1 Cleaning/Disinfection/Sterilisation GUIDELINES FOR HEALTHCARE PRODUCTS Medela AG Lättichstrasse 4b 6341 Baar, Switzerland Medela AG/ / /E Precious life Progressive care
2 General information Guidance notes on cleaning, disinfecting and sterilising Medela Healthcare products. This is only a summary of information available and does not cover the entire range of Healthcare products; some may require other specific cleaning procedures. These notes are for healthcare professionals, such as nurses and infection control practitioners, who work in a hospital environment. Products Type Intended Use Specification Reusable e.g. silicone tubings Disposable / Single use e.g. filters for more than one patient multiple uses possible for one patient only use once only Requires cleaning before use, unless provided in a sterile condition The accessories must be cleaned, disinfected and sterilised after each use Must be checked regularly for damage and appearance and replaced if necessary Ready for use Use immediately after opening the packaging To be disposed of after using Not to be used by more than one person in order to avoid possible health risks. Reprocessing could cause loss of mechanical, chemical and/ or biological characteristics. Reuse could cause cross contamination.
3 Cleaning measures Method Description Cleaning To remove dirt and other matter from healthcare products by: wiping, brushing washing, rinsing, immersing, soaking. Disinfection This removes many or all pathogenic micro-organisms on the various parts ecept for bacterial endospore and gives a selective reduction of viable germs (> 99.9%). Cleaning/Disinfection machine Physical (thermal) Chemical disinfectants Combination thermal/chemical Sterilisation Removes all viable micro-organisms (100%) Autoclave Steam sterilisers Gas Radiation Cleaning method These instructions are for cleaning Medela products. They are general recommendations only that may be adjusted individually, based on the hospital s specific directives and cleaning practices and policies. Disassembly Separate all individual parts before cleaning, disinfecting and sterilising. Cleaning Detergents Use detergents with a ph range between 6.0 and 8.0 only, in order to avoid damaging the instruments and containment devices. Enzymatic detergents help with the removal of organic matter, such as blood. Detergents should be used according to their manufacturer s recommended concentration levels. Some alkaline detergents have been formulated to be safe for reprocessing medical devices. The manufacturers of these detergents should provide information about specific materials that may be damaged by their detergents. Water Use only the purest quality of water for cleaning. Water hardness is a serious consideration since deposits left on medical products may not be properly decontaminated. Use deionised water in order to reduce this problem. The final rinse water is bacterial free and contains no endotoins. Disinfecting Refer to chart. Sterilising Refer to chart.
4 Storing components After sterilising, store the components in sterile foil until required for use. Device care Daily, or as necessary Wipe over with a damp cloth or use a non-abrasive detergent (refer to chart). A hot water rinse (maimum temperature 100 C) may provide a medium-to- high level of disinfection. Every section of the constituent parts must be accessible in order to ensure efficient cleaning. We recommend using a cleaning/disinfecting machine that has been approved by the Robert Koch- Institute and complies with ISO Recommended temperature for noncritical medical devices (i.e. those that only come into contact with uninjured skin) is 90 C for 1 minute. The time is increased to 5 minutes for all medical devices that are considered to be critical. Cleaning/ disinfection machines Disinfection For all potentially contaminated parts: Perform disinfection according to your standard hygiene plan or the instructions of the manufacturer of your disinfecting agent: 1. Wipe the surfaces with a surface disinfectant. Observe the reaction time of the agent. 2. Wipe with disinfectant once more and wipe parts dry with a disposable towel or allow to air-dry. Dispose of protective gloves after the disinfection procedure. Disinfect your hands.
