Decontamination of Flexible Endoscopes Procedure

Transcription

1 SH CP 135 Decontamination of Flexible Endoscopes Procedure (Infection Prevention and Control Policy: Appendix 20) This Appendix must be read in conjunction with the Infection Prevention and Control Policy Summary: Keywords: Target Audience: This policy outlines: the principles of endoscope decontamination and current national legislation and guidance which applies to the decontamination of flexible endoscopes. It provides guidance suitable methods of decontamination and the standards of practice expected of staff to reduce the risk of cross- infection from flexible endoscopes with lumens (does not include decontamination of scopes without lumens such as nasendoscopes) Endoscope, endoscope washer disinfector, cleaning, drying cabinet, periodic testing, validation, disinfection, sterilisation, single use All disciplines of staff who use, decontaminate, maintain, repair flexible endoscopes and the machinery used to decontaminate them. Next Review Date: November 2020 Approved & Ratified by: Infection Prevention & Control & Decontamination Group Date of meeting: Date issued: Author: Director: Jacky Hunt, Infection Prevention & Control Nurse Sara Courtney Chief Nurse and Director of Infection Prevention and Control 1

2 Version Control Change Record Date Author Version Page Reason for Change Jacky Hunt 1 Whole document National documents issued CFPP Jacky Hunt 1 P6 P20 Technical Amendment Previous editions of this and national guidance have recommended the use of enzymatic detergents based on their theoretical ability to digest mucus and other biological material from within narrow endoscope channel lumens. The B.S.G Guidelines (2014) now expresses no preference for enzymatic detergents. A move away from enzymatic detergents has been prompted by reports of occupational asthma and skin sensitization Jacky Hunt 2 As part of periodic review in light of new HTM guidance Reviewers/contributors Name Position Version Reviewed & Date Tom Hall AE(D) Vicky Hill Endoscopy Manager LNFH Jill Angus Area Matron (SE) Theresa Lewis IPCLead Angela Roberts IPCN Mary Pilgrim IPCN Jude Diggins Director of Nursing and Allied Health Tracey England PFI/Non-Clinical Services Manager LNFH Dr Caroline Mitchell Consultant Clinical Scientist Infection Prevention Steve Coopey Practice Development Specialist Nurse Vicky Hill Endoscopy Manager Lymington Hospital Vanessa Lucas Endoscopy Lymington Hospital Marie Corner Medical Device Advisor Infection Prevention Committee Infection Prevention Committee , members members Policy Consultation Group Professional Leads and Clinical Directors Tom Hall AE(D) V Vanessa Lucas Endoscopy Sister Lymington Hospital V Victoria Hill Endoscopy Manager V Joanne Williams IPCN V Lousie Piper IPCN V Steve Coopey Practice Development Specialist Nurse V Tracey Hammond Medical Device Advisor V Infection Prevention Group members Infection Prevention Group members V

3 Contents 1 Introduction 4 2 Definitions (Staff Roles) 4 Page 3 Components of Decontamination Process Handling of endoscopes after use and before decontamination Manual cleaning Process stages of EWD 6 4 Essential Quality Requirements Lumened Endoscopes Reprocessing Accessories Storage and Transport Environment and Layout Training Acquisition new service or new equipment Maintenance -service and repair Tracking and Tracing Water Quality and Water Treatment Validation and Verification TSE Staff Health Independent monitoring 23 5 Best Practice Standard 23 6 Dealing with disinfectant or body fluid spillages 24 7 References 24 Appendices A1 Audit tool IPS 26 A2 Competency assessment tool 27 A3 Testing for Users 29 A. Automatic Control test B. Weekly Checks C. Hardness D. Electrical Conductivity E. Total Viable Count F. Residual Soil A4 Endoscope Management and Decontamination HTM Top Ten Tips 33 3

4 Decontamination of Flexible Endoscopes Procedure 1. Introduction 1.1 This policy is based on the Health Technical Memorandum (HTM) (DOH 2016) which offers best practice guidance on the management and decontamination of flexible endoscopes. HTM replaces CFFP which has been updated to take account of the Advisory Committee on Dangerous Pathogens TSE Subgroup s general principles of decontamination. This updated guidance focuses on improving the washing and cleaning process and reducing the time from patient use to the decontamination process, and the monitoring of cleaning efficiency. It can be found at HTM is divided into five manuals: Part A: The Policy and Management - sets the Department of Health s (DH) policy context. This document outlines effectively two standards: Essential Quality Requirements (EQR) and Best Practice (BP). Endoscopes must always be decontaminated and maintained to a level specified in the EQR as a minimum. EQR standard meets the existing statutory and regulatory requirements. BP standard is the standard that the Trust should aspire to achieve by the end of the life time of this Appendix 20) Transmissible spongiform encephalopathy (TSE) infectious agents are discussed and guidance given on management and handling of an endoscope after it has been used on a patient at increased risk of vcjd. Part B Design and Installation Manual - gives guidance on design and fitting of endoscopy re-processing units. Part C Operational Management Manual gives guidance on operational responsibility together with advice on the procurement and operation of an endoscope washer-disinfector (EWD).. Part D Validation and Verification Manual highlights the types of tests and maintenance procedures that are needed to ensure decontamination has been achieved Part E The Testing Methods Manual - discusses the principles and methods that are used in the tests described in CFPP and the tests detailed in BSEN ISO For decontamination of nasendoscopes please see Appendix 12 Decontamination of Medical Devices 2. Definitions staff roles (HTM Part C 2016) All staff involved in decontamination of endoscopes must have clearly defined roles and responsibilities that are documented. (Please read this appendix in conjunction with Appendix 12 Decontamination of Medical Devices and local Standard Operating Procedure (S.O.P) documents held within the Outpatient and Endoscopy Departments 2.1 The User (e.g. Endoscopy Unit managers/managers of OPDs using endoscopes) has operational responsibility of the process. The User is also responsible for: the Operators the operation of endoscopy decontamination equipment that may be used on the endoscopes under their responsibility but not on their site Reporting issues of concern regarding endoscope instruments Compliance to this Appendix 20 4

