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Silicone Rhinoplasty (Semi‑Open Technique) Policy & Procedure

1. Mục đích

To standardise safe, ethical, and legally compliant performance of silicone rhinoplasty using a semi‑open technique at Contour Clinic Thailand (Bangkok & Pattaya), ensuring patient safety, device traceability, and compliance with Thai regulations for medical facilities, medical devices, data protection, and professional conduct.1 2 3 4 5 6

2. Phạm vi

This policy applies to all surgical team members performing or assisting rhinoplasty in Contour Clinic operating suites, pre‑ and post‑operative rooms, and administrative staff handling patient data, device logistics, and marketing content in Thailand.

3. Definitions

  • Silicone implant: Pre‑formed medical‑grade silicone nasal implant (e.g., Korean or US manufacturers) supplied under Thai FDA regulations (1,4,5).
  • Semi‑open technique: Marginal incisions with limited columellar access allowing controlled dorsal augmentation and tip work without full open exposure.
  • UDI/traceability: Unique Device Identification or equivalent batch/lot tracking to enable recall, vigilance, and post‑market surveillance (4,5).
  • PDPA: Thailand Personal Data Protection Act B.E. 2562 governing patient personal data handling (2,6).

4. Governance & Legal Basis (Thailand)

  1. Medical Devices & Implants. Importers and manufacturers must be licensed and devices registered with the Thai FDA; establishments must hold appropriate licences under the Thai FDA’s medical device framework and ASEAN‑aligned classification (1,4,5).
  2. Medical Facilities. Clinics must operate under the Medical Facility Act B.E. 2541 (1998) (licensing, facility standards, inspections) (3,7,8,9).7 8 9
  3. Personal Data Protection. Processing of patient data, images, and marketing use of before/after photos must comply with PDPA B.E. 2562 and subordinate regulations (2,6,10).10
  4. Professional Conduct & Advertising. The Medical Council of Thailand restricts promotional claims and endorsements; violations (e.g., “on‑sign doctors”) are sanctioned (11,12,13).11 12 13

5. Roles & Responsibilities

  • Lead Surgeon: Case selection, consent, technique, intra‑op decisions, adverse‑event leadership, documentation.
  • Scrub Nurse/Tech: Instrument counts, sterile setup, implant handling and log, specimens/photographs as ordered.
  • Circulating Nurse: WHO‑style timeout, implant sticker capture, incident reporting, device quarantine if defect suspected.
  • Clinic Manager: Licence upkeep, supplier due‑diligence (Thai FDA status), PDPA compliance, staff training records, auditing.

6. Pre‑operative Assessment

  • Full medical history, nasal exam, airway assessment; photography (standardised views) with PDPA consent for care and optional marketing.
  • Risk discussion: infection, extrusion, deviation, tip necrosis, hematoma, scarring, dissatisfaction, revision; alternatives (autologous cartilage, no surgery).
  • Smoking cessation ≥ 4 weeks; control acne/skin infections; anticoagulant management per risk.
  • Indications/contraindications recorded; expectations and cultural/aesthetic preferences discussed and documented.

English (clinical consent)

  • Procedure: silicone dorsal augmentation with tip refinement via semi‑open approach; possible intra‑op conversion to open.
  • Material: medical‑grade silicone implant; brand/model/size logged; alternatives explained.
  • Specific risks: infection, extrusion, skin compromise, implant malposition, dorsal irregularity, need for revision.
  • Anaesthesia: local with sedation or general; risks outlined.
  • Photography: consent for clinical record; separate explicit consent for marketing publication; right to withdraw (PDPA) noted.

ภาษาไทย (หนังสือยินยอม)

  • การผ่าตัดเสริมจมูกด้วยซิลิโคนแบบแผลกึ่งเปิด อาจเปลี่ยนเป็นแผลเปิดได้ตามดุลยพินิจแพทย์
  • วัสดุ: ซิลิโคนทางการแพทย์ ระบุยี่ห้อ/รุ่น/ขนาด บันทึกในเวชระเบียน อธิบายทางเลือกอื่น
  • ความเสี่ยงเฉพาะ: ติดเชื้อ ดันออก ผิวหนังบางหรือเนื้อตาย เบี้ยว ต้องแก้ไข
  • ยาชา/ดมยาสลบ: อธิบายความเสี่ยงและการดูแล
  • รูปถ่าย: ใช้เพื่อการรักษาเท่านั้น ส่วนการโฆษณา/สื่อสังคม ต้องได้รับความยินยอมแยกต่างหากตาม PDPA

8. Implant Selection & Traceability

  • Only procure implants from Thai FDA‑licensed suppliers. Keep copies/screenshots of supplier licence and device registration (Thai FDA portal) in the vendor file (1).
  • Verify packaging integrity, lot/batch, and sterilisation indicators on receipt; quarantine if compromised.
  • Intra‑op: capture implant labels/UDI and affix sticker to the operative record; record brand, model, size, lot, and exp. date (4,5).
  • Maintain an Implant Register mapped to patient MRN to enable recalls and vigilance reporting.

9. Asepsis, Sterilisation & Theatre Safety

  • Clinic licensure and OR set‑up must meet Medical Facility Act standards; log routine environmental cleaning, steriliser cycles, BI tests (7,8,9).
  • WHO‑style surgical safety checklist and Site‑Marking/Time‑Out mandatory.
  • Antibiotic policy: single pre‑incision dose as per local protocol; further antibiotics only by indication.