5 Recommended practice for reusable products Recommended cleaning methods have been validated by Medela to current international guidelines for cleaning. Use the products chart in order to determine the correct cleaning method. Cleaning Unplug before cleaning electrical devices. Follow hospital guidelines on hygiene. Separate all parts before cleaning, disinfecting and sterilising. C1 C2 C3 Recommendation Cleaning Agents NOT for use To remove dirt and other matter, clean by: standard soap wiping, brushing if applicable: washing, rinsing, immersing and soaking Place individual constituent parts in top rack of dishwasher (standard programme > 58 C). Soak all parts thoroughly with warm, soapy water or in enzymatic detergent for 1 5 minutes. standard dishwasher detergent standard soap Do not eceed the manufacturer s recommended concentrations, soaking times or temperatures. 1. Remove visible dirt with a cleaning tool general purpose cleaning brushes, such as pipe cleaners or non-abrasive lint cloths. Brushes and pipe cleaners should fit snugly but still be able to be moved around easily within the area to be cleaned. Rinse thoroughly in clear water. 2. Check the instruments for visible dirt and repeat these steps if necessary.
6 Disinfection Unplug before cleaning electrical devices. Follow hospital guidelines on hygiene. Separate all parts before cleaning, disinfecting and sterilising. D1 D2 D3 D4 D5 Recommendation Cleaning Agents NOT for use Clean the surfaces with a cloth moistened with an aldehydefree non-abrasive cleansing and disinfecting solution. No cleansing solution should penetrate into the equipment. Disinfect with the disinfecting agent group alcohol. Use a disposable cloth to wipe off any visible dirt. Disinfect surfaces with special disinfectant wipes. Ensure use of disinfectants based on aldehydes and quaternary ammonium compounds because of their material compatibility. Suitable for cleaning in a Disinfecting Machine. Maimum temperature for disinfection: 100 C. Soak at room temperature for 30 minutes in a disinfection/ cleaning solution (A). After the reaction time, use water to rinse the solution residue from the individual parts and rinse the tubing. Disassemble parts. Rinse for at least 2 minutes with the cleaning solution (B). Meliseptol rapid (B.Braun Medical AG), Heaquart Plus (B.Braun), Perform (Schülke & Mayr), Incidin foam (Ecolab), QuickClean Antibacterial wipes (Medela Inc) Dispatch (Caltech Industries) Meliseptol rapid (B.Braun Medical AG) Incidur (Ecolab), Gigasept FF (Schülke & Mayr), Bacilloto (Bode Chemie Hamburg), Dismozon pur (Bode Chemie Hamburg), Gevisol(Schülke & Mayr) Neodisher FA (cleaning) and Neodisher Z (neutralisation) (Dr. Weigert) (A) fluid aldehyde-free disinfection solution with cleaning effect for use as a soaking bath, bactericide, fungicide, limited virucide, with good material compatibility for stainless steel, non-ferrous material and plastics including silicone, slightly alkalic. e.g. 2% neodisher Septo MEDsolution (B) Fluid, ph-neutral, enzymatic cleaning solution for the treatment of instruments by machine or manually with very good material compatibility for stainless steel, non-ferrous material and plastics including silicone. Terralin (Schülke & Mayr) TB Quat (3M) halogenreleasing compounds strong organic acids oygenreleasing Cleaning/ disinfecting agents based on phenol. Do not use any cleaning/ disinfecting agents based on phenol.
