Cleaning and Disinfecting and Sterilizing Reprocessing Guide April 2015

Contents Reprocessing Guide (Cleaning / Disinfection / Sterilization)... 3 1

General Information... 3

2

Requirements for Use and Re-Use... 3

3

Staff... 4

4

Definitions... 4

Processing Instructions for Non-Critical Medical Products at Health Care Facilities... 6 5

List of Non-Critical Medical Products... 6

6

Processing Instructions... 9

7

Point of Use...10

8

Thorough Cleaning...11

9

Intermediate Level Disinfection...12

10 Storage...13 Processing Instructions for thermal sensitive Non-Critical Medical Products at Health Care Facilities...14 11 List of thermal sensitive Non-Critical Medical Products...14 12 Processing Instructions...15 13 Point of Use...16 14 Thorough Cleaning and Thermal Disinfection...16 15 Storage...18 Processing Instructions for re-sterilizable Semi-Critical Medical Products at Health Care Facilities...19 16 List of re-sterilizable Non-Critical Medical Products...19 17 Processing Instructions...21 18 Point of Use... 22 19 Thorough Cleaning and Thermal Disinfection... 23 20 Terminal Sterilization...25 21 Storage... 26 Disassembly and Reassembly Chart... 27 References... 27 Phone number... 28

Reprocessing Guide (Cleaning / Disinfection / Sterilization) 1 General Information This Guide is intended to give general instructions on how medical devices supplied by Medela AG may be processed or reprocessed to prepare them for Re-Use and gives advice on cleaning, disinfecting or sterilizing products supplied by Medela AG. Equipment, operators, cleaning detergents / disinfectant agents and procedures have a contribution to the efficacy of the processing and reprocessing of medical products. These guidelines are for healthcare professionals, such as nurses and infection control practitioners, who work in a hospital environment. 2 Requirements for Single Use and Re-Use Type

Use for

Requirements

Re-Use

 m ore than one patient

e.g. tubing

multiple uses possible

– Requires reprocessing after each use – Must be checked regularly for damage and appearance and replaced if necessary

Single Use

 o ne patient only once only

e.g. filters

– Ready for use – U se immediately after opening the packaging – Must be disposed after using – N ot to be used by more than one person in order to avoid possible health risks – Reuse could cause cross contamination – R eprocessing could cause loss of mechanical, chemical and / or biological characteristics

Note: Medela AG does not define the maximum number of uses appropriate for reprocessing and reusing of medical devices. The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses. Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device. Refer to Chapter 19 of the suction pumps’ Instructions for Use for additional re-placement guidelines. Not all products are available in all markets.

3

3

Staff Staff should use suitable personal protective clothing and equipment at all times. In particular take note of the instructions provided by the cleaning detergent / disinfecting agent manufacturer for correct handling and use of the product.

4

Definitions

4.1 Material abbreviations ABS Poly(Acrylonitrile Butadiene Styrene) ASA Poly(Acrylic Styrene Acrylonitrile) PA Polyamide PC Polycarbonate POM Polyoxymethylene (Acetal) PP Polypropylene PS Polystyrene PSU Polysulfone TPE Thermoplastic Elastomer 4.2 Point of Use Reprocessing already begins at the point of use, which includes initial cleaning and measures to prevent drying of soil and contaminants in and on the device and should be carried out directly after application (within a maximum of 2 hours after use). 4.3 Initial Cleaning and Rinsing with sterile cold Water The first step of decontamination is initial cleaning with sterile cold water (< 40 ° C, < 104 ° F). The purpose of the initial cleaning is the removal of all visible soils from an item and the reduction of the number of particulates, micro­o rganisms and potential pyrogens. Many soils, including proteinaceous blood components such as albumin and hemoglobin, are water-soluble and can be easily washed away with water alone. 4.4 Thorough Cleaning Thorough cleaning consists of the removal, usually with detergent and water, of adherent soil (e.g., blood, protein substances and other debris) from the surfaces, crevices, serrations, joints, and lumens of instruments, devices and equipment by a manual or mechanical process that prepares the items for safe handling and/or further decontamination (Disinfection / Terminal Sterilization).

4

4.5 Disinfection Disinfection is a process that removes, inactivates or destroys blood-borne pathogens and other microorganisms by physical or chemical means on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, for use or for disposal. Disinfection processes do not ensure the same margin of safety associated with sterilization processes. 4.6 Thorough Disinfection or Terminal Sterilization The complete elimination or destruction of all forms of microbial life accomplished in health care facilities by either physical or chemical processes.

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Processing Instructions for Non-Critical Medical Products at Health Care Facilities 5

List of Non-Critical Medical Products Recommended cleaning methods have been validated by Medela AG to current international guidelines for cleaning.