10. Procedure — Semi‑Open Rhinoplasty

  1. Marking in upright position (radix, dorsum, tip, columella; planned pocket).
  2. Prep & drape; local infiltration with vasoconstrictor as per protocol.
  3. Marginal incisions; limited columellar step for exposure; sub‑SMAS/supraperichondrial pocket creation along dorsal profile.
  4. Precise pocket dissection on midline; meticulous haemostasis; irrigate with antibiotic solution per protocol.
  5. Implant trimming in sterile field; bevel edges; trial sit → final placement avoiding tension or over‑projection.
  6. Tip refinement (suturing, shield, or grafts if indicated); ensure straight alignment and skin envelope viability.
  7. Layered closure; steri‑strips/splint as required; nasal packing only if indicated.

11. Intra‑operative Risk Controls

  • Continuous assessment of skin flap perfusion; avoid excessive tip pressure.
  • If contamination suspected, switch to new implant; document and quarantine compromised device for vendor report.
  • Convert to open approach if visualisation inadequate or complications arise (document rationale).

12. Post‑operative Care & Follow‑up

  • Head elevation, cold compresses (first 48 hrs), avoid glasses/pressure for 4–6 weeks.
  • Red‑flag instructions: fever, escalating pain, drainage, skin colour change, implant visibility.
  • Follow‑up: 1–3 days (wound check), 7–10 days (suture/splint), 1 month, 3–6 months, 12 months.
  • Record PROMs/patient satisfaction and any adverse events into the Implant Register.

13. Complications & Escalation

  • Infection/Exposure: early antibiotics, consider implant removal if pocket compromised; culture and staged revision.
  • Deviation/Malposition: assess pocket; revision after maturation unless acute compromise.
  • Skin Compromise: urgent decompression, wound care, consider implant removal.
  • Serious incidents reported internally and to authorities per Thai device vigilance rules (4,5).

14. Documentation, Record Retention & Privacy

  • Maintain comprehensive operative notes, implant stickers, consent forms (EN/TH), photos, and follow‑up entries.
  • Store and process personal data under PDPA principles (lawful basis, purpose limitation, minimisation, security, retention & deletion policy) (2,6,10).
  • Marketing use of images requires separate explicit consent; provide withdrawal mechanism and log revocations.

15. Ethical Advertising & Public Claims

  • All public content (web, social, influencers) must avoid prohibited claims, misleading before/after, or use of non‑working “on‑sign” doctors (11–13).
  • Use educational tone; avoid superlatives and guarantees; disclose typical recovery and risks.

16. Training, CPD & Credentialing

  • Surgeons: documented training and case log in silicone rhinoplasty; annual CPD relevant to ENT/Plastics/Aesthetic Surgery.
  • Staff: annual training on PDPA, device traceability, sterilisation, and adverse‑event reporting.

Nguồn

  1. Thai FDA (n.d.) Further steps for manufacturing or importing a medical device for commercial purposes in Thailand. Food and Drug Administration, Ministry of Public Health. Available at: https://en.fda.moph.go.th/…/manufacture-import-commercialpurposes/. ↩︎
  2. Office of the Personal Data Protection Committee (2019) Personal Data Protection Act, B.E. 2562 (2019). Ministry of Digital Economy and Society. English version available at: https://mdes.go.th/…/PDPA. ↩︎
  3. Lexology (2024) ‘Thailand’s Healthcare Regulations: Key licences for hospitals and clinics’, Lexology, 11 months prior. Available at: https://www.lexology.com/…. ↩︎
  4. Asia Actual (n.d.) ‘Thailand Medical Device Registration and Approval’, Asia Actual. Available at: https://asiaactual.com/…. ↩︎
  5. Emerhub (2025) ‘Medical Device Registration in Thailand Explained’. Available at: https://emerhub.com/…. ↩︎
  6. Open Development Mekong (2019) ‘Personal Data Protection Act B.E. 2562 (English translation)’. Available at: https://…/entranslation_of_the_personal_data_protection_act_0.pdf. ↩︎
  7. LawLove (n.d.) ‘Medical Facilities Act of Thailand (1998) — unofficial translation’. Available at: https://www.lawlove.org/…. ↩︎
  8. Benoit Partners (2025) ‘Open a Medical Clinic in Thailand: Legal guide for investors’. Available at: https://benoit-partners.com/…. ↩︎
  9. Ministry of Public Health (n.d.) Official portal. Available at: https://moph.go.th/. ↩︎
  10. Norton Rose Fulbright (2022) ‘Overview of Thailand PDPA B.E. 2562 (2019)’. Available at: https://www.nortonrosefulbright.com/…. ↩︎
  11. Bangkok Post (2025) ‘Medical council warns “on sign” doctors’. Available at: https://www.bangkokpost.com/…. ↩︎
  12. The Thaiger (2024) ‘Ads for cosmetic procedures by medical professionals banned’. Available at: https://thethaiger.com/…. ↩︎
  13. ThaiTimes (2025) ‘Thailand’s Medical Council warns against misuse of doctor endorsements’. Available at: https://thaitimes.com/…. ↩︎

Thông tin tác giả

Contour Clinics Thailand InternationalGovernance & Compliance Division