How often should an autoclave be serviced?
Processing: regularity and validation levels
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As part of the practice inspection, not only are numerous hygienic aspects and the correct reprocessing process of medical devices checked. Rather, the completeness and topicality of validation processes and protocols are also checked. For practices, this is often a significant additional effort, especially since the validation cycles tend to be further apart and are therefore not always in the focus of daily work. In addition, there are always misunderstandings with regard to the requirements for validation and the frequency of validation. A lack of validation, however, can lead to severe penalties. In extreme cases, the practice may even be temporarily closed.
But how and in what rhythm are validations to be carried out, and which devices are subject to validation?
The general opinion is that thermal disinfectors should be checked annually and autoclaves every two years, as part of so-called process validations. The intervals are usually specified by the industry, i.e. by the manufacturer. Unfortunately, this alone is not enough. A new sterilizer, for example, also has to be validated. Immediately. The same applies to thermal disinfectors. On the one hand, the focus is on checking the factory-controlled parameters. In addition, an operational qualification and first-time performance qualification take place. All sub-steps integrated in the preparation process are included in the validation. This can be, for example, the water quality or the location of the device. Aspects such as loading patterns or the choice of program are also carefully examined. So that the initial validation is not accidentally forgotten, it is advisable to order it when ordering the device. In practice, this also saves long waiting times that may occur with the validation technician of choice. Before a new performance qualification can take place after 12 or 24 months, the devices must be serviced. The maintenance may not take place longer than six to twelve weeks before the validation. A revalidation may have to be carried out after repairs. However, this depends on the type of repair. In this case, it is best to ask your technician.
A common mistake is that with regular validation the batch control of sterilizers or thermal disinfectors becomes obsolete. That is simply not correct. As before, every batch, i.e. every run, must be checked using process indicators and the result documented. Other devices to be validated in practice are film sealing devices, the DAC Universal combination autoclave and the Assistina 3x3 reprocessing device from W&H. Sealing processes of film sealing devices partly with validation kits from the manufacturer or based on the "Guideline for the validation of the sealing process" must be carried out by the practice team themselves (www.dgsv-leitlinie.de).
The DAC UNIVERSAL can also be validated in the dental practice using the associated documentation package (initial validation). A new validation is necessary every two years or at the latest after 3,000 cycles. The prescribed documentation of the sterilization process is possible with the DAC UNIVERSAL without great effort.
With the Assistina 3x3, W&H offers a fully automatic, validatable cleaning and care device for dental transfer instruments. The validation can be carried out by the specialist dealer technician. The evaluation of the samples and the reporting of the performance test is carried out by an independent, state-accredited test laboratory. In addition, the new Assistina 3x3 has an integrated process monitoring system that controls the amount of cleaning solution, the amount of oil and the process air. This ensures that the cleaning process of the Assistina 3x3 delivers a consistently constant cleaning result. In summary, a complete validation can be divided into three areas: It must be ensured that all validation reports must be signed by the practice management.
Validations entail considerable additional financial and organizational effort for the practices. However, this is inevitable in view of the increasingly strict practice inspections. After all, possible fines or even the threat of a practice closure can have far more far-reaching consequences and losses.
The post is in theZWP Zahnarzt Wirtschaft Praxis 5/2018 published.
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