Direzione Infermieristica e Tecnica Azienda Unica della Romagna sede di Forlì Dott.ssa Alessandra Rosetti Centrale di Sterilizzazione

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1 Direzione Infermieristica e Tecnica Azienda Unica della Romagna sede di Forlì Dott.ssa Alessandra Rosetti Centrale di Sterilizzazione

2 Instruments Traceability Management PRACTICAL INFORMATION TO TRACK AND TRACE THE STERILIZATION PATH OF REUSABLE MEDICAL DEVICES

3 Tracking surgical set and sterile MD Traceability and Risk Management??!!

4 RISK MANAGEMENT AND INSTRUMENTS TRACKING PATH PATIENT SAFETY OPERATOR SAFETY Tracking the utilization of the sterile supplies in the operating theatre to link individual instruments used to specific operations and patients. Which product? Which patient?..

5

6 Risk Analysis Medical Devices Safety UNI EN ISO Risk management of medical devices riconditioning Use Identification and characteristics related to the safety of the medical device: Devices delivered in a sterile state are sterile... and maintain such quality until the wrapper that ensures the sterility is opened "Raro ma non Impossibile" Castrocaro Terme 16 ottobre 2010

7 UNI EN ISO risk management in medical devices reconditioning Risk Analysis Identification of dangerous situation Risky situation during the process FOR THE OPERATOR FOR THE PATIENT Biological and Chemical Risk Burns Posture damages Failure Deficiency Not sterilized

8 Risk management is an ethical imperative for every health care worker; The possibility to cause significant damage during work procedure to another operator or to a patient should be abolished or reduced according to the knowledge and adoptable technologies.

9 safety

10 UNI EN QUALITY MANAGEMENT SYSTEM Product Requirements: The product has to be clean before sterilization Product given not sterilized.. product characteristics (technical info sheet) Use of suitable equipment Traceability: the organization must have documented procedures for traceability... and keep records of all required data.

11 UNI EN QUALITY MANAGEMENT SYSTEM Special requirements for sterile MD: The organization shall keep records of the process parameters used for each sterilization lot. Records must be linked to each medical device production lot.

12 What we sterilize???? How? In how long???

13 acquire the knowledge Storage Sterilization Packing Risk Management

14 PROCESSO DI STERILIZZAZIONE WASHING RINSING DECONTAMINATION DRYING COLLECTION RECEPTION AND USE SURGICAL UNIT CSSD CHECK AND MAINTENANCE STORAGE AND DELIVERY STERILIZATION PACKING "Raro ma non Impossibile" Castrocaro Terme 16 ottobre 2010

15 The flow of the supply of sterile material Sterile Delivery Sterile Storage Sterilization Use Packing Arrival Dirty Material Wash and disinfection Check and kit Composition

16 E adesso dottore mi fa vedere Lei come fa a lavare, decontaminare, controllare, imballare e sterilizzare il suo endoscopio in ½ ora

17 And once it has been sterilized.. Who did it??? Who has it??? Where is it???

18

19 CSSD WorkFlow Management Washing Area Packing Area Sterile Area Return dirty /decontam/not used Select/ instruments opening Washing basket composition Wash machine load Autoclave load Packing SBS Clean Reception Ordinary and extraordinary Maintenance Unload Wash machine Cycle check and validation Cycle check and validation Autoclave Unload Storage Preparing Trolley per specialty Trolley Delivery DDT Surgical Unit Trasport and Storage in storage room Check in: trolley reception Database Management Availability Trolley going from CSSD/ OT Expiry Dates Use Decontamination

20 Cultural Change

21 Azienda USL di Forlì - CENTRALE DI STERILIZZAZIONE -Direttore: Dott. S. Bianchi Istruzione Operativa gestione tracciabilita TRACKING SYSTEM IN USE

22 The system records all activities relating to individual surgical instruments and complete sets, from the sterilization process to their utilization in theatre. The system helps to achieve a high level of standardization, and guaranteed quality, safety, and productivity, thanks to well-defined operating procedures and the subsequent emphasis on support and supervision that the system offers. The system manages all the activities related to the maintenance of the instruments and stores all the information related to their central of sterilization