7 Sterilisation Comply with in-house directives on hygiene. Separate all parts before cleaning, disinfecting and sterilising. Recommendation Cleaning Agents NOTE S1 Remove any chemical disinfectant residue before autoclaving. Do not stack during autoclaving. In the autoclave at 134 C for 10 minutes. S2 Ethylene oide Ethylene oide S3 Comply with the manufacturer s recommended concentrations, soaking times and temperatures when preparing chemical disinfectants for use. The sterilisation device must comply to ISO 17665:2003. The following procedures are acceptable: In the autoclave with saturated steam at 132 C, with triple pre-evacuation, sterilisation time of 6 minutes. or at C in an porous load vacuum autoclave for minutes Cleaning Agents B.Braun / Meliseptol rapid 100g contains: 50g 1-Propanol 0,075g Dideclydimethylammoniumchloride B.Braun / Heaquart plus Contains: 6% Dideclydimethylammoniumchloride < 10% quaternary ammonium compound < 10% nonionic tensides < 5% Propan-2-ol Schülke & Mayr / Perform 100g contains: 45 g Pentapotassium-bis-(peroymonosulphate) bis(sulphate) Ecolab / Incidin Foam 100g contains: 20g 2-Propanol, 10g Ethanol, 0,2g Benzalkoniumchloride, 0,01g Glucoprotamine Ecolab / Incidur 100g contains: 8,8g Glyoal, 4,5g Glutaral. Schülke & Mayr / gigasept FF 100g contains: 11,9g succine dialdehyde 3,2g Dimethoytetrahydrofuran Bode Chemie / Bacillol plus (instead of Bacilloto) Aldehyde-free, alcohol-based Contains: 400 mg/g Propan-1-ol 200 mg/g; Propan-2-ol 1,0 mg/g. Glutaral Bode Chemie / Dismozon pur Oygen-active disinfectant cleaner Contains: 800 mg/g. Magnesium monoperoyphthalate Heahydrate Schülke & Mayr / gevisol 100g contains: 33,5g chlorcresol 1,5g Biphenyl-2-ol Dr. Wiegert / Neodisher FA Contains: 15-30% Phosphates Dr. Wiegert / Neodisher Z Contains: Organic Acids Dr. Wiegert / Neodisher Septo Med 100g contains: 9.2g Dodecylbisprophylentriamin 13.0g Dideclydimethylammoniumchloride
8 Disposable Cleaning Disinfection Sterilisation Product life Art.Nr Description Material single use C1 C2 C3 D1 D2 D3 D4 D5 S1 S2 S3 steri times years , Angle pieces Plastic (PP) Change-over-valve with clamp holder and tubing set Plastic (PA + POM) Tubing: Elastomere (Silicone) tubings tubings 250 tubings Clamp holder, aluminum, 1025 mm Clamp holder Plastic (PA) Clario Canister set Jar: Plastic (PC) Lid: Plastic (TEEE) Plugs: Plastic (PE) Floater: Plastic (TPE) Clario Car connection cable Clario Carrying bag Plastic (Polyethylene coated with polyester) Clario SafetyChamber Housing: Plastic (PBT+ASA) Lid: Plastic (TEEE) Vacuum regulator knob: Plastic (TPE) Valve discs: Elastomere (Silicone)
9 Clario Vacuum gauge , , , Coupling pieces Plastic (POM) Elastomere (Silicone) CVS: Central vacuum regulator with clamp holder CVS: PVC tubing, yellow 079 Docking Station Invia Liberty and Thopaz Plastic (PC + ABS) Double conical coupling piece Plastic (PP) Drainage valve Plastic (PSU) Elastomere (Silicone) Filter: Bacteria, autoclavable Plastic (PSU) Elastomere (Silicone) Filter: Disposable hydrophobic Plastic (PP)
10 Disposable Art.Nr Description Material single use Filters. Particle Plastic (PP) , Filters: bacteria Plastic (PP) , Filters: bacteria/odour Plastic (PP) Elastomere (Silicone) , , Filters: overflow protection / bacteria Plastic (PP) Filters: overflow protection/ bacteria/odour filter Plastic (PP) Flow meter O2, 0-16 l/min, DIN Plastic (PC + various) Foot vacuum regulator 037, 057 Housing: Basic 30, Dominant 50, Dominant 35 c/i Housing: Plastic (PS coated) Vacuum gauge: Plastic (various) Cleaning Disinfection Sterilisation Product life C1 C2 C3 D1 D2 D3 D4 D5 S1 S2 S3 steri times years
