Centre for Healthcare Related Infection Surveillance and Prevention & Tuberculosis Control. Guideline. Management of Instrument Loan Sets

Transcription

1 Guideline Management of Instrument Loan Sets

2 Guideline Management of Loan Set Instruments Published by the Sate of Queensland (Queensland Health), July, 2013 This document is licensed under a Creative Commons Attribution 3.0 Australia licence. To view a copy of this licence, visit creativecommons.org/licenses/by/3.0/au State of Queensland (Queensland Health) 2013 Page 2 of 21

3 Table of Contents Introduction... 4 Objectives... 4 Risks... 4 Responsibilities... 5 Role of Facilities... 5 Management/Surgical Services... 5 Implementation considerations include:... 5 Education and training... 6 Loan Set coordinator/central ordering group... 6 Before use: Central Sterilizing Department responsibilities... 7 During use: Operating Rooms... 7 After use- Central Sterilizing Department responsibilities... 8 Role of medical industry... 8 URL links Bibliography References Revision History Document Custodian Approving Officer Approval Date Attachment Loan Set Decision Table Attachment Loan Set Usage Report Attachment Loan Set Management Checklist Attachment Decision Flowchart for Incomplete Loan Sets Attachment Decision Flowchart for Contaminated Loan Sets Attachment Decision Flowchart for Inadequate Reprocessing Instructions Attachment Decontamination Declaration Form (Green Form) Attachment Reprocessing Instruction Page 3 of 21

4 Introduction This guideline provides recommendations regarding best practice for the management of specialised instrumentation supplied by medical industry for use in surgical procedures undertaken on behalf of Queensland Health. In recent years the cutting edge of orthopaedic and other speciality surgery has seen improvements in patient outcomes through less invasive techniques and the application of new technologies. Consequently there have been rapid changes in instrumentation, implantable components and transport configuration. The management of loan equipment or loan sets, in the perioperative environment is a common event due to complex surgical requirements, in an era of rapidly changing surgical instrumentation and technology 1. Objectives The purpose of implementing a documented and managed loan set process is to ensure loan instruments are: appropriate for the patient and the procedure available in the operating room at the correct time free from contamination provided in optimum working condition returned to the provider, cleaned and terminally disinfected in a timely manner a cost effective strategy for the surgical and orthopaedic service managed by staff who are adequately trained in reprocessing loan sets packaged and transported in a way that prevents damage to the instruments meeting the manual handling requirements of the Workplace Health and Safety Regulation Risks Risks associated with utilising loan sets include: Patient safety and the transmission of infection from contamination with foreign material due to: - local priority reprocessing instruction not being followed - late delivery of loan sets leading to non-recommended flash sterilization - inadequate time frame for reprocessing due to the workload of the Central Sterilizing Department (CSD) - sterilized instrument contaminated due to inadequate disassembly and cleaning of complex instruments - inadequate instructions for work processes and training by Medical Industry to operating room and CSD staff in the use and reprocessing of loan sets. Cancellation, delay or prolonged surgical procedures related to: - loan set not being ordered - loan set not delivered - missing implants - untimely delivery of loan sets - medical industry unable to undertake their quality management processes as loan sets are delivered directly from one facility to another facility - damaged/incorrect or missing instruments on a tray rendering the loan set unusable Page 4 of 21

