Reprocessing of Intra-Cavity Ultrasound Transducers

GUIDELINE Reprocessing of Intra-Cavity Ultrasound Transducers

This guideline describes the minimum recommended requirements for reprocessing Intra-cavity Ultrasound Transducers in Queensland Health facilities. General Requirements Overview QH-GDL-321-2-1:2013 Intra-cavity Ultrasound Transducers must be reprocessed in accordance with manufacturer s instructions with particular attention given to: cleaning detergents and chemical disinfectants Immersion levels and times. Only purchase medical devices and high level (disinfectants) entered in the Australian Register of Therapeutic Goods by the Therapeutic Goods Administration (TGA). Disinfectants shall have written approval from the specific device manufacturer regarding suitability for use and reprocessing instructions. A copy of the written approval from the medical device manufacturer for the use of a new disinfectant shall be obtained. Workplace Health and Safety regulations in relation to personal protective equipment (gloves, mask, eye protection and gown), exhaust systems and handling/storage of chemical shall be adhered to. Refer to: Occupational Health and Safety Policy Personal Protective Equipment http://www.health.qld.gov.au/qhpolicy/docs/ptl/qh-ptl-275-16-1.pdf Occupational Health and Safety Policy Hazardous Chemicals Safety Management http://www.health.qld.gov.au/qhpolicy/docs/imp/qh-imp-275-3.pdf If sterilization is not possible, high level disinfection is a minimum requirement. Procurement Queensland Health Hospital and Health Services shall purchase transducers (new or replacement) from the Queensland Health Bulk Purchase Agreement. High level disinfection units are available via the Queensland Health Central Sterilizing Department (CSD) Total Solutions Panel Arrangement PL003-1 (The Panel). Quality Control Each individual Queensland Health Hospital and Health Service is responsible for the appropriate reprocessing of intra-cavity ultrasound transducers and a preventative maintenance program. Recommended approved chemicals for high level disinfection need to be approved by the medical device manufacturer. The choice of chemical will be determined by: transducer manufacture s reprocessing instructions type of transducers used in the facility available reprocessing options and capacity of the facility. The decision to centralise transducer reprocessing at the facility s CSD, or reprocess at the point of use is to be considered. To assist facilities to adopt the recommendations of this guideline, an implementation checklist has been provided (Appendix 1). Page 1 of 18

QH-GDL-321-2-1:2013 A reprocessing audit shall be performed annually and as otherwise required by the facility (Appendix 2 Reprocessing Audit Tool). In the event of a failed cycle (automated reprocessor), the transducer shall not be used on any patient until it has undergone a successful high level disinfection cycle. Every transducer shall be reprocessed before release for use on a patient. Intra-cavity ultrasound transducer reprocessing breaches shall be reported via PRIME as per Queensland Health Patient Safety Health Service Directive, available from: http://www.health.qld.gov.au/directives/docs/hsd/qh-hsd-032.pdf. Any transducer or reprocessor faults/damage shall be reported immediately and the transducer or reprocessor removed from circulation. Reprocessing cycle records shall be maintained in each Queensland Health facility, to link reprocessed transducers to individual patients for recall investigations. These records can be manual or electronic and shall be retained in line with Queensland Government Health Sector (Clinical Records) Retention and Disposal Schedule, available from: http://www.archives.qld.gov.au/recordkeeping/grkdownloads/documents/health_sector _clinical_records_retention_and_disposal_scheduleqdan683v1.pdf. Patient details can be included on reprocessing log sheet, or a batch label type sticker system can be used to enter in patients medical records. Minimum record keeping includes: o transducer identification number o method of disinfection o disinfection cycle or load number o date of reprocessing o name and signature of the person releasing the transducer for reuse. Point of Use There indicated, the transducer is to be completely covered with a single use disposable sheath/probe cover before use. The sheath/probe cover shall fully cover the probe, minimising the risk of rupture by over stretching. Although the use of a disposable cover reduces the level of risk of transmission of infection or contamination, covers can be perforated or contain small, unrecognised defects 1, they shall not be used as a substitute for cleaning, disinfection or sterilization procedures. At the end of the procedure, using a gloved hand, the disposable cover should be removed and discarded, taking care not to contaminate the surface of the transducer 1. Remove the transducer from the ultrasound console. Remove all gel and body fluids from the transducer if a delay in reprocessing is predicted. The contaminated transducer must be contained for transportation to the reprocessing area. This can be either a sealed rigid container if reprocessing is conducted external to the clinical area, or a clean plastic bag for reprocessing in the clinical area. This is to prevent damage to the transducer and minimise risk of staff exposure to body fluids. The transducer shall be reprocessed as soon as possible after use. Reprocessing Personal protective equipment (PPE) appropriate for cleaning and disinfection of medical devices shall be worn during reprocessing. Page 2 of 18

