實際實踐中的過程驗證 - 來自德國醫院的案例研究.pdf

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1、PROCESS VALIDATION IN REAL PRACTICE-A CASE STUDY FROM A GERMAN HOSPITALName:Bianca WinklerAffiliation:Head of QM in CSSD of RoMed Clinic(Rosenheim&Bad Aibling)in South Bavaria,GermanyAgendaAgenda1.1.Presentation of the Presentation of the RoMedRoMed GroupGroup2.2.Validation Validation Whats that?Wha

2、ts that?3.3.Why we do process validationWhy we do process validation4.4.Which processes do we validate?Which processes do we validate?5.5.How we do that?4 Main steps in Validation processes in How we do that?4 Main steps in Validation processes in practicepractice6.6.Take a Look into the Validation

3、Process of the CSSDs in Take a Look into the Validation Process of the CSSDs in RoMedRoMedBianca Winkler-Process Validation in a real Practice21.Presentation of the RoMed Group1.Presentation of the RoMed GroupSource:https:/www.stepmap.de/landkarte/deutschland-blau-in-europa-FyG2dyiweZ-i,Upload 25.10

4、.2024Source:https:/www.stepmap.de/landkarte/Bayern-139343.png,Upload 20.04.2024Source:RoMed,Upload 20.04.2024GermanyState of BavariaDistrict ofRosenheimBianca Winkler-Process Validation in a real Practice3With over 1,000 beds,we care for around 50,000 inpatients and 90,000 outpatients every year in

5、our four municipal RoMed clinics in Bad Aibling,Prien am Chiemsee,Rosenheim and Wasserburgam Inn.Around 3,000 employees look after the well-being of our patients around the clock.Bianca Winkler-Process Validation in a real Practice4RoMed RoMed ClinicsClinicsBianca Winkler-Process Validation in a rea

6、l Practice5RosenheimRosenheim-a maximum care hospital.Illnesses from the eyes to the toes are treated here at the highest level.With 622 beds and 2,000 employees,the RoMed Hospital Rosenheim is the largest hospital in the RoMed clinic network.Specialist departments are:certified Chest Pain Unit and

7、Stroke Unit The breast center,gynecological center,oncological center and visceral oncological center for the intestinesOur perinatal center for the support of high-risk pregnancies and the outstanding care of even the smallest premature babies and newbornsBianca Winkler-Process Validation in a real

8、 Practice6The RoMed Clinic Bad Aibling is a basic and standard care hospital and treats around 20,000 outpatients and inpatients every year.The main departments of the house:Visceral and Trauma surgeryinternal medicineanesthesia and ear,nose and throat medicine.There are medical collaborations for g

9、ynecology,as well as orthopedics with endoprosthetics(joint replacement)and spinal surgery.Bianca Winkler-Process Validation in a real Practice7CSSDsCSSDs Places of the RoMed Places of the RoMed ClinicsClinicsCSSD RosenheimCSSD RosenheimSince 2009 placed in the basement of the hospital2022 produced

10、35.000 StU2023 produced 49.000 StU25 employees in a 2 shift system,full-time and part-time workersOpening hours:6 am till 0 amAll surgical departments including robotics and Critical C Medical ProductsManufacture certificated under EN ISO 13485 since 2012Manufacture structure Getinge5 washer one Cha

11、mber washer and 1 large-capacity washer for Container and Transport trollies3 steam sterilizer with capacity of 8 StU eachBianca Winkler-Process Validation in a real Practice8CSSD Bad AiblingCSSD Bad AiblingSince 2022 placed in the basement of the new Building2022 produced 16.000 StU2023 produced 23

12、.000 StU15 employees in a 2 shift system,full-time and part-time workersOpening hours:6 am till 1 amAll surgical departments preparation till Critical B Medical Products of the Clinics Bad Aibling,Wasserburgand PrienManufacture certificated under EN ISO 13485 since 2022Manufacture structure MMM5 was

13、her one Chamber washer and 1 large-capacity washer for Container and Transport trollies3 steam sterilizer with capacity of 8 StUeachBianca Winkler-Process Validation in a real Practice92.Validation 2.Validation WhatsWhats thatthat?The validation is used to verify the performance and to demonstrate t

