Instrument sterilization and traceability protocol

Hospital Infection Control

KEIT DAY HOSPITAL

Instrument sterilization and traceability protocol

Official Manual of Clinical, Care and Organizational Protocols

1. Document Control Information

2. Scope of Application

This protocol applies to surgical instruments, reusable instruments, procedural sets and devices requiring sterilization.

3. Responsibilities

• Sterilization unit personnel or dedicated area personnel: performance of sterilization cycles in accordance with the protocol.
• Scrub nurse and Operating Room Coordinator: verification of the availability of sterile sets before surgery.
• Medical Directorate: verification of compliance with the traceability system.

4. Operating Procedure

• Receive contaminated material in the dedicated area and immediately begin decontamination and cleaning according to the established procedure.
• Dry the instruments, inspect their integrity and assemble the sets in a standardized manner.
• Package the instruments using materials suitable for sterilization and storage.
• Perform the cycle in a validated and monitored autoclave, recording the required physical, chemical and biological parameters.
• Release sterile material only after verifying that the cycle result is compliant.
• Store sterile sets in a clean and protected area, ensuring proper rotation and full traceability.
• Treat as non-conforming any set for which there is uncertainty regarding integrity, date, packaging or processing.

5. KEIT Operational Standards

• KEIT uses autoclaves with cycle recording and documented traceability.
• Surgical sets are prepared and stored according to a clearly defined contaminated-to-clean workflow.
• Any non-conformities are documented and discussed during internal audits.

6. Records and Documentation

• Autoclave cycle register.
• Chemical and biological indicators.
• Traceability records for sterile sets.
• Non-conformity register.

7. Review and Updates

Periodic review including verification of autoclave qualification and process audits.

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