Mongolian Symposium 14-15 September 2016, Ulaanbaatar Dr. Weigert - New Standards in Cleaning and Disinfection of Medical Devices Michael Kacherai Chemische Fabrik Dr. Weigert Hamburg 1
Dr. Weigert Company Profile Dr. Walter Weigert Founder of the Chemical Factory in Hamburg in 1912 Until today an independent, familiy owned Corporation Bernd Ziege Managing Partner Dr. Weigert Company Profile 270 Employees in Germany and the eight Subsidiaries > 70 Mio. turnover, > 45 % overseas Mio 80 70 60 50 40 30 20 10 0 Sales Trend 1949 1970 1980 1990 2000 2010 Year 2011 2013 2
The Core Competence System Solutions for Cleaning and Disinfection in professional applications for mechanical, automated processes Company Site in Hamburg Research & Development Microbiology Application Technology Dosing / Control Technology Production, Logistics and Administration Competence, Flexibility and Customer Orientation 3
Competence in Medical and Laboratory Technology Experience for over 30 years Competence Reliability SK1 Dr. Weigert s System Solution Detergents and Disinfectants Dosing and Control Technology System Solution Attandance and Service 4
Slide 8 SK1 Puzzleteile auf Englisch Stefanie Kahl; 11.05.24
International Federation of Infection Control (IFIC): Cleaning: Cleaning is a process that removes foreign material (e.g. soil, organic material, micro-organisms) from an object. Disinfection: Disinfection is a process that reduces the number of pathogenic microorganisms, but not necessarily bacterial spores, from inanimate objects or skin, to a level which is not harmful to health. Sterilisation: Sterilisation is a process that destroys all microorganisms including bacterial spores. Sterilisation cannot be proved except by culturing, so normally an object is said to have been sterilised if it has gone through a controlled process of sterilisation. Effective factors of cleaning Time Mechanics Temperature Chemistry 5
Effective factors of cleaning Automatic cleaning Temperature Time Mechanics Chemistry Manual cleaning Temperature Time Chemistry Mechanics Effective factors of cleaning Mechanics wash arms, spray nozzles, channel adaption (rigid endoscopes), the right quantity of cleaning solution has to reach every spot on the goods to be washed Chemistry - Contamination varies in composition - Chemicals support the cleaning process by dissolving, emulsifying and dispersing the variety dirt - provides material protection to the instruments - Water quality influences the cleaning result and the materials Temperature best cleaning temperature, depending on the kind of dirt (denaturalisation of proteins) and kind of cleaner; parameters of disinfection Time important parameter, influencing the performance of cleaning and disinfection 6
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Why automated reprocessing? staff of age than > 30 years Monday Tuesday Wednesday Thursday Friday staff of age than < 30 years Monday Tuesday Wednesday Thursday Friday Advantages of machine cleaning and disinfection Standardization Makes the work much easier Lower risks for personal (vapors of disinfectants, allergies, injuries) Lower risk of damaging instruments Lower risk of cross-contamination Documentation ti of fthe process parameters High reliability of the reprocessing Validation of automated process possible! 8
Contamination Proteins blood, tissue, liquor Fat lipids, lipoproteins, glycolipids, ointments (creams) Contamination from medical use Carbohydrates glycogen, glycoproteins, proteoglucane Organics X-ray contrast media, antiseptics Inorganics salts, disinfectants Ingredients of Detergents Caustic alkalinity (e.g. Sodium hydroxide) Silicates (e.g. Sodium silicate/ waterglass ) Phosphates h (Polyphosphates) h Phosphate substitutes (e.g. MGDA, NTA, EDTA, Polycarboxilates) Active Chlorine Active Oxygen Surfactants/ Emulsifiers Enzymes (e.g. protease, lipase,amylase) Phosphoric acid Citric acid Paraffin oil 9
Reprocessing of Medical Devices Automated Cleaning in Washer-Disinfectors with alkaline cleaners Guidelines recommending alkaline detergents: Robert-Koch-Institute (Germany): Alkaline cleaning is characterized by its high efficiency in dissolving up protein and fat residues as well as its antibiotic action. USA: CDC-Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008: Alkaline-based cleaning agents are used for processing medical devices because they efficiently dissolve protein and fat residues. Da Vinci-Endowrist-Instruments 10
Da Vinci- Endowrist-Instruments organic residues Properties of an alkaline, enzymatic cleaner with surfactants 3 different blood soils 6 differnet cleaners 0.5%, 5 min, 45 C, stirred dipping bath Meets national requirements regarding prion-prophylaxis, e.g. Robert Koch-Institute Germany: Alkaline cleaning Swiss-NOSO Switzerland: Cleaners with proteolytic enzymes Better Cleaning strength than ph-neutral enzymatic cleaners Combines advantages of alkaline and ph-neutral enzymatic cleaners 11
Cleaning efficacy: ph-neutral, enzymatic cleaner Cleaning efficacy: Alkaline, enzymatic cleaner with surfactant Material compatibility: Recommended by ISI for the cleaning of Endowrist/ DaVinci instruments And by endoscope manufacturer (e.g. Karl Storz, Fujifilm, Pentax) ph-value and cleaning result? There is no optimal ph-value for best cleaning results or blood removal! 12
