Cleaning/Disinfection/Sterilisation

Cleaning/Disinfection/Sterilisation GUIDELINES FOR HEALTHCARE PRODUCTS Medela AG Lättichstrasse 4b 6341 Baar, Switzerland www.medela.com Medela AG/200.2391/2013-11/E Precious life Progressive care

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.

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.

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 15883. 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.

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.

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.

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 135-137 C in an porous load vacuum autoclave for 3-3.5 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

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 077.1015, 077.1016 Angle pieces Plastic (PP) 077.0563 Change-over-valve with clamp holder and tubing set Plastic (PA + POM) Tubing: Elastomere (Silicone) tubings tubings 250 tubings 2 077.0525 Clamp holder, aluminum, 1025 mm 500 5 077.0521 Clamp holder Plastic (PA) 074.0001 Clario Canister set Jar: Plastic (PC) Lid: Plastic (TEEE) Plugs: Plastic (PE) Floater: Plastic (TPE) 074.0017 Clario Car connection cable 074.0007 Clario Carrying bag Plastic (Polyethylene coated with polyester) 074.0002 Clario SafetyChamber Housing: Plastic (PBT+ASA) Lid: Plastic (TEEE) Vacuum regulator knob: Plastic (TPE) Valve discs: Elastomere (Silicone)

074.0006 Clario Vacuum gauge 077.1011, 077.1012, 077.1018, 077.1019 Coupling pieces Plastic (POM) Elastomere (Silicone) 250 2 077.1100 CVS: Central vacuum regulator with clamp holder 077.1140-077.1154 CVS: PVC tubing, yellow 079 Docking Station Invia Liberty and Thopaz Plastic (PC + ABS) 077.1017 Double conical coupling piece Plastic (PP) 077.1022 Drainage valve Plastic (PSU) Elastomere (Silicone) 250 2 077.0581 Filter: Bacteria, autoclavable Plastic (PSU) Elastomere (Silicone) 250 2 077.1024 Filter: Disposable hydrophobic Plastic (PP)

Disposable Art.Nr Description Material single use 077.0582 Filters. Particle Plastic (PP) 077.0573, 077.0574 Filters: bacteria Plastic (PP) 077.0575, 077.0576 Filters: bacteria/odour Plastic (PP) Elastomere (Silicone) 077.0571, 077.0572, 077.0577 Filters: overflow protection / bacteria Plastic (PP) 077.0092 Filters: overflow protection/ bacteria/odour filter Plastic (PP) 077.1240 Flow meter O2, 0-16 l/min, DIN Plastic (PC + various) 077.0731 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

071.0000-071.0005 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) 077.0420_Sa.eps 077.0411, 077.0420, 077.0430, 077.0440, 077.0450 Lids for reusable system Plastic (PA + TPE + POM) 250 2 077.1021 Overflow protection device Plastic (PP) 250 2 Detail vom 077.0430_Sa.eps 077.1023 Plug for FMS lid Plastic (PP) 077.1241 Pressure regulator with flow meter O2, 0-10 l/min Plastic (PC + various) 077.0531, 077.0532 Quivers with holder Plastic (PP + PC)

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 077.0542 Reusable serial connector Plastic (POM + Silicone) 250 2 077.0711 Safety device plugged into pump Jar: Plastic (PSU) Lid: Plastic (PA + TPE) Tubing: Elastomere (Silicone) 250 2 077.0651 Safety set for central vacuum Jar: Plastic (PSU) Lid: Plastic (PA + TPE) Clampholder: Plastic (PA) Tubing: Elastomere (Silicone) 250 2 077.1432 Santhora: Basic 2 Chamber Systems Jar: Plastic (PSU) Lid: Plastic (PA + TPE) 250 2 077.1454 Santhora: Clamp holder with infusion rod 077.1440, 077.1445 Santhora: Disposable Canister Plastic (PP) Tubing: Plastic (PVC) 077.1452 Santhora: Dust filter Plastic 077.1458 Santhora: Hanger for bed for Disposable Canister 500 5

