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The self-adhesive indicators are printed on temperature stable plastic carriers. Different coloured indicators have varying wash-off characteristics. The indicator chemistry is non-toxic and is dissolved and dispersed with most cleaning agents and flushed away after the process.

The cleaning process of surgical instruments is extremely complex and involves a wide array of variables. The cleaning process can be compromised if any of these variables are altered, and if not monitored can have an adverse effect on the overall process.

Where sterilisation processes comprise a set of known and measurable parameters (time, temperature and steam), the cleaning process has a much wider array of variables, and can vary from one process to the next, and from one hospital/facility to the next.

Which coloured indicator is right for me?

A gke Australia Territory Manager will conduct a trial for you to determine the colour most suitable for your process.

Why is the cleaning process so complex?

There are many factors to consider in the cleaning process. Apart from the 4 main variables of the process (mechanics, temperature, chemicals and time), there are other variables influencing the cleaning process, such as instrument design and material properties and type of contaminants to be cleaned (eg. bone meal, body fluids, drug residues etc).

What do Cleaning Process Indicators (CPI) Tell us?

Unlike the monitoring of sterilisation processes, where chemical indicators identify the achievement of critical variables, in the cleaning process there are no defined critical variables. The critical variables in a cleaning process depend on the type of contamination to be washed and the selection of process. Depending on contaminants, different cleaning programs are selected. Blood and protein-based contamination are only 2 of many more possible contaminants. Therefore, a test soil (on a cleaning process indicator) cannot be specified for the necessary variables but must be selected for each individual process.

There is no universal definition for “clean” and 100% “clean” is never possible. Therefore, a “pass” result on a cleaning process indicator cannot tell us the level of “clean” achieved by a process or that our instruments are now “clean”, it can only tell us that the process has worked according to the original validated specifications.

CPI’s are used in cleaning processes not only to “pass” the process, but to expose the process when something has failed which would have otherwise gone undetected. For example, a washer disinfector has dosed detergent and the machine has executed this process. This process through, has not detected the empty bottle of detergent or break in the hose, resulting in no detergent being dosed to the machine – only a CPI can detect this faulty process.

Why do gke have 5 coloured indicators?

gke in Germany have designed a spray test rig to standardise conditions under which they conduct their research of the cleaning process. Using this test rig, they have demonstrated under given conditions, that the test soils they have developed for the gke CPI’s are equivalent to test soils defined in ISO TS 15883-5, as shown in the table below:
Table 1 Equivalence of gke indicators to ISO TS 15883-5 defined test soils

The 5 different coloured gke CPI’s offer a differing level of challenge to the cleaning process. See videos below to demonstrate.

gke Australia Territory Managers conduct trials within facilities as displayed in the videos. All 5 CPI colours are used in the washer disinfectors to identify which indicator is most suitable for that customer’s process. The gke indicators are guaranteed to remain intact after the pre-wash cycle.

By trialling all 5 coloured gke CPI’s we can tailor fit the selection of indicator to each customer’s process because the cleaning process can vary so greatly from one machine to the next and from one hospital to the next. Water Quality, RO, different machine brands, machine quality, machine maintenance, spray arm efficacy, pressure, selected detergent, type of contaminants and surgeries performed all play a significant role in the cleaning process. Therefore, appropriate Cleaning Process Indicator selection is required.

Applications

The gke Cleaning Process Indicators are used for routine monitoring of cleaning processes in washer disinfectors. Indicators can be held in place with an orange plastic holder clipped to instrument trays.

To simulate the challenge for hollow instruments a special hollow flow process challenge device (PCD) can be connected to ports on the cart manifolds.

Product Benefits

• Use of synthetic test soil on plastic carrier instead of natural test soil comprising blood prevent the transfer of possible pathogens, as well as offering long-term stability, reproducibility of results, long expiry dates, and product stability during storage
• Cost effective due to synthetically printed test soil and plastic carrier
• Allows for economical batch monitoring due to cost effective indicators
• Different colours available mean a tailored approach to each facility
• Ease of documentation due to self-adhesive backing
• Indicators are validated against test soils according to ISO/TS 15883-5 with the gke designed and developed spray test rig

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To contact GKE Australia about GKE Disinfectors | Cleaning Indicators use Get a quote.