New Requirements of ISO 17664/AAMI ST 81

Transcription

1 New Requirements of ISO 17664/AAMI ST 81 How the instrument manufacturer validate the cleaning process Klaus Roth SMP GmbH Tübingen Germany SMP GmbH

2 Operation, which have been cancelled due to not sufficient reprocessed instruments Year Data of 57 hospitals** Estimated for England and Wales ** 57/340 Datensätze * mit freundl. Genehmigung G.Shapp MP SMP GmbH

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4 ISO (2004) Preparation at the point of use Preparation, cleaning, disinfection Drying Inspection, maintenance and testing Packaging Sterilisation Storage SMP GmbH

5 ISO (2004) SMP GmbH

6 Instrument circulation in a hospital Use Available for use Storage/transport Storage Cleaning/disinfection Sterilisation Service and maintenance Functional testing SMP GmbH

7 ISO (2004) 3.5 Cleaning A validated method of cleaning shall be specified. At least one validated automated method using a washer-disinfector shall also be specified unless the medical device cannot withstand any such process, in which case a warning should be issued. Where appropriate, at least the following information shall be included:.accessories required for cleaning process;.identification and concentration of chemicals required for cleaning;.identification of water quality,.limits and monitoring of chemical residues.limits on temperature, concentration of solution(s), exposure time,.process temperature(s);.techniques to be used including rinsing; SMP GmbH

8 Standard EN/ISO 17664: Chapter 5 allows the building of groups of instruments: Where the manufacturer supplies a number of different medical devices which share common features and attributes, the validation specified may be performed with respect to these medical devices as a group of family, provided that the manufacturer can demonstrate the commonality of the medical devices and that the tests and assessments address the worst case feature or attribute of the group of family SMP GmbH

9 ISO (new) Scope 1.1 Inclusions This International Standard specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use. This includes information for processing prior to use or reuse of the medical device. The provisions of this standard are applicable for medical devices that are intended for invasive or other direct patient contact. Processing instructions are not defined in this standard. Rather, this International Standard specifies requirements to assist manufacturers of medical devices in providing detailed instructions for processing that consists of the following activities where applicable: SMP GmbH

10 ISO (new) 1.1 Inclusions a) Pre-treatment at the point of use before processing; b) Preparation before cleaning, c) Cleaning, d) Disinfection; e) Drying; f) Inspection, maintenance and testing; g) Packaging; h) Sterilization; i) Storage j) Transportation. 1.2 This standard excludes: noncritical medical devices not intended for direct patient contact; Textile devices used in patient draping systems or surgical clothing; processing of medical devices specified by the manufacturer for single-use only and supplied sterile SMP GmbH

11 ISO (new) SMP GmbH

12 ISO (new) SMP GmbH

13 ISO (new) If the medical device is intended to be disinfected a validated method of manual disinfection Shall be specified if automated disinfection is not possible SMP GmbH

14 ISO (new) SMP GmbH

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16 Categories of instruments and specific requirements for use: Instruments, to be used outside the body. Instruments, to be used inside the body without penetration of the mucosa or skin. Instruments, penetrating the skin or mucosa. Clean / Disinfected High Level Disinfected Sterile Spaulding Classification by the CDC SMP GmbH

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18 Classification of the instruments groups Group 1: Group 2: Group 3: Group 4: Group 5: Group 6: Group 7: Critical Instruments, like hooks; no hidden surfaces and lumens Critical Instruments Scissors, Clamps Shift shaft instruments Rongeur etc. Shaft instruments for MIS need validation, as the result of the cleaning can not be inspected Micro surgical Instruments need validation, as the result of the cleaning can not be inspected Complex Devices has to be tested, as no analogical conclusions can be made Flexible Instruments need validation, as the result of the cleaning can not be inspected SMP GmbH

19 Comparison of Group 2 Instruments Crile Clamp, 1. Messung nach Kontaminati on 2. Messung nach Vorreinigung + 10 min 40 C Einweichen 4. Messung nach Reinigung 1. Messung nach Kontaminati on 2. Messung nach Vorreinigung + Ultraschall 10 min 40 C 3. Messung nach Reinigung Nr.87/26 Zr Zr Zr Zr Zr Zr Crile clamp Crile clamp Crile clamp SMP GmbH

