PART 5. Sterilisation Consumables RFTHPV

Transcription

1 PART 5 STATEMENT OF REQUIREMENTS Sterilisation Consumables RFTHPV Part 5 Statement of Requirements

2 TABLE OF CONTENTS INTRODUCTION Purpose Scope Product Categories Product Conditions Definitions... 6 STATEMENT OF WORK Indicative Demand Delivery Training and Support Warranty Key Performance Indicators Reporting Service Level Agreement... 9 GENERAL REQUIREMENTS Standards and Compliance Recall Process Backorders and Discontinued Lines Associated devices for consumables categories Infection Control PRODUCT SPECIFICATIONS GENERAL SPECIFICATIONS Substances of Concern Reusable Devices Compliance with Category Specifications CATEGORY SPECIFICATIONS Category 1: Cleaning Agents Category 2: Instrument Cleaning Brushes Category 3: Instrument Protectors Category 4: High Temperature Sterilisable Equipment Category 5: Low Temperature Sterilisable Equipment Part 5 Statement of Requirements Page 1 of 26

3 5.26 Category 6: Single Use Sterilisation Wraps Category 7: Laminate/Flexible Packaging Category 8: Tray Liners Category 9: Rigid Container Consumables Category 10: Process Indicators, tests and associated devices Category 11: Biological Indicator Tests Category 12: Manual Batch Tracking Category 13: Chemical and Gas Sterilants, High Level Disinfectants and Test Strips Category 14: Filters APPENDICES APPENDIX 1 PRODUCT LIST APPENDIX 2 REFERENCES Part 5 Statement of Requirements Page 2 of 26

4 Introduction INTRODUCTION 5.1 PURPOSE The purpose of this Part 5 Statement of Requirements, is to: detail the scope and range of products sought under this Request for Tender (RFT) specify the service requirements that Respondents and/or their offered products must meet (these requirements also form part of any resulting Agreement between HPV and any successful Respondent(s)). 5.2 SCOPE HPV is seeking responses for sterilisation consumables for use in Participating Health Services for the duration of three (3) years, plus one extension of two years duration (3+2). The scope of this RFT includes the supply of sterilisation consumables. 5.3 PRODUCT CATEGORIES The categories of sterilisation consumables required under this RFT include: CATEGORY NUMBER CATEGORY NAME 1 Cleaning Agents 2 Instrument Cleaning Brushes 3 Instrument Protectors 4 High Temperature Sterilisable Equipment 5 Low Temperature Sterilisable Equipment 6 Single Use Sterilisation Wraps 7 Laminate/Flexible Packaging 8 Tray Liners 9 Rigid Container Consumables 10 Process indicators, tests and associated devices 11 Biological Indicator Tests 12 Manual Batch Tracking Part 5 Statement of Requirements Page 3 of 26

5 Introduction 13 Chemical and Gas Sterilants, High Level Disinfectants and Test Strips 14 Filters Respondents may offer products in one, some or all categories. Only products that specifically fit within the category descriptions provided will be considered. Products offered in other subcategories will only be considered where the product meets the specification and the Respondent is successful in at least one of the specific subcategories of that category. HPV reserves the right to not consider any additional products offered. For a full list of product categories and subcategories, see Appendix 1 Category List. 5.4 PRODUCT CONDITIONS Clinical Trials Participating Health Services may, at their discretion, research or trial new technology or use non-contracted products to perform clinical trials at any time throughout any resulting Agreement. Product Duplication HPV will not consider any product that is subject to a current HPV Agreement other than the current agreement for this Category. Respondents must ensure that each product is offered in only one subcategory. It is at the Respondent s discretion to ensure that each product is submitted in the most appropriate subcategory. Product Information Respondents must submit a copy of relevant product diagrams, specifications or brochures to assist in accurately identifying products offered. All product information submitted must: be in electronic format be in English be specific to the product offered contain the Respondent s company name include the product code. Part 5 Statement of Requirements Page 4 of 26

