Archive 2015

New standard draft for biological indicators

New standard draft for biological indicators

During the last ISO meeting gke has offered a standard draft where biological indicators are characterized to check sterilization processes with hydrogen peroxide.

In this draft a test method is presented to determine the resistance of biological indicators for hydrogen peroxide sterilization processes. It will allow to compare biological indicators of different manufacturers for the first time. Using this test method the innactivation kinetics can be determined. This is a very important step to validate and monitor hydrogen peroxide sterilization and disinfection processes.

The test results will be soon published in the “Central Service” magazine.

New gke test system

New gke test system

Type tests described in sterilizer standards EN 285 or EN 13060 are used to test the standard conformity of sterilizers and they are used like the Bowie-Dick Test to check the sterilizer after start-up working correctly.

Sometimes paper packages and helix systems are used for routine monitoring to check the sterility of the load. This procedure is quite often batch monitoring. These tests have no relation to the load. Therefore, it cannot automatically be concluded that loads of complex MIS instruments can be sterilized successfully.

Since the load configuration in hospitals is changing according to the different type of operations carried out routine monitoring to check sterility has to be adapted to the load and cannot assure if the sterilizers are working according to the sterilizer standard requirements only.

This adaption can be achieved in two ways:

  1. Process Monitoring System (PMS): The sterility of the load is assured if the sterilization process has been validated with a worst-case load. The continuous monitoring of the load shall be carried out with a test system which monitors the maximum performance of the sterilizer. Modern sterilizers provide much better performance than the required type tested mentioned above. For this purpose gke offers a variety of different PCDs (process challenge devices) with increasing sensitivities to monitor the process at highest level. These test devices are called process monitoring systems (PMS).

  2. Batch Monitoring System (BMS): If the characteristics of the load to be sterilized are known, a PCD can be designed and validated to be more difficult to sterilize than the defined load using the method according to DIN 58921 (medical device simulator). gke has already tested several typical loads with the method according to DIN 58921 and offers special PCDs for tattoo, dental and ophthalmic loads. For these test systems separate data sheets with detailed information are available.

gke has extended its product range with different test systems having even higher requirements than the hollow load test described in EN 867-5 and which shall be used as a batch monitoring system with every sterilization cycle selected according to one of the procedures described above.

The test system gke VHDH-PMS (very high demand hollow process monitoring system) with Compact-PCD, brown is now available and represents extreme complex instrument loads. More information about this test system and other gke PMS and BMS can be found using the links. The product data sheet is available for download following this link or under Downloads/Product Catalogues and Data sheets.

Very-High-Demand-Hollow-PCD

Medica in Duesseldorf, Germany

Medica 2015 in Duesseldorf

Hospital and clinic employees, dealers, health care authorities and other participants visited the gke-booth during MEDICA which took place from November, 16th – 19th in Duesseldorf, Germany.

More than 70 percent of the visitors were guests from overseas. Many of them came from Latin America and Arab countries.

gke presented new products for process monitoring and documentation for cleaning and sterilization.

gke participates in large exhibitions. The next Medica will be in November 2016.

Medica 2015

New dental brochure

New dental brochure

The reprocessing of dental instruments can differ from other sterilization processes in health facilities.

gke has created a comprehensive dental brochure to explain the application and necessary products for cleaning and sterilization monitoring in dental facilities.

The new brochure is available for download following this link or under Downloads/Product Catalogues.

Self-contained biological indicators (SCBI)

Self-contained biological indicators (SCBI) for sterilization monitoring

Biological indicator strips G. Stearothermophilus and/or B. Atrophaeus are still used. However, those products are old-fashioned and require a microbiological laboratory with a long delay time until the result is available. Modern self-contained biological indicators (SCBI) can be incubated directly after the sterilization process is finished having the results available after 5-24 h. By using gke Steri-Record Instant-SCBIs the sterilized goods can be released very quickly at the end of a steam sterilization process.

This is a very time-saving and cost-effective method compared to the use of traditional spore strips.

Please contact us or your local gke-dealer. The gke application laboratory may support you in technical questions. More information is available by following this link.

Self-contained biological indicator (SCBI)

New labels to be used on containers

New labels to be used on containers

Containers made of stainless steel, aluminium or plastic cannot be adhered with conventional labels since glue residues will remain on the surface. Therefore, many containers have openings where labels can slide-in. The labels need to have special dimensions and are mostly not big enough to add all data. Furthermore the label is placed on a certain position and cannot be scanned without shifting the container.

gke has developed a single self-adhesive label which can be adhered on the container without leaving any residues. Therefore, extensive cleaning with organic solvents is unnecessary. The use of under foil or film for easy removal of the label is also not anymore required.