Electric and electronic equipment and accessories Picture

6

Item No

Description

Material

014.0XXX

Clario / Clario Toni Motor unit AC-version Motor unit AC / DC-version

Housing: Plastics (ABS)

074.0006

Clario / Clario Toni vacuum gauge

Metals (stainless) Plastics (various)

074.0007

Clario / Clario Toni carrying bag

Plastics (PE coated with PET)

026.XXXX

Vario 8 AC + AC / DC Vario 8 c/i AC / DC Vario 18 AC + AC / DC Vario 18 c/i AC / DC

Housing Plastics (ABS)

077.0105

Vario jar adapter

Plastics (ABS)

077.0511

Trolley small

Metals (Zinc-coated steel)

077.0821

Vario rail holder

Metals (AlMgSi)

077.0823

Vario universal holder

Metals (Aluminum)

Picture

Item No

Description

Material

077.0831 077.0832

Vario carrying bag Vario car connection cable

Plastics (Polyester with PVC coating)

087.0000

Invia Liberty pump

Housing: Plastics (ABS) Holder: Plastics (PAA) Button: Plastics (POM)

079.0037

Docking station

Housing: Plastics (PC) Knob: Plastics (PA66)

077.0148

Mains adapter winternational

n/a

071.0000 071.0001

Basic suction pump, rack and portable versions

Housing Plastics (ABS)

071.0002 071.0003

Dominant Flex suction pump, rack and portable versions

Housing Plastic (ABS)

071.0034 071.0035

Trolley to Dominant Flex and Basic suction pumps

PS-coated metal

077.0104 077.0521 077.0152

Clampholder

Plastics (PA)

077.0723

Foot On/Off switch

Metals (Aluminum) Various plastics

7

Picture

8

Item No

Description

Material

077.0731

Foot vacuum regulator

Various plastics

077.0751 077.0752

Tubing holders

Metals (stainless)

017.0015

Apgar Timer

Housing: Plastics (PC/ABS)

077.0523

Wall bracket, single

Plastics (ASA)

079.0000 079.0002 079.0003

Thopaz drainage pump

Housing: Plastics (ABS)

079.1000 079.1002 079.1003

Thopaz+ digital cardio­ thoracic drainage system

Housing: Plastics (ABS)

079.0031

Carrying strap Thopaz

Textiles, Plastics (ABS)

079.1006

Carrying strap Thopaz+

Textiles, Plastics (ABS)

079.0036 079.0040

Holder with standard rail

Metals (stainless, aluminium)

079.0038

Adapter docking station for Thopaz canister 2l

Plastics (PP)

077.1456

Vacuum gauge

Metals (stainless) Various plastics

6

Processing Instructions The sequence of steps required to prepare medical devices for reprocessing are summarized in the chart below. More detailed instructions for each step are given on the following pages.

Point of Use – Disassembly – M anual Initial Cleaning

Thorough Cleaning – Manual Thorough Cleaning – Drying

Disinfection – Manual Disinfection – Drying

Storage – Inspection – Reassembly

9

7

Point of Use

7.1 Utensils and Equipment – Personal Protective Equipment (PPE: Disposable gloves, Proper protective gear). – Lint free nonwoven wipes. – Sterile cold water (< 40 ° C, < 104 ° F). 7.2 Procedure Disassembly – Disinfect your hands. – Put on disposable gloves and proper protective gear. – Disassemble if possible. Housing suction pumps: remove Safety Set as shown. Suction pumps in general: Remove all accessories if attached.

7.3 Procedure Manual Initial Cleaning – Directly after application (within a maximum of 2 hours postoperatively) wipe the surfaces to remove all gross debris by using a lint free nonwoven wipe wetted with sterile cold water (< 40 ° C, < 104 ° F). – Ensure that all surfaces are thoroughly wetted. – Wipe again using another wipe and keep moist for a minimum of 5 minutes then repeat it with another wipe. – Dispose of protective gloves. – Disinfect your hands. 7.4 Cautions – Before cleaning electrical devices, disconnect the power plug from the power socket. – Clean all surfaces immediately after use (maximum 2 hours postoperatively) to avoid residues from drying and to prevent growth of microorganisms. – Never use steel brushes or steel wool for cleaning. – Water temperatures higher than 45 ° C (113 ° F) can cause protein coagulation which may affect the efficacy of the process. – Never place the device in water or other liquids.

