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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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[22] Classifying Medical Devices before Processing (Part 1)Comment on the risk assessment in the RKI Guideline: "Hygiene requirements for processing medical devices" (section 1.2.1 Processing of medical devices (MDs) entails as a rule:
Safe and effective disinfection and sterilisation are possible only for CLEAN MDs. Therefore effective cleaning processes must be used. Preference should be given to automated processes in suitably equipped washer-disinfectors because they assure better standardisation and occupational safety. Alkaline cleaning with a pH value > 10 in the use solution is highly effective for dissolving protein and fat residues. DISINFECTION should preferably be conducted in a washer-disinfector, using thermal processes. For spectrum of action AB, with efficacy against hepatitis B, 90 °C and a holding time of 5 min are needed for the items to be disinfected. Non-critical MDs can be cleaned and disinfected manually. For STERILISATION preference should be given to steam sterilisation at 134 8C using a holding time of 5 min provided that more stringent requirements do not apply (e.g. CJD prophylaxis). Based on the RKI Guideline, modular systems should not be dismantled for sterilisation. The MD manufacturer must furnish proof that this can be accomplished without any problems. The PROCESSES IN WASHER-DISINFECTORS must be validated and subjected to regular checks. The QUALITY ASSURANCE CONCEPT for the washer-disinfectors can entail parametric inprocess checks, e.g. a check of the temperature and holding time in the thermal disinfection step, of dosage quantities as well as independent physical, chemical and microbiological tests and suitable cleaning indicators. Regular maintenance of all equipment constitutes a good basis for safe processing. The operator is responsible for formulating a quality assurance concept and for conducting the relevant tests. The MDs to be processed are classified into RISK GROUPS, while taking account of the preceding and subsequent use, constructional features and material properties. Preference should be given to automated processing, involving an adequate cleaning step and thermal disinfection as well as steam sterilisation at 134 °C. Whether sterilisation is required or not also depends on special types of applications or on transportation channels also in the case of non-critical and semi-critical MDs. INSPECTION FOR CLEANLINESS is carried out by inspecting MDs, using optical aids if necessary. In addition to this and if it is not possible to conduct adequate visual inspection, e.g. in lumened MDs, impeccable functioning of the washer-disinfector must be ensured by means of further additional tests. Such supplementary tests could involve for instance compiling independent temperature profiles with thermologgers, using cleaning indicators, e.g. TOSI, and conducting spot checks for protein with the biuret, ninhydrin or OPA methods. All medical devices (MDs) undergoing processing must first of all be classified by the operator in accordance with the specifications of the Robert Koch Institute into the given groups. In doing so, device groups can be formed. If non-critical MDs are being used together with critical MDs, the non-critical MDs must be assigned to the critical group. (Example: a set with general surgical instruments and kidney dish.)
Non-critical medical devices (MDs) RKI requirements: Conventional processing: Inspection: Semi-critical medical devices (MDs) A RKI requirements: Conventional processing: Inspection: |
The different processing steps CLEAN MDs are required for effective disinfection and sterilisation DISINFECTION should preferably be carried out in a washer-disinfector, using thermal processes FOR STERILISATION preference should be given to steam sterilisation at 134 °C PROCESSES IN WASHER-DISINFECTORS must be validated A QUALITY ASSURANCE CONCEPT entails e.g. parametric inprocess checks and regular maintenance of all equipment RISK GROUPS serve as a basis for classification of MDs, while taking account of different characteristics AN INSPECTION FOR CLEANLINESS is carried out by inspecting MDs, possibly using optical aids and by means of other test procedures. The Risk Groups Requirements for processing non-critical MDs Requirements for processing semi-critical MDs (A) |
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