5 The principal responsibilities of the User e.g. Endoscopy Unit managers/managers of OPDs using endoscopes) that should be included in their job descriptions are: Monitor record-keeping on the use of endoscopes and their decontamination including names of key personnel Oversee tracking and traceability systems relating to endoscopy and maintain production records Be aware of observed defects in condition or function of an endoscope and to certify that the decontamination equipment is fit for use Ensure governance provision in support of users across their areas Liaise with clinical and nursing staff to keep up-to-date with clinical developments within Endoscopy Oversee the audit programme in Endoscopy Keep an inventory of endoscopes Oversee the purchase of new endoscopy equipment Oversee the loan of endoscopic instruments Control local and distant instrument repairs of endoscopes To ensure that decontamination equipment is subject to periodic testing and maintenance; To appoint operators where required and ensure that they are adequately trained; To have documented training records demonstrating that they are competent to undertake assigned responsibilities; To ensure that procedures for production, quality control and safe working are documented and adhered to in the light of statutory requirements and accepted best practice. To develop a plan illustrating development from EQR Quality Requirements to Best Practice for the Unit 2.2 The Microbiologist (Decontamination) See Staffing roles and responsibilities in HTM Part A (2016). The Microbiologist (Decontamination) should also interpret records from endoscope decontamination equipment that have relevance to microbiological methods, infection prevention and related risk management 2.3 Authorising Engineer (Decontamination) (AE (D)) The role of the AE(D) should be fully independent of the healthcare facilities structure for maintenance, testing and management of the decontamination equipment. The AE(D) is defined as a person designated by management to provide independent auditing and technical advice on decontamination procedures, washer disinfectors, sterilizers and sterilization and to review and witness documentation on validation. The AE(D) is required to liaise closely with other professionals in various disciplines and, consequently, the appointment should be made known in writing to all interested parties. The AE(D) should assist healthcare organisations in the appointments and interviews of the AP(D)s and their consequent annual assessments. The AE(D) should have a reporting route to the Decontamination Lead and should provide professional and technical advice to the AP(D)s, CP(D)s, Users and other key personnel involved in the control of decontamination processes in all healthcare facilities. 5

6 The principal responsibilities of the AE (D) are as follows: To provide to Management and others, general and impartial advice on all matters concerned with decontamination; To advise Management and others on programmes of validation and testing; To audit reports on validation, revalidation and yearly tests submitted by the AP(D); To advise Management and others on programmes of periodic tests and periodic maintenance; To advise Management and others on operational procedures for routine production; To advise Management on the appointment of the AP(D); To provide technical advice on purchasing and selection of decontamination equipment for the users; To provide technical advice on the relevant guidance on decontamination equipment and procedures. 2.4 Competent Person (Decontamination) (CP (D)) - The CP(D) reports to the Endoscopy Unit Manager and may be appointed from Trust Estates Department of private contractor. The CP(D) principle responsibilities in relation to decontamination of flexible endoscopes are : To carry out maintenance tasks To carry out repair work To conduct validation and periodic testing 3. Components of Decontamination Process Written local procedures for each stage in the management, use and decontamination of endoscopes should be held within the department Stages of reprocessing for flexible endoscopes Stage Bedside procedure (pre-clean) Leak Test Manual clean (channel brushing) Drying (EWD) Disinfection(E WD) Rinsing (EWD) Drying (EWD) Why To remove readily detachable organic matter. This will help to reduce the possibility of drying and causing channel blockages, especially if there is a delay before manual cleaning takes place To ensure the integrity of the endoscope. Any damage to the outer surface could allow body fluids or chemicals into the internal workings of the endoscope Brushing of accessible channels and flushing of all channels to remove organic matter. This stage will also allow the detection of channel blockages To expel excess fluid that may dilute the disinfectant To eradicate potentially pathogenic microorganisms, i.e. bacteria, including mycobacteria and viruses To remove disinfectant residues that could cause a harmful effect to the patient To expel excess fluid before use on the patient or storage a) Pre-clean (Bedside procedure) - handling of endoscopes after use and before decontamination (HTM Part C 2016) EWDs are incapable of cleaning the endoscope without any pre-treatment. As soon as the endoscope is removed from the patient, the lumens should be flushed in accordance with the endoscope manufacturer s instructions. The outside of the instrument should then be wiped with a swab soaked in an aqueous solution of a 6