6 Introduction To assist in managing this material, all product information submitted must be labelled with the relevant HPV category and subcategory number. HPV reserves the right to not consider any unlabelled submissions. Product Information will not be evaluated, but is necessary to assist in accurately identifying products offered. Where offered products are unidentifiable and the product information provided is not clearly labelled, HPV reserves the right to remove these products from evaluation. Respondents should not submit information relating to products that are not called for in this Invitation to Supply. Respondents should note that product samples and research papers are not to be provided, unless specifically requested by HPV. Third-Party Product Compatibility Respondents offering third-party items must provide clinical testing and evidence of each item s compatibility with specific models of OEM equipment. Successful Respondents must also make these certificates of compliance and/or evidence of testing available to Participating Health Services upon request. Further evidence of testing will be required for product variations requested during the contract period. Certificates of compliance and/or evidence of testing must not be more than two (2) years old at the time the variation request is made. HPV reserves the right to require further testing from successful Respondents if: a product quality issue is identified during the contract an option period is exercised at the end of the contract principal period Ensuing to clauses and , in the event that HPV requires further certificates of compliance and/or evidence of testing to be provided, HPV reserves the right to remove products from contract if the successful Respondent refuses to or cannot produce the required evidence. Part 5 Statement of Requirements Page 5 of 26

7 Introduction 5.5 DEFINITIONS The following definitions apply to this Part 5 Statement of Requirements, unless otherwise stated. TERM business day consumable may must Participating Health Services reusable should single use single-patient use SLA will OEM DEFINITION Any weekday that is not gazetted as a public holiday in Melbourne, Victoria. A component that is used continually until it is exhausted and needs to be replaced. Indicates an optional element; it is at the Respondent s discretion to either meet or not meet this element, and failure to meet this element will not have an impact during evaluation. Indicates a mandatory requirement; failure to meet this requirement will have a significant negative impact during evaluation. Public Hospitals and other Health or Related Services, as defined in Section 3 of the Health Services Act 1988 (Vic), that are described in Appendix 4 of Part 9. A device designed or intended by the manufacturer as suitable for reprocessing and reuse (source: TGA, Regulation of the Re-Manufacture of Single Use Medical Devices). Indicates a highly desirable element; unless justifiable reason exists, not meeting this element may have a medium impact during evaluation. A device that is intended to be used on an individual patient, during a single procedure, and then discarded (source: TGA, Regulation of the Re-Manufacture of Single Use Medical Devices). A device that can potentially undergo more than one episode of use on one patient only. The device may need to undergo some form of reprocessing between each use (in accordance with manufacturers instructions). (source: TGA, Regulation of the Re-Manufacture of Single Use Medical Devices). Service Level Agreement Indicates an anticipated future condition or requirement. Original Equipment Manufacturer. Part 5 Statement of Requirements Page 6 of 26

8 Statement of Work STATEMENT OF WORK 5.6 INDICATIVE DEMAND Part 6 contains indicative data on usage for Sterilisation Consumables expressed on a per annum basis (based on the current 12 month period). Respondents are to note that any usage figures provided are indicative only, and are provided to assist Respondents in the preparation of their submission. 5.7 DELIVERY Sterilisation consumables must be delivered to the location(s) specified by Participating Health Services within the shortest possible timeframe; however, this must not exceed the following timeframes: One (1) business day from receipt of order for metropolitan Participating Health Services Two (2) business days from receipt of order for regional and rural Participating Health Services Preference may be given to Respondents who can offer delivery in less than one (1) business day for metropolitan and (1) business day for regional and rural. Except where there is evidence of inappropriate handling by the receiving Participating Health Service, all damaged or broken products and equipment must be replaced free of charge. Urgent Deliveries For the purposes of this section, urgent deliveries refers to urgent requests placed by an individual Participating Health Service, and does not include state-wide emergency management situations. Respondents should be able to receive and action urgent delivery requests 24 hours a day. Urgent deliveries must be received by Participating Health Services (at specified locations) within the shortest possible timeframe; however, this should not exceed the following timeframes: 12 hours from receipt of order for metropolitan Participating Health Services 24 hours from receipt of order for regional and rural Participating Health Services. Part 5 Statement of Requirements Page 7 of 26

