Medication & Equipment
KEIT DAY HOSPITAL
Anesthesia machine and medical device inspection protocol
Official Manual of Clinical, Care and Organizational Protocols
| Document Code | KEIT-SOP-14 | 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
Applicabile a macchine di anestesia, monitor multiparametrici, pompe infusionali, ventilatori, defibrillatori, aspiratori e altri dispositivi critici.
3. Responsibilities
- Anesthesiologist and anesthesia nurse: completion of the pre-use inspection before each case.
- Technical Service/Clinical Engineering: preventive maintenance, technical testing and traceability of interventions.
- Medical Directorate: verification of documentation compliance.
4. Operating Procedure
- Perform a pre-use inspection of the anesthesia machine before each case, including the breathing circuit, ventilation system, suction system, alarms, power supply, monitors and backup devices.
- Verify the availability and battery charge of portable devices and emergency equipment.
- Label and segregate any non-compliant or defective device, preventing its clinical use.
- Schedule preventive maintenance and periodic functional inspections by a qualified technician.
- Retain intervention reports, technical test certificates and the non-conformity register.
- Immediately activate the replacement plan when a critical device is unavailable.
5. KEIT Operational Standards
- KEIT performs scheduled periodic technical inspections, including monthly interventions by engineers from the supplier company to conduct a complete inspection of critical equipment.
- Pre-use checklists form part of the operating room safety pathway.
- Every malfunction or anomaly is recorded and managed before the device is returned to clinical use.
6. Records and Documentation
- Pre-use checklist.
- Maintenance and technical testing register.
- Malfunction and corrective action register.
7. Review and Updates
Review of the maintenance plan at least annually and immediately following any significant malfunction.
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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