Rigid containers shall be cleaned between uses, i.e. washed in detergent and water and dried. Each disinfected transducer shall have identifying documentation for reprocessing attached to assure the end user that appropriate methods have been followed. Reprocessing Unit The reprocessing unit shall be used in line with manufacturer s instructions, including: documented, validated and reproducible process that is regularly evaluated documented maintenance of the unit in line with manufacturer s instructions. Handling and Storage The shelf life of the reprocessed transducer is not compromised if storage conditions comply with AS/NZS 4187, reprocessing documentation is present and the disinfected transducer has not been tampered with. QH-GDL-321-2-1:2013 The disinfected transducer is to be placed in a rigid container or clean plastic bag for transportation to the designated clean transducer storage area. Plastic bags are single use only and must be discarded after each use. Service Planning Facilities that are planning to use intra-cavity transducer shall consider the following: transducer inventory levels required to meet service requirements and agreed turnaround times CSD workload implications reprocessing method number and types of reprocessors required transportation methods storage and handling requirements Clinical Equipment Purchase Checklist, available from: http://www.health.qld.gov.au/chrisp/sterilising/equip_purchase_ch.pdf. Page 3 of 18

QH-GDL-321-2-1:2013 Glossary of Terms Term Cleaning Disinfectant Healthcare Associated Infection (HAI) High level disinfection Sterilization Transducer TOE Definition / Explanation / Details The removal of soil and a reduction in the number of micro-organisms from a surface, by a process such as washing with detergent solution without prior processing. The inactivation of non-sporing organisms using either heat or water (thermal) or by chemical means. Infections that are acquired in healthcare facilities or that occur as a result of healthcare interventions. The minimum level used to effect disinfection of semi-critical instruments which contact unbroken mucous membranes that are not normally sterile. Validated process used to render a product free of all forms of viable microorganisms. Also known as probe. The removable working component of the ultrasound system that has direct contact with the patient. A trans-oesophageal echocardiogram (TOE) is an alternative way to perform an echocardiogram. A specialized probe containing an ultrasound transducer at its tip is passed into the patient's oesophagus. This allows image and Doppler evaluation which can be recorded. References 1. Australasian Society for Ultrasound in Medicine. Statement on the Disinfection of Transducers [Internet]. 2012 [cited 2013 Sep 6]. Available from: http://www.asum.com.au/newsite/files/documents/policies/ps/b2_policy.pdf&sa=u& ei=dzepuqixbcsulqwmiihacq&ved=0cb4qfjaa&usg=afqjcnhfa8g- D0aTfICgDrKmTjo1Vz-Law 2. AS/NZ 4187 3. Taylor, A., Jones, D., Everts, R., Cowen, A., Wardle, E. Infection Control in Endoscopy. 3rd ed. Sydney: Gastroenterological Society of Australia; 2010 Page 4 of 18

QH-GDL-321-2-1:2013 Document Custodian Director Approving Officer Dr Jeannette Young Acting Deputy Director-General Approval Date 20 September 2013 Revision History Version Number Date of Issue Date of Next Revision QH-GDL-321-2-1:2012 Superceded QH-GDL-321-2-1:2013 20/09/2013 20/09/2016 Page 5 of 18

QH-GDL-321-2-1:2013 Appendix 1 Implementation Checklist This implementation checklist is intended to be used to assist in your facility s adoption of the Guideline for the Reprocessing of Intra-Cavity Ultrasound Transducers. In order to use this tool appropriately: Review the Guideline for the Reprocessing of Intra-Cavity Ultrasound Transducers Utilise the implementation checklist to assist in identifying whether or not your facility meets the recommendations of the guideline: o o o Place a in the box for each compliant criterion. If criteria are not applicable to your facility indicate this in the action required column. If criteria have not been met, identify the actions required to meet the criteria and indicate the responsible individual. Table and minute the completed checklist and associated actions in the minutes of the Infection Control Committee (or equivalent). Page 6 of 18