7 suitable detergent, as recommended by the endoscope manufacturers (for instance neutral general purpose detergent) Flexible endoscopes must be kept moist after use and before manual cleaning. If endoscopes are allowed to dry during this period, soil will be difficult to remove. Therefore endoscopes should be transferred from the point of use to the decontamination area as soon as possible. There are several options available to retain moisture during return transport to the decontamination unit e.g. A damp endoscope could be placed in a plastic bag and the bag sealed. The bag could then be placed onto a tray to support the body of the endoscope and transported on a purpose-built trolley. Used endoscopes can be sprayed and injected with non-drying fluid, then transported in a plastic lines tray designated for the purpose. Used endoscopes can be put in a small volume of water and covered. Endoscopes should not be transported with the lumen full of fluid. This will pose a spill hazard of potentially infective fluids. The use of a load carrier specifically intended for the endoscope(s) to be processed is essential. The detachable parts that are to be re-used (eg air/water and suction valves/pistons) should be removed during pre-cleaning at point of use, and accompany the endoscope Reprocessing accessories (HTM Part A 2016) Single use accessories should always be used. The choice of single use biopsy forceps, guidewires and cytology brushes helps to minimise any possible risk of transmitting prion disease. Re-usable accessories should only be used in situations where no single use equivalent exists, and should be heat tolerant for processing in a Sterile Services Department. Procedures should be available for tracking each patient use in these circumstances (BSG 2016) The biopsy port cap should be discarded whenever breached by biopsy forceps or any other accessories passed down the working channel during the endoscopy procedure (BSG 2016) Ensure re-usable accessories (eg valves) are in the open position to allow steam to access all surfaces Sterile water must be used in the single use water bottle Do not re-use single use items. Once the pre-clean is complete, the endoscope is then detached from the light source/video processor securely contained and transported to the decontamination area. A leak test is then carried out to check the integrity of all channels before reprocessing. b) Leak test: An automatic leak test can be used to supplement the manual leak test carried out during manual cleaning. If a leak is detected the decontamination process should not be carried out as further damage to the endoscope may occur The second stage is the dismantling of detachable parts of the endoscope prior to manual cleaning. c) Manual cleaning The instructions provided by the endoscope manufacturer should be followed, as endoscopes vary in construction and therefore the method of cleaning. 7

8 Before cleaning, all endoscopes should be checked for damage. Test to determine whether there is a fracture or leak by carrying out a leak test and only proceed to cleaning if the test is satisfactory. The endoscope manufacturer s instructions should be followed for this task. A volume of concentrated detergent is added appropriate to the volume of water already present, as recommended by the detergent manufacturer. The use of engraved or other permanent markings on the inner surfaces of sink units may be helpful as may the use of pre-drilled holes to take detergent transfer pipework, supporting accurate and reproducible detergent dilution. The endoscope and accessories should be soaked in the detergent solution recommended by the detergent manufacturer. The temperature of the manual wash water is determined by the manufacturer of the detergent but should be no more than 35 O C. Under detergent fluid, the instrument/biopsy lumens should be brushed through 3 times or more with a cleaning brush designed for the instrument in accordance with the endoscope manufacturer s instructions. Manual cleaning is essential to remove deposits down the lumen and around the controls of an endoscope. An Endoscope Washer Disinfector (EWD) is not able to reproduce the brushing action of manual cleaning or brushing between the control wheels. Manual cleaning is particularly important when using older EWDs, as the cleaning action may be limited. After use, the sink is drained, rinsed with tap water, drained, wiped clean and left dry. The second sink is filled with cold water and the washed endoscope is immersed before each lumen is syringed through to remove the detergent. The endoscope should then be rinsed in clean tap water and carefully examined for damage before connection to a EWD. The endoscope is then transferred to the EWD, taking care water does not drip onto surfaces and the floor. Hands should be washed and clean gloves used before removing the cleaned endoscope after the EWD process. The reprocessed endoscope, from the EWD, should be stored in a clean area or drying cabinet. If the endoscope is to be used directly it may be laid onto a lined transport tray and covered ready for re-use. Process stages of an Endoscope Washer Disinfector (EWD) Connection of endoscope to EWD: The lumens of the endoscope should be connected to the appropriate nozzle on the load carrier to ensure the free passage of fluids through the lumens during processing. If the endoscope to be processed has an open raiser bridge lumen, this should be connected to a specific connector on the EWD to deliver high pressure fluids to carry out the cycle successfully. Initial flush (optional): Cool water at a temperature below 45 C is flushed through all the endoscope lumens and over the endoscope body to remove major debris. During this stage some EWDs carry out the lumen patency test for blocked lumens. The water quality used for the initial flush is not critical, but should be below 200 mg/l CaCO3. Lumen patency: This stage detects lumen blockages, partial blockages and disconnected lumen connectors. Each manufacturer uses a different system to detect 8