14、he reproducibility of the standardized procedures.A validation consists of:Installation Qualification(IQ),Operational Qualification(OQ)and Performance Qualification(PQ).In CSSDs the Performance Qualification is the Validation of Medical devices or Processes which take parts in the reprocessing of a

15、medical product.Is repeated annualy in the form of a so called Requalification and is an exciting process for everyone involved.Bianca Winkler-Process Validation in a real Practice103.3.WhyWhy wewe do process validation?do process validation?a.National RegulationsJoint recommendation of the Commissi

16、on for Hospital Hygiene and Infection Prevention and the Federal Institute for Drugs and Medical Devices“Suitable validated procedures Suitable validated procedures within the meaning of Section 8 MPBetreibV(Medical Device Operator Regulation)are procedures,are procedures,which consistently and repr

17、oducibly deliver a defined resultwhich consistently and reproducibly deliver a defined result(in particular cleanliness,low germ count/sterility and functionality).When reprocessing a medical device,the sum of all the mechanical and manual processes involvedthe sum of all the mechanical and manual p

18、rocesses involved(complementary individual steps of processing)contributes to achieving the respective processing goalcontributes to achieving the respective processing goal.With the validation of the preparation processes,the parameters are also definedthe parameters are also defined,which are requ

19、ired to prove that the respective process(individual step of preparation,e.g.cleaning,disinfection and sterilizationof medical devices)was passed through in a form that achieves guaranteed according to the specified specifications”EpidBull 2018;6:67 68|DOI 10.17886/EpiBull-2018-006Bianca Winkler-Pro

20、cess Validation in a real Practice11Medical Device Operator Regulation Section 8“Processing of medical devices”The reprocessing of medical devices that are intended to be used in a low-germ or sterile manner must be carried out using suitable,must be carried out using suitable,validated procedures,t

21、aking into account the manufacturers informationvalidated procedures,taking into account the manufacturers information,in such a way that the success of these procedures is comprehensibly guaranteed and the safety and health of patients,users or third parties is not endangered.This also applies to m

22、edical devices that are disinfected or sterilized before their first use.(MDBetreibV,8(1),21.04.2021I833)MDR 2017/745Chapter 1,Section 2“Definitions”Number 39“Reprocessing”means a process to which a used product is subjected in order to make it safe can be reused;“Reprocessing”means a process to whi

23、ch a used product is subjected in order to make it safe can be reused;These procedures include cleaning,disinfection,sterilization and similar Procedures as well as tests and restoration of the technical and functional safety of the used product;Guideline compiled by German Society of Hospital Hygie

24、ne(DGKH),German Society of Sterile Supply(DGSV)and Working Group Instrument Preparation(AKI)Bianca Winkler-Process Validation in a real Practice12b)b)Promise Quality Management in the interests of patient safetyPromise Quality Management in the interests of patient safetyControl process that ensures

25、 that our daily work meets our quality standards and regulatory requirementsTechnical exchange with validation experts helps to evaluate and adapt the processes to the latest state of the artValidation of processes and devices enables a critical examination of all components:people-machines consumab

26、lesc)Conclusionc)ConclusionBianca Winkler-Process Validation in a real Practice134.Which processes do we validate?4.Which processes do we validate?a)a)Cleaning and Disinfection process Cleaning and Disinfection process based on the DIN EN ISO 15885 and the Guideline compiled by German Society of Hos

27、pital Hygiene(DGKH),German Society of Sterile Supply(DGSV)and Working Group Instrument Preparation(AKI)for validation and routine monitoring of automated cleaning and thermal disinfection processes for medical devices(2024)b)Sterilization Process b)Sterilization Process based on the DIN EN 285 and D

28、IN EN ISO 17665c)Packaging Process c)Packaging Process based on DIN EN ISO 11607 and the Guideline compiled by German Society of Hospital Hygiene(DGKH),German Society of Sterile Supply(DGSV)and Working Group Instrument Preparation(AKI)for the validation of packaging processes according(2020)Bianca W