9 Statement of Work 5.8 TRAINING AND SUPPORT Successful Respondents may be required to provide training and/or training materials to facilitate the introduction of their sterilisation consumables to clinicians in their operating environment. Such training and/or materials must be available to Participating Health Services upon request. If requested by a Participating Health Service, successful Respondents must provide a plan detailing how they will provide training to nominated staff. The number of staff involved in training may vary greatly between Participating Health Services. Successful Respondents must ensure that the following is available to Participating Health Services (in either hard-copy or electronic format): the credentials of any staff who would be providing support the hours of availability for support the geographical area covered by the support (if support is available on site) details of educational and/or support materials available to clinicians. 5.9 WARRANTY Where applicable, products must be warranted for normal use. Upon request, successful Respondents must provide information (printed or electronic) explaining product warranty. Repairs and Replacements under Warranty The repair of any product under warranty will be at no cost to Participating Health Services. The cost of any pickup or delivery associated with a repair under warranty will be borne by the successful Respondent. Successful Respondents must provide Participating Health Services with a suitable replacement item of the same make and model until the repaired item is returned. This will be done at no cost to Participating Health Services KEY PERFORMANCE INDICATORS Refer to Schedule 6 of Part 7 Agreement for Key Performance Indicators REPORTING Refer to Appendix 5 of Part 9 Non Returnable Appendices for reporting requirements. Part 5 Statement of Requirements Page 8 of 26

10 Statement of Work 5.12 SERVICE LEVEL AGREEMENT Participating Health Services may enter into a Service Level Agreement (SLA) with the successful Respondent(s). Successful Respondents must enter into an SLA if requested by a Participating Health Service. The terms of the SLA are to be agreed between the Participating Health Service and the successful Respondent(s). The SLA may cover arrangements including, but not limited to: requirements for stock management and rotation arrangements for ordering, invoicing and delivery clinical support, including attendance requirements for representatives in relation to education and training communication arrangements for product recalls and safety alerts ongoing calibration, testing and maintenance The SLA will be in addition to the Agreement between the successful Respondent(s) and HPV, and will not alter any terms of the Agreement. HPV will not be responsible for monitoring compliance with any SLA. This is a matter of agreement between the parties to the SLA. Part 5 Statement of Requirements Page 9 of 26

11 General Requirements GENERAL REQUIREMENTS 5.13 STANDARDS AND COMPLIANCE All items offered must comply with relevant Australian Standards (or their equivalent International Standards). Refer to Appendix 2 Standards, Guidelines and other for a list of the minimum relevant standards. All items offered must be approved by the Australian Therapeutic Goods Administration (TGA). Respondents must provide evidence of this (i.e. ARTG certificates) in their response. Successful Respondents must provide evidence of ARTG certification to Participating Health Services upon request. Successful Respondents must provide evidence of compliance to relevant standards in accordance to Appendix 2 upon request RECALL PROCESS All recalls must be managed in line with the Uniform Recall Procedure for Therapeutic Goods (2004). By 30 June 2015, all recalls and/or hazard alerts must be completed using GS1 Recallnet. Class 1 recalls (as defined by the TGA s Uniform Recall Procedure for Therapeutic Goods) must also meet the requirements under section 5.9 (Warranty), where applicable BACKORDERS AND DISCONTINUED LINES In the event that a product is unavailable, successful Respondents must immediately contact (at a minimum): the Sterilisation Services Manager Participating Health Services supply departments the Clinical Product Advisor (where applicable) In the event that a product is unavailable for a period of two or more consecutive weeks, successful Respondents must also contact HPV. Successful Respondents must inform the affected Participating Health Services and HPV of: the anticipated timeframe for resolving the issue the availability of an agreed substitute product. Part 5 Statement of Requirements Page 10 of 26

