The smaller the Instrument, the bigger the Task! Our own Processing Experiences
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1 The smaller the Instrument, the bigger the Task! Our own Processing Experiences Dr. med. Dipl.-Ing. Thomas W. Fengler CLEANICAL R Medical Devices & Related Processes Cleanical Instrumenten-Arbeitsgruppe (CLEANICAL ) Berlin
2
3 History 1993 Foundation of the Instrumenten-AG (CIA) am Krankenhaus Moabit Berlin 1994 Quality of Laparoscopic Instruments retrospective and prospective clinical investigations on medical devices in abdominal surgery at the city hospital Moabit 1998 Projects with different manufacturers (BODE, KARL STORZ Endoskope, Miele PROFESSIONAL, Olympus, Stryker) in surgery and endoscopy on remanent contamination and process control and device improvement 1999 Organisation of the worldwide first clinical multicenter study on remanent contamination after automated cleaning, before thermal disinfection for different instrument design in 6 German CSSD 1. International FORUM Medical Devices & Processes, Congress Centre, MEDICA Düsseldorf New company for CSSD Services - ZEHNACKER CLEANICAL GmbH International FORUM Medical Devices & Processes moves to Berlin 2005 Business Support International: FORUM-Tour Armenien, China, Georgien, Irland, Mexico, Norwegen, Russland 2006 New Companies CMP GmbH (Validation) and CLEANICAL GmbH (Coaching)
4 Invasive Procedures have to be justified. Clinical Instrumenten-Arbeitsgruppe (CLEANICAL ) Berlin
5 Intelligent Medical Devices enable New Therapeutic Approaches in Medicine & Dentistry Clinical Instrumenten-Arbeitsgruppe (CLEANICAL ) Berlin
6 A complexe environment requires understanding and training on the job not only for the surgical staff Clinical Instrumenten-Arbeitsgruppe (CLEANICAL ) Berlin
7 What You see is what You get : Surgery has developed since then. What about Instruments, Devices and last not least Sterile Processing? Clinical Instrumenten-Arbeitsgruppe (CLEANICAL ) Berlin
8 We see the Dentist more often than any other Doctor.
9 German RKI-Recommendation remains debatable: Classification Critical : Penetration in sterile tissue C for complexe design with inner surfaces, rotation etc.
10 Disinfection is not enough! Clinical Instrumenten-Arbeitsgruppe (CLEANICAL ) Berlin
11 UV light and shadows
12 Products & Processes: Potential for Improvement Cleanliness... Clinical Instrumenten-Arbeitsgruppe (CLEANICAL ) Berlin
13 Talking about Sterile Processing means to consider Practices and existing Regulations. Medical Devices become more complexe (Ophthalmology, ENT, MIS, Robotic Surgery) Reusibility depends on knowledge of Processes and Parameters. Monitoring of Parameters is only partially available. Cleanability is a complexe Parameter itself. Good Cleaning Results enable safer Handling (, Hygiene) and Preservation of Value.
14 German Multicenter Study on Remaining Contamination
15 Fengler ThW, Pahlke H, Michels et al.: Are Processed Surgical Instruments Protein-free? Results of the Clinical Multicenter Study on Remaining Contamination. Zentralsterilisation 9 (1): (2001) Clinical Instrumenten-Arbeitsgruppe (CLEANICAL ) Berlin
16 &
17 Products & Process
18 Microbes cannot read a magic barrier
19 Organisation & Facility
20 Preselection no crossways
21 Manual cleaning is limited to daily conditions: Poor reproducibility, temperature < 40 C
22 CSSD unclean side.
23 Proper documentation of device parameters? 4 S
24 Means and devices - which process parameters?
25 Well educated Staff?
26 Correct connection for rinsing?
27 Unconnected tubes lower rinsing pressure
28 Manual (Pre-)Cleaning?
29 It is time-consuming and...
30 might even lead to Damage!
31 Contact with blood is contact to infection
32 es Small parts and manual cleaning remain tricky
33 Baskets for small parts
34 What about the value of ultrasound? An Ultrasound Bath is moving the water on located Spots. It is not affecting the inner Lumen of Medical Devices (unless by rinsing it e.g. Medisafe).