20 Group 2 (Instruments with hidden surfaces): Side cutter 1. Messung nach Kontaminati on 2. Messung nach Vorreinigung + 10 min 40 C Einweichen 3. Messung nach Reinigung 1. Messung nach Kontaminati on 2. Messung nach Vorreinigung + Ultraschall 10 min 40 C 3. Messung nach Reinigung Nr.87/26 Zr Zr Zr Zr Zr Zr Wire cutter Wire cutter Wire cutter SMP GmbH

21 Group 3: Shift shaft instruments Yes 1 Yes 2 Yes 3 Tischler-Morgan (Not dismountable) Step 1 Yes 1 Yes 2 Yes 3 No Step 2 Yes 1 Yes 2 Yes 3 No Step 3 No Validation not successfull SMP GmbH

22 Group 3 (Shift shaft instruments): Rongeur,Arthroskopiezangen etc. 1. Messung nach Kontaminati on 2. Messung nach Vorreinigung + 10 min 40 C Einweichen 4. Messung nach Reinigung 1. Messung nach Kontaminati on 2. Messung nach Vorreinigung + Ultraschall 10 min 40 C 3. Messung nach Reinigung Nr.87/26 Zr Zr Zr Zr Zr Zr Rongeur Rongeur Rongeur SMP GmbH

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24 Group 3: Shift shaft instruments (dismantable) Yes 1 Yes 2 Yes 3 Bronchoscopy Forceps (Dismountable) Step 1 Yes 1 Yes 2 Yes 3 No Step 2 Yes 1 Yes 2 Yes 3 No Step 3 No Validation not successfull SMP GmbH

25 Group 3: Shift shaft instruments (improved design) SMP GmbH

26 Instruments for Minimally invasive surgery Dismountable Not dismountable with Luer adapter SMP GmbH

27 Parameters of the Cleaning Cycle Interacting Time Mechanics: Amount of Water Pressure Ultrasound Temperature Chemical Agent Water Quality SMP GmbH

28 MIS Instruments dismountable Results: Remaining contamination in the shaft Manual pre-cleaning required Anzahl der Instrumrnte unter 5 Counts/sec Anzahl der Instrumrnte über 5 Counts/sec 100% 100% Hunderte 73% 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Miele 7836 Oxivario Gesamt Anteill der Ins. 11 0% Miele 7836 Tw /Tb Gesamt Anzahl der Ins. 11 0% 73% Miele 7735 Alkalisch Gesamt Anteil der Ins.11 27% 27% Miele 7735 Enzymatisch Gesamt Anteil der Ins SMP GmbH

29 ISO (new) Chemistry SMP GmbH

30 MIS Instruments, not dismountable with Luer adapter Results: Remaining contamination in the shaft Anzahl der Instrumrnte unter 5 Counts/sec Anzahl der Instrumrnte über 5 Counts/sec Hunderte 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 100% Niagara Enzymatisch Gesammt Anteil der Ins.19 0% 95% Miele 7836 Oxivario Gesamt Anteill der Ins. 19 Manual pre-cleaning required 5% 84% Miele 7836 Tw /Tb Gesamt Anzahl der Ins % 48% 52% Miele 7735 Alkalisch Gesamt Anteil der Ins.19 42% Miele 7735 Enzymatisch Gesamt Anteil der Ins.19 58% SMP GmbH

31 Effort for cleaning Validation not successfull Validation not successfull Effort for cleaning Influence of the detergent Group 2: Alkaline Step 3 Step 2 Step 1 2 A Titan 2 A Ceramic 2 B 2 C 2 D 2 E 2 F Instruments sorted by category Tab. 58: Zusammengefasste Ergebnisse Gruppe 2 Alkalisch maschinell und ggf. manuellen Vorreinigung Group 2: Enzymatic automated and manual if necessary Step 3 Step 2 Step 1 2 A Titan 2 A Ceramic 2 B 2 C 2 D 2 E 2 F Instruments sorted by category Tab. 59: Zusammengefasste Ergebnisse Gruppe 2 Enzymatisch maschinell und ggf. manuelle Vorreinigung SMP GmbH

32 Power of cleaning processes Multicomponent Process Power Flush Multicomponent Enzymatic process Alcaline process Enzymatic process SMP GmbH