9 blocked or disconnected lumens, but they all should fail the cycle if there is a disconnection, or partial or complete block. Lumen patency checks specified by the manufacturer should be capable of detecting a partial blockage as well as full occlusion. In addition information should be available at the end of the cycle indicating which lumen failed, whether it was blocked or whether a connector tube became detached. Modern EWDs are designed to carry out the lumen patency test throughout the operating cycle; this is to be preferred if available. The EWD manufacturer should state the lumen patency tests specific to their machine with clear instructions. Cleaning: Water and detergent are used to clean the endoscope. Detergents act both as wetting agents in which the reduction of surface tension allows contact with all surfaces and also as a solvent and/or dispersant of soil. They also can degrade soil components, making them more soluble and easier to remove (see Process chemicals for guidance on detergents). Rinsing (optional): Rinsing of the load may be required to remove the cleaning agent before use of a chemical disinfectant, as they may not be compatible. Chemical disinfection: Disinfection is achieved by the action of a microbiocidal chemical solution maintained on the surface (internal and external) to be disinfected at a particular concentration for a set time at a specified temperature. It is important that the disinfectant solution reaches all parts of the endoscope for the correct time to achieve the correct level of disinfection. Therefore all lumens should be flushed with the solution, whether they were used in the clinical procedure or not. A disinfectant from the selection type-tested by the EWD manufacturer should be used (see HTM Op Chapter 4, Process chemicals ). Final rinse: The removal of chemical disinfectant after the disinfection stage is important and should be achieved without compromising the microbial quality of the product. The final rinse should remove any traces of process chemicals to prevent them coming into contact with patient tissue except EWDs that add disinfectants to the final rinse-water that have been validated as compatible with patient safety. Drying: Drying or blowing is an integral part of the cycle, usually by the circulation of air over and through the lumens of the endoscope and may be supplemented by a separate drying cabinet. An alcohol flush at the end of a cycle to aid drying is discouraged, because it is a protein fixative. Whenever an operator suspects that the endoscope may not have been decontaminated properly (e.g. a small area on an endoscope or accessory remains soiled after processing), this will be sufficient to reject the endoscope and accessories. The rejected load should be returned for reprocessing, the User must be informed and the cause of failure be investigated. Documented procedures for reprocessing rejected endoscopes and accessories should be agreed between the User and the AE(D). 9

10 Flexible endoscope decontamination timeline Stage 1 Immediately after a patient procedure has been completed, carry out the bedside clean of the flexible endoscope to the manufacturer s instructions Place the flexible endoscope into the lined tray (or cassette) and cover or seal as per the locally agreed system Stage 2 Transport the endoscope to the decontamination facility without significant delay Stage 3 Carry out a leak test and manual clean procedure, including auxiliary channels, to local policies and procedures Process the endoscope in an EWD no more than 3 hours after the endoscope was used Stage 4 Use the endoscope within 3 hours after removal from the EWD or store in a validated storage system and if not used, return to stage 2. If required to be sterile, dry, pack and sterilise 10

11 4. Essential Quality Requirements (HTM Part A 2016) Endoscopes must always be decontaminated and maintained to a level specified in the EQR as a minimum 4.1 Lumened Endoscopes All endoscopes should be decontaminated according to manufacturer s instructions 4.2 Lumened endoscopes must be reprocessed using a validated automatic process. The process includes all 3 components of decontamination, manual cleaning, automated cleaning and disinfection in a EWD. Risk control is achieved by following verification and validation steps and testing methods as outlined in HTM part D and E 2016 (summarised in this policy). The quality of water used is also important to risk control. (Characteristics are listed in table 3 of HTM0106 Part B 2016) 4.3 Storage and Transport (HTM Part C 2016) Controlled Environment Storage Cabinets and Endoscope Transport (HTM Part C 2016) Some controlled environment storage cabinets operate at an elevated temperature. All cabinets are designed to dry recently processed endoscopes. Cabinets that operate at elevated temperatures will require extra validation tests. Controlled environment storage cabinets should be located either in the clean zone of the endoscope reprocessing area or in a separate clean area close to the endoscopy procedure room (but not in the procedure room itself) (BSG 2016) If endoscopes are hung vertically care should be taken to ensure that the height of the cabinet is sufficient to avoid the distal tip touching or curling up on the floor of the cabinet. The use of pads on the base of the cabinet to protect the tip and collect moisture must NOT be used The drying cabinet should pump filtered air down each endoscope lumen The airflow should be able reach all lumens within the endoscope Lumens with control wires may present a challenge to airflow and will not be easily dried. Therefore such endoscopes should be reprocessed before use The cabinet should pump HEPA-filtered clean air around the stored endoscope body to allow drying of any water droplets, particularly between the control wheels Provision within the cabinet is required for endoscope accessories (for example, control valves). These accessories will need to accompany particular endoscopes for tracking purposes The cabinet should be at a higher pressure than ambient pressure. The air pressure within the cabinet should be at least 5 Pa above the ambient pressure A simple manometer should be provided permanently connected between the inside and outside of the cabinet to demonstrate the relative pressure inside the cabinet specified by the manufacturer Provision should be provided to allow calibration of the in-built manometer from an external transducer The storage cabinet manufacturer at Lymington Endoscopy Department has declared the safe period of endoscope storage (supported by validation data) is 7 days. Once out of the cabinet the scope must be used within 3 hours. A flexible endoscope is a mechanical device; care should be taken to ensure the instrument is not stressed during storage, which could affect its performance The quality of air used to dry and store flexible endoscopes should be of low bacterial count For each endoscope placed into a cabinet, the storage time needs to be recorded and entered into a traceability system so that any incidents can be fully investigated. 11