Standard program sequence Dosing g of Cleaner Dosin ng of Rinse Aid Pre-Wash Cold Water 3-5 Min Cleaning DI-Water 55 C - 10 Min Intermedea te Rinse Softened or DI-Water cold - 1 Min Thermal Desinfection DI-Water 90-5 Min Drying 90 120 C Dra ain Dra ain Dra ain Dra ain Standard program flow for cleaner, which do not require neutralization and second intermediate rinse! Standard program sequence Dosing g of Cleaner Do Neu osing of utralizer Dosin ng of Rinse Aid Pre-Wash Cold Water 3-5 Min Cleaning DI-Water 55 C - 10 Min Neutralization Softened or DI-Water cold - 1 Min Intermedia te Rinse Softened or DI-Water cold - 1 Min Thermal Disinfection DI-Water 90-5 Min Drying 90 120 C Dra ain Dra ain Dra ain Dra ain Dra in Standard program sequence for cleaner, which require neutralization and second intermediate rinse! 13
Rinse aids for medical devices Useable for shorten the drying time in a mechanical cleaning program ph-neutral or slightly acidic Reduced surface tension of water Reduction of adherent moisture, less water drops Toxicological risk assessment in accordance with EN ISO 10993-1 (biological assessment of medical products) Completely biodegradable Recommended dosage: 0,3 3-1,0 ml/l to cold or heated final rinse water Shorter drying time of 30 to 70% Reduction of reprocessing time Lubricant for medical devices Useable for manual instrument care. Also available for instrument care in a mechanical cleaning program. ph-neutral. Reduces friction and abrasion in the joints of instruments. Toxicological risk assessment in accordance with EN ISO 10993-1 (biological assessment of medical products). Compatible with the intended steam and hot-air sterilization process. The sterility of sterile barrier systems during the storage time after using at the highest recommended concentration is not influenced. Each instrument has to be treated after each cleaning and disinfection process! 14
Friction corrosion Reason lack of instrument care Reprocessing of heat-sensitive flexible endoscopes Chemical disinfection with disinfectant based on Glutaraldehyde a) Standard disinfectants with 20% GDA b) With reduced odour based on special combination active substance 15
Reprocessing of heat-sensitive flexible endoscopes Chemical disinfection with disinfectant based on Peracetic Acid a) with and without additional component (e.g. regulator, activator) b) microbiocidal activity from 25-35 C (bactericidal, fungicidal, mycobactericidal, virucidal, sporicidal) c) Good material compatibility (since 2002) d) energy-saving because of low application temperatures e) Environmentally friendly due to harmless decomposition products of peracetic acid Reprocessing of flexible endoscopes Cleaning step Disinfection step Intermediate rinse Final rinse Drying 16
Validation Critical processes, where the success could not be assessed by 100 %, should be validated. Cleaning and Disinfection Sealing Process Sterilization Automatic processes in washer-disinfectors can be validated. Daily Routine Checks Routine Checks of Technical Functions Successful execution of programme sequences, temperature, time, water pressure, dosage of process chemicals Routine Checks of Cleaning and Drying Performance each medical device which is removed from the WD should be visually inspected to ensure that it is clean and dry; if visual inspection is not possible, appropriate tests and testing intervals should be specified Routine Checks of Disinfection Performance not necessary to verify the disinfection performance with biological indicators, since the disinfectant action is assured by the effect of the water temperature for a defined period of time 17
Machine Mains water Softened water Water in the CSSD Deionised water (DI water) Process water from machines Steam Sterilizer Boiler feed water EN 285 (2009) Steam condensate EN 285 (2009) Water ingredients When heating the water Noncarbonate hardness (other Caand Mgsalts) other Solubles e.g. silicic acid Na-,K-salts Carbonate hardness (Ca-Hydrogen carbonate a.-carbonate, Mg-Hydrogen carbonate a. -Carbonate) Non-carbonate hardness remains in solution, but carbonate hardness leads to stubborn lime deposit. Total hardness = carbonate hardness + non-carbonate hardness 200 ppm CaCO3 = 150 ppm + 50 ppm 18
Constituents in tap water, which may cause problems in washer/ disinfectors Water hardness (Calcium, Magnesium): Scaling and deposits in machine and on contents Constituents in tap water, which may cause problems in washer/ disinfectors Heavy and non-ferrous metals (Iron, Manganese, Copper): Dark discolorations and deposits, inactivation of water softener 19
Constituents in tap water, which may cause problems in washer/ disinfectors Silicic acid/ silicates: Stubborn yellowish-brown or bluish-violet glaze-like deposits Constituents in tap water, which may cause problems in washer/ disinfectors Chlorides: Pinhole-like pitting corrosion on chrome steel 20
Chlorides: corrosion on chrome steel Constituents in tap water, which may cause problems in washing machines Evaporation residue 21
Optimal Water-Demineralisation Tap-water Softener Reverse-Osmose Ion-Exchange (1) or Conductivity Control Electrodeionisation Ion-Exchange (2) Deionized Water 22
Recommendations for Proper Maintenance of Instruments free: www.a-k-i.org Thank you for your attention! 23