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Central Service Suppl. 20134 GuidelineGuideline for Validation of Manual Cleaning andManual Chemical Disinfection of Medical Devices 1 Principles of the GuidelineQuality assurance in medical device (MD)processing is not only a legal obligation,it also has important implications for economic efficiency. Prevention of healthcare-associated (nosocomial) infectionsis an interdisciplinary challenge for allparties involved. Expert medical deviceprocessing is an important component inthis regard. The medical devices must bedesigned to withstand automated and/ormanual processing. By assuring processsafety, the procedure used must guarantee proper and reproducible processing.The personnel entrusted with processingmust have the requisite knowledge andqualifications to ensure proper processing.This Guideline for Validation of ManualCleaning and Manual Chemical Disinfection (called «manual cleaning and disinfection» in the following) of medical devicesdisinfected using an immersion method isintended for all establishments in whichmedical devices are processed for use onhumans. The following principles applyfor processing:–– The operator is responsible for settingup and maintaining a quality management system.–– «The use of manual processes, when automated processes are available, presupposes that proof of the equivalenceof the efficacy of manual and automated processes will have been furnished»[KRINKO/BfArM Recommendation2012]–– Effective cleaning is a prerequisite foreffective disinfection and – if necessary– for subsequent sterilization.The objectives of the Guideline are as follows:–– Provision of working materials to compile operator-specific standard operating procedures for manual cleaning anddisinfection of medical devices tailoredto the design of the respective medicaldevice.–– Provision of methods and acceptancecriteria for verification of operator-specific standard operating procedureswith regard to the cleaning and disinfection results as well as for detectionof chemical residues following manualcleaning and chemical disinfection.1.1 Definitions–– The operator is responsible for ensuring that the personnel entrusted withprocessing have the requisite expertise.Alarm ValueA value which, if exceeded, requires implementation of measures to optimize theprocess/standard operating procedure, inorder to attain/undershoot the guide value–– The operator is responsible for ensuringthat validation, performance requalification and periodic routine tests arecarried out.BatchMedical device or group of medical devices subjected at the same time to a processing procedure–– Preference must be given to automatedcleaning and disinfection.Chemical DisinfectionReduction of the number of microorganisms in or on an inanimate matrix attainedthrough the irreversible effect of a product on their structure or metabolism to a–– The acceptance criteria for the efficacyof manual and automated processes areidentical.degree deemed appropriate for a specificpurpose (EN 14885)Chemical DisinfectantA mixture of one or several biocidal substances used for chemical disinfectionCleaningRemoval of soils from an object to the extent needed for subsequent processing orthe intended use (EN ISO 17664)DetergentA substance or mixture of substances thathelps to clean medical devices by removing soilsDetergent DisinfectantA mixture of substances containing detergent as well as disinfectant compoundsExpiry DateA date on the medical device packagingspecifying the date until which the devicemay be used, assuming it is stored as perthe manufacturer's instructionsGuide ValueA value that must not be exceeded in orderto complete performance qualificationGross/Rough SoilingVisible contamination on medical deviceswhich can be easily removed after usingthe medical devices. This includes e. g.tissue residues, bone splinters and dental cement.Hollow Cavity/Lumen in Medical DevicesMedical device which, because of its construction/design, has internal surfaces thatdo not permit complete visual inspectionfrom the outsideInstallation Qualification (IQ)Process of obtaining and documenting evidence that the organizational, structuraland technical prerequisites have been met

Guideline 5Central Service Suppl. 2013Limit ValueA value which, if exceeded, requires immediate process shutdown; the corresponding standard operating proceduremust no longer be used.Manual Chemical DisinfectionChemical disinfection without using awasher-disinfectorManual CleaningCleaning without using a washer-disinfector (EN ISO 17664)Manufacturer/DistributorOrganization or person responsible forconstruction, manufacture, packaging andlabelling of a device before it is placed onthe market under his own name, irrespective of whether these activities were conducted by this person himself or by an appointed third party (EN ISO 17664)Operational Qualification (OQ)Process of obtaining and documentingevidence that the installed equipment operates within predetermined limits whenused in accordance with its operationalproceduresPerformance Qualification (PQ)Process of obtaining and documentingevidence that processes were conductedin