Any unplanned admission, transfer or extended observation. ^{1 8}

Nursing records include instrument and swab counts, key times and critical events. ^{9 10}

7. Post-Operative Safety & Early Recovery

7.1 Immediate Recovery

• All patients are monitored in a recovery area until discharge criteria are met (stable vital signs, adequate consciousness, controlled pain, safe mobilisation, no uncontrolled bleeding). ^{8 9}
• Staff monitor for bleeding/haematoma, airway compromise, excessive pain, nausea, dizziness and allergic reactions. ^{8 9}
• Any deterioration is escalated promptly to the surgeon and, if indicated, to hospital-level care via the documented transfer pathway. ^{1 8}

7.2 Discharge Instructions

Before discharge, the patient (and carer, if present) receives structured verbal and written instructions covering:

• Wound and dressing care. ^{8 9}
• Medication regimen and side-effects. ^{8 9}
• Expected course of swelling, bruising and discomfort versus warning signs. ^{8 10}
• Clear red-flag symptoms that require immediate contact or emergency review (e.g. sudden swelling, vision change, breathing difficulty, uncontrolled pain, fever). ^{8 10}

Instructions are provided in Thai (and other languages as necessary) and include a 24/7 contact pathway for urgent concerns. ^{5 11}

7.3 Medical Tourists & Travel Safety

For patients travelling from other provinces or overseas:

• Minimum recommended local stay periods are defined for each procedure category (e.g. rhinoplasty/eyelid vs facelift), and documented in the consent and discharge summaries. ^{8 11}
• Written advice is given on timing of flights and long-distance travel relative to surgery, considering thrombosis risk and access to review. ^{8 10}
• Where appropriate, telehealth follow-up or liaison with a local doctor is arranged and documented. ^{8 11}

8. Follow-Up, Long-Term Safety & Complication Management

8.1 Standard Follow-Up Schedule

Unless medically justified otherwise, typical follow-up includes review at 24–48 hours, 1 week, 1 month, 3 months, 6 months and 12 months after surgery. ^{8 9}

Each visit assesses wound healing, infection, function (breathing, eyelid closure, oral function, facial expression), contour, scars, and patient psychological adjustment. ^{8 11}

8.2 Complications, Revisions & Incident Reporting

• All complications (including infection, extrusion, haematoma, nerve symptoms, major scarring or serious dissatisfaction) are recorded in the Adverse Events & Complications Register. ^{1 8}
• Patients are given an honest explanation and a documented management plan; revisions are considered based on clinical indication and safety, not promised automatically. ^{7 12}
• Significant or systemic problems (e.g. repeated complications, probable negligence, device failures) are reviewed through clinical-governance meetings and may be reportable to the Medical Council, MOPH or other agencies where legally required. ^{1 2}

8.3 Data, Imaging & PDPA Compliance

• Clinical records, photos and videos are treated as personal data, and images relating to health and facial identity are treated as sensitive personal data under PDPA and Thai privacy guidance. ^{5 6}
• Access is restricted to authorised staff only, using appropriate technical and organisational safeguards. ^{5 6}
• Separate, explicit written consent is required for any use of images outside direct clinical care (teaching, marketing, social media); withdrawal of this consent is respected, documented and does not affect access to care. ^{5 13}
• Patients may request access to, or correction of, their personal data and images, and these requests are handled under PDPA timelines and procedures. ^{5 6}

9. Roles & Responsibilities

9.1 Surgeons

• Hold valid Thai medical licence and, where relevant, recognised specialist qualifications. ^{2 3}
• Work strictly within their documented credentialed scope for rhinoplasty, blepharoplasty, chin implants and lower facelift. ^{2 7}
• Personally perform core elements: assessment, indication, consent, surgical planning, surgery, early follow-up and major complication reviews. ^{2 8}
• Participate in governance activities including audit, morbidity and mortality review and policy updates. ^{2 8}

9.2 Anaesthesia Providers

• Comply with Thai regulations and professional standards for sedation and anaesthesia in outpatient facilities. ^{1 2}
• Ensure safe sedation, monitoring and recovery according to this policy and WHO safe-surgery principles. ^{8 9}
• Escalate promptly to hospital-level care when needed. ^{1 8}

9.3 Nursing & Theatre Staff

• Enforce infection-control and aseptic technique standards consistently. ^{1 8}
• Conduct and document safety checks, including time-out, instrument and swab counts, equipment checks and recovery observations. ^{8 9}
• Maintain accurate, contemporaneous nursing documentation. ^{2 9}

9.4 Management & Governance Team

• Maintain all required licences, permits, Thai FDA registrations, insurances and policy documentation. ^{1 4}
• Oversee credentialing and re-credentialing of clinical staff according to Thai law and internal standards. ^{2 3}
• Conduct regular audits of complication rates, infection rates, documentation quality, PDPA compliance and advertising compliance. ^{1 7}
• Ensure policies and procedures are updated when Thai law, Medical Council guidance or WHO safe-surgery recommendations change. ^{2 8}

10. Quality Assurance, Audit & Review

• Quarterly reviews analyse surgical volumes, complication rates, infection rates, unscheduled transfers and revision rates for each procedure type. ^{8 10}
• Annual reviews confirm alignment with Thai law, PDPA and ethical expectations for aesthetic clinics and for Thailand’s role in medical tourism. ^{1 8}
• Findings from audits are used to revise SOPs, improve patient information materials, and design staff training and competency assessments. ^{8 9}

