Health Service Executive Standards and Recommended Practices for Commissioning, Validation and Testing in Endoscope Decontamination Facilities

Transcription

1 Health Service Executive Standards and Recommended Practices for Commissioning, Validation and Testing in Endoscope Decontamination Facilities Note: The Note: lifecycle The diagram lifecycle used diagram in this used The in lifecycle this document diagram is used Crown in this Copyright document Source Department is is Crown Department of Health United of Health Kingdom United Kingdom

2 Directorate: Title: Quality Improvement Division Health Service Executive Standards and Recommended Practices for Commissioning, Validation and Testing in Endoscope Decontamination Facilities Document Reference Number: QPSD-D Version Number: V.1 Document Purpose: Author: Standards & Recommended Practices HSE Quality Improvement Division Decontamination Safety Programme Approval Date: August 2018 Target Audience: All relevant staff in the public health service who work in and/or are involved in the reprocessing of flexible Endoscopes including the Commissioning, Validation and Testing in Endoscope Decontamination Facilities Description: The Standards and Recommended Practices are a guide to support the Practices for Commissioning, Validation and Testing in Endoscope Decontamination Facilities based on current legal requirements and professional best practice Superseded Docs: HSE Standards and Recommended Practices for Endoscope Decontamination Units. V2.2, 2012 Revision Date: August 2020 Contact Details: Caroline Conneely National Decontamination Safety Programme Lead Quality Improvement Division Health Service Executive Dr Steeven s Hospital, Dublin Eircode: DO8 W2A8 Ireland caroline.conneely1@hse.ie

3 Terminology and Acronyms used within the Guidance Document AED AHU ATP CE CESC CCM CFU CIBSE CP(D) EDUs EN EWD GI HEPA HSE HBS HCAI HIQA HPSC HTM IMS IPC IQ ISO Authorising Engineer for Decontamination Air Handling Unit Adenosine Triphosphate CE Mark that conforms to European Standards Controlled Environment Storage Cabinet Commissioning Manual Colony Forming Units Chartered Institute of Building Services Engineers Ireland Competent Person for Decontamination Endoscope Decontamination Units European Standard Endoscope Washer Disinfector Gastrointestinal High Efficiency Particulate Air Health Service Executive Health Business Services Healthcare Associated Infections Health Information Quality Authority Health Protection Surveillance Centre Health Technical Memorandum UK Independent Monitoring Systems Infection Prevention and Control Practitioners Installation Qualification International Standard

4 Terminology and Acronyms used within the Guidance Document JAG M&E MSDS NAD O&M OQ PCD PCHCAI PCR PES PQ PRQ PTFE RO RIMDs SDA TSA TVC Joint Advisory Group Mechanical and Electrical Material Safety Data Sheet Nicotinamide Adenine Dinucleotide Operational and Maintenance Manual Operational Qualification Process Challenge Device Prevention and Control of Healthcare Associated Infections Polymerase Chain Reaction Programmable Electronic System Performance Qualification Performance Requalification Polytetrafluoroethylene Reverse Osmosis Reusable Invasive Medical Devices Sabouraud Dextrose Agar Tryptone Soya Agar Total Viable Count

5 No. Page Part 1 Introduction 1 Introduction to Commissioning, Validation and Testing in Endoscope Decontamination Facilities 1 2 About this Document 7 3 Standards used to Support Commissioning, Validation and Testing Regimes in Endoscope Decontamination Facilities 8 4 Testing and Testing Terminology 10 5 What is Commissioning? 12 6 What is Validation? 14 7 What is Periodic Testing (including Annual testing/revalidation)? 16 8 What are the Types of Tests We Need to Perform? What should I do if a Test Fails? 19 9 Management of Outsourced Contracts 20

6 No. Page Part 2 in an Endoscope Decontamination Facility 1 Commissioning of EDU Services and Facilities including Handover and Periodic Testing HIQA Theme 2: Effective Care and Support Standard 2.2, 2.4, 2.6, 2.7, 2.8. HIQA Theme 5: Leadership governance and Management Standard 5.3, 5.4, Commissioning of EDU Services and Facilities Periodic Testing of EDU Services and Facilities 29 2 Commissioning of EDU Decontamination Equipment Commissioning of EDU Equipment Performance Qualification Tests for EWDs and CESCs Commissioning of Other Storage and Transport Systems Surrogate Devices 37 3 Periodic Testing of EDU Decontamination Equipment HIQA Theme 2: Effective Care and Support Standard 2.2, 2.4, 2.8 HIQA Theme 5: Leadership Governance and Management Standard General Concepts-Endoscope Product Family Validating the Effectiveness of the Endoscope Journey EWD Testing Methods for Water Quality Testing Methods for EWD Performance EWD Maintenance 70

7 Part 2 in an Endoscope Decontamination Facility Page for Controlled Environment Storage Cabinet Performance Testing Methods for CESC Performance CESC Performance Requalification (PRQ) Annual Testing Periodic Testing for Other Storage and Transport Systems 4 Environmental Control HIQA Theme 2: Effective Care and Support Standard 2.4, Figures Tables Part 1 Introduction Figure 1: Themes for Quality and Safety 4 Table 1: What do HIQA PCHCAI Standards mean for the Endoscope Decontamination Unit? 5 Table 2: Periodic Tests and Check Intervals for EDUs 16

8 Figures/Tables Part 2 in an EDU Page Figure 1: Example of an Endoscope from Product Family 1 40 Figure 2: Example of an Endoscope from Product Family 2 41 Figure 3: Example of an Endoscope from Product Family 3 42 Table 1: Requirements for Water Hardness 27 Table 2: Maximum Permitted Values for Final Rinse Water 28 Table 3: Summary of Ventilation Requirements 30 Table 4: Quality Assuring the Endoscope Journey 43 Table 5: Testing the Decontamination Processes 44 Table 6: EWD Daily Tests 45 Table 7: EWD Weekly Tests 46 Table 8: EWD Quarterly Tests 47 Table 9: Yearly and Revalidation Tests 48 Table 10: EWD Rinse Water Total Viable Count Results Guide 50 Table 11: Example Calculation for the Number of Protein Tests Required 62 Table 12: Example of the Sampling Strategy for Disinfection Efficacy 67 Tests Table 13: CESC Daily and Weekly Tests 73 Table 14: CESC Optional Tests 73 Table 15 CESC Quarterly Tests 73 Table 16: CESC Annual Tests 74

9 Figures/Tables Page Table 17: CESC Microbiological Testing 74 Table 18: Parameters for assessment of microbiological air quality by Settle Plate method Table 19: Parameters for assessment of microbiological air quality by Active Air Sampling Table 20: Typical microbial Action limits 87 Appendix I: Possible Causes of Microbial Contamination of Endoscopes, Water or CESCS 89 Appendix II: Acknowledgements 90 Resources 91

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11 1 Part 1 Introduction to Commissioning Validation and Testing in Endoscope Decontamination Facilities

12 Part 1 Introduction 1. Introduction Standards and Recommended Practices for Endoscope Decontamination Units were reviewed in Based on extensive consultation with service providers, HSE Health Business Services (HBS) Estates and experts in the field of Endoscope Decontamination it was agreed that there was a need to provide more in-depth guidance on the design of Endoscope Decontamination Units (EDUs), testing of equipment and operational management of the service. Additionally, the publication of EN (2015) "Controlled Environment Storage Cabinet (CESC) for processed thermolabile Endoscopes" has led to changes in the expected validation regimes for such cabinets. Thus, the HSE Standards and Recommended Practices for Endoscope Decontamination Units will now be presented in three parts. Part-1 Part-2 Part-3 HSE Standards and Recommended Practices for Facility Design and Equipping of Endoscope Decontamination Units. HSE Standards and Recommended Practices for Commissioning, Validation and Testing in Endoscope Decontamination Facilities. HSE Standards and Recommended Practices for Operational Management of the Endoscope Decontamination Unit. Purpose of the Standards and Recommended Practices for Commissioning, Validation and Testing in Endoscope Decontamination Facilities This document has been developed to support best practice in the commission, validation and testing of Endoscope decontamination services, facilities and equipment and is written to reflect the need to continuously improve outcomes in terms of patient safety, clinical effectiveness and patient experience. The primary aim of this document is to provide information to all decontamination facilities who process all types of flexible Endoscopes and it reflects the need to ensure that the environment in which decontamination procedures are carried out is fit for purpose ensuring the safety of the service provider, the user and the patient. The content of this document is based on: Extensive literature search; consideration of the opinion of experts knowledgeable in the subject; consideration of the available current best practice, both in Ireland and Internationally, that may impact on decontamination of Endoscopes; feedback from service providers which has been considered and where appropriate, incorporated into this revised version of the standards and recommended practices. Page 1

13 Part 1 Introduction 1.1 Who Should Use This Document? This document aims to provide support and guidance to Healthcare Planners, HBS Estates and Facility Managers, Endoscope Decontamination Unit (EDU) Managers, Central Decontamination Managers (CDM), CEOs, General Managers, Infection Prevention and Control Practitioners (IPC), Microbiologists, Theatre Managers, Health and Safety Managers, Risk Managers, Procurement Officer, Clinical Engineers, Capital Planning, Design Teams, suppliers of specialised equipment, Competent Persons for Decontamination (CP(D) and Authorising Engineers for Decontamination AE(D) when commissioning, validating and testing EDU facilities, equipment and services. The commissioning, validation and testing of decontamination equipment, facilities and services critically impacts on the safe effective management and control of cross contamination risks associated with the decontamination of Endoscopes. Commissioning, validation and testing of EDU facilities equipment and services requires input from relevant experts in the field. The following personnel must be included in any commissioning process: Commissioning, Validation and Testing Team Authorising Engineers for Decontamination (AE(D)); Competent Persons for Decontamination (CP(D); Building and Design Engineers; Infection Prevention and Control representative; Procurement; The Users of the service/theaters/day Surgery/Endoscopy; Suppliers of the required specialist equipment; IT Specialties, Health and Safety Managers; Experts involved in the management of Endoscope decontamination service provision, Estates and Facility Managers. 1.2 Aim of the Standards and Recommended Practices for Commissioning, Validation and Testing of EDU facilities, equipment and services The overall aim the Standards and Recommended Practices for Commissioning, Validation and Testing in EDUs, is to achieve a reprocessed flexible Endoscope that meets with the general requirements identified in Annex I Chapter II of the Medical Devices Regulations 2017/745 and the decontamination requirements identified by the Joint Advisory Group (JAG) on GI Endoscopy, the HSE Standards and Recommended Practices for Endoscope Decontamination Units and the Health Information Quality Authority (HIQA) Standards for Prevention and Control of Healthcare Associated Infection Page 2

14 Part 1 Introduction The Medical Devices Regulation (2017/745) The Medical Device Regulation applies to manufacturers, including those who perform in-house manufacturing and those placing medical devices on the market. In doing so, it specifies the general requirements to be met by any medical device. These general requirements should be regarded as the minimum acceptable Standard whether or not the decontamination unit qualifies as a manufacturer within the terms of the Regulations. Validation Requirements Associated with the Regulation Devices shall be designed to facilitate their safe cleaning, disinfection, and/or re-sterilisation (Annex I, Chapter II paragraph 11.2); The device and manufacturing processes must be designed to eliminate or reduce as far as possible the risk of infection to the patient, user and third parties (Annex I, Chapter II paragraph 11.1). Devices delivered in a sterile state must be manufactured and sterilised by an appropriate, validated method (Annex I, Chapter II paragraph 11.5). Devices intended to be sterilised must be manufactured in appropriately controlled environmental conditions (Annex I, Chapter II paragraph 11.6). (Note: The general requirements in paragraphs 11.5 and 11.6 refer to sterile devices. However, the requirements apply equally in respect of devices intended to be disinfected. Disinfection must be achieved by using an appropriate validated method and undertaken in an appropriately controlled environment. New research identifies that Endoscopes are being used more invasively and therefore may require sterilisation after high level disinfection depending on their intended use) (Note: Information for the User must include details of any preparatory treatment or handling of the device before it is ready for use or during its use, such as sterilisation, final assembly, calibration, etc., including the levels of disinfection required to ensure patient safety and all available methods for achieving those levels of disinfection. Products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) 2017/745 are deemed medical devices under the Regulation) Page 3