accordance with the standard operatingprocedures, thus yielding products thatmeet the respective specificationsProcessA series of interrelated activities that convert inputs into results (ISO 9000)Process ChemicalChemical substances or mixture of substances used for cleaning and/or disinfection of medical devices, such as detergents, disinfectants, care agents, water,etc.Processor/OperatorAn organization or person responsible forperforming actions needed to prepare anew or used medical device for its intended use (EN ISO 17664)ProcessingProcessing of medical devices, whichshould be sterile or, at most, have only alow microbial count (disinfected) whenused, involves their cleaning, disinfection and sterilization, including associatedworking steps as well as testing and restoration of functional safety, after use forthe purpose of reuse (MPG Section 3 [14])Product Group/Medical Device GroupMedical devices that are comparable interms of design and cleaning and disinfection requirements, and for whose cleaningand disinfection one single standard operating procedure can be compiledShelf Life of Unused Application Solution of aDisinfectant/Detergent DisinfectantPeriod of time during which the provendisinfection efficacy of a ready-to-use solution is preserved, when prepared according to the manufacturer's instructions in the recommended concentrationand then left to stand unused, in a coveredcontainer, for the time period specified bythe manufacturerStability of Used Application Solution of a Disinfectant/Detergent DisinfectantPeriod of time during which the provendisinfection efficacy of a ready-to-use solution is preserved on repeated use, whenprepared according to the manufacturer'sinstructions in the recommended concentration and then used for the time periodspecified by the manufacturerStandardizationThe totality of measures taken for harmonization, simplification, classification,limitation or restriction of processes in theform of optimum technical solutionsStandard Operating Procedurecontains a detailed standardized description of how to carry out a task or working stepValidationA documented process for obtaining, recording and interpreting the results required to establish that a process will consistently yield products complying withpredetermined specifications (EN ISO17664)WorkstationStructural arrangement and layout equipped with the fittings needed to conductmanual cleaning, rinsing, disinfection anddryingMedical DevicesBGBlFederal Health GazetteBGRRules adopted by the statutoryBGVGuidelines issued by the statutoryBiostoffVBiological Substances RegulationBSABovine serum albuminaccident insurance institutionsaccident insurance institutionsC  DCleaning and disinfectionCJDCreutzfeldt-Jakob diseasecmCentimetrecm2Centimetre squaredCWCold waterdB DecibelDGHMGerman Society for Hygiene andDGKHGerman Society for Hospital Hy-Microbiology e. V.giene e. V.DGSVGerman Society for Sterile Supplye. V.DINGerman Institute for Standardi-DVVGerman Society for Control ofzation e. V.Viral Diseases e. V.DW Demineralized waterEN European standardESGE European Society for Gastrointestinal EndoscopyESGENA European Society of Gastroenterology and Endoscopy Nurses andAssociatesEEC European Economic CommunityGMBIJoint Ministerial GazetteHBVHepatitis B virusHCVHepatitis C virusHFHigh frequencyHIVHuman immunodeficiency virusIEC/TR International ElectrotechnicalCommission/Technical RulesIfSG Infection Protection ActIQ Installation qualificationISO International Organization forStandardizationkHzKRINKOKilohertzCommission for Hospital Hygieneand Infection Prevention at the1.2 List of abbreviationsRobert Koch InstituteAbbreviation ExplanationLAGA 18 C Degree CelsiusDisposal, Implementation Guide 18AKIWorking Group Instrument Prepa-LED Light emitting dioderationm3Cubic metreFederal Institute for Materials Re-mgMilligramsearch and TestingMISMinimally invasive surgeryBCABicinchonic acidminMinutesBfArMFederal Institute for Drugs andmmMillimetreBAMState Working Group on Waste

6 GuidelineMDMedical devicemPasMillipascalMPBetreibV Medical Devices Operator OrdinanceMPGGerman Medical Devices al qualificationPCDProcess Challenge DevicePEPolyethylenePPEPersonal protective equipmentPQPerformance qualificationprENPreliminary standard of a European standardQMQuality management systemRKIRobert Koch InstituteSDSSodium dodecyl sulphateSGBGerman Code of Social LawSOPStandard operating procedureTMBTetramethyl benzidineTRBATechnical Regulation on Biological SubstancesTrinkwV Drinking Water RegulationVAHAssociation for Applied HygienevCJDVariant Creutzfeldt-Jakob diseaseVDI e. V.Association of German EngineersWWatte. g.for exampleµgMicrogramµmMicrometreµSMicrosiemens1.3 Using the GuidelineThe Guideline consists of an explanatorysection as well as of annexes, a test matrixand checklists.The annexes describe structural prerequisites, test methods and processes. Theyprovide additional information on the respective topic.Annex 9 «Acceptance criteria for assessment of cleaning efficacy» sets out the currently valid acceptance criteria.The Test Matrix gives the user tips on howto plan and verify the various validationsteps. Details of the recommended testintervals help the processing departmentsdraw up the relevant schedules.The Checklists have been designed to helpthe user to verify the different validationsteps. Individual checklists can be directly implemented in the processing departments to facilitate planning and conductof validation and to record the test results.Central Service Suppl. 