11 Housing: Basic, Dominant Fle Housing: Plastic (PC + ABS) 014, 017, 026 Housing: Clario, Apgar Timer, Vario Housing: Plastic (PC + ABS) 087 Housing: Invia Liberty Housing: Plastic (PC + ABS) 079 Housing: Thopaz Housing: Plastic (PC + ABS) _Sa.eps , , , , Lids for reusable system Plastic (PA + TPE + POM) Overflow protection device Plastic (PP) Detail vom _Sa.eps Plug for FMS lid Plastic (PP) Pressure regulator with flow meter O2, 0-10 l/min Plastic (PC + various) , Quivers with holder Plastic (PP + PC)
12 Disposable Cleaning Disinfection Sterilisation Product life Art.Nr Description Material single use C1 C2 C3 D1 D2 D3 D4 D5 S1 S2 S3 steri times years Reusable serial connector Plastic (POM + Silicone) Safety device plugged into pump Jar: Plastic (PSU) Lid: Plastic (PA + TPE) Tubing: Elastomere (Silicone) Safety set for central vacuum Jar: Plastic (PSU) Lid: Plastic (PA + TPE) Clampholder: Plastic (PA) Tubing: Elastomere (Silicone) Santhora: Basic 2 Chamber Systems Jar: Plastic (PSU) Lid: Plastic (PA + TPE) Santhora: Clamp holder with infusion rod , Santhora: Disposable Canister Plastic (PP) Tubing: Plastic (PVC) Santhora: Dust filter Plastic Santhora: Hanger for bed for Disposable Canister 500 5
13 Santhora: Holder for bed , Santhora: Holders for Disposable Canister , Santhora: Thora sets Plastic (PVC + POM + Silicone) Santhora: Universal holder Santhora: Vacuum gauge to Disposable Canister Sets with suction jar PC Jar: Plastic (PC) Liner: Lid: Plastic (PA + TPE) Tubing: Plastic (PVC) liner, tubing jar jar lid lid 250 lid , Sets with suction jar PSU Jar: Plastic (PSU) Lid: Plastic (PA + TPE) Clampholder: Plastic (PA) Tubing: Plastic (PVC) tubing Silicone tubing Elastomere (Silicone) , Specimen cup, disposable Plastic (PP)
14 2 2 Cleaning Disinfection Sterilisation Product life Art.Nr Description Material single use C1 C2 C3 D1 D2 D3 D4 D5 S1 S2 S3 steri times years , Suction liner with solidifier, disposable Plastic (PA + PE) solidifier: natrium salt , Suction liner, disposable Plastic (PA + PE) Disposable , , Suction Cups: Bird Suction Cups: Bird (New Generation) metal (stainless) Plastic (PP + Nylon) Suction cups: Bird, bottomplates Plastic (PP) Suction Cups: CaesAid Elastomere (Silicone) Suction Cups: Malmström Elastomere (Silicone) Suction Cups: Malmström traction handle with stop clip 60 5
15 , Suction Cups: Silc Cup with trumpet valve Elastomere (Silicone) , Suction Cups: Silc Cups Elastomere (Silicone) Suction Cups: Single Use Bird Cup Plastic (PC) Suction Cups: Single Use Silc Cup Suction Cups: Traction handle with hook to Bird Cups , , , , , , , Suction jar PC Plastic (PC)
16 Disposable Cleaning Disinfection Sterilisation Product life Art.Nr Description Material single use C1 C2 C3 D1 D2 D3 D4 D5 S1 S2 S3 steri times years , , , , , , Suction jar, PSU Plastic (PSU) Trolley for Basic 30 and Dominant 50 Plastic (PS-coated) , Trolley for Basic and Dominant Fle PS-coated metal Trolley small Metal (stainless-coated) Trolley with infusion holder, Euro plugs , Tubing holders Tubing set: double drainage Plastic (POM + Silicone) Y-piece , , , Tubing: disposable Plastic (PVC)
17 Tubing: disposable drainage Plastic (PVC) Tubing: Silicone, green Plastic (POM + Silicone) Tubings: Silicone with coupling pieces Plastic (POM + Silicone) , Tubings: Silicone without coupling pieces Elastomere (Silicone) Vacuum Ejector with clamp holder , Vacuum etractor: pump Plastic (PP + various) Vario carrying bag Plastic (Polyester + PVC) Vario Disposable Filter Set with Overflow Protection/ Bacteria Filter Plastic (PP + POM) Tubing: Elastomere (Silicone) , Vario rail holder 1025 mm 500 5
18 Disposable Cleaning Disinfection Sterilisation Product life Art.Nr Description Material single use C1 C2 C3 D1 D2 D3 D4 D5 S1 S2 S3 steri times years Vario trolley plate Vario universal holder Vario: Car connection cable 12 V DC , Wall brackets Plastic (ASA) Y-piece Plastic (PP)