29、inkler-Process Validation in a real Practice14Yearly repeating Yearly repeating Validation Schedule Validation Schedule OktOktCleaning Cleaning ValidationValidationNovNovSteam Sterilizer Steam Sterilizer ValidationValidationMayMayPackaging Packaging ValidationValidationEvery yearly cycle can be seen

30、 as Every yearly cycle can be seen as a continuous improvement loopa continuous improvement loop5.How we do that?5.How we do that?At first we define the hole procedure for the Validation define the hole procedure for the Validation of Processes in the CSSD together with the hospital Hygiene and medi

31、cal technology.Process ResultScopeProcess descriptionEvaluationPlanImplementationDocumentation an ReleaseRequalificationPartner in ProcessValid DocumentsBianca Winkler-Process Validation in a real Practice154 Main Steps of Validation4 Main Steps of Validation1.Scheduling and Preliminary Talk2.Proces

32、s Validation3.Final Meeting and Validation Report4.Review Validation Report and Release Bianca Winkler-Process Validation in a real Practice161.Scheduling and Preliminary TalkMaintenance must be done before validationMaintenance must be done before validationFilling out the Checklist of the validati

33、on TechnicianFilling out the Checklist of the validation Technician3 pages with information Company/Hospital contact informationReason of Validation(IQ,OQ,PQ or REQ)Periodical without a special ReasonFor special ReasonWater AnalysesProgram overviewDevice ListUsing Types of packing(Sterilization REQ)

34、Changes compared to the last REQRoutine ChecksScheduling and Information of Partner in Process Scheduling and Information of Partner in Process OR Coordination and StaffDepartment of Medical TechnologyCSSD TeamBianca Winkler-Process Validation in a real Practice172.ProcessValidationBianca Winkler-Pr

35、ocess Validation in a real Practice18Definition of Load configuration of the Washer/Sterilizer Definition of Load configuration of the Washer/Sterilizer-in Cooperation in Cooperation with Validation Technician with Validation Technician Set Focus on:Soiled Medical Device(MP)Worst case loadHeavy sets

36、Difficult construction of the MPMP with difficulties in reprocessing during the last validationNew MP GroupChallenge for the Validation Team(CSSD+Technician):Challenge for the Validation Team(CSSD+Technician):Getting same load configuration for the hole days of validationWillingness to cooperate on

37、the part of the operating room staff3.Final Meeting and Validation ReportBianca Winkler-Process Validation in a real Practice19Final Meeting between Technician and CSSD staffFinal Meeting between Technician and CSSD staffDiscussion of the validation process with notes for future reprocessing process

38、Validation ReportValidation ReportStructure of the documentation includes:a summary,tests process,routine checks,results and differences,recommendations for improvement and observation periodThe appendix contains calibration documents and evidence of the technicians qualifications.During the first 4

39、 Pages of the Report,the Result of the Validation will be written.4.Review Validation Report and Release Bianca Winkler-Process Validation in a real Practice20Each validation report must be released by the CSSD operatorEach validation report must be released by the CSSD operator.1.Review the Report

40、with Focus on:CompletenessAccuracyClarity2.Let other disciplines take a look in the Report Department of Hospital hygieneDepartment of Medical Technology3.Release of Validation Report by the Management of the Hospital6.6.Take a Look into the Validation Process of the CSSDs in RoMedTake a Look into t

41、he Validation Process of the CSSDs in RoMeda)a)Validation of the Cleaning and Disinfection ProcessValidation of the Cleaning and Disinfection ProcessBianca Winkler-Process Validation in a real Practice21loading rack with 3 levels for standard and Instruments with lumensloading rack with 4 levels for

42、 standard and Instruments without lumensLoading rack with 3 levels for standard and special instruments(ophthalmology)Load carrier for medical devices for anesthesiaBianca Winkler-Process Validation in a real Practice22Loading rack with 2 levels for standard and special instruments(Robotic MD,DaVinc

43、i)Loading trollies for the big chamber washerLoading trollies for the big chamber washerLoading trollies for baskets,plastic transport tubes,containerLoading trolly for Loading trolly for standard Instruments standard Instruments without lumenswithout lumensTesting method in practiceTesting method i

