Surgical Control
KEIT DAY HOSPITAL
Safety protocol for surgery involving implants and prostheses
Official Manual of Clinical, Care and Organizational Protocols
| Document Code | KEIT-SOP-09 | Version | 2.0 |
|---|---|---|---|
| Revision | 02 | Status | Official |
| Issue Date | 28/03/2026 | Next Review | 28/03/2027 |
| Prepared by | Medical Directorate / Quality | Approved by | |
| Signature and Date | Distribution | Controlled - Internal Use |
Purpose of the document. To officially define the scope, responsibilities, operating procedure, KEIT standards, records and protocol review criteria.
1. Document Control Information
| Application | All clinical, nursing, technical and organizational personnel involved in the described process. |
|---|---|
| Archiving | KEIT internal document management system and controlled copy in the relevant areas. |
| Review | At least annually or earlier in the event of regulatory, organizational or technological updates. |
2. Scope of Application
This protocol applies to all procedures involving the permanent or temporary implantation of prosthetic devices or biomaterials.
3. Responsibilities
- Operating surgeon: indication, device selection, technique and implant documentation.
- Scrub nurse and operating room nurse: verification of the batch number, integrity and sterile opening.
- Clinical Coordination: retention of traceability records and documents provided to the patient.
4. Operating Procedure
- Verify the type, brand, volume, side, batch number and integrity of the device before opening.
- Perform a dedicated implant time-out before introducing the device.
- Open the implant under sterile conditions and minimize exposure time and handling.
- Replace gloves and materials in accordance with the team protocol before final placement, when required.
- Document all implant identification data in the medical record and attach labels or traceability records.
- Provide the patient with the required documentation and follow-up instructions.
5. KEIT Operational Standards
- In breast augmentation pathways, KEIT requires strict control of prosthesis traceability and a change of sterile gloves before the final implant placement phase.
- Every implant procedure is subject to particular attention regarding antisepsis, reduced handling and batch documentation.
- Any additional technical decisions made by the team regarding pocket irrigation or implant management are documented in internal surgical protocols subject to periodic review.
6. Records and Documentation
- Implant/prosthesis traceability records.
- Implant time-out checklist.
- Information form provided to the patient.
7. Review and Updates
Update in the event of new evidence, market changes or device safety alerts.
Implementation Note
This document is an internal operational draft. Before final adoption, review by the Medical Directorate, Clinical Directorate, Legal Advisor and the relevant department managers is recommended.
This document is an internal operational draft. Before final adoption, review by the Medical Directorate, Clinical Directorate, Legal Advisor and the relevant department managers is recommended.
8. Related Attachments and Forms
- Operational checklists, recording forms, audit sheets and maintenance registers applicable to this protocol.
- Any department-specific or equipment-specific technical attachments are referenced in the relevant local operating instructions.
9. Final Approval
| Position | Name and Signature | Date |
|---|---|---|
| Medical Directorate |
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