Spypach endoscope surrogate device for routine inspection and validation of endoscope washer-disinfectors of various manufacturers
Simple and reproducible testing of the complete function of endoscope washer-disinfectors has been an unsolved problem. With the Spypach endoscope surrogate device it is now possible to test the cleaning and disinfection performance of automated endoscope reprocessors from various manufacturers in a reproducible manner. It is suitable for both wash systems, single channel control and pressure box.
This testing device is modelled on a thermo-labile flexible gastroscope respective bronchoscope. To test the endoscope washer-disinfector, it is simply placed into the relevant machine, instead of an endoscope. The reason that this particular surrogate device provides a reproducible result is that it is possible to position both the endoscope and the indicators for cleaning and disinfection at identical positions in various tests. The test system allows the placement of indicators for cleaning performance in the flexible channel of the endoscope surrogate device, on the outsides and in the connection between biopsy and washing channel. This innovative solution permits simple and rapid routine control and simplifies validation, thus ensuring maximal patient safety and minimal test costs.
Fast routine inspections
Belimed technicians are regularly trained, to ensure they are up-to-date with the latest technology. Our worldwide service also carries out routine testing of endoscope washer-disinfectors with Spypach. Using Spypach provides additional security by alerting the user to any possible adjustments that may be required for the cleaning and disinfection program. The added value of this method increases safety in endoscopy testing and comes at little overall cost in validating the cleaning and disinfection performance.
Structure of the test system
The test system consists of an operating component, a patient component with working or biopsy channel and a service component with leak tester. For routine inspections, all current and commercially available test bodies can be tested by simply pushing the test plates onto the guides intended for this purpose. Test bodies with E. faecium carriers are available for testing the disinfection performance. After simple unscrewing, three test chambers are available for checking the channel or internal cleaning. The first test chamber is in the patient component at the access to the biopsy channel. The second chamber is at the end of the biopsy channel (distal chamber). The flow conditions in the endoscope surrogate device are the same as in a genuine endoscope, as the patented and off-set test chamber does not affect flow. The third test chamber allows the uptake of a test body in the connection between biopsy and washing channel. This position is particularly important, as it is not covered by the inspection in accordance with EN ISO 15883-4. This lateral channel of the flexible endoscope is the most difficult one to clean, as it bends by almost 90 degrees after the cleaning opening.
For validation inspections, the specially developed stainless steel plates can be used; test contamination according to EN ISO 15883-Part 5 can be applied to these. This guarantees the highest reproducibility for cleaning validation, as the test always uses exactly the same test sites, independently of the tester. In addition, a leak test can be performed for validation on the service component. The most common adapters (e.g. Olympus, Pentax, Fujion, Storz) are included in the delivery for this purpose. The test system can then be connected with a pressure logger or pressure gauge, to check the manufacturing data, such as the holding pressure throughout the whole cleaning cycle.
The following options for validation are available:
- Adapter for leak tester
- Blocking adapter to simulate channel blockade
- Double connection adapter for connecting a measuring instrument, pressure logger or temperature sensor
- Adapter with possibility of adjusting flow pressure
- Various Luer lock adapters
- Teflon tubes of various diameters
- Test expert report for the practical use of the endoscopy surrogate device, in accordance with EN ISO 15883 Parts 4 and 5
Of course, the Belimed service team offers Spypach as part of the validation performance, providing a simple and easy routine testing and inspection of your automated endoscope washer-disinfector.