15 Part 1 Introduction 1.3 HIQA Standards for Safer Better Healthcare The Health Information Quality Authority identify 8 themes for quality and safety which are intended to work together. Collectively, these themes describe how a service provides high quality, reliable safe care. The four themes on the upper half of Figure 1 relate to dimensions of quality and safety, the four themes on the lower half of Figure 1 relate to capacity and capability. Endoscope decontamination practice is aligned to all 8 themes in some way; however Effective Care and Support (Theme 2) and Safe Care and Support (Theme 3) are the key dimensions of quality and safety needed to support the delivery of safe decontamination services in Endoscope Decontamination Units. HIQA Standards for Prevention and Control of Healthcare Associated Infections (2017) aim to promote evidence-based practice and encourage a multidisciplinary team-based approach within acute services to prevent and control Healthcare Associated Infections (HCAI). Figure 1: Themes for Quality and Safety 1.4 Definitions Themes = HIQA identify 8 themes for Quality and Safety which are intended to work together. Collectively, these themes describe how a service provides high quality, reliable safe care. Standards = term used by the Health Information Quality Authority and the Health Service Executive to describe the high-level outcomes required to contribute to the quality and safety of decontamination services. Features = term used by the Health Information Quality Authority to describe elements of a standard that when taken together, will enable progress toward achieving the standard. Recommended Practices = best practice in relation to the decontamination process. The recommended practices are intended to define correct decontamination practice and to promote service user and staff safety and serve as the basis for policy and procedure development. Page 4

16 Part 1 Introduction Table 1: What do HIQA PCHCAI Standards mean for the Endoscope Decontamination Unit Theme 1: Patient Centred Care and Support Standard 1.1 Service providers effectively communicate with their patients about prevention, control and management of Healthcare Associated Infection, (HCAI). Theme 2: Effective Care and Support Standard 2.4 Standard 2.6 Standard 2.7 Standard 2.8 A monitoring programme is in place to measure and report on effectiveness of infection prevention and control practices. Healthcare is provided in a clean and safe physical environment that minimises the risk of transmitting a HCAI. Equipment is cleaned and maintained to minimise the risk of transmitting a HCAI. Reusable Invasive Medical Devices are decontaminated and maintained to minimise the risk of transmitting a HCAI. Theme 3: Safe Care and Support Standard 3.2 Standard 3.3 Standard 3.4 Standard 3.5 Standard 3.8 Service providers integrate risk management practices into daily work routine to improve the prevention and control of HCAI. Service providers effectively identify, manage, report and investigate any HCAI incidents. Service providers support initiatives to promote and encourage quality improvements in infection prevention and control practices. Service providers adhere to hand hygiene practices to minimise the risk of acquiring or transmitting infection. An occupational health service is in place to decrease the risk of infection to staff. Theme 5: Leadership Governance and Management Standard 5.3 Standard 5.4 Standard 5.5 Service providers have formalised governance arrangements in place for the prevention and control of HCAI. Service providers have effective management arrangements in place for the prevention and control of HCAI. Service providers ensure that externally contracted services adhere to safe and effective Infection Prevention and Control practices. Page 5

17 Part 1 Introduction Theme 6: Workforce Planning Standard 6.1 Standard 6.2 Service providers plan, organise and manage their workforce to meet the service s infection prevention and control needs. Service providers ensure their workforce have the competencies and training required to provide safe and effective infection prevention and control practices. Theme 7: Use of Resources Standard 7.2 Service providers ensure medical devices and equipment that are purchased, loaned, borrowed, serviced or repaired are safe to use. Theme 8: Use of Information Standard 8.2 Service providers have effective arrangements in place for information governance for infection prevention and control related data. 1.5 What does this mean to the Service User? The service is always looking for ways to make healthcare safer. The service is not just reacting when things go wrong it is actively looking for ways to make the way it provides care safer. The service learns from international and national evidence about the best ways of keeping the service user safe. The service uses information relevant to the provision of safe services to inform continuous improvement of the safety of the service. Note: HIQA Standard 2.6, 2.7 and Standard 2.8 under Theme 2 Effective Care and Support and Standard 5.5 are most applicable to Commissioning, Validation and Testing in Endoscope Decontamination Units. Page 6

18 Part 1 Introduction 2. About this Document Flexible Endoscopes are complex Reusable Invasive Medical Devices (RIMDs) that require unique consideration with respect to validating the decontamination process. Internationally it is recognised that Endoscopes are the most common medical device to be associated with cross contamination and infection transmission (CDC,2008; Of Stead et al., 2010; Greenwald, 2011). With the emergence of multi-drug resistant organisms, the increasing risk of infection transmitted via endoscopic procedures have been highlighted in the literature. Endoscope procedure related HCAIs have been linked to decontamination equipment, practice and process failures (Schelenz & French, 2000; Sirinivasan et al., 2003, Shimono et al., 2008, NHS Northumbria, 2014, FDA Safety Notice, 2015). Environment, equipment and practice are therefore considered significant risk factors for transmission of infectious agents, placing a greater emphasis on the need for organisations to have effective mechanism in place to control these risks. Commissioning Validating and Testing of Endoscope Decontamination Units is governed by International Standards, European Standards and European Regulation. In addition, the HIQA National Standards for the Prevention and Control of Healthcare Associated Infection (2017) clearly identify the need for Hospitals to have necessary resources in place to meet their Infection Prevention and Control needs and priorities (HIQA, 2017). The HSE Standards and Recommended Practices for Commissioning, Validation and Testing in Endoscope Decontamination Facilities provides guidance to EDU Managers, Theatre Managers, Facilities Managers, Authorising Engineers for Decontamination (AEDs), Infection Prevention and Control Managers, Health and Safety Managers, Procurement Managers, Healthcare Planners, Quality Risk and Safety Managers and Senior Management Teams, on testing principles and regimes required to support safe reliable care. How should we read this document? This document is provided in two parts: Part 1 provides you with critical features associated with Commissioning, Validation and Testing in Endoscope Decontamination Facilities; Part 2 provides guidance on the methods, frequencies and acceptable process parameters for Commissioning, Validation and Testing to ensure the service meets the requirements of International Standards and HIQA Standards for the Prevention and Control of Healthcare Associated Infection(2017). All elements within Part 2 correspond with HIQA Standards for Prevention and Control of Healthcare Associated Infection (2017) Themes 2,3,5,7 and 8. (Note: Authorising Engineers, who are involved in the support of Commissioning, Validation and Testing in EDUs in Ireland, must use this document as a template to ensure compliance to HSE Standards for Commissioning, Validation and Testing of EDU facilities, equipment and services) Page 7

19 Part 1 Introduction 3. Standards Used to Support Commissioning, Validation and in the EDU 3.1 Decontamination Equipment Commissioning, Validation and Testing of Endoscope Decontamination Equipment is performed in accordance with the requirements set out in the following: Endoscope Washer Disinfectors (EWDs) EN ISO Part 1: Washer disinfectors General Requirements, Terms, Definitions and Tests. EN ISO Part 4: Requirements and Tests for Washer disinfectors employing Chemical Disinfection for Thermolabile Endoscopes. CEN ISO/TS Part 5: Test Soils and Methods for Demonstrating Cleaning Efficacy. Controlled Environment Storage Cabinets (CESCs) EN Controlled Environment Storage Cabinet for Processed Thermolabile Endoscopes. Low Temperature Sterilisation EN ISO 14937: Sterilisation of healthcare products general requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilisation process for medical devices. 3.2 Decontamination Facilities Commissioning, Validation and Testing of Decontamination Facilities is performed in accordance with the requirements set out in the following: Ventilation EN ISO Part 1: Cleanrooms and Associated Controlled Environments Classification of Air Cleanliness by Particle Concentration. EN ISO Part 2: Cleanrooms and Associated Controlled Environments Monitoring to Provide Evidence of Cleanroom Performance Related to Air Cleanliness by Particle Concentration. EN ISO Part 3: Cleanrooms and Associated Controlled Environments Test Methods. EN ISO Part 1: Cleanrooms and Associated Controlled Environments. Biocontamination Control. General Principles and Methods. EN ISO Part 2: Cleanrooms and Associated Controlled Environments. Biocontamination Control. Evaluation and interpretation of Biocontamination Data. Page 8

20 Part 1 Introduction Health Technical Memorandum Specialised Ventilation for Healthcare Premises Parts A and B. HSE Standards and Recommended Practices for Facility Design and Equipping of Decontamination Units (2017). Water Quality HPSC/HSE (2015): Guidelines for the Prevention and Control of Infection from Water Systems in Healthcare Facilities. EN ISO Part 1: Washer-disinfectors General Requirements, Terms, Definitions and Tests Section 6.4 Tests on Water Quality and Water Volume. EN ISO Part 4: Requirements and Tests for Washer-disinfectors employing Chemical Disinfection for Thermolabile Endoscopes Section 4.5. Final Post-disinfection Rinsing Section Disinfection of Water Treatment Equipment. Environmental Monitoring EN ISO Part 1: Cleanrooms and Associated Controlled Environments Classification of Air Cleanliness by Particle Concentration. EN ISO Part 2: Cleanrooms and Associated Controlled Environments Monitoring to Provide Evidence of Cleanliness Performance Related to Air Cleanliness by Particle Concentration. EN ISO Part 3: Cleanrooms and Associated Controlled Environments Test Methods. EN ISO Part 4: Cleanrooms and Associated Controlled Environments. Design, Construction and Start-up. EN ISO Part 5: Cleanrooms and Associated Controlled Environments. Operations. EN ISO Part 1: Cleanrooms and Associated Controlled Environments Biocontamination Control. General Principles and Methods. EN ISO Part 2: Cleanrooms and Associated Controlled Environments. Biocontamination Control. Evaluation and interpretation of Biocontamination Data. Page 9

21 Part 1 Introduction 4. Testing and Testing Terminology The decontamination of flexible Endoscopes is a complex process and requires continuous vigilance of the performance of the equipment and services, to minimise the risk of cross contamination and ensure the delivery of consistent, safe and reliable care. Failure to adequately decontaminate flexible Endoscopes between patient use may increase the risk of infection transmission and/or compromise the quality of clinical samples, e.g. biopsy samples. Therefore, a strict regime of testing has been devised to ensure that facilities, equipment and the environment are performing to their original specification identified at point of installation every time for every patient. Hospitals must have clearly defined policies, procedures, protocols and guidelines for maintaining, testing, validating and the day to day operation of decontamination equipment and services. The hospital must have a register of equipment that includes as a minimum, the date of purchase, the manufacturer, the supplier, commissioning data and evidence that the equipment was commissioned (validated) to the manufacturers specification. All records should be maintained for a period of time equivalent to the life-time of the equipment plus eleven years. (Note: The validation and verification terminology used in guidance has been kept consistent with EN and ISO standards for decontamination process validation. They use the terms in the following way: Validation takes place when the machine is first commissioned (and consists of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). The annual periodic tests are called annual revalidation and are not necessarily the same as the full range of validation tests undertaken at commissioning. Revalidation and periodic tests are designed to establish the continued conformance of the equipment and its performance with data established during the original validation study. There are occasions when it may be necessary to repeat the full set of tests carried out during the initial validation in order to obtain a new set of data. It will not always be necessary to carry out a full revalidation. The advice of the AE(D) should be sought on which tests are required following any particular event. Repeat validation is a repeat of all the validation tests (IQ OQ and PQ) undertaken when the machine is first commissioned. This is called for after a complete rebuild of equipment. See page 16 for further guidance as to when this may be required) Page 10

22 Part 1 Introduction The term commissioning is a generic term often used to describe the initial validation that takes place after equipment or a process is installed and prior to first use. The term commissioning is often used in guidance for the validation of systems providing services such as ventilation and water before they are put into first use) Competent Person for Decontamination CP(D) The Competent Person for Decontamination CP(D) is defined as a person who holds appropriate qualifications to perform validation, revalidation and periodic testing on specific EDU equipment. The CP(D) may also be known as the Test Person. The CP(D) or Test Person is designated by Management to carry out maintenance, validation and periodic testing of EDU Equipment. The CP(D) should report directly to an appropriate member of the estates department or should be subcontracted by them to perform this work and report to the responsible person for decontamination e.g. in cases where the responsible person may be a biomedical engineer, head of decontamination or decontamination manager. The principal responsibilities of a CP(D) are to carry out maintenance tasks; to carry out repair work; to conduct validation tests and periodic tests as given in HSE Standards and Recommended Practices for Commissioning, Validation and Testing in EDU Units in compliance with EN standards and EU regulation and to conduct any additional tests at the request of the User. Cycle Variables Cycle variables are the physical and chemical properties such a time, temperature, pressure, flow rate, concentration and chemical composition which influence the efficacy of the cleaning and disinfection processes. Many of the tests described in this document require the values of cycle variables to be determined experimentally and then compared with specified or standard values. An indicated value is that which is shown by a visual display fitted to the EWD or CESC. A recorded value is that which is shown on the output of a recording instrument fitted permanently to the EWD. A measured value is that which is shown on a test instrument, for example, a temperature recorder attached to the EWD for test purposes. A noted value is that which is written down following personal observation of an indicated, recorded or measured value. Page 11