11. Record-Keeping & Legal Defence

• All clinical notes, consent forms, photos and implant records must be legible, accurate and retained for at least the minimum legal period under Thai law, or longer if internal policy requires. ^{1 5}
• In any complaint or legal claim, well-kept records demonstrating adherence to Thai law, Medical Council ethics and WHO safe-surgery principles are critical for fair assessment and defence. ^{2 8}
• Records of adverse events, corrective actions and communications with patients are preserved as part of the clinic’s governance archive. ^{2 12}

12. Complaints & External Escalation

• Patients are informed that, in addition to the clinic’s internal complaint-handling process, they may file complaints with the Department of Health Service Support (MOPH), the Medical Council of Thailand, the Office of the Consumer Protection Board or the courts if they believe standards were breached. ^{1 12}
• The clinic cooperates fully with lawful investigations and uses any findings to improve systems, not to retaliate against complainants or staff who raise safety concerns. ^{2 7}

13. Legal Disclaimer

This policy is an internal clinical-governance document summarising key Thai legal and ethical requirements as at the date of approval; it is not legal advice, and Contour Clinic International must obtain independent Thai legal review before relying on it for regulatory, contractual or medico-legal decisions. ^{1 2}

If Thai laws, regulations or professional standards change, the policy must be updated promptly and not relied on in its outdated form. ^{5 6}

14. Version Control

• Policy Title: Best-Practice Surgical Safety & Governance for Core Procedures
• Organisation: Contour Clinic International — Thailand (Bangkok & Pattaya)
• Version: ².0 (Thai Governance–Enhanced Edition)
• Prepared by: Governance & Compliance Division
• Approved by: Designated Thai-licensed Surgeon (Clinical Governance Lead)
• Review Date: ¹² months from approval, or earlier if Thai law or PDPA/Medical Device standards change.

Sources

1. Tilleke & Gibbins 2018, ‘Advertisements for Medical Facilities Now Require Preapproval in Thailand’, analysis of amendments to the Medical Facility Act B.E. 2541 (1998) and (No.4) B.E. 2559 (2016), including Section 38 on clinic advertising, viewed 28 November 2025, https://www.tilleke.com/insights/advertisements-for-medical-facilities-now-require-preapproval-in-thailand/ ↩
2. ClinRegs (NIAID) 2024, ‘Thailand – Medical Council Regulations on the Maintenance of Medical Profession Ethics (B.E. 2549)’ and related regulatory summary, viewed 28 November 2025, https://clinregs.niaid.nih.gov/country/thailand ↩
3. Mahidol University Siriraj IRB 2022, Standard Operating Procedures (SOPs) citing the Thai Medical Profession Act B.E. 2525 and Medical Council Ethics Regulations B.E. 2549, viewed 28 November 2025, https://www.si.mahidol.ac.th/irb/files/SIRB_SOP_2022.pdf ↩
4. Thai FDA / Medical Device Control Division, Enforcement material and commentary on the Thai Medical Devices Act B.E. 2551 and (No.2) 2562 – device registration, listing and enforcement, viewed 28 November 2025, https://www.fda.moph.go.th/sites/medicaldevice/SitePages/Regulation.aspx ↩
5. Open Development Mekong / Government Gazette, Personal Data Protection Act B.E. 2562 (2019), official English translation, viewed 28 November 2025, https://data.opendevelopmentmekong.net/dataset/personal-data-protection-act-be-2562 ↩
6. DLA Piper 2022, ‘Overview of Thailand Personal Data Protection Act B.E. 2562 (2019)’; DLA Piper Data Protection Handbook, viewed 28 November 2025, https://www.dlapiperdataprotection.com/index.html?t=law&c=TH ↩
7. Saenkam, T & Nuchprayool, B 2018, ‘Legal Measures on Regulating Beauty Clinics Business Operation’, Naresuan University Law Journal, viewed 28 November 2025, https://so01.tci-thaijo.org/index.php/nuulawjournal/article/view/165250 ↩
8. Gopalan, N 2023, ‘Ethical and Regulatory Gaps in Aesthetic Medical Practice in Top Asian Medical Tourism Destinations’, Asian Bioethics Review, viewed 28 November 2025, https://doi.org/10.1007/s41649-022-00232-3 ↩
9. World Health Organization 2009, WHO Guidelines for Safe Surgery 2009: Safe Surgery Saves Lives, viewed 28 November 2025, https://www.who.int/publications/i/item/9789241598552 ↩
10. World Health Organization 2009, Implementation Manual: WHO Surgical Safety Checklist 2009, viewed 28 November 2025, https://www.who.int/publications/i/item/9789241598590 ↩
11. International Trade Administration (U.S. Department of Commerce) 2024, ‘Thailand Aesthetics Medicine’, viewed 28 November 2025, https://www.trade.gov/market-intelligence/thailand-aesthetics-medicine ↩
12. Wongsakornsiri Law Office 2025, ‘When Facial Surgery Goes Wrong: How to Claim Compensation?’, viewed 28 November 2025, https://wongsakornsirilaw.com/when-facial-surgery-goes-wrong/ ↩
13. Global Law Experts 2025, ‘PDPA: Personal Data in Medical Certificates Defined by the Medical Council’, viewed 28 November 2025, https://www.globallawexperts.com/NewsArticle.aspx?PID=4011 ↩
14. Benoit & Partners 2025, ‘Open a Medical Clinic in Thailand: Legal Guide for Investors’, viewed 28 November 2025, https://www.benoit-partners.com/open-a-medical-clinic-in-thailand/ ↩