12 Endoscopes should be recorded in to and out of a cabinet. This activity may be achieved by manual input using a computer keyboard and mouse or by scanning the unique endoscope identification tag. Drying Cabinet tests: Table of daily and weekly tests on cabinets for flexible endoscopes (HTM Part D) Daily and weekly tests a) Check the air pressure within the cabinet using the in-built manometer b) Check door operation and that locks and seals are in good condition c) Check that hangers/brackets/shelving systems are in good condition d) Ensure good cleaning regime is in place for the cabinet e) Check the log book and traceability systems are functioning correctly f) Visually check that all connectors are in good condition g) Visually check that relevant illumination devices within the cabinet are correctly functioning. Optional air quality tests measured against manufacturer s specifications (moisture content, oil content, particulate content) Quarterly tests Carry out daily and weekly tests Check the air pressure within the cabinet using the in-built manometer Check the differential pressure across the HEPA filter Test for airflow through each endoscope lumen Verification of calibration of instruments if thermal control is employed in the process. Carry out alarm function tests (refer to manufacturers spec) Test efficacy of drying function (within the cabinet) Annual and performance tests Carry out daily and weekly tests b- g Check the differential pressure across the HEPA filter Test for airflow through each endoscope lumen Verification of calibration of instruments if thermal control is employed in the process Carry out alarm function tests (refer to manufacturers spec) Check air pressure within the cabinet using in-built monitoring device Check that the cabinet is capable of maintaining the quality of the endoscopes Evaluate airborne microbial contamination Test efficacy of drying function (within the cabinet) Carry out endoscope lumen decontamination test (sterile water) optional test Determine the contamination levels on the inside surfaces of the cabinet. Transport of reprocessed endoscopes should not compromise the cleanliness or bio burden of the device. The transport of soiled endoscopes needs equal care to prevent contamination. When transporting endoscopes they must be transferred in lidded rigid receptacles of appropriate size so as not to contaminate the environment. The receptacle itself should be lined with a single use liner and undergo a separate decontamination process. If transporting endoscopes off site, the inner receptacle must be transported inside a rigid lidded leak proof container. Where endoscopes are reprocessed off site, a system of documentation must be established to record that the user is satisfied it has undergone a satisfactory documented cleaning and disinfection stage as well as passed a visual inspection. 12

13 4.4 Environment and Layout (HTM Part B 2016) Decontamination of re-useable medical devices must take place in appropriate facilities designed to minimise risk. For Essential Standard Requirement (ESR): Ensure workflow within the department is from dirty to clean to avoid the possibility of recontamination of reprocessed endoscopes from surfaces contaminated by unprocessed devices. Manual cleaning should be carried out in a dedicated double basin sink. Carry out decontamination of endoscopes in a dedicated area, with separate dirty, clean and storage areas and separate hand wash sink. The hand washing sink must have liquid soap from a single use cartridge, paper towels, foot operated domestic waste bin, mixer elbow or sensor taps. Within the decontamination area only include the essential equipment required to clean and treat endoscopes Make sure decontaminated endoscopes are stored in a clean environment ideally a drying cabinet Make sure endoscopes are stored securely when the unit is unmanned If possible store chemicals for EWD in a secure chemical cabinet near EWD. Position spill kit near to EWDs but not in same room. Allow sufficient storage for single use items and other spares Use a system for trolleys or other transport devices to keep clean and dirty scopes separate. Surfaces and furnishings must be kept clean, made of impermeable material and easy to clean. Consult the Infection Control Team and AED if you intend to commission a new endoscopy service or change current facilities /throughput and follow guidance in HTM Part B Training (HTM Part C 2016) Staff must be trained in cleaning and decontamination processes and hold appropriate competencies for their role (See Appendix 2). The User (Unit /Departmental Manager) must ensure that personnel at all levels must have a sound knowledge of: a) Decontamination, including some knowledge of: The basic elements of infection control Microbiology Process chemicals (in order to ensure their health and safety obligations). b) How to decontaminate all endoscopes (and endoscope accessories) that they will encounter. They must demonstrate demonstrated competence on those types and models eg assembly and dismantling of scopes, pre-cleaning, manual cleaning, reprocessing accessories and ancillary equipment, disinfection and use of the EWD, drying, transportation storage, tracking/traceability, maintenance, testing and validation Their particular model of EWD. Ensure, adequate and separate training is provided by the manufacturer, either on site or by courses at their premises. Training and competence assessment given to individuals should be recorded in detailed training logs and reviewed by the Departmental/Unit Manager (User) or their appointed deputy at least annually as part of an annual personal development planning (PDP) review 13