10

8

Thorough Cleaning

8.1 Utensils and Equipment – Personal Protective Equipment (PPE: Disposable gloves, Proper protective gear). – Lint free nonwoven wipes wetted with an enzymatic detergent. – Sterile cold water (< 40 ° C, < 104 ° F). 8.2 Procedure Manual Thorough Cleaning – Disinfect your hands. – Put on disposable gloves and proper protective equipment. – Use the wipes wetted with an enzymatic detergent according to the manufacturer’s instructions for use. – Ensure that all surfaces are thoroughly wetted. – Check surfaces for visible dirt and repeat these steps if necessary. – At the end use a wipe wetted with sterile cold water (< 40 ° C, < 104 ° F) to wipe surfaces. Repeat these steps if necessary. 8.3 Procedure Drying – Allow surfaces to dry from the enzymatic detergent according to the manufacturer’s instructions for use. – Dispose of protective gloves. – Disinfect your hands. 8.4 Cautions – Before cleaning electrical devices, disconnect the power plug from the power socket. – Never use steel brushes or steel wool for cleaning. – Water temperatures higher than 45 ° C (113 ° F) can cause protein coagulation which may affect the efficacy of the process. – Never place the device in water or other liquids.

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9

Intermediate Level Disinfection

9.1 Utensils and Equipment –  Personal Protective Equipment (PPE: Disposable gloves, Proper protective gear). –  D isinfecting wipes. 9.2 Procedure Manual Disinfection –  D isinfect your hands. –  Put on disposable gloves and proper protective equipment. –  U se disinfecting wipes according to the manufacturer’s instructions for use. – After 5 minutes wipe with another disinfecting wipe. 9.3 Procedure Drying –  A llow the surface to dry for a minimum of 5 minutes. –  D ispose of protective gloves. –  D isinfect your hands. 9.4 Caution –  N ever place the device in water or other liquids. 9.5 Recommended agent: –  C aviWipes ® Metrex ® Research Address: 1717 West Collins Avenue, Orange, CA 92867, U.S.A. Homepage: http://www.metrex.com Phone: (800) 841 1428 Email: [email protected] –  M ikrozid ® AF Wipes Schülke&Mayr GmbH Address: Robert-Koch Str. 2, 22851 Norderstedt, GERMANY Homepage: http://www.schuelke.com Phone: +49 (0) 40 521 00 0 Email: [email protected]

12

10

Storage

10.1 Procedure Reassembly and Storage – Where appropriate the cleaned, disinfected and checked medical products should be reassembled again and prepared for Re-Use. Housing suction pumps: Reattach Safety Set as shown Suction pumps in general: Configure pump with necessary accessories

– Sufficient protection of the medical products must be provided in order to keep medical products dry and dust free. 10.2 Cautions – Store medical products dry and dust free.

13

Processing Instructions for thermal sensitive Non-Critical Medical Products at Health Care Facilities 11

List of thermal sensitive Non-Critical Medical Products Recommended cleaning methods have been validated by Medela AG to current international guidelines for cleaning. Thermo sensitive medical products

Picture

14

Item No

Description

Material

074.0001

Clario / Clario Toni canister Set consists of canister, lid with plugs for closing and floater (074.0010)

Jar: Plastics (PC) Lid: Plastics (TPE-E) Plugs: Plastics (PE) Floater: Plastics (TPE-V)

074.0002 014.0030

Clario / Clario Toni SafetyChamber is a set consisting of lid, housing, 2 valves (074.0008)

Housing: Plastics (PBT+ASA) Lid: Plastics (TPE-E) Valves: Elastomers (MQ)

014.0005

Clario / Clario Toni vacuum regulator Knob

Plastics (TPE-V)

077.0082 077.0085

PC suction jar, 1.5l PC suction jar, 2.5l

Plastics (PC)

077.0531 077.0532

Quiver, 280 ml with holder Quiver, 480 ml with holder

Plastics (PP)

12

Processing Instructions The sequence of steps required to prepare medical devices for reprocessing are summarized in the chart below. More detailed instructions for each step are given on the following pages.

Point of Use – Disassembly – M anual Initial Cleaning

Thorough Cleaning – Automated Cleaning with Washer Disinfector

Thermal Disinfection – Automated Disinfection with Washer Disinfector – Inspection

Storage – Reassembly – Packaging – Storage

15

13

Point of Use

13.1 Utensils and Equipment –  Personal Protective Equipment (PPE: Disposable gloves, Proper protective gear) –  S terile cold water (< 40 ° C, < 104 ° F) 13.2 Procedure Disassembly –  D isinfect your hands. –  Put on disposable gloves and proper protective equipment. –  P C jars: –  W hen used with the disposable liners from Medela: remove liners according to suction pump’s Instructions for Use, chapter 10 –  R emove jar from clamp holder –  Q uiver: –  R emove from holder 13.3 Procedure Initial Cleaning with Rinsing Water –  R emove gross debris. –  R inse all parts with sterile cold water (< 40 ° C, < 104 ° F) for 3 minutes. –  D ispose of protective gloves. –  D isinfect your hands. 13.4 Cautions –  C lean all parts immediately after use (maximum 2 hours postoperatively) to avoid drying of residues and to prevent growth of microorganisms. –  N ever use steel brushes or steel wool for cleaning. –  Water temperatures higher than 45 ° C (113 ° F) can cause protein coagulation which may affect the efficacy of the process.