2013 2 Legal and Normative BackgroundMedical establishments are obliged to conduct medical device processing in line withthe dictates of quality assurance as imposed directly and indirectly by a series oflegal acts, regulations, recommendationsand standards.2.1 Legal acts and regulationsAll service providers in the healthcare sector are obliged to implement quality assurance measures aimed at improving theoutcome quality. To that effect, they mustset up an inhouse quality management system and continue to develop this (Sections135–137 of Book V of the German Code ofSocial Law).The Infection Protection Act (IfSG) callsfor compilation of Infection Control (Hygiene) Policies. These policies must define parameters for processing, includingchecks and tests.The German Medical Devices Act (MPG),which transposed Council Directive 93/42/EEC of 14 June 1993 concerning medicaldevices into German law, regulates, interalia, the requirements for functional andhygienic safety of medical devices.The Medical Devices Operator Ordinance(MPBetreibV) calls for, in Section 4(2),inter alia, validation of processing procedures.The Drinking Water Regulation definesmicrobiological and chemical requirements for drinking water.The Regulation on Health and Safety WhenHandling Biological Substances (BiostoffV) applies to tasks involving biological substances (pathogens) and must beobserved when processing medical devices. It calls for hazard assessment anddefinition of protective measures for a particular degree of protection.Biostoff V is supplemented by the Principles of Prevention (BGV A1), this is adocument relating to health and safety inthe workplace compiled by the Employers' Liability Insurance Association (statutory accident insurance associations),and by Biological Agents in the Healthcare Sector and in the Welfare Services(BGR 250/TRBA 250). It stipulates specialprecautions and behavioural approachesfor healthcare personnel that run the riskof contracting infection from pathogens.2.2 KRINKO RecommendationsPursuant to Section 23(3) IfSG, compliance with the relevant state of medical science is assumed if the published KRINKORecommendations for the respective areaare observed.Furthermore, pursuant to Section 4(2)MPBetreibV appropriate processing isassumed if the KRINKO/BfArM Recommendation for hygiene requirements forprocessing medical devices, jointly compiled by the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute (RKI) and the FederalInstitute for Drugs and Medical Devices(BfArM), are observedThis KRINKO/BfArM Recommendationsets out the requirements to be met by theprocessing procedures. Annex 1 describes«suitable validated processes»: «Whenprocessing a MD, the sum of all automated and manual processes involved (the various, mutually complementary processingsteps) contribute to achieving the processing goal. Hence, inadequately validatedindividual steps (processes), as well asfailure to observe the standard operatingprocedures, detract from the processingquality outcome».In addition, at least the following KRINKORecommendations must be observed:–– Hygiene requirements for cleaning anddisinfection of surfaces–– Requirements for the design, featuresand operation of decentralized disinfectant dispensers–– Hand disinfection.2.3 StandardsStandards are anticipated expert opinions on the state of the art. The standardsof importance for this Guideline include:–– EN ISO 14971 describes risk management with regard to medical devices–– EN 14885 specifies which claims by disinfectants (spectrum of action) must besubstantiated by which European teststandards–– EN ISO 17664 is intended for reusablemedical devices and single-use devicesthat are supplied in an unsterile state butmust be sterile when used. This standard specifies the information to be provided by the medical device manufacturer for processing medical devicesclaimed to be resterilizable. This information must include details of safe, val-

Guideline 7Central Service Suppl. 2013idated processing while ensuring thatthe medical device's functionality is preserved. «A validated process must bespecified for manual cleaning. In addition, at least one automated processin a washer-disinfector must be specified, unless the medical device does notlend itself to such a process. If that isthe case, a warning should be issued».Information on the manufacturer's instructions are given in Annex 1 «Contents of EN ISO 17664».2.4 RecommendationsThe recommendations of importance forthis Guideline are:–– Disinfectants List by the Association forApplied Hygiene (VAH), setting out thechemical disinfection methods testedand deemed effective for prophylacticdisinfection and hygienic handwashing.