EN15883 and HTM2030 Guidelines recommend periodical validation tests carried out in endoscope washer-disinfectors. These include Weekly, Quarterly and Annual tests to ensure that the performance of the machine meets the specifications and, therefore, endoscope devices are in optimal conditions for their use in patients.

Our staff is fully trained to perform these tests 'on site'. To do so, a series of devices and procedures have been developed by our company. Alternatively we can provide the kits for the adequate validation to your hospital and offer training to hospital staff to carry out the tests.

Surrogate Devices

Specially designed surrogate devices which connect to the washer channels are inoculated with the recommended bacteria, and then a standard cycle is performed. This test measures the amount of bacteria removed during the disinfection cycle and ensures that endoscopes are sterilised during general use of the machines.

Biofilm Testing

Biofilm relates to a matrix of micro-organisms adhered to a surface and is extremely difficult to remove. These biofilms are most commonly found on plastic surfaces, and cause common infections in catheters. We have developed a way to test the capability of the washer-disinfector at removing biofilms in surrogate devices. Biofilm removal by Self Disinfection cycles ensures that biofilms can be removed if they become present in the machine tubing.

Soil Testing

Test soils are designed to challenge washer disinfectors, to ensure that the equipment is performing its desired function adequately and that proteinacious matter is removed during the detergent stage of the cycles. All our soils are made to specifications in EN 15883 and HTM2030 guidelines.

Water sampling and testing

All necessary water tests are carried out during our validations. These include TVC testing during quarterly validations and Chemical purity, Endotoxins and Mycobacterium tests during annual validations. Medipure has also developed methods for water sampling in washers that, due to their design, present a difficulty in this particular aspect.