14 4.6 Acquisition new service or new equipment If you are responsible for setting up a new endoscopy service, planning to purchase new equipment (eg EWD, drying cabinet, endoscope) or are planning to change the layout of an existing facilities please inform the Infection Control Team and the Authorised Engineer Decontamination AE(D) as soon as possible. Advice will be based on HTM (Part B 2016). 4.7 Maintenance Service and Repair The designated User must ensure all EWDs are subjected to a planned programme of preventive maintenance, as recommended by the manufacturer. The designated User is responsible to ensure records are kept of all testing and maintenance work carried out on an EWD, disinfectant generators, water treatment systems and storage cabinets. This data should be kept with tracking records and form part of the audit trail of the endoscopy department. Records must be kept for the duration of the EWD. The retention period is 11 years after decommissioning of the equipment. Ventilation installation and maintenance must be only carried out by competent persons with a working and up to date knowledge of the requirements within a decontamination environment (BSG 2016). Reprocessed instruments should be inspected to show that they clean and safe for reuse. There should be a planned programme for replacement of endoscopy equipment and decontamination equipment Whenever any work has been carried out on an EWD the User should be satisfied it is fit for use Following major repairs the User and AED should draw up a schedule of checks and tests to be carried out before the EWD is returned to service 4.8 Tracking and Tracing (HTM Part C Operational) Serial numbers of all endoscopes and accessories must be recorded for each patient examined, and endoscopes must be properly tracked throughout their decontamination processes (BSG 2017). Throughout each stage of the decontamination cycle tracking of the personnel and patient associated with each endoscope must be undertaken using a computerised or manual method. Traceability cannot be achieved if the endoscope and its accessories are not uniquely identified. Each step of the decontamination cycle should be recorded, including the name of the person undertaking each step, and this information should be linked to each individual patient examined with that endoscope. The detachable components should be kept with their corresponding endoscope, forming a unique set. A record of the decontamination process should be retained in a log book or on computer database. A procedure for the withdrawal of endoscopes from service should be in place. This should include the management of prion-related incidents or other events that may render the endoscope unfit for purpose (such as damage or failing a leak test). A record of the decontamination process must be recorded in the patient s notes. If a print out from the EWD is used, this must be used in conjunction with a log book if an electronic system is not in place. All endoscopes must have a record of their decontamination status such that they are fit to use on patients. There must be electronic tracking of endoscopes between units and remote facilities (BSG 2016) Yearly the effectiveness of the tracking system should be evaluated by audit. This should consist of tracking a scope from patient to another and what information is carried with it. In addition quarterly flexible endoscope decontamination should be audited using the Infection Prevention Society tool. 14

15 Traceability records should consist of the following: Uniquely identified endoscope and accessories (preferably GS1 system) Manual wash result (pass/fail) including visual inspection, manual leak test and cleaning of valves When required, chemicals used during the manual wash and EWD process EWD used EWD cycle number EWD result (pass/fail) Where required, record of the drying cabinet an endoscope has been stored in Data to show correct operation of the drying cabinet Evidence that the endoscope is fit for use on a patient, eg, checks to see whether all components are present; Compliance to shelf-life requirements; Patient identification; The responsible operator at each operational stage; All data entries dated and time-stamped. 4.9 Water Quality and Water Treatment (HTM Part B 2016) Water is used in a EWD to rinse the scope at various stages in the cycle and as a diluent for chemicals. All EWDs and associated water treatment systems pipework, pumps, water filtration systems) must undergo a self-disinfect cycle at the beginning of each day to prevent biofilm build up. Self disinfection cycles must be recorded eg in a log book The quality of final rinse water should be high as some of the residual water from the re-processed endoscope may be transferred into the patient and should cause no harm. As numerous factors can affect the quality of the water used in the EWD (eg water hardness, temperature, ionic contaminants, microbial contamination; water deposits; bacterial endotoxins) see HTM Part B 2016). HTM Part E 2016) gives details of the maximum levels of specific chemicals and organisms suitable for water. The level of purity is also described in BS EN ISO Please see Appendix 3 of this document on more detail for the User on how to carry out periodic testing. 15