12 General Requirements 5.16 ASSOCIATED DEVICES FOR CONSUMABLES CATEGORIES Preference may be given to respondents who can provide associated devices at no cost that enhance the safety and effectiveness of the product INFECTION CONTROL Where applicable, all items must meet the requirements of the Australian Guidelines for the Prevention and Control of Infection in Healthcare (2010). Upon request by Participating Health Services, successful Respondents must provide specific cleaning instructions for all reusable products. Recommended cleaning products must be available for purchase within Australia. Part 5 Statement of Requirements Page 11 of 26

13 Product Specifications PRODUCT SPECIFICATIONS GENERAL SPECIFICATIONS 5.18 SUBSTANCES OF CONCERN Preference may be given to products (including their accompanying packaging) that are Latex-free, unless otherwise stated. Preference may be given to products that are Di-(2-Ethylhexyl) phthalate (DEHP)-free REUSABLE DEVICES For reusable devices, the following information must be readily available to all Participating Health Services in either hardcopy and/or electronic format: instructions for cleaning, sterilisation and reuse as per the relevant Australian Standard warranty information COMPLIANCE WITH CATEGORY SPECIFICATIONS Products offered with optional components must also comply with the specifications for other relevant categories (where applicable). CATEGORY SPECIFICATIONS 5.21 CATEGORY 1: CLEANING AGENTS A range of cleaning agents and associated products is required to support decontamination of reusable medical and surgical instruments and equipment within the central sterile processing area. This includes: a range of volumes and presentations of: o enzymatic cleaners o cleaning solutions for manual and automated cleaning processors o rinse aid/neutraliser/drying agents o stain removers for instruments and sterilisation and washing equipment o de-scaling agents a range of compatible additional components including: o opening devices e.g. spanners for removing the cap or lid on containers of cleaning agents. o replacement caps Part 5 Statement of Requirements Page 12 of 26

14 Product Specifications o lubricants compliant to Australian standards o measuring and dispensing devices, including a closed system for dispensing o supporting or retaining brackets to stabilise containers of cleaning chemicals Opening devices (eg: spanner) should be provided free of charge. For each cleaning agent offered, Respondents must advise if the product is recommended for a specific brand/model of equipment. Where the items offered are suitable for generic use Respondents must advise of any recalibration and testing required supporting effective use of the offered products. Respondents must advise the availability and any costs associated with the provision of additional services that will assist in maintaining the integrity of the cleaning systems and cycles e.g. monthly testing and reporting on pump function, dilutions, dosing etc. Additional Information Successful Respondents must make the following information readily available for all contract users in electronic and/or hard copy documentation: current Material Safety Data Sheets toxicology reports that discuss the presence of residue that may remain on any products following the cleaning cycle compatibility of chemicals with other products CATEGORY 2: INSTRUMENT CLEANING BRUSHES A range of instrument cleaning brushes is required in the central sterile processing area. This includes: metal and synthetic handles single use reusable full range of sizes and lengths single and double ended Cleaning brushes with metal handles must be rust resistant. Where brushes are deemed to be reusable, they must be capable of withstanding thermal disinfection. Preference may be given to products that can withstand high temperature sterilisation processes Part 5 Statement of Requirements Page 13 of 26