QH-GDL-321-2-1:2013 -: September 2013 IMPLEMENTATION CHECKLIST REPROCESSING OF INTRA-CAVITY ULTRASOUND TRANSDUCERS CRITERIA COMPLIANT Yes No ACTION REQUIRED BY WHOM 1. ASSESSMENT OF FACILITY / HOSPITAL HEALTH SERVICES (HHS) IMPLICATIONS Has the facility determined the location of all departments currently using, or planning to use, intra-cavity ultrasound probes? Have all users been advised of the recommendations of the Queensland Health Reprocessing Intra-cavity Ultrasound Transducer Guideline? Does each department have sufficient capacity to accommodate the reprocessing of their own inventory of intra-cavity ultrasound probes? Does the facility CSD have sufficient capacity to accommodate the reprocessing of intra-cavity ultrasound probes? Has the facility / HHS executive endorsed a reprocessing strategy that: Meets the auditable recommendations of this guideline Considers the clinical service requirements and turnaround times Considers the costs associated with consumables Incorporates Facility or HHS Infection Control Committee 2. TRANSPORT OF TRANSDUCERS Are designated puncture proof and leak resistant containers available for the transport of transducers to and from the reprocessing area? 3. REPROCESSING OF TRANSDUCERS Are all intra-cavity ultrasound transducers used within the facility reprocessed to the appropriate level (either sterile or high level disinfection)? All staff responsible for the reprocessing of intra-cavity ultrasound transducers have undergone training and competency assessment Page 7 of 18

QH-GDL-321-2-1:2013 -: September 2013 IMPLEMENTATION CHECKLIST REPROCESSING OF INTRA-CAVITY ULTRASOUND TRANSDUCERS CRITERIA COMPLIANT Yes No ACTION REQUIRED BY WHOM The manufacturer s instructions are available for each transducer used in the facility. The manufacturer s instructions are available for the disinfectant and/or reprocessor used in the facility. Are Occupational Health and Safety requirements met for PPE, chemical storage, handling and waste disposal, extractor fans etc.? Does the facility have documented instructions for the reprocessing of intra-cavity ultrasound transducers? 4. STORAGE OF TRANSDUCERS Are specific storage cupboards available for transducers to be hung (if applicable)? Is there a documented process available for identification of individual transducer and reprocessing details that remains with transducer until used? Page 8 of 18

QH-GDL-321-2-1:2013 -: September 2013 Appendix 2 Intra-cavity Ultrasound Transducer Reprocessing Audit Tool This audit tool is intended to be used to check that the reprocessing of intra-cavity ultrasonic transducers is being performed in accordance with the Queensland Health Guideline for the Reprocessing of Intra-cavity Ultrasound Transducers. In order to use this tool appropriately: Review the audit tool and schedule the audit Determine when the audit will be conducted (ideally at least annually, or if major changes are made in the personnel or equipment used for reprocessing) Conduct the audit o o o Place a in the box for each compliant criterion. If criteria are not applicable to your facility indicate this in the risk rating & actions required column At the end of each section or subsection tally the scores for the applicable criteria Adequate (100%) Requires Improvement (70 99%) Inadequate (<70%) No Action Required Assess the Risk Conduct a risk assessment using your Organisation s Risk Management Process (Queensland Health Risk Management) and document the risk rating Communication of the audit outcome Table the completed audit document at the relevant committees within your facility (e.g. departmental committee and the infection control committee) Develop an Action Plan Identify an Action Plan for each non-compliant Criterion. This should include: Identification of Strategies to meet the criterion Identification of the person responsible for implementing the strategies, and the reaudit date Communication of Action Plan Table the completed audit document and action plan at the relevant committees within your facility (e.g. departmental committee and the infection control committee), and then provide these committees with progress reports as required. Reaudit in 12 months or sooner if required by your Action Plan Page 9 of 18

QH-GDL-321-2-1:2013 Version -: September 2: September 2013 2013 INTRA-CAVITY ULTRASOUND TRANSDUCER REPROCESSING AUDIT CRITERIA RISK RATING & ACTIONS REQUIRED 1. OPERATIONS 1.1 Transducer decontamination and disinfection is undertaken or supervised by a dedicated person(s) with a recognised qualification or training 1.1.1 Staff have access to relevant documentation: AS/NZS4187 Australasian Society for Ultrasound in Medicine (ASUM) Statement on the Disinfection of Transducers. Queensland Health Disinfection and Sterilization Infection Control Guidelines Queensland Health Guideline for Reprocessing of Intracavity Ultrasonic Transducers Manufacturer s Instruction Manual for each type of intracavity ultrasonic transducer reprocessed 1.2 Transducer cleaning is undertaken immediately after the transducer is used 1.2.1 Appropriate PPE is worn. 1.2.2 Work areas are well ventilated and include at least one sink which is designated dirty 1.2.3 Appropriate detergents are used 1.2.4 Detergent and water dilution is measured to ensure correct dilution as per manufacturer s instructions 1.2.5 Submersion level of each individual transducer must be identified before decontamination commences 1.2.6 Detergent is left in contact with the transducer surfaces for manufacturer s specified time 1.2.7 Appropriate cleaning equipment is used e.g. soft, lint free cloths, soft bristle brush REVIEW DATE BY WHOM Centre Centre for Healthcare for Healthcare Related Related Infection Infection Surveillance Surveillance and and Prevention Prevention & Tuberculosis Control Page 10 of 18 Page 6 of 9