23 Part 1 Introduction 5. What is Commissioning? This is a generic term for the process of obtaining and documenting evidence that equipment or a service has been supplied and installed in accordance with its specifications by the manufacturers. Even though the manufacturer will have tested the equipment or service before it left the factory or before it has been installed, there is no guarantee that it will function correctly when installed in the EDU. Therefore, the equipment or service should be tested, to ensure that it is working correctly and will perform as intended, prior to use. Services should be commissioned in accordance with industry best practice and equipment commissioned in accordance with the relevant standard. Where a low temperature steriliser is installed the standards specific to the process should be used. Where no standards exist EN ISO (Sterilisation of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a Sterilisation process for medical devices) should be used. Commissioning of equipment includes, Installation Qualification Tests (IQ), Operational Qualification Tests (OQ) and Performance Qualification Tests (PQ). At the time of commissioning, the planning team should assess the ability of the engineering services and systems as installed to meet the agreed design criteria and risk management strategies. Where variations occur against agreed performance parameters, the designer should ensure that the implications of such variations (in clinical and organizational terms) are understood and accepted by the planning team and users. Where particular test facilities (other than those provided locally) are required for commissioning of services that may be difficult to install or connect after the installation stage (such as for connections for testing flow measurement and proportional balancing of air and water systems) these should be incorporated at the manufacturing stage. Once services and plant has been commissioned the supplier/manufacturer should provide training to the hospital staff on the safe use and operation of the plant and equipment. (Note: The baseline data obtained during the commissioning phase must be used as a basis to compare subsequent test results (obtained from the annual/revalidation testing). The contractor who provides the installation of services, for example ventilation, is responsible for providing the data relating to the commission and performance qualification of these services in accordance with relevant standards) Page 12

24 Part 1 Introduction 5.1 How Should Commissioning be Carried Out? A frequent cause of failure of projects to meet their design intent is ineffective commissioning. When construction projects are behind schedule, commissioning is sometimes squeezed into an inadequate timescale. This should be avoided as the lifetime running cost and user satisfaction can be adversely affected, possibly with serious consequences and large rectification costs. Commissioning of engineering systems should not be left entirely in the hands of the installing contractor. Adequate time allowance must be made for commissioning. The ideal arrangement is the use of independent specialist for commissioning, however where the technical nature or scale of the project does not justify this, independent verification of commissioning and testing should be carried out. The person with professional responsibility for signing off the commissioning and testing of each engineering service should be clearly identified. Consult your AE(D) for advice on commissioning of decontamination equipment. Full commissioning and operational documentation should be provided on completion of the project and users should be formally trained in the operation of the engineering services within the facility. Responsibility for delivery of this training should be clearly defined prior to commissioning activities. Two hard copies and one soft copy of commissioning documentation relating to each piece of equipment, service or facility design must be given to a designated member of the local planning team. Page 13

25 Part 1 Introduction 6. What is Validation? Validation is the documented procedure for obtaining, recording and interpreting the results needed to show that a process will consistently yield a product or service complying with pre-determined specification. Validation is a total process beginning with a review of the specification and type-test data of equipment or services against which the equipment or service has been purchased, to ensure it will meet the User s specification. A complete validation process is made up of the following: Installation Qualification (IQ); Operational Qualification (OQ); Performance Qualification (PQ); Periodic testing which includes Daily, Weekly Quarterly and Annual revalidation and Performance Requalification. 6.1 What is Installation Qualification (IQ)? This is the process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification and is safe to operate. The supplier (or their representative such as an installation contractor or competent test person) should carry out the required installation checks and commissioning on delivery of the decontamination equipment to ensure that the machine has been supplied and installed correctly, is safe to operate, has been provided with satisfactory services that do not impair the performance of the machine, and that in operation the machine does not interfere with other equipment. When these checks have been completed and found satisfactory, the installation tests necessary to demonstrate that the decontamination equipment is working satisfactorily should be undertaken. If any modification, maintenance or repair work is carried out on the steam, water, compressed air ventilation, piped gas services or drainage systems after the installation tests have been completed, the relevant installation tests should be repeated before the operational tests are undertaken. 6.2 What is Operational Qualification (OQ)? This is the process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures. Page 14

26 Part 1 Introduction When the decontamination equipment has been installed and accepted the competent test person (who will usually be a representative of the supplier) should carry out a sequence of operational performance tests to evaluate the basic performance and safety of the decontamination equipment. Some of these tests are identical to those specified as installation tests, and need not be repeated if operational testing follows within ten working days of the completion of the installation tests. 6.3 What is Performance Qualification (PQ)? Performance Qualification is the process of obtaining and documenting evidence that the equipment or services will consistently produce reproducible results when operated in accordance with the pre-defined acceptance criteria within the process specification. PQ tests are performed as part of the initial validation procedure, as part of any repeat validation procedure and whenever the user, acting on the advice of the Independent AE(D), judges that new loading or operating condition require a new PQ test. Circumstances that may lead to new PQ tests would include changes to the quality of the water supply, changes to the chemical additives used in the cleaning and disinfection process, changes to the loading system or the requirement to process a new type of product. These changes should be risk assessed to determine the possible impact on the system prior to implementation. PQ consists of tests designed to show that: For EWDs, soil removal and cleaning have been effective throughout the load and the washer-disinfector chamber, and the products are of the required standard of cleanliness, free from process residues (when applicable); decontamination conditions have been attained throughout the Endoscope and the machine s chamber, and to the required standard for the type of load being processed; for CESCs that the decontamination status of particular Endoscopes types used by the EDU has not been compromised by the storage and drying process. Page 15 In principle, a PQ test is required for each loading condition that an item of decontamination equipment is required to process. In practice, it is possible to identify reference loads and reference loading conditions that present an equal or greater challenge to the process than the loads that might be encountered in normal use, these are often called product families. EN Annex G (see Part 2 of this document) identifies typical Endoscope product families. For Endoscopes that do not belong to one of those three Endoscope product families identified in the standard, or for Endoscopes that have a different connector set, further PQ tests may need to be undertaken.

27 Part 1 Introduction 7. What is Periodic Testing (including Annual Testing/Revalidation)? Once the EWD, CESC or service has become operational the equipment or service must be subjected to a schedule of periodic tests. Periodic tests should be carried out at daily, weekly, quarterly and annual intervals. They are the shared responsibility of the validation engineer and the User. The annual test schedule should be identical to the revalidation schedule and should contain tests for recommissioning and Performance Requalification (PRQ). This Annual testing schedule is a revalidation of the equipment or service and provides a more comprehensive programme of testing than other periodic testing. Annual tests are performed to prove that the data collected during commissioning and performance qualification are still valid. Data obtained from the Annual testing or revalidation must be checked against the original commissioning and performance qualification data. This ensures that the equipment or service continues to operate to the original specification at installation. (Note: An annual revalidation is performed on EWDs and CESCs. In addition, annual revalidation either in full or in part will be required whenever any major change is made to the equipment, process or cycle or nature of the loads to be processed. Advice should be sought from the AE(D) on which tests are required following any particular event. Annual revalidation of Air Handling Units is also required) Table 2: Periodic Tests and Check Intervals for EDUs Equipment/Service Type Daily Weekly Quarterly Annual EWD Water Treatment Plant (including RO) CESC Ventilation Plant Environment (Note: There are no EN Standards applicable to Prolonged Storage Vacuum Systems. However a robust mechanism to validate prolonged storage of each Endoscope type must be in place where these systems are to be used. The validation process must be recommended by the manufacturer of the vacuum system and evaluated by the decontamination team, providing assurances that this method of prolonged storage will not comprise the disinfection efficacy of the Endoscope/Endoscope type to be stored in their department/hospital. This process must be repeatable. All packaging should be visually inspected for damage prior to use) Further detail on the testing regimes is given in part 2 of this document. Page 16

28 Part 1 Introduction 7.1 When Should Revalidation be performed on EWDs and CESCs other than Annually? When the EWD or CESC is returned to service after a breakdown or a repair that required the replacement of components that may affect satisfactory attainment of the pre-set variables of the operating cycle when the pre-set values of the cycle variables have been modified or an alternative CE-marked chemical has been introduced by the manufacturer; when the software in a Programmable Electronic System (PES), used for control of the process, has been modified; whenever the User or AE(D) advises that revalidation is necessary; there has been a change in the process chemicals used. (Note: The revalidation procedure is identical to that specified for the yearly tests and must include performance qualification if that was included as part of the original validation) 7.2 When Should Repeat Validation be Performed on EWDs and CESCs? Whenever it is required by an authorised inspectorate or licensing authority; when an EWD or CESC has been moved and installed at a new location; when the EWD or CESC has been dismantled or extensively overhauled; whenever revalidation fails to confirm compliance with the original validation data and no cause for the discrepancy can be found; when the device has been out of use for a significant period of time as determined by local risk assessment in consultation with the AE(D) and Consultant Microbiologist. (Note: It will not always be necessary to carry out a full revalidation or repeat validation and the advice of the AE(D) should be sought as to which tests are required following any particular event) Page 17

29 Part 1 Introduction 8. What are the Types of Tests We Need to Perform? Automatic control tests: designed to verify the correct functioning of the operating cycle from the readings obtained from the instruments fitted to the EWD or independent electronic records. Thermometric tests: (for self-disinfection or temperature control, if used) forming part of the EWD cycle and designed to provide assurance that the temperature requirements for disinfection are met during self-disinfection, by employing accurate measuring equipment (independent of the instruments fitted to the EWD) to monitor the temperatures attained within the chamber and reference loads. Microbiological disinfection efficacy tests: designed to show that disinfection conditions are attained during an EWD process cycle and, if chemical self-disinfection is used, during the self-disinfection cycle. Microbiological tests on Endoscope lumens and surfaces: designed to assess the efficacy of the cleaning and disinfection process or assess the efficacy of the cleaning, disinfection and storage process. They are also used to assess the ability of an Endoscope to be decontaminated. Microbiological tests on water: designed to confirm that the quality of water supplied for the final rinse stage of the decontamination process is within the specifications identified in ISO Parts 1 and 4 and the additional requirements of this document. Microbiological tests on surfaces: designed to establish that the level of growth within a CESC or on a surface in the cleanroom of the EDU will not represent a risk of adventitious contamination to disinfected Endoscopes processed or stored in these areas. Microbiological testing of the environment: designed to establish that the quality of air in the clean room complies with HSE Standards and Recommended Practice for Facility Design and Equipping of EDUs, ventilation requirements, which are outlined in Part 1. Process challenge device: is a system that will monitor the effectiveness of the wash cycle (cleaning efficacy) in the EWD ensuring the EWD is performing at its optimum. Cleaning efficacy tests: designed to show, by monitoring the removal of a test soil or naturally occurring soil, that the process will effectively clean products of the type to be processed. Chemical residuals test: designed to detect small amounts of chemical on the processed Endoscope to confirm adequate rinsing has taken place. Page 18

30 Part 1 Introduction Air Quality tests: designed to confirm that the quality of air used to dry and store flexible Endoscopes is compliant to EN Residual Protein tests: these tests are performed on the external surfaces and internal channels of the Endoscope. Much of the contamination which occurs on medical devices is, in whole or part, proteinaceous in nature. Residual protein tests are designed to determine the effectiveness of the cleaning process of the Endoscope and the ability of the Endoscope to be decontaminated. ATP tests: there are indicators, such as Adenosine Triphosphate (ATP) bioluminescence, that may be useful for determining general cleanliness. ATP can be used as measure of the presence of living cells including microbial and complex somatic cells. These can be present in residual complex organic soils arising from clinical use of the Endoscope and/or microbial biofilms. ATP measurement systems may be used as a general indicator of cleanliness and can be used to monitor the effectiveness of the decontamination process, however, ATP testing cannot be seen as a replacement for residual protein or microbial testing. 8.1 What Should I do if a Test Fails? Correctly installed and maintained decontamination equipment and services should comply with both the validation tests and periodic tests described without any problem. The failure of a test generally indicates that a machine is not working to specification. In practice, a test failure should precipitate a risk assessment and implementation of corrective action. The corrective actions should be monitored closely to ensure the route cause has been eliminated. It might be acceptable for the equipment to continue operating under carefully defined restrictions until the route cause of the failure can be established and rectified. This may be the case with failures of microbiological water quality whereby use of the equipment may be restricted to certain Endoscope types. A risk assessment should be undertaken in consultation with the User and the AE(D) to agree the action to take. In the case of microbiological test failures, the hospital microbiologist and Infection Control Team should be included in the risk assessment process. The User has the ultimate responsibility for certifying that decontamination equipment is fit for use. Page 19