14

Thorough Cleaning and Thermal Disinfection

14.1 Utensils and Equipment – Disposable gloves 14.2 Procedure Automated Cleaning and Disinfection with Washer Disinfector – Disinfect your hands. – Put on disposable gloves. – Load items into the washer disinfector. – Choose the washer disinfector washing cycle. – Operate the washer disinfector.

16

– On completion, unload the washer disinfector. –  V isually check for remaining soil and dryness. If soil remains, repeat the procedure Cleaning and Disinfection with Washer Disinfector. –  R emaining wetness may be removed with medical grade compressed air or by heating in an oven below 110 ° C (230 ° F). 14.3 Procedure Inspection –  C heck the parts visually for damage and throw away at first signs of damage or weakness. –  D ispose of protective gloves. –  D isinfect your hands. 14.4 Cautions –  Water temperatures higher than 45 ° C (113 ° F) during the cleaning cycle can cause protein coagulation which may affect the efficacy of the process. –  Avoid contact between items (movement during washing could cause damage). –  A rrange items so that channels and openings are always oriented downwards –  Please follow Instructions for Use of manufacturer: –  for washing disinfector and –  for detergents and disinfectants –  I f available, attach tubing to nozzles in washer disinfector. 14.5 Recommended agents for thorough cleaning and thermal disinfection: –  n eodisher ® FA as the Liquid Detergent and neodisher ® Z as the Liquid Neutralizing Agent Miele, Inc. Address: 9 Independence Way, Princeton, NJ 08540, U.S.A. Homepage: http://www.miele.us Phone: (800) 991 9380 Email: [email protected] –  n eodisher ® FA as the Liquid Detergent and neodisher ® Z as the Liquid Neutralizing Agent Chemische Fabrik Dr. Weigert GmbH & Co. KG Mühlenhagen 85, D-20539 Hamburg, GERMANY Homepage: http://www.drweigert.com

17

15

Storage

15.1 Procedure Reassembly and Storage –  W here appropriate, the cleaned, disinfected and checked medical products should be prepared for Re-Use. –  S ufficient protection of the medical products must be provided in order to keep medical products dry and dust free. 15.2 Cautions –  S tore medical products dry and dust free.

18

Processing Instructions for re-sterilizable Non-Critical Medical Products at Health Care Facilities 16

List of re-sterilizable Non-Critical Medical Products Recommended cleaning methods have been validated by Medela AG to current international guidelines for cleaning. Sterilizable Medical Products

Picture

Item No

Description

Material

077.0420 / 077.0430 077.0440 / 077.0450

Lid

Plastics (PA, TPE, POM)

077.0110 / 077.0120 077.0125 / 077.0130 077.0150 / 077.0155

Suction jar PSU

Plastics (PSU)

077.0900 / 077.0901 077.0902 / 077.0905 077.0970 / 077.0095 077.0542 / 077.0912 077.0913 / 077.0921 077.0922 / 077.0931 077.0961 / 077.0185

Silicone tubing

Elastomers (Silicone) Plastics (POM) Elastomers (silicone o-ring)

077.1018 077.1019

Coupling pieces

Plastics (POM) Elastomers (silicone o-ring)

077.1022

Drainage valve

Plastics (PSU) Elastomers (silicone o-rings, bellows)

077.0563

Changeover valve

Plastics (PSU, PA) Elastomers (silicone tubing)

19

20

077.0651 / 077.0701 077.0702 / 077.0703 077.0704 / 077.0705 077.0706 / 077.0707 077.0715 / 077.0716 077.0711

Assembled products and sets

Jar: PSU Lid: PA, TPE, POM

077.0029 / 077.0030 077.0031 / 077.0038 077.0175 / 077.0176 077.0177

Malmström Cups

Metals (stainless) Elastomers (silicone)

077.1041 / 077.1042 077.1043 / 077.1044 077.0173 / 077.0172 077.0171

Bird Cups

Metals (stainless) Plastics (PP, POM) Tubing: Elastomeres (Silicone)

077.0063 077.0174

Bird Posterior Cup

Metals (stainless) Plastics (PP, POM) Tubing: Elastomeres (Silicone)

077.0078

Reusable Silc Cup with trumpet valve

Metals (stainless) Elastomers (silicone)

077.0761 077.0762

Reusable Silc Cups

Metals (stainless) Elastomers (silicone)

077.0080

CaesAid Cups for Caesarean sections

Elastomers (silicone)

077.0081

Manual Vacuum Extractor

Metals Plastics (PP) Elastomers (silicone)