QH-GDL-321-2-1:2013 Version -: September 2: September 2013 2013 INTRA-CAVITY ULTRASOUND TRANSDUCER REPROCESSING AUDIT 1. OPERATIONS 1.2.8 All surfaces of the transducer are cleaned CRITERIA RISK RATING & ACTIONS REQUIRED 1.2.9 Clean running water is used for rinsing to ensure all debris and detergents are removed prior to disinfection 1.3 When chemical disinfection of transducers is undertaken: REVIEW DATE BY WHOM 1.3.1 Disinfectant manufacturer s instructions are followed 1.3.2 The submersion level for each individual transducer must be identified before disinfection 1.3.3 Machines which contain a tank of disinfectant for re-use are monitored for disinfection concentration daily (each cycle for OPA) 1.3.4 A maintenance schedule which includes tanks, pipes, strainers and filters of both the fume cabinet are available 1.4 When automated transducer disinfection (probe reprocessor) or automated flexible endoscope reprocessors (AFER) are utilised 1.4.1 Staff operating automated reprocessor are trained and competent in use 1.4.2 Manufacturer s Instruction are followed for each disinfection cycle and for maintenance/repairs processes 1.5 Intra-cavity Ultrasonic transducers are stored in either: 1.5.1 Designated tray/container, suitable for transporting the transducer. These can be in work trolleys Centre Centre for Healthcare for Healthcare Related Related Infection Infection Surveillance Surveillance and and Prevention Prevention & Tuberculosis Control Page 11 of 18 Page 6 of 9

QH-GDL-321-2-1:2013 Version -: September 2: September 2013 2013 INTRA-CAVITY ULTRASOUND TRANSDUCER REPROCESSING AUDIT CRITERIA RISK RATING & ACTIONS REQUIRED 1. OPERATIONS 1.5.2 Designated cupboard for handing (TOE probes) REVIEW DATE BY WHOM ADEQUATE (100%) REQUIRES IMPROVEMENT (>70%) INADEQUATE (<70%) Centre Centre for Healthcare for Healthcare Related Related Infection Infection Surveillance Surveillance and and Prevention Prevention & Tuberculosis Control Page 12 of 18 Page 6 of 9

QH-GDL-321-2-1:2013 Version -: September 2: September 2013 2013 INTRA-CAVITY ULTRASONIC TRANSDUCER REPROCESSING AUDIT CRITERIA 2. QUALITY ASSURANCE 2.1 Records are kept and shall include, but are not limited to the following: 2.1.1 Every intra-cavity transducer reprocessed including: date of procedure, patient details, instrument details, cycle/load number 2.1.2 Name of person who reprocessed the transducer 2.1.3 Batch number of biocide, date biocide was decanted into tank and date biocide changed (if applicable) 2.1.4 A unit based record is kept regardless of the information contained in the patient health care record 2.1.5 Computer print-outs from an AFER are attached to the unit record 2.1.6 Validation of process 2.2 Microbiological testing of AFER (if applicable) are routinely performed 2.2.1 AFERs are monitored every four (4) weeks 2.2.2 Low temperature gas plasma sterilizers are monitored as per AS/NZ 4187 2.2.3 Transducer reprocessors are monitored as per manufacturer s instructions ADEQUATE (100%) REQUIRES IMPROVEMENT (>70%) RISK RATING & ACTIONS REQUIRED REVIEW DATE INADEQUATE (<70%) BY WHOM Centre Centre for Healthcare for Healthcare Related Related Infection Infection Surveillance Surveillance and and Prevention Prevention & Tuberculosis Control Page 13 of 18 Page 6 of 9