31 Part 1 Introduction 9. Management of Outsourced Contracts Many of the services that support the operational functioning and validation of the EDU environment and equipment are outsourced. To ensure safe effective decontamination of Endoscopes the hospital must ensure that effective systems are in place to monitor and control services supplied by such contractors. This should always include a review of contractor and competent person competence. In addition, a procurement group must be in place and include representation from the Decontamination Lead, Authorising Engineer for Decontamination AE(D) and Infection Prevention and Control Team where appropriate. It is also important that there is clear oversight of and accountability for externally contracted services that the hospital uses. Best practice contract management features include: Effective governance arrangements are in place to ensure that externally contracted services adhere to safe and effective Infection Prevention and Control practices, through setting up, managing and monitoring contracts of agreement. The contracts of agreement include the scope of service provided, audit requirements and governance arrangements for the quality and safety of services delivered. It includes complying with Infection Prevention and Control best practice and relevant legislation. The Decontamination Lead and/or where appropriate the Infection Prevention and Control Team are involved in the procurement decision for externally contracted services related to microbiological testing, validation, maintenance and periodic testing of EDU equipment, facilities, environment, water systems and AHUs. A microbiology laboratory service should be in place to support the service to prevent and control healthcare-associated infections. Features of such a service include the following: A microbiological service that is in line with best practice, evidence-based guidelines, national recommendations and legislation; The microbiological service provides at minimum a 5 days-a-week access to: an accredited microbiology laboratory with appropriately trained and qualified staff; expert advice by a consultant Authorising Engineer for Decontamination, Clinical Microbiologist or Environmental Microbiologist; Microbiology results include information with interpretive comments to aid appropriate decision-making; Page 20

32 Part 1 Introduction A system for the rapid reporting of alert organisms to the User and the Infection Prevention and Control Team, which is accompanied by expert microbiological advice; The microbiology laboratory has the ability or has formal arrangements in place for the identification of alert organisms or micro-organisms that are epidemiologically associated with a known or potential out-break; Safe and effective systems are in place for microbiological sample collection and transportation within the hospital and between laboratory sites in accordance with UN3373 regulations and advice given in the Guidelines for the Safety, Health and Welfare at Work (Biological Agents) Regulations Page 21

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35 2 Part 2 in an Endoscope Decontamination Facility

36 1. Commissioning of EDU Services and Facilities including Handover and Periodic Testing HIQA Theme 2: Effective Care and Support Standard 2.6 Healthcare is provided in a clean and safe physical environment that minimises the risk of transmitting a HCAI. Theme 5: Leadership Governance and Management Standard 5.5 Service providers ensure that externally contracted services adhere to safe and effective Infection Prevention and Control practices. Features of a service meeting this HIQA Standard include: A physical healthcare environment that is planned, designed, developed, maintained and operated to facilitate effective cleaning and compliance with Infection Prevention and Control best practice (HIQA, 2017) Effective governance arrangements are in place to ensure that externally contracted services adhere to safe and effective Infection Prevention and Control practices, through setting up, managing and monitoring contracts of agreement (HIQA, 2017) The contracts of agreement include the scope of service provided, audit requirements and governance arrangements for the quality and safety of services delivered. It includes complying with Infection Prevention and Control best practice and relevant legislation (HIQA, 2017). Page Regular monitoring of the formalised arrangements is in place with external recruitment agencies to assure their service complies with National Standards and relevant legislation: As stated in Part 1, services and facilities should be commissioned in accordance with industry best practice. Once services and plant has been commissioned the supplier/manufacturer should provide training to the hospital staff on the safe use and operation of the plant and equipment (HIQA, 2017). 1.1 Commissioning of EDU Services and Facilities Documentation Required for Handover The services, plant and equipment suppliers/manufacturers should provide extensive documentation when handing over to the client on completion of the commissioning process. This documentation shall include a data information file for all services installed (and when under a turnkey arrangement, all plant included within the turnkey contract). Separate sections will be dedicated to instrumentation, valves, cable schedules, and relevant standard operating procedures.

37 The data information file sections for each item of equipment will include a data sheet, an operating and maintenance manual, certificates of conformity/compliance and material certificates. Three copies of the data information file will be handed over to the client on completion of the validation, one of which will contain original certificates and manuals. The other two copies will be exact copies of the original. The data information file will include signed off copies of all specialist equipment documents and the signed off and P&ID copies of the relevant drawings. Equipment manufactures/suppliers should hand over data information files for their own equipment when supplied under individual contract arrangements. Three copies of a health and safety statement, commissioning reports, an instrument/equipment list, a valve list, a document list, drawings, general arrangement drawings, wiring schematics and control wiring schematic. Control panel logic and software shall also be handed over to the client. All documentation as referred above will be handed over at the end of the commissioning period. Handover of the Endoscope Decontamination Unit project incorporates all of the following documentation listed below being received and reviewed by the client representative: RO water treatment system commissioning report including water quality tests and associated commissioning data; ventilation system commissioning report including environmental microbiology reports; M&E test certificates and reports. (Fire Alarm, emergency lighting, ETCI wiring regulations); EWD/CESC commissioning report; Authorising Engineers sign off of the validation report; 3 complete sets of O&M manuals; Health and Safety Officer report. Commissioning of EDU Services Designers should consider how the installation will be commissioned and how the required test measurements will be made. This will include the inspection of services (such as pipework and cables) that may be hidden at the time of handover. The design team should make an application to connect any new services to other services and supply networks within the healthcare site prior to doing so. At this point, the installation should be suitably safe. Page 26

38 The CIBSE (Chartered Institution of Building Services Engineers) Commissioning Manual (CCM), which contains very useful data and commissioning techniques for building services in the construction industry, provides valuable guidance in general commissioning strategies. Electrical installation testing should meet the requirements of the National Rules for Electrical Installations, Fourth Edition ET101:2008 including as modified by Amendment 1 (2011) and Amendment 2 (2016). Commissioning of Water Systems The quality of water used at all stages of the decontamination process is critical to the successful outcome of the process, as the water is the last product to make contact with the Endoscope prior to the service user procedure. Analysis of the existing water supply for the building should be taken and recorded at design stage. The pretreatment plant for the RO system should be designed based on the condition of the existing water supply. Water systems should be regularly checked during installation to ensure that open pipes, valve ends, cylinder connections etc., are sealed to prevent the ingress of dust/debris that could cause problems during commissioning and subsequent operation. There should be no dead legs in the water supply system. Checks should also be made to ensure that fittings and materials comply with National Regulations. Procedures used for commissioning water, as a minimum should comply with those found in the relevant Irish CIBSE Commissioning Codes, UK Health Technical memorandum and the HSE/HPSC Guidelines for the Prevention and Control of Infection from Water Systems in Healthcare Facilities (2015). Table 1: Requirements for Water Hardness Application Initial flush Intermediate flush Water for diluting disinfectants and detergents Final rinse-water Requirements Hardness less than 200mg/L preferably 50mg/L of CaCOɜ Hardness less than 200mg/L preferably 50mg/L of CaCOɜ Hardness less than 50mg/L of CaCOɜ Hardness less than 50mg/L of CaCOɜ Note: If any of the above parameters for the final rinse-water are above the stated limits, additional water analysis will be required to determine the source of the problem (for example, ph, chloride, heavy metals etc.,) Page 27

39 Table 2: Maximum Permitted Values for Final Rinse Water Determinant and Unit Maximum Permitted Values Final Rinse Other Stages Appearance Clear, colourless Degree of acidity (ph) 5.5 to 8.0 Conductivity at 25º (us/cm) 30 Total dissolved solids (mg/100ml) 4 Total hardness, CaCOɜ (mg/l) Chloride, CI (mg/l) Heavy metals, determined as Lead, Pb 10 (mg/l) Iron, Fe (mg/l) 2 Phosphate, P2O5 (mg/l) 0.2 Silicate, SiO2 (mg/l) 0.2 Total viable count (TVC) at 30ºC <10/100mls Bacterial endotoxins (EU/mL) 0.25 (Note: RO Treatment Plant The water quality generated by the RO treatment plant must be retested at least annually, best practice requires quarterly sampling, or more frequently if results give rise for concern. Results must comply with the requirements in Table 2 above. Water should be sampled from the permeate water distribution ring main) Commissioning of Ventilation Plant Commissioning of ventilation systems is an essential process. It is important that consideration of this process is given at the design stage of the project. Commissioning can be subdivided into sections looking at individual components of the system and each section may be commissioned by its own specialist contractor or installer. The components are often accepted in isolation. The purpose of commissioning and validation is to consider the whole installation from air inlets to discharge and assess its fitness for purpose as a whole. This involves examining the fabric of the building being served by the system as well as inspecting the ventilation equipment fitted and measuring the actual ventilation performance. All Endoscopy Decontamination Unit ventilation systems must be commissioned and validated in order that its fitness for purpose and ability to meet the requirements of this document is demonstrated prior to hand over. Procedures used for commissioning ventilation systems, as a minimum should comply with those found in the relevant CIBSE Commissioning Codes and Health Technical memorandum Page 28

40 Permeability Testing On completion of the installation, the facility should be subjected to a permeability test to check the room air leakage. The test pressure should be +50 Pascal followed by 50 Pascal. The acceptable leakage rate will be 1L/m3 of the facility envelope, averaged across the two tests. In the case of a double room layout, the Endoscope cleanroom should then be subject to a permeability test designed to measure the leakage across the wall between it and the wash room. To conduct this test, the entrance door, room supply terminal, and pressure stabiliser, should be taped up to eliminate any air leakage through them. The test will be as for the suite permeability above. 1.2 Periodic Testing of EDU Services and Facilities Periodic Testing of Services Services should be tested in accordance with requirements of national regulations. Periodic Testing of Ventilation Plant Ventilation plant used in Endoscopy Decontamination Units is not generally deemed a critical ventilation system and as such need only be subject to an annual inspection. The purpose of the inspection is to establish that: The system is still required; the AHU conforms to the minimum standard; the fire containment has not been breached; the general condition of the system is adequate for purpose; the system overall is operating in a satisfactory manner. However, where the ventilation plant is used to supply air for an Inspection, Assembly and Packing room for Sterilisation of Endoscopes (see Standards and Recommended Practices for Facility Design and Equipping of Endoscope Decontamination Units QPSD-D Part 2, Additional Requirements for Sterilisation of Surgically Invasive Flexible Endoscopes), a quarterly inspection as detailed above should be undertaken. An annual verification should also be performed. The purpose of the annual verification will be to additionally ensure that the system: Page 29

41 Achieves minimum standards specific to the application; is operating to an acceptable performance level; remains fit for purpose. Table 3: Summary of Ventilation Requirements Page 30

42 2. Commissioning of EDU Decontamination Equipment Theme 2: Effective Care and Support Standard 2.2 Standard 2.4 Standard 2.6 Standard 2.7 Standard 2.8 A microbiological service is in place to support the service to prevent and control HCAI. A monitoring programme is in place to measure and report on effectiveness of Infection Prevention and Control practices. Healthcare is provided in a clean and safe physical environment that minimises the risk of transmitting a HCAI. Equipment is cleaned and maintained to minimise the risk of transmitting a HCAI. Reusable Invasive Medical Devices are documented and maintained to minimise the risk of transmitting a HCAI. Theme 5: Leadership Governance and Management Standard 5.3 Service providers have formalised governance arrangements in place for the prevention and control of HCAI. Standard 5.4 Standard 5.5 Service providers have effective management arrangements in place for the prevention and control of HCAI. Service providers ensure that externally contracted services adhere to safe and effective Infection Prevention and Control practices. Features of a service meeting this HIQA Standard include: All reusable invasive medical devises are safely and effectively decontaminated maintained and managed in accordance with legislation and National and International Decontamination Standards (HIQA, 2017). As described in Part 1, commissioning of decontamination equipment consists of a series of validation tests performed by the manufacturer/supplier/ manufacturer s agent or another suitably qualified test engineer defined in the following categories: Installation qualification (IQ); operational qualification (OQ); and performance qualification (PQ). Page 31

43 2.1 Commissioning of EDU Equipment Endoscope Washer-Disinfector Commissioning All Endoscope washer-disinfectors must be commissioned and validated in order that their fitness for purpose and ability to meet the requirements of this document are demonstrated prior to hand over. Procedures used for commissioning washer-disinfectors shall be in accordance with the HSE Standards and Recommended Practices for Commissioning, Validation and testing in Endoscope Contamination Facilities and EN ISO Part 1 and Part 4. (Note: As there is a gap between installation, commissioning of Endoscope decontamination equipment and hand over to the user (e.g. whilst waiting for Mycobacterium water results) the hospital and the equipment supplier must ensure that during the waiting time all EWDs are run on a daily Monday to Friday basis. At minimum, a self-disinfect cycle should be used to prevent bio-film formation in pipe work and internal circulation systems. Ensure thermal disinfection of RO loop has been performed at least once a week during the waiting period. Water samples must be taken from each sampling point on a weekly basis during this waiting time) Controlled Environment Storage Cabinet Commissioning All Controlled Environment Storage Cabinets must be commissioned and validated in order that their fitness for purpose and ability to meet the requirements of this document are demonstrated prior to hand over. Procedures used for commissioning controlled environment storage cabinets shall be in accordance with the HSE Standards and Recommended Practices for Commissioning, Validation and Testing in Endoscope Contamination Facilities and EN Installation Qualification Checks (for both EWD and CESC) All ancillary equipment should, be installed and commissioned before validation of the reprocessing equipment begins. Checks should be made for the following engineering services: The engineering services should be installed correctly, should be adequate to meet the demands of the decontamination equipment, should not leak and all necessary isolating valves/switches and test points should be installed; the drains should remove effluent effectively when all plant in the vicinity, including the decontamination equipment, is connected and operating; the water treatment plant should operate correctly and the quality of water supplied for each stage of the process should be in accordance with the specification; Page 32