33 Parameters of the Cleaning Cycle Mechanics: Amount of Water Pressure Ultrasound Interacting Time Temperature Chemical Agent Water Quality SMP GmbH

34 Validation of the cleaning step Monitoring of water pressure SMP GmbH

35 Foaming SMP GmbH

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37 Vario SMP GmbH

38 Influence of Velocity of Flow Laminar Flow SMP GmbH

39 Influence of Velocity of Flow Turbulent Flow R e r v l m u Reynolds number Density Velocity Length Viscosity kin. Viscosity R e = l r v m SMP GmbH

40 Test procedure: OPA-Testing according to ISO Improved Cycle of the Medisafe PCF with High Pressure Ultrasonic Irrigation Pre-Wash internal & 3 bar Detergent Dispense De-gas 15 minute Ultrasonic Main Wash internal/external 3 bar Pre-Rinse internal & 3 bar Final Rinse Empty each cycle SMP GmbH

41 Guidelines and legal Requirements SMP GmbH

42 Cleaning: Contamination of the artery clamps with 100µl coagulable sheep blood Investigation of Cleaning Performance Following the Standard pren/iso Zentr Steril 2005; 13: SMP GmbH

43 SMP GmbH Validation of Washer/Disinfectors (Cleaning tests) PCD: Vacuum package Real contamination

44 SDS-Elution for OPA-testing SMP GmbH

45 Results of the round robin test 2004 Charge I 1 x und Charge II 2 x = 100 Charge III 1 x = 100 Charge I 1 x = 100 Charge II 1 x = SMP GmbH

46 First results of the year 2005 of automated reprocessing In order to implement the up and coming EN ISO in practice, we worked out the Guidelines of the DGKH, DGSV and AKI for validating and routinely monitoring automatic washing and disinfecting processes for thermo-stable medical devices, and principles for selecting a washer-disinfector (WD) Part 1**. In an inter-hospital trial conducted with 18 hospitals, the practicability and meaningfulness of the test method was investigated. 5 of 18 WD involved in the trial were over threshold. Although the sensitivity of the semi-quantitative Biuret / BCA method used in the tests is fairly low, it can be presumed that the evaluation framework is sufficient for the moment to identify WDs with poor cleaning quality, and to monitor the quality of the measures carried out here. Inter-hospital trials to determine minimal cleaning performance according to the Guidelines from DGKH, DGSV and AKI; Zentr Steril 2005; SMP GmbH

47 Summary of 10 years validation Remaining protein on test instruments (4122) in 2012 Restprotein an Prüfinstrumenten, Anzahl: % 2% 20% unwg 50µg µg µg 73% SMP GmbH

48 Summary of 10 years validation Restprotein an Realinstrumenten, Anzahl: 3780 Remaining protein on real used instruments (3780) in % 6% 18% 64% unwg 50µg µg µg SMP GmbH

49 Summary of 10 years validation Remaining protein on real used MIC instruments (786) in SMP GmbH

50 Protein detection methods Bradford-Method Modified OPA-Method Biuret-Reaction BCA-Protein Assay Kit Ninhydrin-Reaction TOC (Total organic Carbon) ATP Combur 3Test HemoCheck-S SMP GmbH

51 Protein detection methods 0, ,1 Protein: 16 µg/ml 160 µg/ml 1,6 mg/ml 160 mg/ml SMP GmbH

52 SMP GmbH HemoCheck-S Test Kit for a qualitative determination blood on surgical instruments 100µg 1µg 0µg

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54 Dilution of Blood Full blood Visual detection of blood is possible up to 1: SMP GmbH

55 Combur 3 Test SMP GmbH

56 SMP GmbH Combur 3 Test Hemoglobin katalysed the Oxidation of the indicator by organic H 2 O 2 Very sensitive Detection limit at 0,3 µg/ml Extraction of the protein from the instrument can be performed with SDS

57 Criteria for selection of the test method Method Sensitivit y Recovery Training Costs Results Bradford OPA Biuret BCA Ninhydri n TOC ATP Hemo check Combur test SMP GmbH

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60 Recovery of protein: Group 1 instruments SMP GmbH