15 Product Specifications 5.23 CATEGORY 3: INSTRUMENT PROTECTORS A range of instrument protectors is required in the central sterile processing area. This includes: single use paper/laminate vented single use plastic vented re-usable silicone full range of sizes and shapes clear, tinted and solid colours CATEGORY 4: HIGH TEMPERATURE STERILISABLE EQUIPMENT A range of re-usable, high temperature sterilisable equipment is required in the central sterile processing area. This includes a full range of sizes and volumes of: plastic perforated trays, with and without lids tray inserts: silicone bars and holders plastic kidney dishes plastic gallipots plastic bowls metal trays with or without lids metal baskets High temperature sterilisable equipment must: have no rough or sharp edges be compatible with the range of cleaning agents be durable and lightweight be easily cleanable with no ridges or lips that may trap moisture or blood and body fluids. Additional Information Successful Respondents must make the following information readily available for all contract users in electronic and/or hard copy documentation: instructions for recommended high level disinfection and sterilisation, according to Australian standards, including any warnings regarding known conditions that may reduce the useful life expectancy of the equipment. Part 5 Statement of Requirements Page 14 of 26

16 Product Specifications 5.25 CATEGORY 5: LOW TEMPERATURE STERILISABLE EQUIPMENT A range of re-usable, low temperature sterilisable equipment is required in the central sterile processing area. This includes a full range of volumes and sizes for: plastic perforated trays, with and without lids tray inserts: silicone bars and holders metal trays, with and without lids Low temperature sterilisable equipment must: have no rough or sharp edges be compatible with the range of cleaning agents. be durable and lightweight be easily cleanable with no ridges or lips that may trap moisture or blood and body fluids. Additional Information Successful Respondents must make the following information readily available for all contract users in electronic and/or hard copy documentation: instructions for recommended high level disinfection and sterilisation, according to Australian standards, including any warnings regarding known conditions that may reduce the useful life expectancy of the equipment CATEGORY 6: SINGLE USE STERILISATION WRAPS A range of single-use, non-woven, low-linting sterilisation wraps is required in the central sterile processing area. This includes: a range of materials: o cellulose based o polypropylene o combination of cellulose and polypropylene a range of sizes and strengths single and multi-layer presentations Respondents note: For the purposes of this Statement of Requirements, Extra Heavy Strength refers to material that exceeds the specification of Heavy Duty for tensile strength as per AS Part 5 Statement of Requirements Page 15 of 26

17 Product Specifications 5.27 CATEGORY 7: LAMINATE/FLEXIBLE PACKAGING A range of single-use laminate/flexible sterilisation packaging for steam and low temperature sterilisation processes is required in the central sterile processing area. This includes: a range of materials: o cellulose based o porous non-cellulose based flat and gusseted rolls and pouches heat sealing a full range of sizes, widths and lengths Laminate/flexible packaging must: have the sterilisation process indicator located on the laminated side of the packaging incorporate a directional arrow to indicate direction of peel to open packaging CATEGORY 8: TRAY LINERS A range of non-sterile, single-use, low linting tray liners are required in the central sterile processing area. This includes: a range of materials: o paper o non-woven a range of sizes CATEGORY 9: RIGID CONTAINER CONSUMABLES A range of brand specific and generic use rigid container consumables is required in the central sterile processing area. This includes a range of sizes, volumes and colours of: single use and reusable filters tamper evident locks and arrows with and without steam sterilisation process indicators indicator tabs. Part 5 Statement of Requirements Page 16 of 26

18 Product Specifications 5.30 CATEGORY 10: PROCESS INDICATORS, TESTS AND ASSOCIATED DEVICES A range of process indicators, tests and associated devices is required in the central sterile processing area. This includes: Class 1: process indicators Class 2: specific test indicators Class 3: single parameter indicators Class 4: multi-parameter indicators Class 5: integrating indicators Class 6: emulating indicators soil tests soil testing kits chemical residue tests water tests chemical ph tests cleaning challenge devices/tests performance tests process challenge tests CATEGORY 11: BIOLOGICAL INDICATOR TESTS A range of biological indicator tests for steam, ethylene oxide, peracetic acid and low temperature sterilisation is required in the central sterile processing area. This includes: self-contained biological indicators rapid read-out biological indicators biological indicator disposable test packs a range of incubators compatible with indicators. Additional Information Successful Respondents must make the following information readily available for all contract users in electronic and/or hard copy documentation: details of repair, maintenance and validation programs CATEGORY 12: MANUAL BATCH TRACKING A range of manual batch tracking labels, labelling devices and accessories is required in the central sterile processing area. This includes: single adhesive identification labels for batch identification purposes Part 5 Statement of Requirements Page 17 of 26