44 The exhaust ventilation and/or condenser unit fitted to the equipment should be adequate to remove the hot, humid air evolved from the processes; for washer disinfectors employing volatile process chemicals, the exhaust ventilation should maintain the environmental concentration below any limit specified for occupational exposure and the discharge should be to a safe place. Preliminary Checks on Endoscope Washer Disinfectors After the equipment has been installed, check that the following criteria have been met: The manufacturer has supplied all the documents specified in the contract; the equipment has been supplied and installed in accordance with the contract; the electrical equipment on the machine is correctly connected to the electrical service; calibration verification certificates for the measuring instruments and controller(s) on the equipment have been supplied; no defects are apparent from a visual inspection of the equipment; all supports, bases and fixings are secure and without imposed strain from service connections; thermal insulation is in good condition and securely attached for all relevant services; security and settings of door safety switches are in compliance with data supplied by the manufacturer; keys, codes or tools required to operate locked controls and control over-rides have been supplied, operate correctly and only operate the control for which it is intended, and cannot unlock controls on other machines in the vicinity; connectors, loading conveyors and trolleys, load carriers and load baskets are effective and safe when in use and compatible with the Endoscopes to be processed; appropriate connections for irrigation are available to flush all channels of all Endoscope types/models in use; Laminated connection cards detailing the correct configuration for connecting each Endoscope type/model to the EWD or the CESC are provided. Page 33

45 Functional Checks on the EWD and CESC During an operating cycle, with an empty chamber, check that the following recommendations are followed (several cycles may be necessary to complete all the checks): The selection of automatic or manual control is by key code or tool. The selection of one control mode inactivates the other control mode; under automatic control, water, steam, compressed air or chemical additives cannot be admitted into the chamber, and the operating cycle cannot start until the door is closed (locked and sealed); under manual control the operator can advance the cycle only sequentially through each stage. Any stages designed to remove chemical additives from the chamber and load cannot be circumvented; throughout the cycle the indicated and recorded values of cycle variables are within the limits specified by the manufacturer; throughout the cycle there are no leaks of water, steam aerosols, toxic chemicals, air, gas or effluent; there is no evidence of interference to or from other equipment connected to the same services; there is no evidence of electromagnetic interference to or from other equipment; operation and reading of all instruments appear to be satisfactory; the temperature of surfaces routinely handled by the operator do not present a hazard. At the end of the cycle check that the following recommendations are followed: For EWDs only, the door opening system cannot be opened until the cycle has been completed without causing the cycle to abort and a fault/incomplete cycle indication produced, that is, the automatic controller has operated in accordance with its specification; for EWDs incorporating one or more cycle stages at pressures 200 mbar above or below atmospheric pressure: the door opening system cannot be operated until the chamber has been vented to atmosphere and the chamber pressure is within 200 mbar of atmospheric pressure; the door retaining parts cannot be released until the seal between the door and chamber has been broken, and the chamber is effectively vented to atmospheric pressure; Page 34

46 the door interlock system is either fail-safe or is fitted with at least two independent interlocks. Failure of one interlock, or any one service, does not allow the door to be opened when conditions within the chamber would cause a hazard (for example, pressure in excess of 200 mbar or unacceptable level of chemical vapours); the automatic controller has operated in accordance with the parameter values determined at validation. Response to External Faults on the EWD and CESC The decontamination equipment should be checked to ensure it reacts correctly and safely when exposed to a number of external fault conditions; that is, a safety hazard is not created and a false indication of satisfactory completion of a cycle is not obtained. During each stage of an operating cycle, check the response of the decontamination equipment to the following simulated faults (as appropriate to the type of machine): Operation of the emergency stop button; power failure; water pressure too low; water pressure too high; temperature too low; temperature too high; air pressure too low; air pressure too high; failure of chemical additive supply (detergent, disinfectant, etc.); failure of extract ventilation; communication systems failure. Endoscope Washer-Disinfector Schedule of Installation and Operational Tests Full testing protocols for Endoscope washer-disinfectors can be found in EN ISO Parts 1 and 4. Controlled Environment Endoscope Storage Cabinets Schedule of Installation and Operational Tests Full testing protocols for controlled environment Endoscope storage cabinets can be found in EN (Note: when commissioning new EWDs or CESCs the user must ensure that the appropriate connector sets have been purchased for each type/model of Endoscopes in use. All Endoscopes must be interfaced with the EWDs, CESCs and the national tracking system) Page 35

47 2.2 Performance Qualification Tests for EWDs and CESCs The extent of the PQ required will depend on the type of equipment (EWD/CESC) and the nature of the load to be processed or stored. Performance qualification tests are carried out by the CP(D) and should be carried out with the equipment at normal working temperature and after any Installation and Operational Qualification has been satisfactorily completed. A loading condition is a used to specify a combination of the following: The model/type of the items to be processed or stored; The maximum number of load items to be processed or stored in any one cycle; The items of chamber/cabinet furniture, and Distribution of the load items within the chamber/cabinet. For example, a load placed on the topmost level of a two level load carrier in an EWD constitutes a different loading condition from the same load placed on the lowest level in the EWD. In principle, validation is not complete until a PQ test has been performed for each loading condition that the equipment is expected to process/store. In practice however, the loading conditions specified in the tests to be carried out during commissioning are designed to represent the nature of production loads and to present the greatest challenge to the process compared to normal production loads. In these cases further PQ tests may not be required; the data obtained from the commissioning tests may be sufficient. However a risk assessment must be performed to determine the possible impact on the system prior to implementation. Users should adopt the following procedure: Establish a list of potential product families (see page 42-44) and their relationship to the validation loads. Each product family should be tested. EN Annex G identifies typical Endoscope product families and further guidance is given in the next section on Periodic Testing; establish a list of the different loading conditions to be processed in the EWD. Each production load should correspond to one of the listed loading conditions for example if two or three Nasendoscope are processed on one level or one chamber of the EWD compared to one Gastroscope; determine whether each loading condition presents a greater or lesser challenge to the process than the used in the cleaning efficacy and thermometric tests carried out during validation; Page 36

48 where the loading condition is a lesser challenge than the validation loads, the results of the validation tests may be used as PQ data; where the loading condition is a greater challenge than the validation loads, PQ tests should be carried out. Where PQ tests have not been undertaken and no PQ report will be created, the AE(D) should be satisfied that the range of installation, operational and periodic tests undertaken is representative of the range of loads and product families processed by that particular EWD. This should be documented. Circumstances that may lead to new PQ tests would include changes to the quality of the water supply, changes to the chemical additives used in the cleaning and disinfection process, changes to the loading system or the requirement to process a new type of Endoscope product. 2.3 Commissioning of other Storage and Transport Systems All storage systems must be commissioned and validated in order that their fitness for purpose and ability to meet the requirements of this document are demonstrated prior to hand over. Procedures used shall be based upon those recommended by the manufacturer of the system that as a minimum demonstrate no deterioration in the microbiological quality of the Endoscope over the stated maximum storage time when in use in the hospital environment. The proposed validation schedule should be clearly identified and supplied as part of the procurement process. The manufacturer should provide a table and schedule of tests that can be adopted to ensure patient safety. 2.4 Surrogate Devices Many of the devices that constitute the most difficult loads to process in an EWD, which therefore require PQ, are difficult to monitor either thermometrically or microbiologically, are in short supply and are extremely expensive. A surrogate device is a test piece designed and constructed to emulate the characteristics of a device to facilitate appropriate monitoring of the cleaning and disinfecting processes. An example of a surrogate device might be a flexible Endoscope simulated by a similar length of Polytetrafluoroethylene (PTFE) tube of appropriate diameter and bore. The surrogate device can be constructed to incorporate the appropriate temperature sensors and so that it can be separated into sections to facilitate the evaluation of residual test soil or survivors from a microbial challenge. Page 37

49 The surrogate device should have similar geometry and thermal mass and, as far as practicable, should be constructed of the same materials and with the same surface finishes as the device it is designed to emulate. When a device presents particular problems in validation, the manufacturer of the device should be requested to provide details of the method by which they recommend that PQ studies should be performed. For flexible Endoscopes, the EN15883 Part 4 surrogate device consists of Endoscope trumpet valves in combination with three tubes of Polytetrafluoroethylene (PTFE), simulating the water channel (inner diameter of 2 mm, length 1500 mm on both sides of the trumpet valve), the air channel (inner diameter of 2 mm, length 1500 mm on both sides of the trumpet valve) and the biopsy/suction channel (inner diameter 4 mm, length 1500 mm on both sides of the trumpet valve), 100 mm tube between the biopsy port and the suction valve. Additional tubes may be added to simulate the construction of particular Endoscopes that the EWD is intended to process. For example to simulate the elevator channel a separate tube of inner diameter 1 mm, with a stainless steel wire with an outer diameter of 0,7 mm, length 2000 mm may be used. Figure 2 Annex F EN ISO illustrates an example of a suitable surrogate device. Each channel is provided with a means (e.g. Luer lock connectors) to place test pieces, in the channels, on the positions indicated in Figure 2 of Annex F. The test pieces can be used to limit the flow through the channels in the channel non-obstruction test. The test pieces can be contaminated with a test soil for the test of cleaning efficacy. When specific connectors/separators are recommended by the EWD manufacturer for the purpose of the channel non-obstruction test, the test shall be repeated with a specific surrogate device modified to include those specific connectors/separators. As flexible Endoscopes with irrigation lumens include valve systems to control air and fluids, these need to be simulated in a test device. Examples of such devices are illustrated in EN ISO Annex F. At present there are no standard designs for these test pieces, but a design that simulates the internal structure of a flexible Endoscope would be acceptable. For the cleaning efficacy test and channel patency tests described in this document, a simpler surrogate device can be used which consists of two 1.5m lengths of Polytetrafluoroethylene (PTFE) tube (2mm inner diameter) and one 1.5m length of PTFE tube (1mm inner diameter). These should be bound together at intervals of approximately 15cm. For EWDs with more than 3 channels, two sets of three surrogate devices may be required so that each of the machine channels can be tested. Page 38

50 3. Periodic Testing of EDU Decontamination Equipment Theme 2: Effective Care and Support Standard 2.2 Standard 2.4 Standard 2.8 A microbiological service is in place to support the service to prevent and control HCAI. A monitoring programme is in place to measure and report on effectiveness of Infection Prevention and Control practices. Reusable Invasive Medical Devices are documented and maintained to minimise the risk of transmitting a HCAI. Theme 5: Leadership Governance and Management Standard 5.5 Service providers ensure that externally contracted services adhere to safe and effective Infection Prevention and Control practices. Features of a service meeting this HIQA Standard include: 2.8.1: All reusable invasive medical devises are safely and effectively decontaminated maintained and managed in accordance with legislation and National and International Decontamination Standards (HIQA, 2017). As described in Part 1, commissioning of decontamination equipment consists of a series of validation tests performed by the manufacturer/supplier/ manufacturer s agent or another suitably qualified test engineer defined in the following categories: Installation qualification (IQ); operational qualification (OQ); and performance qualification (PQ) : The external contracts of agreement includes the scope of service provided audit requirements and governance arrangements for the quality and safety of services delivered. It includes complying with Infection Prevention and Control best practice and relevant legislation.(hiqa, 2017). Page 39

51 3.1 General Concepts Endoscope Product Family When testing Endoscopes for the presence of microbes, protein or chemical residue, Endoscopes are grouped into product families. Endoscope Product Families are a group of Endoscopes with comparable clinical application and design, including the number, construction and purpose of the different Endoscope channels. In accordance with Annex G (EN ISO 16442) there are three Endoscope product families which have been identified and defined based on the relevant characteristics of Endoscopes. Classification of Endoscope product families. Endoscope product Family 1 includes Endoscopes: With air/water channels; with biopsy/suction channel; with/without additional instrument channel; with/without water jet channel. Endoscopes belonging to this family are typically intended for use in the gastrointestinal (GI) tract. Gastroscopes and colonoscopes are the main representatives of this Endoscope product family. Duodenoscopes with an encapsulated elevator wire, also belong to this group. Figure 1: Example of an Endoscope from Product Family 1 Page 40

52 Endoscope product Family 2 includes Endoscopes: With air/water channels; with biopsy/suction channel; with/without additional instrument channel; with/without elevator wire channel; with up to two control channels for balloon functions. Endoscopes belonging to this family include models which can be used in the gastrointestinal tract. They are equipped with a so-called elevator wire channel and/or control channels, the latter designed to fill and deflate balloons as components of the Endoscope. Examples for this product family are duodenoscopes with open elevator channel, Endoscopes for Endoscopic ultrasound, and Enteroscopes. Figure 2: Example of an Endoscope from Product Family 2 Page 41