61 Recovery of protein Group 2 instruments SMP GmbH

62 Elution of protein: Group 3 instruments SMP GmbH

63 Elution of protein Group 4 instruments SMP GmbH

64 Qualification of the recovery SMP GmbH

65 Products: ADVICE: Reprocessing Instructions Endoscopic Take-Apart Instrument / Company:... Reprocessing procedures have only limited implications to a surgical instrument. The limitation of the numbers of reprocessing procedures is therefore determined by the function / wear of the device. In case of damage the device should be reprocessed before sending back to the manufacturer for repair. Preparation at the Point of Use: Transportation: Remove gross soiling by submerge the instrument into cold water (<40 C) immediately after use. Don t use a fixating detergent or hot water (>40 C) as this can cause the fixation of residua which may influence the result of the reprocessing process. Safe storage and transportation to the reprocessing area to avoid any damage and contamination to the environment. Preparation for The devices must be reprocessed in a disassembled state. Decontamination: Pre-Cleaning: Warning: Do not allow the instruments to rest on the bottom of an ultrasonic cleaner unit during cleaning, as damage or incomplete cleaning could result. 10 minutes at 40 C in an ultrasonic bath with 0,5% detergent. Brushing the instrument under running tap water until all visible residues are removed Flushing the inner lumens of all parts with a water jet pistol (pressure min. 3 bar) with cold tap water for at least 10 seconds. Cleaning: Manual Cleaning Process: Automated Cleaning: 1. Rinsing under running tap water (<40 C) Connect the instrument to a rack for MIS-instruments until all visible soil has been removed. If and start the program needed a soft bristle brush should be used to 4 min pre-washing with cold water (<40 C); remove visible soil; 6 min washing with 0,5% detergent at 55 C; 2. Submerge instruments in an detergent (if 3 min neutralising with warm water (>40 C); ultrasonic bath is used, ultrasonic process of 2 min intermediate rinsing with warm water 3 minutes and ultrasonic frequency of 35 khz (>40 C). have been shown to be effective). Follow the Special instructions of the manufacturer of the instructions of the manufacturer of the automated washing machine have to be followed. detergent; 3. Rinse the instrument under running tap water to remove the detergent SMP GmbH

66 Disinfection: Drying: Manual Disinfection: 1. Submerge instruments in an disinfection detergent according to the instructions of the manufacturer of the detergent; 2. Rinse the instrument with sterile water to remove the detergent. Manual Drying: Dry the instrument with a lint free towel. The instrument may never be heated up >140 C. To avoid water residues we recommend using sterile compressed air to insufflate cavities. Automated Disinfection: Automated Thermal Disinfection in washer/disinfector under consideration of national requirements in regards to A0-Value (see EN 15883) Automated Drying: Drying of outside of instrument through drying cycle of washer/disinfector. If needed, additional manual drying can be performed through lint free towel. Insufflate cavities of instruments by using sterile compressed air. Functional Testing, Maintenance: Packaging: Functional testing, if available according to instructions of use and visual inspection for cleanliness. If necessary perform reprocessing process again until instrument is visibly clean. Appropriate packaging for sterilization. Sterilization: Sterilization of instruments by applying a fractionated pre-vacuum process (according DIN EN 554 / ISO 11134) under consideration of the respective country requirements. Storage: Reprocessing validation study information Parameters for the pre-vacuum cycle: 3 prevacuum phases with at least 60 milli bar Heat up to a minimum sterilization temperature of C Minimum Holding time: 3,5 min Drying time: minimum 10 min Flash sterilization is not allowed on lumen instruments! Storage of sterilized instruments in a dry, clean and dust free environment at modest temperatures of 5 C to 40 C. The following testing test devices, materials & machines have been used in this valdition study; Detergent: deconnex 28 Alka One, (Borer, Zuchwil, Switzerland) deconnex 23 Neutrazym, (Borer, Zuchwil, Switzerland) Washer / Disinfector: Miele 7735 CD Instrument Rack: Miele E450-1 Details: See report SMP SMP GmbH

67 Conclusion ISO is demanding more information from the manufacturer for the user ISO is requiring qualified equipment according to the standard and validated processes Methods for the evaluation and quality control of cleaning processes has already been developed and establish in some countries. They have led to an improvement of the outcome of the cleaning process Sensitive test methods have to be validated when applied in the daily routine SMP GmbH

68 Thank you SMP GmbH Hechingerstrasse Tübingen SMP GmbH