Validation for disinfection of endoscopes
Flexible endoscopes are increasingly offering more technical capabilities. As a result, they are becoming more complex, making it increasingly difficult to clean and disinfect them. Manual disinfection is no longer accepted; machine cleaning is the recommended method. And this requires a controlled process.
THE ADDED VALUE OF VALIDATION
To meet current standards, hospitals must demonstrate that the entire process, from one patient to the next, is under control. The person responsible for disinfection must be able to demonstrate the correct operation of both the endoscope disinfector and the drying or storage cabinet. This ensures that the endoscopes are always properly cleaned and disinfected.
To determine the efficiency of these devices, a specific validation program is necessary. Endoscopes differ significantly in use and composition from traditional instruments. Agidens provides a tailored solution.
- Through validation, you gain insight into what actually happens inside the device. If desired, process improvements can be implemented.
- With a brand-independent execution, every defect is noticed.
- We check if your endoscope disinfector complies with all applicable standards (ISO 15883-1/4/5) and guidelines (SFERD, HGR, …).
- We check if your drying and storage cabinet meets the applicable standards (NEN-EN ISO 16442).
- Our validation report is your documented proof and adds value during audits. It demonstrates that the entire process is under control.
WHAT TO CHECK?
Drying Cabinet (ISO 15883)
- Temperature and pressure profile of the process
- Measurement of the dosed detergent/disinfectant
- Verification of registration of blocked/not connected channels
- Demonstration of complete cleaning (cleaning indicators)
- Demonstration of disinfection (bio-indicators, contaminated with E. faecium)
- Proper functioning of the device’s self-disinfection (chemical/thermal)
- Conducted tests depending on the brand & type of device
Scope Disinfector (EN 16442)
- Microbial quality of drying cabinet walls
- Airflow and particle count control
- Scope leakage check
- Verification of registration of unconnected channels
- Temperature and pressure profile during drying cycle
- Complete installation qualification of the device
- Checking the presence of documentation and daily use
TAILOR-MADE SOLUTION
Each project requires a specific approach. Therefore, we tailor our validation and qualification projects to the needs and requirements of our clients. We consider the equipment to be validated, urgency, applicable procedures, occupancy rate of the department and specific use of the devices.
Contact us for more information
Agidens has over 25 years of experience in validation & compliance and is a well-known name in the hospital world. Our clients trust us because of our expertise and ‘no nonsense’ approach, and with reliable service, we are a long-term partner.
