European Forum for Hospital Sterile Supply |
EFHSS Education
Recommendations by the Quality Task Group |
Recommendations | AK "Qualität" |
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with kind permission of mhp-Verlag GmbH |
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[19] Cleaning (Part 1) - Instruments Causing ProblemsThe standard prEN 15883 "Validation of Washer Disinfectors" outlines requirements for washer-disinfectors and the process as well as test methods. Here the cleaning performance plays a pivotal role. In this STANDARD it is presupposed that during the cleaning step the washer-disinfector provides for adequate detachment, dissolution and removal of typical soils. The updated GUIDELINE OF THE ROBERT KOCH INSTITUTE "Hygiene Requirements for Processing Medical Devices" even calls for medial devices that are free of any residues, as otherwise disinfection and sterilisation could be impeded. It is, however, obvious that it is not possible to achieve a state where absolutely no residues remain. Problem Instruments A small survey conducted by the Quality Task Group revealed that some instruments are not being properly cleaned even in washer-disinfectors with optimal settings. This is attributable either to the design of the instrument or to the nature of residues and to the degree to which they have dried. Such "problem-causing instruments" can vary depending on the medical discipline and on the way they are used. Below we give examples of processing for some disciplines and instrument groups. Neurosurgery: Trepans for drilling a hole through the skull: blood and bone meal compromise their functionality. The material begins to cake due to the heat generated while drilling, thus hampering the cleaning process. Gynaecology: Orthopaedics: MIS Instruments: Instruments for closing vessels: ENT instruments: Proposals for solving problems What can be done with these items that are demonstrably difficult to clean? They are subjected to manual pre-cleaning as described above, e.g. in an ultrasonic bath. Hence in the case of these instruments part of the automated processing procedure is omitted. Strictly speaking these pretreatment tasks cannot be validated. In the context of quality assurance, these pretreatment tasks must be defined for the specific instrument in working instruments. Disruptions caused by pretreatment tasks Manual and ultrasonic pretreatment tasks can lead to disruptions in the ensuing automated process and lead to ad absurdum where a validated process is concerned. Such forms of pretreatment can have particularly negative effects when used with aldehyde-based disinfectant solutions if they result in COAGULATION OF PROTEIN, which cannot be removed during processing. If this takes place in lumened instruments, it may not be noticed. Another common source of interference is entrainment of foaming surfactants during the automated process. Due to FOAM FORMATION in the washer-disinfector the mechanical action is impeded or brought to a standstill. Nor is heat conduction assured due to air bubbles, hence disinfection is jeopardised. |
STANDARD prEN 15883 calls for clean medical devices. THE RKI GUIDELINE calls for residue-free medical devices. Dealing with instruments causing problems Proposals for solving problems COAGULATION OF PROTEIN can be caused by pretreatment with aldehyde-based disinfectant solutions and can impede automated cleaning. FOAM FORMATION impedes the mechanical action of the washer-disinfector. |
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