Clear conscience with validated disinfection and sterilization processes!
In Norway, we are far ahead in terms of dental health. Norwegian dentists have a well-deserved share of the credit for this. Until now, however, it has not been easy to meet the requirements for validation of the washing and sterilization processes at the clinic - simply because almost no one has offered the service.
From the authorities, there has also been so-so information about the obligations that rest on the industry regarding the control and validation of washing and sterilization processes in the business. In 2018, however, came "Professional recommendations for infection control in clinical dental practice" - prepared by the universities of Tromsø, Bergen and Oslo, the Institute of Public Health and the Norwegian Dental Association. The recommendations make it easier for dentists to keep track of how the requirements can be met. When it comes to the autoclave, the recommendations are clear:
"All autoclaves must be validated and checked regularly. Validation means that there is written documentation that the process produces reproducible results, and that the products can be expected to become sterile after treatment with the process"
We at Valideringsservice are equipped with the latest generation of data loggers as well as TÜV-certified software for the evaluation of all washing and sterilization processes in the washer-disinfector, autoclave and DAC Universal - so you can be sure that the machines deliver clean, sterile and safe instruments.
What does "validation" of washing and sterilization processes entail?
The only thing that can show that washing and sterilization processes actually produce the desired result is a so-called process validation: a validation is reproducible proof that a given process produces the expected outcome. In other words, a validation must clearly demonstrate that processes, equipment, materials, work steps or systems actually lead to the required results. At the dental clinic, the instruments to be validated are washed, disinfected and sterilised.
Such validation is a central and necessary part of the clinic's infection control work, and must lead to a validation report: Patients should be able to see documentation that they are not unnecessarily exposed to bacteria and viruses from the clinic's other clients via the instruments used.
For example, validation of an autoclave involves several runs with test loads that at least correspond to the load it is usually run with, and that the load must consist of the type of instruments that are usually sterilized in the machine. To evaluate the results of the process, specially adapted data loggers and suitable software are used which create a report with the result "pass" or "fail", as well as in-depth information about the process - information that is also useful for a technician who has to troubleshoot a machine that does not deliver as expected.
Service is not validation
Det er lett å tenke at så lenge service og ettersyn utføres på maskinparken, så er alt under kontroll. Dette stemmer ikke. En vellykket validering skal gi klare beviser på at sluttresultatet er sterile og trygge instrumenter. Derfor er det ikke maskinens komponenter som testes, men prosessen maskinen er laget for å utføre. En validering må derfor også inkludere måten maskinen brukes på.
Which machines must be process validated?
I følge internasjonale og europeiske standarder (hhv. ISO og EN) gjelder følgende:
According to international and European standards (respectively ISO and EN), the following applies:
All (large and small) autoclaves must be validated annually in accordance with the procedures described in EN ISO17665
All washer-disinfectors must be validated annually in accordance with EN ISO 15883
All DAC Universal must be validated annually in accordance with EN ISO 17665-3 (as small autoclave). In addition, the washing capacity should also be tested, as the machine runs a washing cycle before sterilisation.
Both the autoclave and the washer-disinfector must be validated.
How are the reprocessing machines at the clinics?
A compilation made by the National Competence Center for Decontamination in 2018 showed that only a quarter of the autoclaves checked were error-free, and that almost a third (!) delivered such poor results that the use of the machine had to be stopped immediately. Admittedly, the sample was small, and the figures mostly apply to machines in hospitals - but there is no reason to think that the figures are not representative: a lot can go wrong in an apparently well-functioning machine, so that the result is not what you like to take for granted.
Who must validate their machines?
The Directorate for Social Security and Preparedness (DSB) is clear that the regulation for medical equipment (MDR) is the same for both dentists and the rest of the healthcare system: dental equipment is considered "critical equipment" on a par with surgeon's scissors and scalpels. All dentists and dental clinics must therefore validate their washing and sterilization processes – regardless of the size of the business. Whether the clinic is private or public does not matter either.
Who is responsible?
DSB further states that while it is the manufacturer of the equipment who is responsible for ensuring that the machines are suitable to do the job for which they are intended, as well as providing a manual that describes use, service and validation, it is the end user (i.e. the dentist himself) who is responsible for choosing the right machine, using it correctly and ensuring that both service and validation are carried out in accordance with norms and professional guidelines.
What do the professional recommendations say?
As mentioned, the universities of Tromsø, Bergen and Oslo, the Institute of Public Health and the Norwegian Dental Association have prepared "Professional recommendations for infection control in clinical dental practice". On p.17 it says:
"All autoclaves must be validated and checked regularly. Validation means that there is written documentation that the process produces reproducible results, and that the products can be expected to be sterile after treatment with the process"
How can you make sure?
With a third-party validation, you can be sure that reprocessed equipment is actually sterile, as well as that you are following standards and professional recommendations.
Ask us about offers for third-party validation
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