35 This is no thermal disinfection!
36 Ultrasound: cleaning or bathing? It takes Time, it needs Space and it is noisy.
37 Cleaning Parameters (Sinner) generally Time Mechanics: Water Amount Pressure Ultrasound Temperature Detergent - Disinfectant Water Quality
38 Main Parameters of the Ultrasound Effect Cleaning Agent (Detergent Disinfectant) Volume of Solution (Level in Relation to Transducers) Number and Location of Transducers Tray Material, Construction & Position Temperature of Solution Particle Content
39 Possible Energy Distribution US 1 Different Levels/Volumes US 2
40 Temperature Influence
41 What to be verified with Ultrasound Quantity and Quality of Load Kind of Tray used Positioning of the Tray Cleaning Agent (Chemistry) Interval of Renewal of Cleaning Agent Level/Quantity of Solution Actual Temperature Movable Transducers?
42 For Example: Influence of Silicon Mat No Cavitation
43 Heavy Loads absorbing Energy Too much is not enough
44 Parameters of Ultrasound (to conclude) Ultrasound cleaning is difficult to standardize. contact time to instruments can be enlarged. Specific instruments can be severely damaged. Ultrasound remains an additional tool for pre-cleaning of selected Instruments. These results were confirmed by similar investigations of L. Jatzwauk (Dresden, Germany).
45 Ultrasound and Rinsing
46 What about Washer Disinfector? Washer Disinfector can possibly rinse even Inner Lumina with a defined Pressure...
47 Automated Processing... if Positioning in specifically constructed Trays is correct and the Pressure adequate high.
48 Validation of the Cleaning Step Monitoring of water pressure
49 ... beware of the Load! Approval of CEN ISO Part 1-3 has just been decided...
50 Cleaning must be(come) reproducible
51 Baskets allow Cleaning of Small Parts
52 Correct Cleaning dries the Load...
53 ... the Precondition for Sterility
54 Efficient Loads? Kidney dishes are possibly disposables. Save the load for instruments.
55 Differing Loads Different parameters for cleaning efficiency: Textiles have soft surfaces and big volumes. Instruments are small and have hard and complexe surfaces.
56 These are no medical devices. There intended use is somehow different. Clinical Instrumenten-Arbeitsgruppe (CLEANICAL ) Berlin
57 Incomplete Manual CEN ISO 17664: The manufacturer must provide the clinical user with valid informations about the medical device, its function, maintenance and reusability which includes validated methods for cleaning, disinfection and sterilisation.
58 Keep Your Working Place in Order... You will have more Space needing less Instruments! Clinical Instrumenten-Arbeitsgruppe (CLEANICAL ) Berlin
59 Having the right Instruments in Place is better than having them in Store. Clinical Instrumenten-Arbeitsgruppe (CLEANICAL ) Berlin
60 The right instrument in the wrong place
61 Adequate Transport Containment...
62 ... ready for Automated Cleaning
63 Transport and Cleaning Tray
64 Inadequate Container
65 Switched to Overload Clinical Instrumenten-Arbeitsgruppe (CLEANICAL ) Berlin
66 The Art of Packaging Failures...
67 Wet means not sterile! Clinical Instrumenten-Arbeitsgruppe (CLEANICAL ) Berlin
68 Trays for trauma are sometimes a trauma!
69 Modern Set-Pack with Baskets
70 Packaging
71 Sealing
72 Correct Sterilisation - what s inside? Sterile Units: 6 StE 98,5 kg 4 or 5 StE Mixed Fill?
73 Documentation is knowledge Appropriate means? Just do it!
74 Working place description in place
75 Process Control (not only) for Sterilisation Clinical Instrumenten-Arbeitsgruppe (CLEANICAL ) Berlin
76 Alternatives to steam
77 Regulatory Affairs A Compexe Hierarchy European and German Laws Health and Safety for Staff Ecology Guidelines for Training on the Job Guidelines and Recommendations of Notified Bodies and Scientific Associations (RKI, DGKH, DGHM, DGSV) National and International Normation
78 Regulatory Affairs - debatable DIN, DIN-EN (CEN), DIN-ISO und Richtlinien oberster Bundesbehörden (BGA/RKI) gelten als antizipierte Sachverständigengutachten zum aktuellen Stand von Wissenschaft und Technik. Der Bundesgerichtshof hat in ständiger Rechtsprechung ein Abweichen von DIN-Normen, sowie von Richtlinien oberster Bundesbehörden als haftungsbegründend im Schadensfall bewertet, wenn der Verantwortliche nicht nachzuweisen vermag, dass der Schaden auch bei Beachtung dieser Vorschrift eingetreten wäre. Bundesgerichtshof Entscheidungen in Zivilsachen 103, 338, 341