19 Product Specifications manual dual adhesive tracking system labels i.e. double label or piggy back label with and without: o Class 1 indicator for steam, ethylene oxide and hydrogen peroxide /plasma gas sterilisation o additional space for writing comments a full range of combinations of ink and background colours labelling guns including spare parts and recording sheets accessories e.g. ink roller and ink pad Preference may be given to suppliers for labels that: retain clarity of label information after the sterilisation process incorporate an effective and durable adhesive compatible with sterilisation processes used. Additional Information Successful Respondents must make the following information readily available for all contract users in electronic and/or hard copy documentation: loading instructions for labelling guns CATEGORY 13: CHEMICAL AND GAS STERILANTS, HIGH LEVEL DISINFECTANTS AND TEST STRIPS A range of chemical sterilants and high level disinfectants and test strips is required in the central sterile processing area. This includes: Glutaraldehyde Ortho-phthalaldehyde Peracetic Acid Ethylene Oxide Hydrogen Peroxide a full range of: o presentations o volumes o concentrations. Additional Information Successful Respondents must make the following information readily available for all contract users in electronic and/or hard copy documentation: copies of current Material Safety Data Sheets Part 5 Statement of Requirements Page 18 of 26

20 Product Specifications recommended method for safe disposal of cartridges, cassettes and waste chemicals. compatibility of chemicals with other products CATEGORY 14: FILTERS A range of filters is required for automatic and manual reprocessing systems, that includes but is not limited to: peracetic acid sterilisation systems ortho-phthalaldehyde systems closed glutaraldehyde systems Part 5 Statement of Requirements Page 19 of 26

21 Appendices APPENDICES APPENDIX 1 CATEGORY LIST CATEGORY SUBCATEGORY 1. Cleaning Agents 1.1. Cleaning agent, enzymatic cleaner 1.2. Cleaning agent, manual and automated cleaning processor 1.3. Cleaning agent, rinse aid, neutraliser, drying agent 1.4. Cleaning agent, stain remover 1.5. Cleaning agent, de-scaling agent 1.6. Cleaning agent, lubricants 1.7. Cleaning agent, soil testing kit 1.8. Cleaning agent, chemical testing kit 1.9. Cleaning agent, replacement cap Cleaning agent, measuring and dispensing device Cleaning agent, supporting or retaining bracket 2. Instrument Cleaning Brushes 2.1. Instrument cleaning brush, metal handle, reusable Instrument cleaning brush, synthetic handle, reusable Instrument cleaning brush, with or without handle, to pass through cannulated instruments, reusable Instrument cleaning brush, metal or synthetic handle, single use. 3. Instrument Protectors 3.1. Instrument protector, single use paper/laminate 3.2. Instrument protector, single use, plastic, vented 3.3. Instrument protector, re-usable, silicone, vented 4. High Temperature Sterilisable Equipment 4.1. High temperature sterilisable equipment, plastic tray, perforated 4.2. High temperature sterilisable equipment, tray insert: silicone bars and holders 4.3. High temperature sterilisable equipment, plastic kidney dish 4.4. High temperature sterilisable equipment, plastic gallipot 4.5. High temperature sterilisable equipment, plastic bowl 4.6. High temperature sterilisable equipment, metal basket 4.7. High temperature sterilisable equipment, metal trays with or without lids Part 5 Statement of Requirements Page 20 of 26