16 4.9.1 Water Hardness Requirements for Water Hardness Table 3 of HTM Part b Application Initial flush Intermediate flush Water for diluting disinfectants and detergents Final rinse water Requirement Hardness less than 200 mg/l CaCO3 Hardness less than 200 mg/l CaCO3 Hardness less than 50 mg/l CaCO3 Hardness less than 50 mg/l CaCO3 TOC(total organic carbon) less than 1 mg/l Conductivity less than 40 μs/cm, unless disinfectant added 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). The criteria and parameter limitations for other contaminants including salts not listed in this Table should accord with the rolling revision of the WHO guidelines for drinking water quality. In light of the use of variable supply quality through the recently established national water grid, it is appropriate for providers to periodically discuss this issue with their water supplier. The water filters in the EWD s should be changed at periods stated by the manufacturer s instructions; however, it may be necessary to change them more frequently if the water quality is poor in the event of a failed water sampling test. Filter changes are carried out either by the Estates department or by external contractors and will form part of the department s planned program of maintenance. Water treatment options - Water used in an EWD should be free of particulate and chemical contamination and of micro-organisms. This can be achieved either by using bacteria-retaining filters or by other methods, for example reverse osmosis. In-line water softeners may be needed if the local supply delivers hard water. The final rinse water should be sampled from the EWD and tested weekly for its microbiological quality in accordance with EN ISO or Health Technical Memorandum (HTM 01-06). Trending of results is advised to identify any potential problems (BSG 2016). If you are considering a new water treatment option or water quality in your existing system is unsatisfactory please consult the Infection Control Team and AE (D) and follow HTM Part B

17 4.9.2 Quality of Final Rinse Water Total Viable Count Final Rinse Water From EWD Bowl or Chamber Aerobic colony count in 100 ml Interpretation/action Colour grade Less than 1 Satisfactory Green 1 9 on a regular basis Acceptable indicates that bacterial numbers are under a reasonable level of control Risk assessment required to investigate potential problems and super-chlorinate or repeat EWD self-disinfect Over 100 Risk assessment required to consider taking EWD out of service until water quality improved Yellow Orange Red Notification will be received by the Endoscopy Unit Manager, Sister, Decontamination Technicians and a member of the Infection Prevention Team from Public Health England (PHE) Food, Water and Environmental Microbiology Laboratory, Porton via each week of the water sample results If the TVC result is unsatisfactory See chart (Fig. 1) overleaf for details on the action which should be taken if the TVC count is above 10 CFU/100ml Unsatisfactory results will be telephoned through to the Endoscopy Unit by laboratory staff at PHE. The Endoscopy Unit staff should contact the IPC Team, AED /Manufacturer if further advice is required. HTM Part E recommends identification of species (particularly check Pseudomonas aeruginosa or atypical Mycobacteria are present) in samples of final rinse water with counts above 10 cfu/100ml. Two negative results must be received following failed water test before the chamber can be put back into clinical us Microbiological results from weekly tests should be monitored for trends (HTM 0106 Part E) 17

18 Figure 1 Management of weekly final rinse water test results. Extra transportation for water sampling may be considered via PHE courier service in order that samples are collected directly from LNFH (rather than UHS) & received by PHE lab in a timely manner. Managerial approval required. User to discuss result with PHE and determine if Pseudomonas aeruginosa and atypical Mycobacteria are present 2 consecutive negative results must be received following failed water test before the chamber can be put back into clinical use. 18

19 4.9.3 Other Water Quality Standards For EWD Final Rinse Water (CFPP01-06 Periodic Testing 2016): Standard Water Hardness Conductivity of final rinse water Endotoxin Water temperature Requirement Hardness less than 50 mg/l CaCO3 TOC less than 1 mg/l Conductivity less than 40 μs/cm, unless disinfectant added Range = µs/cm Resolution =0.1 µs/cm Accuracy = ±1% full scale Should not contain more than 30 endotoxin units/ml Manufacturers will advise on the temperatures required for the detergent and disinfectant at various stages of decontamination Water PH- PH Environmental mycobacteria - Ionic contaminants Deposits from water Total organic carbon (TOC) Legionella and Pseudomonas aeruginosa For EWDs in which the product is rinsed after the disinfection stage there should be no recovery of mycobacteria from 200ml of rinse water Water used in the cleaning and decontamination of flexible endoscopes should have a chloride concentration between 0 and 120mg/l chlorine to avoid the risk of corrosion Should be clear and colour less - If the EWDs self-disinfection cycle is demonstrated to be effective (by TVC monitoring), TOC testing is not required Not usually required unless problem identified by TVC and TOC results See guidance from Department of Health, Health Technical Memorandum Validation and Verification (CFPP01-06 Part D 2016) Performance qualification (PQ) Performance qualification (PQ) is the procedure for obtaining documented evidence that the EWD, as commissioned, will produce cleaned and/or disinfected goods of the standard required when operated in accordance with the operational instructions PQ tests are performed as part of: The initial validation procedure As part of any repeat validation procedure Whenever the User, acting on the advice of the AE(D), judges that new loading or operating conditions require a new PQ test (eg 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 flexible endoscope) PQ should not be undertaken on any EWD until the requirements of the installation and operational tests specified in Table 3 have been met (see 'Commissioning tests'). PQ tests are carried out by the competent Person Decontamination (CP (D) the schedule of tests is given as per table 4 of HTM Testing Methods Manual

