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Endoscope reprocessing

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OUR GOAL

To ensure the effectiveness of the procedure for reprocessing heat-sensitive endocavitary medical devices.

The health sector is governed by strict hygiene rules that are essential when it comes to guaranteeing patient safety.

With endoscopies, managing infection risks is a key priority Due to their complexity and sensitivity to temperature, flexible endoscopes must be handled in a specific way involving a number of steps.

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REGULATORY OBLIGATIONS

In order to ensure the quality of the reprocessing procedure, healthcare establishments are subject to certain obligations*

- A microbiological check on an endoscope identified as being at risk (at least) once a year
- A microbiological control of the rinsing water of endoscope washers once a quarter.
- Regular qualification of the endoscope washer and the drying/storage cabinet or validation of the endoscope conservation conditions.

These obligations fulfil the requirements of the regulatory texts and scientific recommendations in place to guarantee patient safety during their diagnosis and treatment.

Requirements

Annex IIB of the Royal Decree of 30 September 2020*

Standards

NF EN 16442
NF EN ISO 15883-4

Scientific recommendations

Avis (statement) 9446 from the CSS*

*benchmark used for work carried out in Belgium. Requirements and regulatory benchmarks are specific to each country and need to be adapted according to the standards in force for your establishment.

The 4 stages involved in reprocessing:

– Pre-processing in the examination room after use

– Manual cleaning

– Automatic cleaning and disinfection of the endoscope in the EWD (endoscope washer-disinfector)

– Drying and storage (in an SCHE storage cabinet or other type of storage solution)

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HeX’s EXPERTISE

HeX offers customised support and bespoke solutions to ensure compliance with, and respect for, the recommendations in place.

Auditing

Quality systems

Microbiological controls

EWD and SCHE Qualification and Monitoring

Staff training

Auditing

Document system

Microbiological controls

Management of instances of non-compliance & recommendations for corrective measures

Staff training

EWD and SCHE Qualification and Monitoring​

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