44、n practiceBianca Winkler-Process Validation in a real Practice231)Standardized test specimen-Crile Clamp The Crile Clamp with test soiling according to guidelines 2017.Test soiling is carried out in a qualified laboratory using sheep blood.The instrument is then dried in a drying cabinet and vacuum

45、packed.2)Real soiling MD of the ORTesting of cleaning performance Testing of cleaning performance with real soiled Instruments or testing deviceswith real soiled Instruments or testing devicesBianca Winkler-Process Validation in a real Practice24Testing Examples for the LCWTesting Examples for the L

46、CWExamples of soiled Instruments with different construction(Heavy or lumens)Bianca Winkler-Process Validation in a real Practice25Anesthesia MD with preparingTesting of real soiled MD of robotics and ophthalmologyb)Validation of the Sterilization ProcessValidation of the Sterilization ProcessRefere

47、nce load configuration for validation including:-Heavy loads,-all different packaging materials,-maximum stackingCSSD Bad AiblingCSSD RosenheimCSSD RosenheimBianca Winkler-Process Validation in a real Practice26Instruments with temperature or pressure sensorsBianca Winkler-Process Validation in a re

48、al Practice27Bianca Winkler-Process Validation in a real Practice285 5 Set LSK Grund“Packaging:inside paper,outside fleece,set standing directly on absorb fleece9 9 Set RF Bipo Kabel“Packaging:double in foil-paper sealed packaging Bianca Winkler-Process Validation in a real Practice29c)Packaging pro

49、cess validationPackaging process validationNoteNote:Every type of packaging must be validated-not only as part of sterilization,but also the packaging process itself must be validated.3 Types of packaging process3 Types of packaging processHard packaging ContainerSoft packaging FleeceSoft packaging

50、Foil MaterialBianca Winkler-Process Validation in a real Practice30ContainerPhoto Documentation of Packaging for SterilizationPhoto Documentation of Packaging for SterilizationNote:Note:all different types of container or fleece must be validatedBianca Winkler-Process Validation in a real Practice31

51、FoilMaterialNote:Note:Each type of foil paper/fleece(with and without folds)and manufacturer must be validated depending on the sterilization programBianca Winkler-Process Validation in a real Practice32What are the advantages and disadvantages of validation in my personal What are the advantages an

52、d disadvantages of validation in my personal experience?experience?Validation as a tool allowed us for a better understanding our processesFind weaknesses and address themHave an external expert who supports us every year againFor questionsRefine our processesLet us implement a continuous improvemen

53、t cycleA written proof to ourself and to our stakeholders that we are following best practicesValidation is like a seal of quality,it shows us that our processes meet the high national Validation is like a seal of quality,it shows us that our processes meet the high national requirements and the sta

54、te of the art.requirements and the state of the art.Carrying out validation can sometimes be a challenging journey for the CSSD and its partners in the Carrying out validation can sometimes be a challenging journey for the CSSD and its partners in the process process-in a positive sense.in a positiv

55、e sense.Bianca Winkler-Process Validation in a real Practice33ReferencesReferencesRKI/BfArM 2012:Hygiene Requirements for the Reprocessing of Medical Deviceshttps:/www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Kommission/Downloads/Hygiene_Requirements_Medical_Devices_2012.pdf?_blob=publicationFile

56、(English);DOI 10.1007/s00103-012-1548-6(German)DIN EN 285:2016 Sterilization-Steam sterilizers-Large sterilizersISO 17665-1:2006 Sterilization of health care products Moist heat Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devicesGuide

57、line for validation and routine monitoring of automated cleaning and thermal disinfection processes for medical devices(DGKH,DGSV+AKI)-2024Guideline for validation of Packaging Process DIN EN ISO 11607(DGKH,DGSV+AKI)2021Link for all Guidelines:https:/www.dgsv-ev.de/fachinformationen/leitlinien/Copyright of all pictures shown belongs to CSSD RoMedBianca Winkler-Process Validation in a real Practice34The CSSDs of Rosenheim The CSSDs of Rosenheim and Bad Aibling sends and Bad Aibling sends greetings to Chilegreetings to ChileThanks for your attention!Thanks for your attention!