20 On completion of this validation process the CP(D) or contractor should prepare a summary report and a validation report containing the results of the commissioning and PQ tests and essential working data. This summary report must be kept securely by the User. The AE(D) should review and countersign the completed validation report. After PQ qualification and initial validation and when the EWD is passed into service, it should be subject to a schedule of periodic tests at daily, weekly and quarterly and yearly intervals according to Table 5 in HTM Part D 2016 (see below). Details on how the User can carry out the test that they are responsible for can be found in Table 3 HTM The annual test schedule is a revalidation procedure. Interrelationship of test programmes Periodic Testing After validation when the EWD is passed into service it should be subject to a schedule of periodic tests at daily, weekly, quarterly and yearly intervals to provide evidence that the EWD continue to operate within the limits established during commissioning. Table 5 HTM Schedule of Periodic Tests Daily tests User or operator 1. Automatic control test 2. Remove and clean strainers and filters Visual checks Inspection of spray arms to check free movement and that all channels are patent Cleanliness of the chamber Filters/strainers are clean The door lock functions (the user should not be able to access the AER whilst in progress) Door seals are in a good state of repair LED display functioning. Weekly tests User or operator, CP(D) or contractor 1. Weekly safety checks-examine the door seal (s) check the security and performance of door interlocks 2. Carry out daily tests 3. Water hardness (all process stages) 20

21 4. Water conductivity (final rinse stage if appropriate) 6. Final rinse-water supply total viable count Quarterly tests CP(D) or contractor 1. Weekly safety checks 2. Weekly tests including automatic control test 3. Verification of calibration 4. Final rinse-water tests: appearance TOC total viable count environmental mycobacteria electrical conductivity water hardness 5. Leak and patency testing: leak test lumen patency detection test lumen disconnection detection test 6. Thermometric tests: chamber wall temperature for the self-disinfection cycle (if used) temperature during routine cycle 7. Cleaning efficacy test 8. Residual protein detection test Yearly and revalidation tests CP(D) or contractor 1. Weekly safety checks 2. All quarterly tests including automatic control test 3. Verification of instruments 4. Final rinse-water system: TOC total viable count environmental mycobacteria volume of water used per stage 5. Drainage: blocked drain protection free draining efficacy of discharge through the trap estimation of dead volume of pipework 6. Venting system: load contamination from ductwork droplet emissions chemical vapour emission 7. Doors and door interlocks: cycle start interlock in-cycle interlock double ended EWDs on sensor failure door opening force failed cycle interlock fault indication on sensor failure 8 Chemical dosing: reproducibly of volume admitted indication of sufficient chemical additives 9 Load carriers 10 Chamber wall temperature for the self disinfection cycle 11 Load carrier temperature during self decontamination 12 Over temperature cut out test 21

22 13 Temperature during routine cycle 14 Verification of calibration 15 Air quality!6 Sound Pressure Failure of a test generally indicates that a EWD is not working to specification and it should be withdrawn from service and the failure investigated (HTM Part D Manual 2016). The AE(D), User and Infection Control Team should agree the course of action to be taken. The User has ultimate responsibility for certifying that the EWD is fit for use TSE VCJD is one of the human prion diseases, a group of invariably fatal neurological disorders also known as transmissible spongiform encephalopathies (TSE).The normal prion protein PrP c undergoes a change in conformation to become an abnormally folded form of the protein known as PrP Sc during the course of the disease. PrP Sc is heat stable and exceptionally resistant to enzymatic digestion and once dried onto surfaces of endoscopes, it is very difficult to remove or inactivate. The sporadic form of CJD affects approximately 1 person per million per year worldwide. Variant CJD (vcjd) is an acquired form of CJD that was first reported in It exhibits a unique neuropathological phenotype (15) and affects mainly young adults. The incubation period for VCJD could be as long as 30 years (BSG 2016).Invasive procedures such as endoscopy with biopsy have the potential to transmit the disease from affected asymptomatic individuals in the incubation phase. The differing distribution of the PrPSc in the body in sporadic and vcjd reflects their different pathogenesis. In sporadic CJD, prion infectivity is largely limited to the CNS and retina (so gastrointestinal endoscopy is not considered a vector for transmission of sporadic CJD. By contrast in VCJD the lymphoreticular system throughout the body contains PrPSc and may contain significant levels of infectivity during the incubation period (BSG 2016). Guidance regarding TSEs and endoscopy is available from Advisory Committee Dangerous Pathogens (ACDP) TSE Subgroup s Annex F Endoscopy Last revised Oct 2015) which is available on: 2/ACDP_TSE_Annex_F_Oct_2015.pdf Summary of Classification of vcjd risk relevant to GI Endoscopic Practice (BSG 2016) Type and status of vcjd diagnosis Management of the endoscope 1. vcjd diagnosis confirmed Destroy or decontaminate and store in quarantine for use on the same patient 2. Symptoms of CJD but awaiting Decontaminate and store in quarantine. If diagnosis vcjd confirmed manage as 1. above 3. Asymptomatic patients at increased Destroy or decontaminate and store in risk through receipt of labile blood quarantine for use on the same patient components (whole blood, red cells, white cells or platelets) from a donor who later developed vcjd. Presumed infected 4. Asymptomatic patients at increased Decontaminate and reuse risk for public health purposes (e.g. plasma product recipients) For details about the different types of at increased risk classification see the 22