–– Guideline by the German Association forControl of Viral Diseases (DVV) e. V. andthe Robert Koch Institute (RKI) describing the methods for testing chemicaldisinfectants for efficacy against the viruses encountered in human medicine. 3 ScopeThis Guideline for Validation of ManualCleaning and Disinfection of Medical Devices is intended for all centres in hospitals and medical practitioners' offices inwhich medical devices for use on humansare processed. It also applies for piercingand tattooing studios as well as for podiatry establishments.The Guideline should be consulted formanual cleaning and disinfection, including manual pre- and re-cleaning in combination with automated cleaning/disinfection processes of all medical devices usedon patients. The following are not coveredby this Guideline:–– Processing steps such as inspection,care, functional testing, packing, labelling, sterilization, release for use aftersterilization, distribution and storage–– Heat-sensitive endoscopes–– Medical devices designated for singleuse by the manufacturer–– Medical devices excluded by regulation(e. g. by the KRINKO/BfArM Recommendation)–– Medical devices requiring wipe disinfection.Pursuant to the KRINKO/BfArM Recommendation, for cleaning and disinfection of medical devices belonging to theCritical B group automated cleaning andthermal disinfection must in principle becarried out with validated processes. Ifsubstantiated and following risk analysisand evaluation it is revealed that medicaldevices belonging to the Critical B grouplend themselves only to manual cleaningand chemical disinfection, the medical device manufacturer's instructions for validated manual cleaning and disinfectionmust be observed.The Guideline does not take account ofspecial aspects of medical device processing in relation to CJD/vCJD.It is pointed out that a detailed descriptionof all aspects of the accessories needed formanual cleaning and disinfection is outside the scope of this Guideline (e. g. details of the water and air operating pressure needed, compressed air quality),since precise details are not available inthe literature or in the manufacturer's instructions. 4 Requirements for processesManual cleaning, disinfection, rinse anddrying processes must be carried out in astandardized manner. Under no circumstances should the manual processes leadto a poorer outcome compared with thatassured by an automated process. Thismust be demonstrated in the context ofvalidation of standardized manual processes. All steps of manual processes mustbe performed, verified and recorded bydemonstrably qualified personnel.4.1 Preconditions for standardizationEstablishment of a quality managementsystem is a prerequisite for standardization and facilitates organization of workingpractices. Standard operating proceduresfor cleaning and disinfection processesalso serve as verification standards. Thequality of manual cleaning and disinfection is demonstrably assured by definingand implementing suitable test measuresas well as by observing the defined acceptance criteria and, if applicable, taking remedial action. Process reproducibility canonly be assured if all process participantsare appropriately trained.The operator must draw up standard operating procedures, describing in detailsall processing steps. Depending on themedical device's intended purpose anduse, SOPs must also be compiled for anyprocessing steps prior to and/or aftercleaning and disinfection. This appliesfor testing and operating equipment andsystems used during the cleaning and disinfection process (for example an ultrasonic bath/cleaner, stopwatches, dosingequipment).Note : Standard operating procedures aretailored to a specific process, medical device or workplace. They serve as serviceinstructions for all staff members to ensurethat tasks can be demonstrably dischargedin a quality-assured and reproducible manner. The individual working steps are commonly presented in flow charts, tables orsummarized in short sentences.To standardize a manual cleaning and disinfection process, the prerequisites described below, at the very least, must bemet by the operator and by the manufacturers of the medical devices, accessories(e. g. ultrasonic bath, brushes) and of process chemicals.4.1.1 Structural, technical and organizational prerequisites at operator's premisesFirst, the structural and spatial prerequisites are verified and, if necessary, amended. Of paramount importance here is definition of working sequences while takingaccount of occupational health and safetyrequirements.If structural separation of the cleaning/disinfection zone from the clean zone isnot possible, by taking appropriate functional and/or organizational measures itmust be ensured that transmission of microorganisms and particles is kept to aminimum. Standardization can begin onlyafter the circuit allotted for manual cleaning and disinfection has been properly setup, connected and is operational, and alloperating materials of the required quality are available.An example of the workstation for manualcleaning and disinfection is illustrated inAnnex 2 «Workstation – example».Quality assurance measures are amongthe organizational prerequisites of vitalimpor

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