53 Figure 3: Example of an Endoscope from Product Family 3 Endoscope product Family 3 includes Endoscopes: With up to two instrument channels, but without channel system in the umbilical cord; or without any channels within the entire Endoscope. Endoscopes belonging to this family comprise of models with only one channel system for biopsy, irrigation and suction, or models without any channel. They are used in bronchoscopy, ear-nose-throat applications, gynaecology and urology. Page 42

54 3.2 Quality Assuring the Endoscope Journey Traditionally validation concepts have focused on ensuring that the individual items of equipment are validated and that they all perform to a satisfactory level. This document introduces the concept of measuring various parameters of the Endoscopes decontamination status as it passes through its reprocessing journey. Whilst there is still an obvious need to validate individual processes, knowing how to check the status of an Endoscope at the reprocessing stages can help understand where processes go wrong and whether there are issues with individual devices themselves. Some of the new tests introduced in this document are designed to provide assurance that Endoscopes themselves are fit for use. Table 4: Quality Assuring the Endoscope Journey from the Manual Clean in the EDU to Storage Page 43

55 Table 5: Testing the Decontamination Processes Page 44

56 (Note: Tables (4 and 5) are used to indicate the tests required from two different perspectives i.e., the Endoscope journey and efficacy of the decontamination process. It should be noted that many of the tests are the same in both tables. This does not mean that these tests have to be undertaken once for testing the Endoscope journey and once for testing the Endoscope process. A single test may serve both purposes) 3.3 EWD (Note: Where test methods are not described within this document, the relevant method from the EN ISO series of documents should be used) Table 6: EWD Daily Tests Schedule of Daily Tests EN ISO Reference (Part 1 unless otherwise stated) 1 If fitted check spray arm rotation for free movement N/A 2 If fitted check spray nozzles for blockage (Paying particular attention to those fitted to carriages for instruments). 3 Remove and clean strainers and filters etc., N/A N/A 4 Check of the channel separators N/A 5 Check of the connectors N/A 6 Check of the connection tubes N/A 7 Machine self disinfection (if weekly self disinfection is insufficient to maintain TBC at an acceptable level). 8 Check Detergent and Disinfectant level. N/A N/A (Note: Channel Separators the channel separator shall not impair the operation of the EWD as a result of leaks, flow restrictions or other limitations. Channel separators inspection consists of: The mechanical operation of movable parts: do parts move smoothly? attachment of fixed parts, are parts that need to be attached indeed attached? completeness of the channel separator, are parts missing? condition of O-rings and interface with the Endoscope; damage, scratches, bending of parts. Correct channel separators and Endoscope - EWD channel irrigator connectors must be used for each channelled scope type and model. Contact EWD Manufacturer for further advice) Page 45

57 Connectors the connection between the EWD and the Endoscope shall not impair the operation of the machine as a result of leaks, flow restrictions or other Limitations. Connector inspection consists of: State of O-rings and interface with the Endoscope; damage of the connector and the tubes attached to it. Connector Tubes The connection tubes shall not be damaged and shall not be blocked by bending or twisting. Table 7: EWD Weekly Tests Schedule of Weekly Tests EN ISO Reference (Part 1 unless otherwise stated) 1 Weekly safety checks (recommended by the N/A manufacturer) 2 Carry out daily tests N/A 3 Removed and clean strainers and filters etc., N/A 4 Water conductivity, hardness and ph (final rinse water and water for other stages) 5 Water used for final rinsing TVC Part Automatic control test Cleaning efficacy test by residual soil detection e.g. protein tests 8 Cleaning Efficacy Test using a Process N/A Challenge Device 9 Machine self-disinfection N/A Page 46

58 Table 8: EWD Quarterly Tests Quarterly Tests EN ISO Reference (Part 1 unless otherwise stated) 1 Weekly safety checks N/A 2 Automatic control tests Verification of calibration of WD and IMS instruments (both temperature and pressure) 4 Thermometric test for machine thermal self-disinfection if thermal disinfection is fitted, (if chemical self-disinfection is used then the advice of the AE(D) should be sought) 5 Cleaning efficacy test using a EN ISO Part 5 test soil, surrogate device and residual protein measurement using a Process Challenge Device and Part , , and Part Channel patency test (disconnection and obstruction) Part and Part Final rinse water (sampled from the EWD) conductivity hardness TVC Pseudomonas aeruginosa environmental mycobacteria 6.4 and Part RO Permeate water conductivity hardness TVC N/A Page 47

59 Table 9: Yearly and Revalidation Tests Test EN ISO Reference (Part 1 unless otherwise stated) Yearly and Revalidation tests (Re-qualification in EN terminology) 1 Yearly safety checks N/A 2 Automatic control test Verification of calibration of WD and IMS instruments (temperature and pressure) 4 Final rise water tests (sampled from the EWD) conductivity hardness TVC bacterial endotoxins Pseudomonas aeruginosa environmental mycobacteria 5 RO Permeate water conductivity hardness TVC chemical purity and Part and Part Drainage free drainage efficacy of discharge 6.5.2, Venting system Part and IEC Doors and interlocks cycle start in-cycle failed cycle 9 Fault interlocks and alarms (including leak alarms where fitted) 10 Chemical vapour discharge test N/A* , , Part Chemical additives dosing tests reproducibility low level detection 12 Local carriers alignment (and Part for single dose containers) *EWDs using chemical additives for which there maybe specified exposure limits under the chemical agents regulation. It must be ensured that emissions from the EWDs do not cause personal exposure to exceed the legal limits. Advice should be sought from the EWD manufacturer, the supplier of the chemical and/or the Health & Safety Officer or Dangerous Goods Advisor. Emissions from the EWD during normal operation and maintenance including when opening the EWD at the end of the cycle or when changing chemical reservoirs should not expose personnel to concentrations in excess of legal limits. Page 48

60 Table 9: Yearly and Revalidation Tests Continued Test EN ISO Reference (Part 1 unless otherwise stated) 13 Channel patency test (disconnection and Part and Part obstruction) 14 Disinfectant concentration test (if a multi-shot Part disinfectant is used 15 Chamber wall temperature/load carrier Part temperature tests 16 Cleaning efficacy tests , and Part Using a ENISO Part 5 test soil, surrogate device and residual protein measurement Using a Process Challenge Device 17 Over temperature cut-out test (if temperature control is fitted) Thermometric test for machine thermal self-disinfection if thermal disinfection is fitted, (If chemical self-disinfection is used then the advice of the AE(D) should be sought) 19 Test of chemical disinfection efficacy (using surrogates and at least two organisms) 6.8 and Part Part and Part Load dryness test 6.12 and Part Test for air quality Process residues chemical additives (for performance re qualification only if required) Testing Methods for Water Quality Total Viable Count The test method, as described in EN ISO Part 1 Annex D should be used. Testing should be carried out weekly on the final rinse water from the EWD and quarterly for the RO permeate from the delivery ring main. If there is concern of water contamination, the culture plates should be examined and reported after 48 hours incubation. The incubation should continue for 5 days, as described in EN ISO and a final report issued. This method uses R₂A media with an incubation temperature of C. Page 49

61 If particular microorganisms are of concern, other recovery conditions (growth medium, incubation temperature, etc.) should be used as appropriate. In such cases, the advice of the microbiologist should be sought. Identification of bacterial species may be particularly useful in aiding any risk assessment when high results are reported and can be undertaken relatively quickly (within an additional hours). Table 10: EWD Rinse Water Total Viable Count Results Guide Aerobic colony count (cfu) in 100mL Interpretation Action and advice <1 cfu Satisfactory Use as normal Green Colour grade 1 9 cfu on a regular basis Acceptable indicates that bacterial numbers are under a reasonable level of control Use as normal Green cfu Risk Assess Request identification of predominant organisms and resample Carry out formal risk assessment, based upon clinical needs in consultation with the consultant Microbiologist the IPC team and the AE(D) to decide whether to continue to decontaminate Endoscopes. Instigate a re-test of the rinse water. Run additional self disinfection cycle on the EWD, or super-chlorinate. Change EWD filter if recommended by the manufacturer. Resample and if the second sample fails undertake remedial work on the water distribution system to investigate the problem e.g. check the purification/filtration system and any internal components on the EWD. Orange >100cfu Risk Assess As above. Request identification of predominant organisms and resample EWD should be taken out of service until water quality has improved / issue resolved. Investigations should be undertaken as above. Seek advice regarding continued use of the EWD from the Consultant Microbiologist / IPC team, AE(D) and RO/EWD manufacturer. Multi-disciplinary teams should work together to identify the source of contamination within the final rinse supply. A risk assessment should be performed prior to the re-introduction of the EWD. Red Page 50

62 Environmental Mycobacteria Environmental mycobacteria present a particular problem when they occur in the final rinse-water of some Endoscopes used for diagnosis. Environmental mycobacteria maybe easily confused, on initial detection, with pathogenic mycobacteria and may lead to misdiagnosis. Other mycobacteria that occur in water, for example Mycobacterium kansasii and M.chelonae, are opportunistic pathogens. The test for environmental mycobacteria is intended as a quarterly periodic test. It should be carried out in an accredited microbiology laboratory. The method uses Middlebrook 7H10 agar plates incubated at 30ºC (+0/ 2 C). The sample should be taken from the EWD final rinse water. During the prolonged incubation period cultures should be examined weekly for the presence of rapid growing mycobacteria and if detected should be reported as an interim result. The use of alternative media may allow for a shorter incubation time if validation data is available. However, viable counts of a test suspension on the medium of choice should not be statistically different from those obtained on a published quality control medium (Middlebrook 7H10) proven to be appropriate for environmental mycobacteria. Presumptive rapid growing mycobacterial cultures should be transferred to an accredited laboratory with established expertise in mycobacteria identification so the strains isolated can be identified. There should be no recovery of mycobacteria from 100 ml of final rinse-water. Pseudomonas aeruginosa Test This test is based upon the methodology published in the English Health Technical Memorandum It is undertaken quarterly and the sample should be taken from the EWD. The method used is Pseudomonas selective CN agar incubated at 37 C (+0/ 1 C) for 2 days. Any colonies that show a blue-green pigmentation can be reported as P. aeruginosa. Suspect colonies may be further confirmed by sub culturing onto milk cetrimide agar and incubated at 37 C (+0/ 1 C) for 1 day. There should be no P. aeruginosa in 100 ml of final rinse-water. Endotoxin Tests The method described in the European pharmacopeia is recommend. Other LAL methods (chromogenic, turbidimetric or kinetic turbidimetric) are equally suitable. It is undertaken annually and the sample should be taken from the EWD. There should be less than 0.25 Endotoxin Units/mL Page 51

63 Water Hardness Tests The sample should be taken weekly from the EWD and quarterly from the RO Permeate water. When sampling water from the EWD, if different water quality is used to feed stages before the final rinse (RO) then additional tests should also be undertaken on this water. For measurements on site, commercially available kits for the titrimetric determination of both total hardness and calcium hardness are available. These often use novel titration methods instead of burettes and the test reagents are specific to each kit. Therefore manufacturer s instructions should always be followed. For laboratory measurements Ion selective electrodes can be used. When using this method both analyte and calibration standard solutions must be adjusted to the same ionic strength. Use a high impedance millivoltmeter to measure the potential between the ion selective electrode and a suitable reference electrode. The total hardness (CaCO 3 ) should be less than that specified in Table 1. Conductivity Tests The sample should be taken weekly from the EWD and quarterly from the RO Permeate water. There is a wide variety of portable conductivity meters available. The unit chosen should meet the performance criteria given in the table below. The meter, or meters, used should have a range of μs cm 1, a resolution of 0.1 μs cm 1 and an accuracy of ±1% full scale. They must be temperature-compensated over the range 0 40ºC and the meter should be calibrated at a frequency recommended by the manufacturer. A comprehensive range of standard conductivity reference solutions, including pure water standards, also known as absolute water, are available commercially, standardized at 25ºC and traceable to national standard reference materials. The sample should be collected in a high-density polyethylene bottle and tested as soon as practicable. Follow the meter manufacturer s instructions for making the measurement; this will usually require a short stabilization period before noting the reading. The conductivity at 25ºC should not exceed 30 μs cm 1 Page 52