23 Tracking of sterilized material possibility to rebuild the history, the use or the location of a sterile product.

24 Safety and Reliability Standardization of the production process Real time alarm if anomalies occur More safety for the patient More safety for the Operator

25

26 Kit status Development Washed Packed Returned In Autoclave Used Sterilized In Storage Room Delivered

27 CSSD WorkFlow Management Washing Area Packing Area Sterile Area Return dirty /decontam/not used Select/ instruments opening Washing basket composition Wash machine load Autoclave load Packing SBS Clean Reception Ordinary and extraordinary Maintenance Unload Wash machine Cycle check and validation Cycle check and validation Autoclave Unload Storage Preparing Trolley per specialty Trolley Delivery DDT Surgical Unit Trasport and Storage in storage room Check in: trolley reception Database Management Availability Trolley going from CSSD/ OT Expiry Dates Use Decontamination

28 Azienda USL di Forlì - CENTRALE DI STERILIZZAZIONE -Direttore: Dott. S. Bianchi Istruzione Operativa gestione tracciabilita

29 CSSD WorkFlow Management Washing Area Packing Area Sterile Area Return dirty /decontam/not used Select/ instruments opening Washing basket composition Wash machine load Autoclave load Packing SBS Clean Reception Ordinary and extraordinary Maintenance Unload Wash machine Cycle check and validation Cycle check and validation Autoclave Unload Storage Preparing Trolley per specialty Trolley Delivery DDT Surgical Unit Trasport and Storage in storage room Check in: trolley reception Database Management Availability Trolley going from CSSD/ OT Expiry Dates Use Decontamination

30

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32 Azienda USL di Forlì - CENTRALE DI STERILIZZAZIONE -Direttore: Dott. S. Bianchi Istruzione Operativa gestione tracciabilita

33

34 Azienda USL di Forlì - CENTRALE DI STERILIZZAZIONE -Direttore: Dott. S. Bianchi Istruzione Operativa gestione tracciabilita

35 CSSD WorkFlow Management Washing Area Packing Area Sterile Area Return dirty /decontam/not used Select/ instruments opening Washing basket composition Wash machine load Autoclave load Packing SBS Clean Reception Ordinary and extraordinary Maintenance Unload Wash machine Cycle check and validation Cycle check and validation Autoclave Unload Storage Preparing Trolley per specialty Trolley Delivery DDT Surgical Unit Trasport and Storage in storage room Check in: trolley reception Database Management Availability Trolley going from CSSD/ OT Expiry Dates Use Decontamination

36 Azienda USL di Forlì - CENTRALE DI STERILIZZAZIONE -Direttore: Dott. S. Bianchi Istruzione Operativa gestione tracciabilita

37

38 CSSD WorkFlow Management Washing Area Packing Area Sterile Area Return dirty /decontam/not used Select/ instruments opening Washing basket composition Wash machine load Autoclave load Packing SBS Clean Reception Ordinary and extraordinary Maintenance Unload Wash machine Cycle check and validation Cycle check and validation Autoclave Unload Storage Preparing Trolley per specialty Trolley Delivery DDT Surgical Unit Trasport and Storage in storage room Check in: trolley reception Database Management Availability Trolley going from CSSD/ OT Expiry Dates Use Decontamination

39

40

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42 Itineris system tracks instrument kits or single Instrument previously marked with a datamatrix 2D unique code that could be made with laser or micropercussion technique. Having instruments marked helps the operator with a little experience in packing phase, prevent the loss of expensive equipment tracking each instrument move inside the hospital and outside when it is send to external companies for maintenance activities.

43 If one of the instrument belonging to a kit It is not available as it is faulty, it is highlighted also in that kit check list in packing phase

44 You cannot pretend to be what you have never been mai stati Thanks! ;)

(Samuel LAW Tat Hong) (COM CSSD NTWC)

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