22 Appendices CATEGORY 5. Low Temperature Sterilisable Equipment SUBCATEGORY 5.1. Low temperature sterilisable equipment, plastic, perforated tray 5.2. Low temperature sterilisable equipment, tray insert: silicone bars and holders Low temperature sterilisable equipment, metal trays with or without lids 6. Single Use Sterilisation Wraps 6.1. Single use sterilisation wrap, cellulose based, single layer 6.2. Single use sterilisation wrap, polypropylene, single layer 6.3. Single use sterilisation wrap, combination, single layer 6.4. Single use sterilisation wrap, cellulose based, multi-layer 6.5. Single use sterilisation wrap, polypropylene, multi-layer 6.6. Single use sterilisation wrap, combination, multi-layer 7. Laminate/Flexible Packaging 7.1. Laminate/flexible packaging, cellulose based, flat, roll 7.2. Laminate/flexible packaging, cellulose based, flat, pouch 7.3. Laminate/flexible packaging, cellulose based, gusseted, roll 7.4. Laminate/flexible packaging, cellulose based, gusseted, pouch 7.5. Laminate/flexible packaging, porous non-cellulose based, flat, roll 7.6. Laminate/flexible packaging, porous non-cellulose based, flat, pouch 7.7. Laminate/flexible packaging, porous non-cellulose based, gusseted, roll 7.8. Laminate/flexible packaging, porous non-cellulose based, gusseted, pouch 8. Tray Liners 8.1. Tray liner, paper 8.2. Tray liner, non-woven 9. Rigid Container Consumables 9.1. Rigid container consumable, single use filter 9.2. Rigid container consumable, reusable filter 9.3. Rigid container consumable, tamper evident lock 9.4. Rigid container consumable, arrow 9.5. Rigid container consumable, indicator tabs 10. Process Indicators, Tests and Associated Devices Class 1: Process Indicator Class 2: Specific Test Indicator Class 3: Single parameter Indicator Class 4: Multi-parameter Indicator Class 5: Integrating Indicator Class 6: Emulating Indicator Part 5 Statement of Requirements Page 21 of 26

23 Appendices CATEGORY SUBCATEGORY Soil Tests Chemical Residue Tests Water Tests Chemical ph Tests Cleaning Challenge Device/Tests Performance Tests 11. Biological Indicator Tests Biological indicator test, for steam Biological indicator test, for ethylene oxide Biological indicator test, for peracetic acid Biological indicator test, for low temperature hydrogen peroxide / plasma sterilisation Incubators compatible with indicators Compatible accessories e.g. record keeping log book, thermometer 12. Manual Batch Tracking Manual batch tracking, single adhesive identification label with indicator Manual batch tracking, single adhesive identification label without indicator Manual batch tracking, manual dual adhesive label with indicator Manual batch tracking, manual dual adhesive label without indicator Labelling gun (including spare parts and recording sheets) Accessories e.g. ink roller and ink pad 13. Chemical and Gas Sterilants, High Level Disinfectants and Test Strips Glutaraldehyde Ortho-phthalaldehyde Peracetic acid Ethylene oxide Hydrogen peroxide 14. Filters Filter for peracetic acid sterilisation systems Filter for ortho-phthalaldehyde systems system Filter for other systems in use Part 5 Statement of Requirements Page 22 of 26

24 Appendices APPENDIX 2 STANDARDS, GUIDELINES AND OTHER REFERENCES Standards References to the below standards include any amendments, revisions or consolidations to those standards. The standards below are current as at June For each standard listed, respondents are to ensure the latest publication of each standard is used. Note: Standard AS4187 is currently under review with a new standard planned to be published in late 2014 / early Respondents must consider the new standard, currently in draft, for AS4187 in their tender submission. The current draft in development by Standards Australia is available through the SAI Global website, Select Search for a Draft, using the reference STANDARD NUMBER STANDARD NAME Category 1 Cleaning Agents AS/NZS 4187 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities Category 2 Instrument Cleaning Brushes AS/NZS 4187 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities Category 3 Instrument Protectors AS/NZS 4187 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities Category 4 High Temperature Sterilisable Equipment AS/NZS 4187 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities Category 5 Low Temperature Sterilisable Equipment AS/NZS 4187 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities Category 6 Single Use Sterilisation Wraps AS AS Packaging of items (sterile) for patient care Part 1: Selection of packaging materials for goods undergoing sterilization Packaging of items (sterile) for patient care Part 5: Non-re-usable, non-woven wrapping materials For goods undergoing sterilization in health care facilities Part 5 Statement of Requirements Page 23 of 26

