Standards › Standard 2B › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · EQP-SOP-002 · Version 1.1 · Approved by the ASF Expert Committee
Supports: 2B.10
At a glance
- Clean the endoscope at the point of use, before it dries, following the manufacturer’s instructions.
- Leak-test and disinfect (or sterilise) to the documented standard before each use.
- Store the endoscope dry and hanging, in a cabinet that protects it.
- Record each reprocessing cycle and test against the device ID.
- Do not use an endoscope that has not completed the full cycle.
- Stop and get help straight away if: a reprocessing step is missed, a leak test fails, or the record cannot be linked to the device and patient.
1. Purpose
To make sure each endoscope is cleaned, tested and reprocessed to a documented standard before every use, and that every use can be traced to the device and the cycle [EC].
2. Scope
| Applies to | Endoscopy and reprocessing staff, and all staff who handle endoscopes |
| Locations | Endoscopy suites, reprocessing rooms and storage at the facility |
| When | After every use, before every use, and during storage |
| Does not apply to | Non-endoscopic instruments, covered by the instrument reprocessing SOP (SOP-039) |
3. Definitions
| Term | Meaning |
|---|---|
| Endoscope | A flexible instrument used to look inside the body |
| Reprocessing | Cleaning, leak test, disinfection or sterilisation, drying and storage |
| Leak test | A test that checks the endoscope channels are not damaged |
4. Background
Endoscopes are complex to clean and have a documented risk of transmitting infection when reprocessing fails. Criterion 2B.10 asks for a documented standard and a record linking each use to its device and cycle. The generic procedure (SOP-030) is adapted here.
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Endoscopy lead | Owns the standard; approves products and staff; reviews records | Endoscopy competence |
| Reprocessing staff | Carry out each step; record each cycle | Trained and assessed |
| Infection prevention lead | Audits the process and advises on problems | Infection prevention |
| Biomedical engineer | Maintains and repairs endoscopes and washers | Biomedical engineering |
6. Materials and equipment
| Item | Requirement | Condition |
|---|---|---|
| Endoscope washer-disinfector or manual cleaning kit | As the manufacturer requires | Validated, serviced |
| Leak tester | Calibrated as the manufacturer sets | Working |
| Approved detergent and disinfectant | Per the product label and the standard | In date |
| Drying cabinet and storage cabinet | Clean, dry, ventilated | Working |
| Reprocessing log (EQP-REG-002) | Current | Available at the reprocessing room |
7. Safety
- Wear gloves, eye protection and a gown during manual cleaning.
- Keep the endoscope wet and cleaned until reprocessing starts. Do not let blood or tissue dry on it.
- Handle sharp or fragile parts with care.
8. Before you start
- Check the endoscope is recorded on the inventory and is due for use.
- Check the washer, leak tester and products are in date and working.
9. Procedure
Step 1. Pre-clean at the point of use.
- Wipe the insertion tube and flush the channels at the point of use, before the material dries.
- Record the time of use on the log.
Key point: Dried material is very hard to remove and can protect organisms.
Step 2. Transport to reprocessing.
- Transport the endoscope in a sealed, labelled container to the reprocessing room.
- Record the transfer.
Key point: Transport is a point where damage and contamination occur.
Step 3. Leak test.
- Carry out a leak test before cleaning, as the manufacturer requires.
- If the test fails, stop and take the endoscope out of use. Report to the endoscopy lead.
Key point: A leaking endoscope may carry contamination inside.
Step 4. Clean and disinfect.
- Clean the endoscope using the manual or automated method, following the manufacturer’s steps.
- Brush and flush all channels as set.
- Disinfect or sterilise to the level set by the standard, with the contact time on the label.
- Record the cycle, the product batch and the operator.
Key point: Each step is necessary. A missed channel can remain contaminated.
Step 5. Dry and store.
- Dry the channels with filtered air, then store the endoscope hanging in a clean cabinet.
- Do not store wet.
- Record the storage time.
Key point: Wet storage allows growth of organisms.
Step 6. Link the record to the device and the next use.
- Record the device ID, the cycle, the test result and the release for use on EQP-REG-002.
- Do not use an endoscope whose cycle record is missing or incomplete.
Key point: The link is what allows any patient exposed to be traced.
10. Decision points
- If a cycle is incomplete, repeat it. If the endoscope has been used without a complete cycle, the endoscopy lead decides on patient notification and follow-up (EC).
11. Special situations
| Situation | Action |
|---|---|
| Endoscope with a suspected fault or damage | Take out of use, label it, report to biomedical engineering. |
12. Escalation
- A failed leak test, a missed cycle, or an endoscope used without reprocessing is reported as an incident at once.
13. Monitoring
| Measure | Target | Frequency | Owner | If not met |
|---|---|---|---|---|
| Cycles recorded with device ID and test result | 100% | Weekly audit of 10 cycles | Endoscopy lead | Retrain; repeat audit within 7 days |
| Endoscopes used only after full cycle (audit) | 100% | Monthly | Infection prevention lead | Immediate review of the endoscope and the patients |
| Staff competence assessed | 100% | Yearly | Endoscopy lead | Retrain |
14. Records
| Record | Kept in | Retention |
|---|---|---|
| EQP-REG-002 Reprocessing and Test Log | Endoscopy file | the period set by the facility’s records policy years, or as the national rules require (EC) |
| Incident report (INC-POL-001) | Incident log | the period set by the facility’s records policy years |
15. Training
- Reprocessing staff are trained, and assessed by observation before working alone (EC).
- Annual refresher and reassessment (EC).
16. Related documents
| ID | Title | Use |
|---|---|---|
| EQP-REG-002 | Reprocessing and Test Log | Used in step 6 |
| SOP-030 | Endoscope Reprocessing Procedure (generic) | Basis for this standard |
| SOP-039 | Instrument Processing and Reprocessing Procedure (generic) | Other instruments |
| SOP-037 | Infection Prevention and Control Procedure (generic) | Hand hygiene after handling |
17. Evidence
| Reference | Note |
|---|---|
| E-009 | ASF Expert Committee consensus. Products, contact times, and sterilisation level must be confirmed against the endoscope manufacturer’s instructions and national infection prevention guidance before approval. |
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
References
- Accréditation Sans Frontières (2026). ASF Expert Committee consensus on Standard 1. (E-009)