Item number: 144210
Hygiene check for washing machines. Suitable for testing the disinfection effect of washing processes. For own operational control. Easy to use. High safety. Closed germ carrier. - Including laboratory evaluation and protocol.
10-fold germ carrier with 5 x ATCC 6538 Staph. Aureus + 5 x ATCC 6057 Ent. Faecium
- 1 strip with 10 bioindicators (5 x ATCC 6538 Staphylococcus Aureus + 5 x ATCC 6057 Enterococcus Faecium) with germ densities 10 to the power of 7 in 5 chambers each
- Size of the strip approx. 20 x 8 cm
- Transport control (1 chamber each with ATCC 6538 and ATCC 6057, germ density 10 to the power of 7 in each case)
- Including laboratory evaluation (microbiological examination) and protocol
Suitable for checking the disinfection performance of washing machines (reprocessing of textiles) in accordance with the RKI guideline ("Hygiene requirements for laundry from healthcare facilities"), VAH guideline and following DIN ES ISO 16616 and DIN EN ISO 14885.
The amfora KT-10W DES-CONTROLler® is a closed bioindicator for chemical, chemothermal and thermal disinfection devices. Specially trained personnel are not required for testing - this not only saves money, but also time. It can be used to check disinfection devices cost-effectively and independently. Therefore, it is also particularly well suited, for example, for your own early detection.
The amfora KT-10W DES-CONTROLler® complies with current norms and standards and contains as test germs: Enterococcus Faecium (ATCC 6057) and Staphylococcus. Aureus (ATCC 6538) on a germ carrier (standard cotton lobules 1×1 cm according to DIN 53919) inoculated according to DIN 53919 with a bacteria-sheep blood test soil according to the guideline of the RKI, VAH.
The germ densities in each of 5 chambers with 10 to the power of 7 per test germ are enveloped by a thermally, mechanically and chemically stable yet flexible semi-permeable membrane. This special membrane allows heat as well as water and disinfection liquor to pass through reliably and in sufficient quantity, which thus act on the germs, but it does not let the germs out of the membrane !
Advantages Bioindicators washing machine:
- The test bacteria are safely enclosed to avoid contamination or recontamination. Contamination of the machine to be tested is excluded by the membrane. This makes it possible to have the tests performed by in-house personnel during everyday operation. There is no need to run empty washing cycles, as contamination of the machine to be tested is ruled out.
Re-germination of the germ carriers after the disinfection run is also not possible.
- Error results due to incorrect handling are ruled out, as germs from outside cannot penetrate the membrane either.
Required quantities of bioindicators:
For textile washing machines, the following is required for the inspection per washing machine
1 x amfora KT-10W DES-CONTROLLer® strip = 10 bioindicators
according to the new guidelines are required.
The strip inserted e.g. in a laundry bag must run through the same complete washing program as the laundry itself.
Note on the number of transport controls:
As a rule, each order for a KT-10W also comes with a transport control.
However, if several washing machines are tested in one house and the bioindicators used are also returned in one shipment, only 1 transport control is required. The transport control is also evaluated and ensures that no germ reduction of the reference germs has occurred in the mail.
Frequency of testing:
Usually an annual inspection of the devices is sufficient. Exceptions are disinfection devices that come into contact with so-called risk laundry. This includes, for example, hospital and nursing home laundry, but laundries that wash this type of laundry must also test every six months.
Test performance:
- Use amfora KT-10W DES-CONTROLler as soon as possible after receipt. As there are living microorganisms in the germ carriers, the test strips have a limited shelf life. Upon delivery, you will receive test strips that are ready for use for approx. 4-6 weeks, so that you remain flexible in your time planning.
- The optimal storage until use should be dry and at room temperature (preferably not higher than 35° C), no direct sunlight, recommended is e.g. a closed cabinet or drawer.
- Put the supplied TPK transport control aside unopened in the separate shipping bag. You will only need the TPK again for the return shipment. DO NOT wash with it.
- amfora KT-10W DES-CONTROLler e.g. in a laundry bag or add it directly to the wash. The only thing to take care of when handling is that none of the 10 germ chambers are damaged! (The germs, each with a density of 10 to the power of 7, are - when viewed from the front with ID no. visible - equipped with the Faecium germs on the left side/column, and with the Aureus germs on the right side/column).
Safety note: The germs cannot escape if handled properly. Therefore, the membrane must not be opened or cut, so there is no risk of contamination.
- Start the washing/disinfection process of the laundry (with KT-10W). To do this, select the wash program and laundry for which you want to prove the disinfection effect of the machine.
- Remove the amfora KT-10W DES-CONTROLlers after the washing process has been completed.
Note: It is recommended to rinse the closed bioindicators with water again after the disinfection run. This prevents disinfectant residues from remaining, thus eliminating error results.
Allow to dry for approx. 20 - 30 minutes. Any residual moisture still present has no influence on the result.
- Fill in the return form, put the used test strip back into the shipping bag, put it into an envelope together with the transport control set aside, and return it by normal mail (for your safety by registered mail).
Ideally, send the amfora KT-10W DES-CONTROLler - strips at the beginning of the week to avoid unnecessary delays in the mail.
Instructions (test procedure) as well as the required documentation for the test report will be sent to you together with the bioindicator.
- You will receive the result of the evaluation (test report) by email for your documentation.
Evaluation:
If the laboratory evaluation is negative, i.e. no sufficient disinfection effect (in this case: germ reduction by 7 log levels) is proven, suitable measures for fault rectification must be taken immediately. After the fault has been rectified by qualified personnel, a new check must be carried out.
IMPORTANT NOTE for purchase:
Please note that the bioindicators require a microbiological evaluation. For this purpose, the test strips used are prepared with a special procedure and nutrient solution. The evaluation with test protocol for your documentation is included in the price.
The test strips are only produced upon receipt of your order and are then ready for use for approx. 6 weeks. It is not possible to exchange or return them, nor is it possible to store or stock them, as the test strips, like the transport control, contain living germs and can only be used for a limited period of time.
Use the control strips as soon as possible after receipt.
Regular monitoring of the disinfection effect, among other things, is an essential part of medical quality assurance and self-monitoring.
Interesting facts about the amfora KT-10W DES-CONTROLler® bioindicator for the washing machine:
The amfora KT-10W DES-CONTROLler® is a special production of meducomp for amfora with an optimized membrane. meducomp has developed this bioindicator in cooperation with the Institute for Hygiene of the Medical University of Lübeck according to scientific standards. Years of research were successfully completed in 1994 and the final product was a closed bioindicator in its present form. The production of DES-CONTROLler® is subject to continuous quality and manufacturing control based on the international standard DIN EN ISO 9001.
The laboratory reports - among others also from VAH-certified laboratories - confirm the conformity of the DES-CONTROLler (based on DIN EN ISO 16616, DIN EN ISO 14885, RKI and VAH criteria) and a perfect functioning and applicability for the washing and disinfection procedures described in the standards and guidelines. There are no restrictions or disadvantages compared to other, open test bodies.
They also confirm "that (contrary to the sometimes still widespread but untenable opinion) these closed bioindicators are suitable for use in washing machines. They are recommended by renowned institutes and laboratories. Expert opinions from Germany and Europe confirm the functionality and recommend the use of closed bioindicators."
The laboratory results show that the tested closed system as well as the open system achieve the required germ reduction comparably. "Due to the lower risk of contamination when used by the end customer, the DES-CONTROLler is preferable to the open system."