25 Appendices AS/NZS 4187 AS Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities For the purposes of this Statement of Requirements, Extra Heavy Strength refers to material which exceeds the specification of Heavy Duty for tensile strength as per AS Category 7 Laminate/Flexible Packaging AS AS AS/NZS 4187 Packaging of items (sterile) for patient care Part 1: Selection of packaging materials for goods undergoing sterilization Packaging of items (sterile) for patient care Part 4: Flexible Packaging Systems for single use in hospitals Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities Category 8 Tray Liners AS AS/NZS 4187 Packaging of items (sterile) for patient care Part 1: Selection of packaging materials for goods undergoing sterilization Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities Category 9 Rigid Container Consumables AS/NZS 4187 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities Category 10 Process indicators, tests and associated devices ISO ISO ISO ISO ISO BS EN867-1 BS/EN867-3 BS/EN867-4 Sterilization of health care products Chemical indicators Part 1: General Requirements (including all amendments) Sterilization of health care products Chemical Indicators Part 2: test equipment and methods Sterilization of health care products Chemical indicators Part 3: Class 2 indicators for steam penetration test sheets Sterilization of health care products Chemical Indicators Part 4: Class 2 indicators for steam penetration test packs Sterilization of health care products Chemical Indicators Part 5: Class 2 indicators for air removal test sheets and packs Non-Biological systems for use in sterilizers. General Requirements Non-Biological systems for use in sterilizers. Specification for Class B indicators for use in the Bowie and Dick test Non-Biological systems for use in sterilizers. Specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetration Part 5 Statement of Requirements Page 24 of 26

26 Appendices AS/NZS 4187 AS1410 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities Sterilizers Steam Pre-Vacuum Category 11 Biological Indicator Tests ISO ISO ISO AS/NZS 3100 AS/NZS 4187 Sterilization of health care products - Biological indicators Part 1: General Sterilization of health care products - Biological indicators Part 2: Biological indicators for ethylene oxide sterilization Sterilization of health care products - Biological indicators Part 3: Biological indicators for moist heat sterilization Approval and test specification General requirements for electrical equipment. Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities Category 12 Manual Batch Tracking, manual dual adhesive tracking system labels and batch labels AS/NZS 4187 ISO Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities. Where a Class 1 Process Indicator is present, Sterilization of health care products Chemical indicators Part 1: General Requirements (including all amendments) Category 13 Chemical and Gas Sterilants, High Level Disinfectants and Test Strips AS/NZS 4187 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities Category 14 Filters AS/4260 ISO 9001 HEPA Filters Water Filters Material Safety Data Sheets The references to the below legislation include any amendments, revisions or consolidations to those references. For the purpose of evaluation of this tender, suppliers must provide a copy of the MSDS for all cleaning agents offered. Cleaning Agents suppliers must make copies of Material Safety Data sheets for all cleaning agents and available to all hospitals for their own records. Legislation The references to the below legislation include any amendments, revisions or consolidations to those references. Part 5 Statement of Requirements Page 25 of 26

27 Appendices Therapeutic Goods (Medical Devices) Regulations 2002 Therapeutic Goods Act 1989 Guidelines and Other References The references to the below guidelines include any amendments, revisions or consolidations to those guidelines. NHMRC (2010), Australian Guidelines for the Prevention and Control of Infection in Healthcare, Commonwealth of Australia Therapeutic Goods Administration (2004), Uniform Recall Procedure for Therapeutic Goods, Commonwealth of Australia Therapeutic Goods Administration (2011), Australian Regulatory Guidelines for Medical Devices Part 5 Statement of Requirements Page 26 of 26