The labels are available on roll with 3” core, other core diameter and dimensions on request. The labels can be ordered as endless labels for printers with cutting device or single perforated labels with 6 and 8 cm width.

Please request a sample roll for testing!

Label to be used on containers

New gke buildings

Opening of new gke buildings

The 3 new buildings with an area of 10.000 sm have been completed.

gke will move into some parts of the new buildings in the next couple of months. The new buildings come with high speed glassfiber internet connection, easy accessibility with elevators, air-conditioned conference- and server rooms, 6 truck ramps and a covered parking area for 125 cars.

On the roof of two buildings a photovoltaic plant with 200 kW maximal power point (MPP) has been installed which produces a large part of the required power. Rain water is collected in a cistern and used for toilet flushing. Efficient energy saving LED lights are used, the buildings are isolated and only need low heat capacity in the winter and air-conditioning is only necessary in the conference and server rooms.

Opening ceremony of new gke buildings

Wall calendars 2016

Wall calendars 2016

The gke wall calendars for 2016 (70 x 100 cm) are now available free of charge. Please contact your local dealer. We are happy to plan the next year with you!!

Standard ISO 11140-6 will replace EN 867-5

Standard ISO 11140-6 will replace EN 867-5

The ISO/TC 198/WG6 working group has been working for more than 3 years to replace the old EN 867-5 by a new ISO Standard. Continuous tests have been carried out to replace the old Hollow Load test procedure in the EN standard which did not give reproducible results.

The new EN ISO 11140-6 specifies performance requirements and test methods for chemical indicators and process challenge devices intended for use in small steam sterilizers, which are intended to sterilize solid, hollow and porous medical devices.

The ISO committee stopped this work item after 3 years because of exceeded deadlines. During the last meeting of the working group in Denver/USA, ISO has decided to continue this work in order to finalize a new standard ISO 11140-6.

This modification is important because currently a lot of different alternative Hollow Load Tests are on the market and all claim to be equivalent to the original Teflon Hollow Load Test. However, they differ in sensitivity.

Cleaning indicator for bedpan washers

Cleaning indicator for bedpan washers

The cleaning efficacy in bedpan washers has to be checked regularly. Until now bedpans have been manually contaminated with a test soil, e.g. mustard, saw dust, wheat flour, ketchup or other. After cleaning the positions can be determined where the spray jet is redirected and the cleaning is poor.

By using the new gke cleaning indicators level 0 this test is quick and easy. The self-adhesive indicators will be be adhered directly on the bedpans or urine bottles. At the end of the process they can be documented with the same adhesive.

The data sheet with detailed information is available through this link or in „Products/Cleaning monitoring/Bedpan washers".

Cleaning indicators for bedpan washers

International Dental Show in Cologne

International Dental Show in Cologne

Dentists, manufacturers of dental equipment, dealers and other participants visited the gke-booth during the International Dental Show (IDS) which took place from March, 10th – 14th in Cologne, Germany.

The IDS is the largest dental show worldwide. gke took the chance to present its products for process monitoring and documentation especially for dental instruments.

The technical equipment of dental practices becomes more comprehensive. Practices and dental units worldwide invest in high quality washer disinfectors and sterilizers. The monitoring can be carried out with special gke test systems for dental instruments.

gke participates in large exhibitions and gke will also be present with a booth at Medica in Düsseldorf in November 2015.

Updated EN ISO 11140-1

New Version of Standard EN ISO 11140-1

Chemical indicators to monitor sterilization processes are described in the standard EN ISO 11140-1 and are divided into six different indicator types (former classes). The number does not allow any conclusion about the quality, e.g. an indicator type "6" according to EN ISO 11140-1 is not "better" than an indicator type "2", but specifies different characteristics by application. The type 2 indicator systems are intended for use in specific tests, where a PCD (process challenge device) is used.

The standard EN ISO 11140-1 has been updated. The process challenge device is now defined as PCD and the corresponding indicator strip is called indicator. The combination of PCD and corresponding indicator is defined as indicator system type 2. From now on the everyday language and the terms of the standard are identical and easier to understand.

The details are described in our technical information TI 730-044, available through this link or in „Downloads“.

International Dental Show

International Dental Show in Cologne

Taking place every two years, IDS in Cologne is the top event for the international dental sector with more than 2000 exhibitors and over 100.000 national and international visitors. IDS presents the entire range of products available on the international dental market. IDS will take place from March 10 - 14, 2015 (www.ids-cologne.de) and gke will participate with a booth N-059 in hall 10.2.

gke presents monitoring and documentation systems for validation and routine monitoring of cleaning and sterilization processes. We are looking forward to your visit. To allow us some time for discussions please contact us using our contact form or by e-mail to make an appointment in advance.

International Dental Show

Best wishes for the New Year

Best wishes for the New Year

 We wish you all a healthy and prosperous new year 2015!