64 Chemical Purity Tests The sample should be taken annually from the RO Permeate water. The Determinants to be analysed and the maximum permitted values are listed in Table 2. The methods used for analysis are as follows: Degree of acidity (ph) There are two common on-site methods available, the colour disc comparator and portable ph meter. Either can be used. When using a meter, it should include built-in temperature compensation. Only those ph meters specifically designed for the measurement of low ionic strength solutions should be used for determining the ph of RO water. It should be noted that the electrodes used for measurement need replacing periodically and that old electrodes will often drift during the measurement. Colorimetric tests for ph are suitable for high purity, low conductivity, water samples of the type required to be tested. Manufacturers of colorimeters usually provide indicators to cover a range of 2 or 3 ph units. Wide-range indicators should not be used because of their poor discrimination. Photometric apparatus can also be used for laboratory analysis. When sending samples to laboratories for ph analysis certain precautions should be taken with the sample to avoid absorption of Carbon Dioxide from headspace within the bottle and subsequent formation of carbonic acid in the water which lowers the ph result artificially. This is usually only a problem when the ph is expected to be at the borderline of an acceptable result (e.g. 5.5 mark). Therefore bottles should always be filled to the neck and sent to the laboratory as soon as possible. Retest if ph levels are 4.5 or below. Consideration should be given to adding an additional final rinse if low ph levels persist. Total dissolved solids (mg/100ml) The laboratory test for the determination of total dissolved solids is a gravimetric method. This involves determining the weight of the residue obtained by evaporating a known sample volume to dryness. The following apparatus should be used: Silica or borosilicate dish or beaker of >150 ml capacity; oven set to 110ºC ± 2ºC; boiling water bath or heating mantle set to 100ºC ± 2ºC; 1 L polypropylene bottle; Page 53

65 Take the silica dish (or equivalent), dried for 2 hours in the oven set to 100ºC ± 2ºC and then cooled to ambient temperature, and weigh it to the nearest 0.1 mg. Dispense 100 ml of the sample into the weighed dish and evaporate it over the boiling water bath until visibly dry. Evaporate two further 100 ml aliquots of the sample in the same dish in the same manner. Dry the dish in the oven to constant weight to an accuracy of 0.1 mg. Calculate the mass of residue in the dish and hence calculate the mass of residue per 100 ml of water. Chloride, CI (mg/l) For on-site use, commercial Silver nitrate titrimetric kits are available that are based on the method described in ISO 9297:1989. This method is not quantitative for purified water, which should have chloride concentrations well below the range for accurate determinations; it can be used, however, as a limit test. The European Pharmacopeia limit test, based on comparison of the turbidity obtained from a known chloride concentration, can also be used. There are also commercially available chloride selective electrodes that have a working range from 1 M to 10 5 M. These should be used for laboratory analysis. Other laboratory tests with an equivalent or greater sensitivity can be used. Heavy metals, determined as Lead, Pb (mg/l) Determine the total concentration of heavy metals using the limit test described in the European Pharmacopoeia, see also ISO Iron, Fe (mg/l) One of the commercially available colour disk comparator kits can be used for on-site analysis for this test. Typically these are based on the reference method described in ISO Most kits include methods and reagents for pre-treatment to reduce any iron (III) compounds to the iron (II) form in which they can be analysed. Laboratory tests with an equivalent or greater sensitivity can be used. Phosphate, P2O5 (mg/l) Commercially available colour disc comparator kits are available that are generally based on the reference method described in EN ISO 6878:2004, EN :2004. Page 54

66 (Note: Phosphate is readily absorbed on to many plastic surfaces. When polypropylene bottles are used as sample containers the sample for phosphate analysis should be transferred immediately to a glass container and assayed as soon as possible. This glassware should be borosilicate which has been subject to acid hardening, that is, cleaned and allowed to stand overnight, filled with sulphuric acid (d201.84), then rinsed several times and stored filled with water, in the dark at 0 4ºC until required for use. The glassware should not be allowed to come into contact with detergents or alkaline liquids) Laboratory tests with an equivalent or greater sensitivity can be used. Silicate, SiO2 (mg/l) On-site methods based on the use of commercially available colour disc comparator kits can be used for softened water. However these may be only sufficiently sensitive to act as a limit test for RO water. Other laboratory tests with a greater sensitivity can be used for RO water. Page 55

67 3.5 Testing Methods for EWD Performance Automatic Control Test The automatic control test is designed to show that the chosen EWD operating cycle functions correctly as shown by the values of the cycle variables indicated and recorded by the instruments fitted to the EWD. In the absence of an independent monitoring system (IMS), this test is carried out daily and is the main test for ensuring that the EWD continues to function correctly within the validated parameters. Where an independent monitoring system is fitted, the test is undertaken weekly. The IMS records should be checked in conjunction with validation data. Test Procedure Place a test device or a routine Endoscope in the chamber. Select the routine operating cycle and start the cycle. Ensure that a traceability record is made of the test. Note chamber temperatures (if appropriate), leak test pressure and duration of all significant points of the operating cycle, for example the beginning and ending of each stage or sub-stage. The test should be considered satisfactory if the following requirements are met: A visual display indicating cycle complete occurs; the recorded temperatures/times are within the limits set by the manufacturer for each stage of the cycle; the hold time for the disinfection is as recommended by the manufacturer; no mechanical or other fault is observed; the IMS is satisfactory; record the EWD results and certify as fit for use as appropriate; If elevated temperatures are used during the routing cycle, the time for which the temperature is maintained is not less than that established during validation; the door cannot be opened until the cycle is complete; the person conducting the test does not observe any mechanical or other anomaly. (Note: Ensure that during the whole of the operational cycle, the values of the cycle variables as indicated by the instruments on the EWD or shown on the batch process record are within the limits established as giving satisfactory results either by the manufacturer or during validation) Page 56

68 Cleaning Efficacy by residual soil detection Cleaning Efficacy Tests Introduction Cleaning efficacy tests can be divided into three types: Test 1: Cleaning efficacy tests undertaken by the Competent Person using an artificial test soil and surrogate device; Test 2: Process Challenge Device (PCD) tests undertaken by the Competent Person during quarterly and annual validation and the User on a weekly basis; and Test 3: Residual protein tests on reprocessed Endoscopes undertaken by the User using a commercially available protein detection kit. Test 1 above is designed to demonstrate the ability of the EWD to remove soil and contamination from the chamber, carriage and load channels and to ensure the EWD is working to a defined level of cleaning efficacy. Test 2 and 3 are designed to monitor the removal of a standardised challenge soil (in the case of the PCD) or naturally occurring soil (in the case of the residual protein test), and that the EWD process will effectively clean products of the type to be processed. Test 1: Cleaning Efficacy by the CP(D) Using an Artificial Soil The CP(D) who performs periodic testing on the EWD will use artificial soils and apply these soils to the chamber, load carrier and surrogate device. Surrogate devices will be used to simulate the Endoscope (see page 37 for more information on surrogate devices) and be contaminated with a test soil to test for cleaning efficacy. Test soils are used to simulate naturally occurring contamination. During periodic testing of cleaning efficacy using test soils, the disinfection stage and drying stage should be disabled, unless it can be demonstrated that inclusion makes little difference to the results. Test Soils The choice of test soil to be used should be that specified in the type tests (manufacturers testing regime) or made up as described below: water, 50 ml; glycerol, 30 ml; horse serum, 30 ml; dehydrated hog mucin, 5 g; unbleached plain flour, 2 g; aqueous safranine solution, 2% mass fraction, 1 ml. Page 57

69 The test soil should be used immediately or stored in an airtight container at 2 5ºC for not more than one month or as per manufacturer s recommendations. EN ISO Part 5 contains a list of alternative test soils that may be used to simulate other soiling types. If the soil has been stored, it must be allowed to equilibrate to room temperature before use. CP(D) Cleaning Efficacy Tests for Chamber Walls and Load Carrier The chamber walls and load carrier should be contaminated with the test soil in accordance with EN ISO Part 5. The load surfaces are dried in air for minutes. A normal operating cycle should be run. After completion of the wash stage and before the disinfection stage, the cycle should be aborted unless it can be demonstrated that inclusion makes little difference to the results. Requirements to be met The chamber walls and load carrier should be free of residual soil when examined according to the examination methods on page 59. CP(D) Cleaning Efficacy Tests Using a Surrogate Device This test should only be undertaken after successful completion of the test for chamber walls and load carrier. The test load should consist of items of similar size, mass and materials of construction to the range of EWD it is intended to process. A surrogate device for investigation of cleaning and disinfection may be constructed from two 1.5 m lengths of Polytetrafluoroethylene (PTFE) tube (2 mm inner diameter) and one 1.5 m length of PTFE tube (1 mm inner diameter). These should be bound together at intervals of approximately 15 cm. Advice from the EWD manufacture may be required to select suitable test tube diameters. Surrogates should be connected to all channels within the EWD. For EWDs with more than three lumens per scope connection, two sets of surrogate devices may be required so that each of the machine s lumens can be tested. If the EWD is capable of processing more than one Endoscope at once, sufficient surrogates should be used during the test so that processing of the maximum number of Endoscopes is simulated. A normal operating cycle should be run and after completion of the wash cycle and before the disinfection stage, the cycle should be aborted. At the end of the test, the surrogate should be examined for the presence of residual soil using the method detailed in examination methods on page 59. Additionally, none of the test soil should have transferred to the chamber and load carrier. Page 58

70 Examination Methods Visual examination alone is not sufficiently sensitive and can only be used to detect gross failures. The result should be measured using technologies with the best available sensitivity, consistent measurement standards and quantifiable results to measure effective control of residual protein levels. Ninhydrin based systems will not be sensitive enough. Commercial swabbing methods based on Bradford assay or Coomassie blue reagents are widely available and can currently be used if appropriately validated. The result should show less than 6.4 /µg/cm² of protein. The Competent Person should ensure that photographic evidence of the soiling of the chamber, load carrier and load is provided in the test report. Photographs of the chamber, load carriage and load are of minimal value in checking soil removal post testing. However photographic records of the residual protein test result should be provided in addition to the name of a member of staff from the reprocessing department who witnessed the result. A typical post cleaning efficacy residual protein photograph for a report is shown below. Number of Tests For commissioning tests two consecutive tests should be undertaken on the chamber and load carrier. On successful completion of these tests an additional test should be performed on a load using the surrogate device(s). For annual and quarterly tests a single chamber and load carrier test should be performed followed by a single load test using the surrogate. The tests should be repeated for every cycle type available to the User unless the process stages up to the end of the cleaning stage are identical. Test 2: Process Challenge Device Tests Process challenge devices containing cleaning efficacy indicators are used to verify that cleaning has been achieved and that the level of performance measured during the validation is still being achieved. These tests should be undertaken during both the annual and quarterly validation by the Competent Person and as part of the weekly tests undertaken by the User. Page 59

71 The process challenge device used during the validation shall be of the same type used by the department for its weekly PCD tests. If the department changes the type of PCD it should do so at the time of the annual or quarterly validation so that its performance can be aligned with satisfactory performance of the EWD and results aligned with the results of ISO surrogate device used by the CPD during cleaning efficacy test. PCDs used must be validated for use in an EWD. It is important that manufacturers instructions are followed correctly to ensure the EWD is working to a defined level of cleaning efficacy. The evaluation of the result should be according to the method specified by the PCD manufacturer. PCDs or cleaning efficacy indicators can also be used as an independent audit tool to compare the performance of EWD processes. Several models of PCD are available. Some devices include connections for all the channels in the EWD and others are single channel devices. All channels in each connection set/chamber will require testing during each test. Therefore, it is important that where single channel PCDs are purchased that sufficient numbers are obtained to avoid running several consecutive cycles in order to test all channels. Where an EWD has independent chambers within the same machine, the chambers can be tested separately but both will require testing each week. Where an EWD can process several endoscopes within a single chamber, all Endoscope connection sets will require testing each week. This can either be performed on separate consecutive cycles or with multiple devices in a single cycle. This is a new test introduced in this document to provide continual monitoring of the cleaning efficacy process and as such, its continued use and performance will be evaluated by the HSE. A spreadsheet should be created and maintained to record the results of the PCD tests. The spreadsheet should include the following details: Time and date of the test, EWD manufacturer and model and serial number; the chamber/sink/bowl tested; the type and manufacturer of PCD; the result of the test; any comments regarding the test (such as partial failures, channel disconnections). (Note: Commercial process challenge devices are being developed whose challenge simulates soiling of Endoscopes, are validated for use by the manufacturer of the EWD and whose analysis is quantitative. When these become available, EDUs are advised to implement their use. In the interim, EDUs should begin using existing commercially available devices on a trial basis, 12 months from the date of publication of this document, to become familiar with the concepts of using a PCD. All PCDs should be stored according to manufacturer instructions, expiry date checked and validated for use by the manufacturer of the EWD and contain test soil suitable for challenging the EWD process in compliance with 15883) Page 60

72 Test 3: Residual Protein Testing Programme Initial testing of the cleanliness of the external surfaces of the Endoscope, including the control section and the light source connector is performed visually. However this method cannot be used to assess the internal lumens of the Endoscope for cleanliness. Residual contamination can be made clearly visibly by swabbing the surfaces or lumens of the Endoscope using residual protein tests capable of detecting <1µg of protein. This test method i.e. Residual protein detection - is performed on the external surfaces and internal channels of the Endoscope. Much of the contamination which occurs on medical devices is, in whole or part, proteinaceous in nature. Residual protein tests are designed to determine the effectiveness of the cleaning process of the Endoscope and the ability of the Endoscope to be decontaminated. (There is no requirement to swab the basin). The result should be measured using technologies with the best available sensitivity, consistent measurement standards and quantifiable results to measure effective control of residual protein levels. Ninhydrin based systems will not be sensitive enough. Commercial swabbing methods based on Bradford assay or Coomassie blue reagents are widely available and can currently be used if appropriately validated. The result should show less than 6.4µg/cm² of protein. (Note: The aim of the test programme is to ensure that every product family is tested in every basin/chamber configuration over every quarter and that every individual scope is tested over a 12 month period (Table 11). The rationale for not performing additional testing in examples A and C is that all of the scopes will have been tested as part of machine performance over the course of 12 months) Page 61

