Standards › Standard 2B › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · EQP-SOP-001 · Version 1.1 · Approved by the ASF Expert Committee
Supports: 2B.4
At a glance
- List every clinical device on the inventory, with its last service date and next due date.
- Service each device on the schedule, and record it.
- When a device is faulty, label it “out of use”, remove it, and report it.
- Do not return a faulty device to use until it is repaired and tested.
- Review the schedule every quarter.
- Stop and get help straight away if: a faulty device is in use on a patient, or a device is past its service date and still in use with no approved reason.
1. Purpose
To keep every clinical device safe and working through a planned maintenance programme, and to remove faulty equipment from use until it is repaired [EC].
2. Scope
| Applies to | Clinical engineering, biomedical staff, clinical users and the facilities team |
| Locations | All clinical areas at the facility |
| When | On the schedule, on any fault, and after any repair or incident involving equipment |
| Does not apply to | Non-clinical equipment such as office equipment, covered by the facilities plan |
3. Definitions
| Term | Meaning |
|---|---|
| Clinical device | Any device used in patient care, diagnosis or monitoring |
| Planned maintenance | Checks and servicing done on a set schedule by the manufacturer, approved contractor or trained engineer |
| Out-of-use tag | A tag attached to a faulty device that prevents use until released |
4. Background
Faulty equipment is one of the most avoidable causes of patient harm in hospitals. Criterion 2B.4 requires a schedule covering all clinical equipment and removal of faulty equipment from use, not keeping it in service while it waits for repair.
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Biomedical or clinical engineering lead | Owns the inventory and the schedule; releases repaired equipment | Biomedical engineering |
| Ward or department head | Checks equipment before use; reports faults at once; keeps the device out of use | Trained in equipment use |
| Users | Check the device before use; report faults; do not use a tagged device | Induction and device training |
| Procurement lead | Ensures new equipment comes with service information and a service contract where needed | Procurement |
6. Materials and equipment
| Item | Requirement | Condition |
|---|---|---|
| Equipment inventory (EQP-REG-001) | Every clinical device listed | Current |
| Out-of-use tags (EQP-FRM-001) | Printed, in stock | Available in each area |
| Test equipment | Calibrated as required by the manufacturer | In date |
7. Safety
- Never use a device with an out-of-use tag, even if it seems to work.
- Never remove the tag yourself. Only the authorised engineer releases a device.
- Follow the manufacturer’s safety instructions when servicing.
8. Before you start
- Check the device is clean and has its inventory number.
- Check the device’s next service date.
9. Procedure
Step 1. Build the inventory.
- List every clinical device with its name, model, serial number, location, owner, last service and next service due.
- Check the inventory every quarter against the devices in use.
Key point: A device not on the inventory is never serviced.
Step 2. Service on schedule.
- Carry out maintenance at the interval set by the manufacturer or the committee (EC).
- Use a qualified or approved engineer.
- Record the service on EQP-REG-001 with the date, engineer and result.
Key point: The service record proves the device was checked, not just that it was supposed to be.
Step 3. Check before each use.
- The user checks the device is clean, undamaged, and within its service date.
- Test the device as the manufacturer requires for daily checks.
Key point: Daily checks catch faults that the scheduled service will miss.
Step 4. Remove faulty equipment from use.
- When a device is faulty, stop using it at once.
- Attach an out-of-use tag (EQP-FRM-001) that states the fault, the date and the user’s name.
- Move it to the store for repair, out of the clinical area.
- Report to the engineering lead the same shift.
Key point: A tagged device cannot be used by mistake. A device left in place can be.
Step 5. Repair, test and release.
- The engineer repairs the device and tests it.
- Only the engineer releases the device by removing the tag and recording the release on EQP-REG-001.
- If the device cannot be repaired, withdraw it and record the disposal.
Key point: Release is a controlled step. Repair alone is not enough.
Step 6. Review the schedule quarterly.
- Review overdue services, repeated faults and equipment ages.
- Set actions for devices with repeated faults, including replacement.
Key point: Repeated faults show a device or a process that needs changing.
10. Decision points
- If a device is found in use with a fault, the engineer and the ward head review all patients treated with it in the last period and decide on further action (EC).
11. Special situations
| Situation | Action |
|---|---|
| Emergency device needed | Use the nearest working equivalent. Inform the engineering lead and record the substitution. |
12. Escalation
- Faults causing patient harm are reported as incidents at once (INC-POL-001).
- Overdue services for life-critical devices are escalated to the chief executive.
13. Monitoring
| Measure | Target | Frequency | Owner | If not met |
|---|---|---|---|---|
| Clinical devices in inventory with a service date | 100% | Quarterly | Engineering lead | Add to inventory within 7 days |
| Services completed by due date | 95% (EC) | Monthly | Engineering lead | Escalate to chief executive |
| Faulty devices removed from use the same shift | 100% | Each event | Ward or department head | Review of the event |
14. Records
| Record | Kept in | Retention |
|---|---|---|
| EQP-REG-001 Equipment Inventory and Service Log | Engineering file | Life of the device plus the period set by the facility’s records policy years |
| EQP-FRM-001 Out-of-Use Tag record | Engineering file | the period set by the facility’s records policy years |
15. Training
- Users are trained on each device before use, and on daily checks (EC).
- Engineers are trained and approved for each device type.
16. Related documents
| ID | Title | Use |
|---|---|---|
| EQP-REG-001 | Equipment Inventory and Service Log | Used in steps 1 to 3 |
| EQP-FRM-001 | Out-of-Use Tag | Used in step 4 |
| FAC-REG-001 | Integrated Facility Risk Register | Equipment risks are recorded there |
| SOP-031 | Equipment Malfunction Procedure (generic) | Malfunction response |
17. Evidence
| Reference | Note |
|---|---|
| E-009 | ASF Expert Committee consensus. Service intervals must follow each manufacturer’s instructions; the committee sets the review rules. |
18. Change history
| Version | Date | What changed | Approval |
|---|---|---|---|
| 1.0 | the date of approval | First version | Approved by the ASF Expert Committee |
| 1.1 | the date of approval | Internal quality review: corrected cross-references, status wording and document control | Approved by the ASF Expert Committee |
E-learning for this document
- Environment & Shared Spaces (H-03)
- Electrical Safety & Appliance Inspection (ELEC-01)
References
- Accréditation Sans Frontières (2026). ASF Expert Committee consensus on Standard 1. (E-009)