The 22nd Congress of the German Society of Sterile Supply (DGSV) was held once again at its usual venue of the Esperanto Congress Centre in Fulda. In his opening speech to the congress DGSV chairman, Maik Roitsch, thanked the speakers, among others, pointing out that the DGSV was donating 25 euros for each lecture to the INDRENI project, aimed at supporting children in Nepal.
Standardization – the latest?
Next, in the first lecture Prof. Dr. Heike Martiny gave a summary of what to expect from revision of DIN ISO/TS 15883-5.
The currently valid Part 5 (Test Soils and Methods for Demonstrating Cleaning Efficacy) of DIN EN ISO 15883 was published in 2006 and had been undergoing revision for a few years now. Part 5 featured a list of all test soils submitted at that time. The Technical Specification did not contain any uniform requirements regarding the efficacy of the cleaning processes.
The conditions for cleaning tests must be precisely defined in the future.
That Technical Specification was now to be upgraded to a standard. Prof. Martiny explained that at a meeting of the working group in June 2018, debate on 155 commentaries from April 2017 had been concluded. Hence, the first part of the standard would soon be published for commentary as a Draft International Standard [DIS].
One new aspect would be the requirement that the conditions for cleaning tests should be precisely defined. The choice of test soil would then have to be justified and documented. Requirements for validation of the method applied for cleaning tests would also be featured.
Verification of the cleaning efficacy was based on visual inspection and quantitative protein detection. Prof. Martiny pointed out that the meaning of several terms/definitions would change because of the new standard DIN EN ISO 11139. For example, for protein there was now a “warning threshold” of ≥ 3 μg/cm² (identical to the “acceptance value” adopted in the Guideline for validation and routine monitoring of automated cleaning and thermal disinfection processes for medical devices published in 2017 by the German Society of Hospital hygiene [DGKH)] German Society of Sterile Supply [DGSV] and Working Group Instrument Preparation [AKI]).
Read more in Steri-World Issue 06/18.
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Publication Date: 21.12.2018
22nd DGSV Congress / 30 September – 1 October 2018 in Fulda, Steri-World 2018; Volume 1; 06/2018; p. 3-11.
Author: Gudrun Westermann
Citation of this article: 22nd DGSV Congress. 30 September - 1 October 2018 in Fulda. Zentr Steril 2018; 26 (6): 357-365.