077.1453 Santhora: Holder for bed 077.0826, 077.0827 Santhora: Holders for Disposable Canister 500 5 077.1411, 077.1412 Santhora: Thora sets Plastic (PVC + POM + Silicone) 077.1471 Santhora: Universal holder 500 5 077.1456 Santhora: Vacuum gauge to Disposable Canister 077.1445 077.0811 Sets with suction jar PC Jar: Plastic (PC) Liner: Lid: Plastic (PA + TPE) Tubing: Plastic (PVC) liner, tubing jar jar lid lid 250 lid 2 077.0701-077.0707, 077.0715-077.0716 Sets with suction jar PSU Jar: Plastic (PSU) Lid: Plastic (PA + TPE) Clampholder: Plastic (PA) Tubing: Plastic (PVC) tubing 250 2 077.0051-077.0056 Silicone tubing Elastomere (Silicone) 250 2 077.0562, 077.0564 Specimen cup, disposable Plastic (PP)

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 077.0084, 077.0087 Suction liner with solidifier, disposable Plastic (PA + PE) solidifier: natrium salt 077.0083, 077.0086 Suction liner, disposable Plastic (PA + PE) Disposable 077.1041-077.1043, 077.0763, 077.0063 Suction Cups: Bird 60 5 077.0068-077.0071 Suction Cups: Bird (New Generation) metal (stainless) Plastic (PP + Nylon) 60 5 077.1045-077.1047 Suction cups: Bird, bottomplates Plastic (PP) 60 1 077.0080 Suction Cups: CaesAid Elastomere (Silicone) 60 2 077.0029-077.0037 Suction Cups: Malmström Elastomere (Silicone) 60 5 077.0038 Suction Cups: Malmström traction handle with stop clip 60 5

077.0078, 077.0079 Suction Cups: Silc Cup with trumpet valve Elastomere (Silicone) 60 2 077.0761, 077.0762 Suction Cups: Silc Cups Elastomere (Silicone) 60 2 077.0792 Suction Cups: Single Use Bird Cup Plastic (PC) 077.0791 Suction Cups: Single Use Silc Cup 077.1044 Suction Cups: Traction handle with hook to Bird Cups 60 5 077.0211, 077.0212, 077.0221, 077.0222, 077.0231, 077.0232, 077.0082, 077.0085 Suction jar PC Plastic (PC)

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 077.0110, 077.0111, 077.0120, 077.0125, 077.0130, 077.0150, 077.0155 Suction jar, PSU Plastic (PSU) 250 2 600.0680 Trolley for Basic 30 and Dominant 50 Plastic (PS-coated) 071.0034, 071.0035 Trolley for Basic and Dominant Fle PS-coated metal 077.0511 Trolley small Metal (stainless-coated) 077.1460-077.1463 Trolley with infusion holder, Euro plugs 077.0751, 077.0752 Tubing holders 500 5 077.0093 Tubing set: double drainage Plastic (POM + Silicone) Y-piece 250 2 077.0951, 077.0962, 077.0963, 074.0003 Tubing: disposable Plastic (PVC)

077.0974 Tubing: disposable drainage Plastic (PVC) 077.0961 Tubing: Silicone, green Plastic (POM + Silicone) 250 2 077.0912-077.0931 Tubings: Silicone with coupling pieces Plastic (POM + Silicone) 250 2 077.0900-077.0905, 077.0970 Tubings: Silicone without coupling pieces Elastomere (Silicone) 250 2 077.1160 Vacuum Ejector with clamp holder 077.0047, 077.0081 Vacuum etractor: pump Plastic (PP + various) 077.0831 Vario carrying bag Plastic (Polyester + PVC) 077.0834 Vario Disposable Filter Set with Overflow Protection/ Bacteria Filter Plastic (PP + POM) Tubing: Elastomere (Silicone) 077.0821, 077.0825 Vario rail holder 1025 mm 500 5

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 077.0824 Vario trolley plate 500 5 077.0823 Vario universal holder 500 5 077.0832 Vario: Car connection cable 12 V DC 077.0523, 077.0524 Wall brackets Plastic (ASA) 500 5 077.1020 Y-piece Plastic (PP)