Standards · Standard or regulation
HTM 01-06 / ISO 15883
Decontamination of flexible endoscopes, and washer-disinfector requirements
In plain words
What it covers.
HTM 01-06 is NHS guidance on managing and reprocessing flexible endoscopes: design of the decontamination unit, endoscope washer-disinfectors, drying cabinets, water quality and testing. ISO 15883 sets the performance and test requirements for washer-disinfectors, with Part 4 covering those for thermolabile endoscopes.
Who uses it: Decontamination leads, authorised engineers (decontamination), endoscopy units and clinical engineers.
A summary written by BMEssentia for learning, not the text of the standard. Always work from the current official edition and the manufacturer's instructions.
It covers
- Endoscope decontamination unit design
- Endoscope washer-disinfectors (EWDs)
- Water treatment and final rinse quality
- Storage and drying cabinets
- Periodic testing
- Traceability of endoscope to patient
Key points
What engineers need to know.
- Reprocessing runs one way: dirty to clean, with physical separation between them.
- Each endoscope must be traceable to each patient for look-back after a failure.
- Final rinse water quality is tested because bacteria in rinse water can recontaminate a clean scope.
- Washer-disinfectors need validation, then periodic tests as set out in ISO 15883.
- Channel blockage detection is essential: an unflushed channel is not disinfected.
- A failed cycle means the scope is not used and the look-back process starts.
Devices
Devices it applies to.
Each device in the Medical City Device Lab, with its Device Library course on the Platform.
Medical City
Where you practise it.
- Hospital Architect
- Room Builder
- Clinical Engineer Campaign
- Installation and Commissioning
- Hospital Operations Manager
- S1-M057 endoscopy suite
- S1-M094 decontamination failure
- S2-M023 and S2-M078 decontamination suite and validation