73 Table 11: Example Calculation for the Number of Protein Tests Required. DESCRIPTION A B C D E F G Endoscopes and Product Families Processed Bronchoscope and Cystoscopes, both belonging to product family number 3 Bronchoscopes and Cystoscopes, both belonging to product family number 3 ERCPs product family number 2 Gastroscope / Colonoscopes both belonging to product family number 1 ERCPs and EUS both belonging to product family number 2 Gastroscope product family number 1 Gastroscope product family number 1 ERCP product family number 2 Cystoscope product family number 3 Total Number of Product Families Processed Basins (positions) Required Number of Test for Machine Performance per quarter (A x B) Required Number of Test for Machine Performance per year (CX4) Total number of scopes available to the user Required number of additional tests to establish scope integrity. E-D when E D+F is more than D tests tests tests tests tests Total number of tests per year (Note: The aim of the test programme is to ensure that every product family is tested in every basin/chamber configuration over every quarter and that every individual scope is tested over a 12 month period (Table 11). The rationale for not performing additional testing in examples A and C is that all of the scopes will have been tested as part of machine performance over the course of 12 months) Page 62

74 Disinfection Efficacy Tests Introduction Disinfection efficacy tests can be divided into three types: Test 1. Quarterly and Annual EWD self-disinfection efficacy tests. Heat (thermal processes) or chemicals may be used by an EWD to self-disinfect the machine depending on the EWD model/ manufacturer. The HSE preference is for machines that use thermal self-disinfection cycles, all EWDs on the HSE Framework use thermal self-disinfection cycles. For EWDs using thermal self-disinfection cycles, quarterly and annual testing of disinfection efficacy is performed using thermocouples. For EWDs using chemicals to self-disinfect, microbiological tests of disinfection efficacy are performed. Test 2. Annual microbiological disinfection efficacy tests using a surrogate device are performed for EWDs using thermal disinfection cycles; Test 3. Quarterly and Annual microbiological disinfection efficacy tests on reprocessed Endoscopes are undertaken by sampling of the exterior surfaces and lumens. Test 1. The first set of tests above is designed to demonstrate the ability of the EWD to disinfect its self. Test 2. The second set of tests are designed to monitor the disinfection of a standardised challenge using a surrogate device representative of a normal challenge. Test 3. The third set of tests are used to prove the process is effective against the naturally occurring challenges experienced by the department and prove the EWD process will effectively disinfect products of the type to be processed. It is also useful for checking the ability of a particular endoscope to be disinfected. Internal damage to Endoscope lumens may give rise to normally unseen areas that harbour contaminants and lead to the formation of biofilms. This third test can assist in identifying Endoscopes that have been subject to biofilm formation. Test 1. Self-Disinfection Efficacy Tests Thermometric test for self-disinfection: This test is used to prove the ability of the EWD to disinfect itself when thermal self-disinfection cycles are used. A successful self-disinfection cycle ensures that the EWD does not become a focus for contamination of the load and provides a means of disinfecting the EWD after maintenance, repairs or testing. Equipment and materials A temperature recorder complying with the requirements specified in EN ISO , clause 6.2.1, and having no fewer than 10 sensors is necessary. Page 63

75 Method Thermocouples should be located one in each corner of the chamber, one in the centre of the two side walls, one in the centre of the roof of the chamber and one adjacent to the temperature sensor used as the reference sensor for chamber temperature. In addition, a probe should be positioned adjacent to the EWDs process control sensor and a probe positioned in the centre of the chamber free space. For commissioning tests, the temperature attained should be measured throughout three self-disinfect cycles; one should be at least 60 minutes since the machine was last used a ( cold start ). For Annual validation, only a single test cycle is required and it should be run at least 60 minutes since the machine was last used. The EWD should be operated empty except for chamber furniture (for example, load carriers). Results The results should be the following: The temperatures recorded on the surface of the chamber and any load carriers should be within 0 5 C of the disinfection temperature throughout the holding period for the cleaning/disinfection stage. The temperatures recorded on the surface of the chamber/load carrier should be within ±5 C of the set disinfection temperature throughout the holding period. The temperature indicated/recorded by the EWD instruments should be within ±2 C of that recorded by the test instrument from the sensor adjacent to the reference sensor throughout the holding period for the disinfection stage. For commissioning tests, the temperature profile obtained for the operating cycle should be consistent within ±2 C for three test cycles. The cycle shall have achieved an A0 value of at least 600 (for example, 80 C for 10 minutes or 90 C for 1 minute). Test 1 for EWDs using chemicals to self-disinfect. For chemical self-disinfection systems, a microbiological test is required to prove disinfection efficacy. The test shall be designed to ensure that the self-disinfection cycle will disinfect contaminated tubing by evaluating the effect of the cycle against a biofilm containing Pseudomonas aeruginosa. The advice of a microbiologist and the Authorising Engineer for Decontamination should be sought regarding the details of the test to be performed. Page 64

76 The weekly tests of the final rinse water are sufficient to routinely verify the self-disinfection cycle at intervals less than annually. Test 2. Annual microbiological disinfection efficacy tests using a surrogate. The ability of the EWD to disinfect a standard surrogate test load (disinfection efficacy) should be verified at least annually using the test method described in EN ISO part 4 Annex B. This test should not be carried out until the adequacy of the WD self-disinfection cycle has been established (see preceding section Test 1). A Surrogate Device which has been inoculated with a range of test organisms representing the major groups of concern and showing the highest level of resistance to the disinfectant must be used. EN ISO offers advice on the range of test organisms and the test methodology, (at least one Gram-negative organism such as Pseudomonas aeruginosa and one Gram-positive organism such as Staphylococcus aureus should be used) Test Organisms: Pseudomonas aeruginosa (e.g. ATCC 15442). Staphylococcus aureus (e.g. ATCC 6538). Candida albicans (e.g. ATCC 10231). Mycobacterium terrae (e.g. ATCC 15755). Test Device: A surrogate device for investigation of cleaning and disinfection should be used (see page 37). Test pieces for inoculation may be formed from 150 mm lengths of the same diameters of PTFE tubing. These may then be positioned at each end and in the middle of the long lengths of tubing. They should be held in position with a sleeve made from a short length of silicone rubber tube of greater diameter. General: The method detailed in ISO EN should be employed. The concentration of the organisms prior to the test (control), the concentration of organisms following test and the log reduction in the organisms shall be reported. Suspending Menstruum: Test organisms shall be suspended in a suitable sterile isotonic solution, e.g. for bacteria, peptone water with 10 % sodium glutamate. Page 65

77 Inoculum: The inoculum shall contain known high numbers of the test organism, e.g. for bacteria the inoculum shall contain not less than 108 cfu/ml. The population in the original inoculum and deposited on the test piece for exposure to the disinfection process shall be counted using a validated method. Results: There should be at least a log reduction for each of the following organisms after the disinfection stage as noted below: Pseudomonas aeruginosa >10⁶; Staphylococcus aureus >10⁶; Mycobacterium terrae >10⁵; Candida albicans >10⁴ Test 3. Quarterly and Annual Microbiological Disinfection Efficacy Tests on Reprocessed Endoscopes. At least quarterly and when necessary, the adequacy of the disinfection process may be verified on actual Endoscopes processed by the department by using the methods given on page 68. (Note: The sampling strategy should include the sampling of all the channels of an Endoscope from each of the three product families every quarter. If there is more than one Endoscope of a particular product family then a different Endoscope should be sampled each quarter) Page 66

78 Table 12: Examples of the sampling strategy for disinfection efficacy tests. Endoscopes and Product Families Processed Cystoscopes, belonging to product family number 3 Cystoscopes, belonging to product family number 3 Bronchoscopes and Cystoscopes, both belonging to product family number 3 ERCPs product family number 2 Gastroscope / Colonoscopes both belonging to product family number 1 ERCPs and EUS both belonging to product family number 2 Gastroscope product family number 1 Gastroscope product family number 1 ERCP product family number 2 Cystoscope product family number 3 Total Number of Product Families Processed Scopes available to the user in each product family Sampling Strategy 1 1 Cystoscope The single Endoscope will be sampled every quarter. 1 2 Cystoscope The Endoscopes will be sampled alternatively every quarter. Therefore, each Endoscope will be sampled twice in the year. 1 1 Bronchoscopes 1 Cystoscope 2 1 ERCP Endoscope 1 Gastroscope 1 Colonoscope 2 1 ERCP Endoscope 3 EUS Endoscopes 1 Gastroscope 3 7 Gastroscopes 4 ERCP Endoscopes 2 Cystoscopes The two Endoscopes will be sampled alternatively every quarter as they are part of the same product family. Therefore, each scope will be sampled twice in the year. The ERCP Endoscope will be sampled every quarter. The gastroscope and colonoscope will be sampled alternatively every quarter as they are part of the same product family. The ERCP and EUS Endoscopes will be sampled once each over the 12 month period as they are part of the same product family and testing should be rotated amongst them each quarter. The gastroscope will be sampled every quarter as it is the only member of that product family. The gastroscopes will be sampled once each over a 21 month period. As there are more than four gastroscopes in this product family it would not be possible to sample them all in a 12 month period. The full range of gastroscopes could either be subject to increased sampling (e.g. 2 per quarter) if there are concerns based upon previous results or sampled over the longer time period. It is not acceptable to replace sampling in one product family with Endoscopes from another. The ERCP Endoscopes will be sampled once each over the 12 month period. The cystoscopes will be sampled alternatively every quarter. Therefore, each cystoscope will be sampled twice in the year. Page 67

79 Endoscope Lumen Sampling Method 1: This is the preferred method of lumen sampling when Endoscopes are wet: The Endoscope should be brushed through with a sterile disposable long-stemmed cleaning brush after processing; It may take two persons to aseptically sample an Endoscope lumen. All Endoscope lumens should be sampled. There is no requirement to reprocess the Endoscope prior to use if the test person is assured that no contamination of the Endoscope or its lumens has occurred during the sampling process; The brush end should be aseptically cut from the stem and aseptically transferred to 10 ml of sterile peptone water containing 0.05% polysorbate 80 and ultrasonicate between 30 and 50 khz for 10 minutes; Other neutralising medium may be used in consultation with the laboratory performing the analysis; The eluate should then be filtered through a 47 mm diameter 0.45 m filter and then the filter placed onto a R₂A agar plate and incubated at 30±2 C for five days; The number of colony forming units (cfu) counted will give an indication of the adequacy of the disinfection process; A result of less than 10 cfu per brush sample should be obtained if the Endoscope has been satisfactorily disinfected. Endoscope Lumen Sampling Method 2: An additional test that may be useful to measure the microbiological performance of the EWD cycle, manual cleaning and possibly the drying cabinets is to examine an Endoscope after it has been used, decontaminated and dried. This test method is better suited for testing Endoscopes when the lumens are dry. The test involves passing liquid down the Endoscope lumens, collecting the effluent and subjecting it to bacteriological counting. The following apparatus is necessary: Sterile water, enough to capture a minimum 10ml sample from each Endoscope lumen sampled; sterile syringe, care should be taken with the size of the syringe used in line with Endoscope manufacturer recommendations; sterile collection bottles; channel separators and lengths of sterile tube to connect the syringe to each Endoscope port in turn lengths; Page 68

80 sterile gloves and sterile drapes. Use of sterile gloves and aseptic techniques are essential to obtain good results. Example Endoscope Sampling Set up (Note: Consult manufacturer instructions for each endoscope type prior to initiating testing. The volume of sterile water required to capture a 10ml sample from each specific endoscope lumen may vary depending on the make or model of the Endoscope. The size of the syringe to be used may vary depending on manufacturer recommendations for each lumen size. If there is suspicion that there is residual disinfectant remaining in the Endoscope lumens after high level disinfection or storage (e.g. vacuum storage systems) use a sterile neutralising solution with proven efficacy to inactivate the type of residue concerned. This sterile neutralising solution is used to sample the Endoscope lumens in place of sterile water. In such cases the Endoscope will need to be reprocessed after sampling. The biopsy, suction, air water, auxiliary lumens, elevator channel (ERCP Endoscope), jet channel etc., should be tested) in an accredited microbiology laboratory, examine the chilled samples collected within four hours of sampling if stored at room temperature, or within 24 hours if stored at 2 5 C, carry out a total bacterial count/ml on each sample using R₂A ( EN ISO Annex D), TSA or YEA media and incubation at 30±2 C for five days. Results The results should be below 10 cfu/100 ml. Page 69