QH-GDL-321-2-1:2013 Version -: September 2: September 2013 2013 INTRA-CAVITY ULTRASONIC TRANSDUCER REPROCESSING AUDIT CRITERIA RISK RATING & ACTIONS REQUIRED 3. EDUCATION 3.1. Manager and staff are educated on how to reprocess transducers when: 3.1.1. First employed 3.1.2. Updated annually 3.1.3. Any change in process 3.1.4. New reprocessing equipment purchased 3.1.5. New medical equipment / devices requiring reprocessing are purchased REVIEW DATE BY WHOM ADEQUATE (100%) REQUIRES IMPROVEMENT (>70%) INADEQUATE (<70%) Centre Centre for Healthcare for Healthcare Related Related Infection Infection Surveillance Surveillance and and Prevention Prevention & Tuberculosis Control Page 14 of 18 Page 6 of 9

QH-GDL-321-2-1:2013 Version -: September 2: September 2013 2013 INTRA-CAVITY ULTRASONIC TRANSDUCER REPROCESSING AUDIT CRITERIA RISK RATING & ACTIONS REQUIRED 4.MANAGEMENT 4.1 Standard Precautions and Workplace Health and Safety protocols are applied during all stages of cleaning and reprocessing of transducers 4.2 Items designated to be reprocessed are processed to a level for their intended use 4.3 Manufacturer s instructions are provided and available for staff who clean and reprocess transducers, associated equipment 4.4 Safety Data Sheets (SDS) are available for all cleaning agents and chemicals SDS have been read and understood by staff prior to initial use 4.5 Processes are in place to notify the Unit Manager or shift coordinator of all faults with o transducer reprocessing and o AFER/probe reprocessor (if applicable) 4.6 Incidents relating to the reprocessing of transducers are reported, risk rated and actioned Unit is provided with a summary of incidents regularly (e.g. via PRIME or relevant local committee) 4.7 There is a record available to subsequent users of the stored transducers indicating the date and time they were last reprocessed e.g. batch label 4.8 There is evidence of documented maintenance program for transducers and reprocessing equipment, including annual performance qualification (if applicable) Comments: ADEQUATE (100%) REQUIRES IMPROVEMENT (>70%) REVIEW DATE INADEQUATE (<70%) BY WHOM Centre Centre for Healthcare for Healthcare Related Related Infection Infection Surveillance Surveillance and and Prevention Prevention & Tuberculosis Control Page 15 of 18 Page 6 of 9

QH-GDL-321-2-1:2013 Version -: September 2: September 2013 2013 Appendix 3 Intra-cavity Ultrasound Transducer: FACILITY: Proof of process for Biocide High Level Disinfection DEPARTMENT: Date Scope Number/ Item Cleaned by Rinsed by Biocide Final Rinse by Patient Name Medical Records No. Order on List Batch no. Expiry date Date 1st Use Immerse Time Temp Sign Centre Centre for Healthcare for Healthcare Related Related Infection Infection Surveillance Surveillance and and Prevention Prevention & Tuberculosis Control Page 16 of 18 Page 6 of 9

QH-GDL-321-2-1:2013 Version -: September 2: September 2013 2013 Intra-cavity Ultrasound Transducer: Proof of Process for Automated Transducer Disinfection FACILITY: DEPARTMENT: REPROCESSOR UNIT No.: Date Transducer Serial No. Cleaned by: Reprocessor cycle No. Name of operator in: Pass/Fail Name of operator out: Patient Details Centre Centre for Healthcare for Healthcare Related Related Infection Infection Surveillance Surveillance and and Prevention Prevention & Tuberculosis Control Page 17 of 18 Page 6 of 9

QH-GDL-321-2-1:2013 -: September 2013 Appendix 4 EXAMPLE - Automated Transducer Reprocessor Training Competency Name: Payroll No.: Facility: Date: Trainer/Assessor: Task 1. Turning machine on/off 2. Setting date 3. Setting time 4. Use of the electronic menu 5. Use of PPE 6. Handling and storage of chemical disinfectant 7. Loading of disinfectant into reprocessor 8. Unloading of used disinfectant from reprocessor 9. Chemical indicator loading (if applicable) 10. Recognising chemical indicator pass/fail 11. Loading of transducer 12. Commencing cycle 13. Removal of transducer 14. Documentation for quality control and tracking 15. Other specific requirements for reprocessor (if applicable) 16. Testing cycles (if applicable) 17. Cleaning regime of reprocessor 18. Transporting reprocessor 19. Contact number for problems/servicing Completed COMPETENT NOT YET COMPETENT Trainee sign: Trainer/Assessor sign: Centre for Centre Healthcare for Healthcare Related Related Infection Infection Surveillance Surveillance and Prevention and Prevention & Tuberculosis Control Page 18 of 18