79 Medizinprodukt Nur Berührung mit intakter Haut? Nein Berührung mit Schleimhaut oder krankhaft veränderter Haut? Nein Haut oder Schleimhautdurchdringung? Nein Zur Anwendung von Blut, Blutprodukten, sterilen Arzneimitteln? Ja Ja Ja Ja Nein Unkritisches Medizinprodukt Reinigung / Desinfektion A Ohne besondere Anforderungen an die Aufbereitung Einfache Konstruktion, keine Scharniere, keine Hohlräume Semikritisches Medizinprodukt B Mit erhöhten Anforderungen an die Aufbereitung Aufwendige Konstruktion mit z.b. Hohlraum Kritisches Medizinprodukt Gruppe A, B oder C Siehe Seite 2 Kein Medizinprodukt z.b. Babyflaschen und Sauger Nicht fixierende Vorreinigung bei Bedarf Verwendete Mittel / Verfahren müssen bakterizid, fungizid u. virus-inaktivierend sein. (Die Definition der Wirkungsbereiche A und B gemäß RKI-Liste ) Nicht fixierende Vorreinigung bei Bedarf Reinigung / Desinfektion Sterilisation bei Bedarf Nicht fixierende Vorreinigung sofort nach Anwendung Bevorzugt maschinelle Reinigung / Desinfektion Kennzeichnung z.b. bei begrenzter Anzahl der Sterilisationszyklen Verwendete Mittel / Verfahren müssen bakterizid, fungizid u. virus-inaktivierend sein. (Die Definition der Wirkungsbereiche A und B gemäß RKI-Liste ) Reinigung / Desinfektion Sterilisation bei Bedarf Sterilisation bei Bedarf oder bei Einsatz in sterilen Körperhöhlen DGSV Deutsche Gesellschaft für Sterilgutversorgung Arbeitskreis Qualität September 2002
80 Kritisches Medizinprodukt Liegen Angaben des Herstellers vor? Ja Nein Kann aufgrund von Kenntnissen eine wirtschaftliche Aufbereitung festgelegt werden? Ja Dokumentiertes, validiertes Aufbereitungsverfahren vorhanden? Nein Nein nicht aufbereiten Prozessende Dampfsterilisation möglich? Ja Nein Kritisch C mit besonderes hohen Anforderungen an die Aufbereitung Ja Einfache Konstruktion? Ja Nein Sind Hohlräume und oder schwer zugängliche Teile vorhanden? Nicht fixierende Vorreinigung unmittelbar nach Anwendung Weitere Aufbereitung: Nur in ZSVA mit extern zertifiziertem Qualitätsmanagementsystem Standardisierte, dokumentierte manuelle Aufbereitung möglich? Ja Nein Maschinelle Aufbreitung möglich? Ja Ja Reinigung / Desinfektion Kritisch A ohne besondere Anforderungen an die Aufbereitung Kritisch B mit erhöhten Anforderungen an die Aufbereitung Geeignetes Sterilisationsverfahren EO-, FO-, Gas-Plasma-, Flüssigsterilisation (siehe pren ISO 17664) Nicht fixierende Vorreinigung bei Bedarf Nicht fixierende Vorreinigung unmittelbar nach Anwendung Reinigung / Desinfektion bevorzugt maschinell Reinigung / Desinfektion maschinell / thermisch Durchführender: Nachweis einer anerkannten Ausbildung zum Sterilgutassistenten Begrenzte Anzahl der Aufbereitungszykleln? Begrenzte Anzahl der Aufbereitungszykleln? Ja Ja Kennzeichnung Nein Kennzeichnung Nein Dampfsterilisation Dampfsterilisation
81 China Provisions for Medical Device Classification
82 Quality Cycle
83 Every Medical Device has an Intended Use described in the Manual of the Manufacturer (EN ISO ) Disposable or Reuse: A Decision of the Manufacturer But a Decision with Consequences: Costs (Products and Process) (Design, Ergonomy, Performance) Hygiene (Reusibility Cleanability) Success of the Operation is the common Interest of Patient and Hospital / Doctor
84 ... but how common is the interest? First: What kind of Operation is performed? Liability and Weighting of the Interests: Indication for Surgical Intervention can be Vital (Accident) Elective (Gall Bladder) Optional (Liposuction)
85 ... last not least: The Medical Device is Part of the Action. Availability of all Means Skills at the State of the Art Adequate Devices and Accessories Time and Organisation Money and Investment Documentation of Process & its Parameters
86 ...?! We must investigate a Solution adapted to existing Problem: Medical Device for Intended (Re)Use Type Testing Validated Products and Processes Form follows Hygiene, Costs, Usefulness Respect for Regulatory Affairs Verification, Validation, Documentation Clinical Instrumenten-Arbeitsgruppe (CLEANICAL ) Berlin
87 Process Control next
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