Validation of Endoscopes

Home Life Sciences Validation & Compliance Validation for desinfection of endoscopes and dry cabinets

Validation for desinfection of endoscopes and dry cabinets

Flexible endoscopes offer many technical possibilities, making it increasingly complicated to clean and disinfect them. Mechanical cleaning is the recommended method, but requires a controlled process.

In order to meet all of the requirements from the JCI or NIAZ-accreditation, it is required to be able to demonstrate that all hospital devices, that are part of a disinfection or sterilization process, work properly. Since the devices in the department endoscopy are entitled to a disinfected scoop, they should be validated. Validation ensures correctly cleaned and disinfected endoscopes. In addition, it assures that the scopes can be dried and stored.

A specific validation program is necessary to determine the efficiency of these devices. After all, endoscopes differ fundamentally from traditional instruments in terms of both use and composition.

What should be checked?

The validation of your scopes disinfector and drying and storage closet gives you insight into what is effectively happening in the unit. In addition, our validation report is your documented evidence and added value in audits.

Scopes disinfector in accordance with ISO 15883-4
  • Determination of the temperature and pressure profile of the process in the scoop
  • Measurement of the dosed detergent / disinfectant
  • Control alarms plugged or unplugged channels
  • Control alarm at simulated ingress
  • Verification of proper cleaning in an endoscope, on the basis of cleaning indicators, placed in a surrogate endoscope
  • Verification of adequate disinfection in an endoscope, on the basis of bio-indicators, infected with E. faecium, placed in a surrogate endoscope
  • Demonstrate proper self-disinfection of the unit (chemical or thermal)
Dry cabinet in accordance with ISO 16442
  • Measurement of number of colony forming units on the walls of the dryer
  • Measurement of the particle air in the dryer, at 0.5 and 5.0 microns. By performing both measurements, you are certain that there is no possibility of contamination.
  • Control residual moisture in the scopes that have undergone a drying process
  • Control alarm disconnected channels
  • Determination of the temperature and pressure profile during the drying cycle

Custom approach

Each project requires a specific approach. That is why Agidens Life Sciences coordinates its validation and qualification projects with the client’s needs and requirements. We take into account the equipment to be validated, urgency, procedures within the hospital, occupancy of the department, or the specific use of the equipment.

How can we help?

Is it Agidens Life Sciences you’re looking for? We’re eager to hear your questions or challenges.

 

  • This field is for validation purposes and should be left unchanged.