5 - incorrect check list (i.e. instrument count inaccurate) provided by medical industry. Financial risks associated with utilisation of loan sets within a facility: - inappropriate ordering practices - budget overrun due to the introduction of new procedures utilising unevaluated loan sets and prostheses - replacement costs associated with damage to instruments caused by reprocessing with mixed grade metals instruments - Workcover and civil litigation claims related to the manual handling injuries - application of a surcharge resulting from orders placed in less than 48 hours - loan sets ordered and not used - consideration not given to consignment arrangements for frequently used loan sets. Responsibilities Role of Facilities Management/Surgical Services In order to facilitate decision making processes regarding the use of loan sets the following business case criteria are to be considered: (refer attachment 1 Loan Set Decision Table for further information) Surgical services to be provided - range and volume of surgical procedures being performed - credentialing/scope of practice of surgeons & tenure of Visiting Medical Officer - surgeon preference. Loan sets identified for hire have been formally evaluated and deemed fit for purpose by referring to the Schedule of Particulars as part of the Queensland Health Standing Offer Arrangements 13 (SOA 13) & 705 (SOA 705) Identification of key stakeholders; determining roles and responsibilities Identification of financial and resource impacts, for example: - funding for surgical service and hiring of loan sets - human and material resource requirements - financial delegation for the ordering of loan sets - education of surgeons and others in relation to the process involved in the management of loan sets - CSD s capacity to accommodate the volume, complexity, storage and resources required for reprocessing loan sets in accordance with AS/NZS 4187:2003 Cleaning disinfecting and sterilising reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities (AS/NZS 4187). Utilise the Loan Set Usage Report (refer Attachment 2 Loan Set Usage Report) and table at the relevant committee e.g. Surgical Services Departmental meetings, Clinical Product Committee, Hospital and Health Service (HHS) Quality and Safety Committee. Implementation considerations include: Queensland Health SOA 13, Standing Offer Arrangement for Hip, Knee & Shoulder Arthroplasty Implants & Accessories covers major hip, knee and shoulder loan set implants and instruments Page 5 of 21

6 Establish and maintain a structured process for any new Loan Sets. - All items contained in new Loan Sets must be entered on the Australian Register of Therapeutic Goods (ARTG). Relevant Medical Industry must be informed that the facility is implementing the CHRISP&TB Guideline for the Management of Loan sets Service agreements are in place whereby commitments made by both the provider and end user can be monitored and evaluated Service agreements which include legal liabilities and communications on the use of loan instruments are to be agreed upon before the instruments are loaned (refer to local contract hubs for assistance) Ensure all relevant Manufacturer Instructions, tray lists and graphic photographs for cleaning and sterilizing instrumentation are available to all staff. Implement the Loan Set Management Checklist (refer Attachment 3 Loan Set Management Checklist) for ordering, reprocessing and recording of used product. Establish and maintain communication between the areas that are involved in the management of loan sets including; - elective bookings - surgical team including the departments business manager - operating suite and CSD - supply services. Education and training All staff involved in the ordering, receipt, checking, reprocessing and use of loan sets are to receive appropriate training Develop an education and training program for new procedures, techniques and instrumentation for the Operating Suite and CSD when new loan sets are introduced to the facility Include the requirements of Manual Handling of Surgical Loan Sets a process for risk management in all staff education and training. Loan Set coordinator/central ordering group All facilities are to have a central booking system/group responsible for the ordering and management of loan sets. (This does not preclude surgeons from ordering loan sets but requires a communication process to be in place with the rest of the team) Consideration is to be given to the allocation of designated staff to manage loan sets Patients are to be assessed as close to the date of surgery to determine loan set requirements Loan sets for elective surgery MUST arrive onsite a minimum of 24 hours prior to surgery There is to be a designated central point for the delivery of loan sets. The delivery point shall be a secure enclosed area to maintain integrity of prosthetics and instruments Appropriate manual handling equipment for the lifting and movement of loan set trays is easily accessible. Utilise the Loan Set Management Checklist (refer Attachment 3) to ensure all the checks and balances for loan sets have been documented. A copy of this checklist must also be provided to the courier upon dispatch The loan set instruments (and implants if applicable) are to be checked in by the Loan Set Coordinator at the time of delivery ensuring: - The order is correct and trays are complete Page 6 of 21

7 - Two copies of the tray lists, which identify contents with written and photographic or graphic outline are included with delivery - Discrepancies are to be reported to the provider immediately (refer Attachment 4 - Decision Flowchart for Incomplete Loan Sets) when incomplete loan sets are received - Ensure appropriate reporting and documentation of incomplete loan sets is completed through: Clinical Incident Management System (PRIME) TGA for Medical Device Adverse Event Clinical Resource manager &/or SOA Manager as per local product complaint process. Before use: Central Sterilizing Department responsibilities The loan set instruments are to be checked prior to the reprocessing to confirm the contents are correct and all appropriate documentation is present (i.e. tray list) (refer Attachment 5 Decision Flowchart for Contaminated Loan Sets) - Ensure appropriate reporting and documentation of contaminated loan sets is completed through: PRIME TGA for Medical Device Adverse Event Clinical Resource manager &/or SOA Manager as per local product complaint process. Multi-component instruments are disassembled, checked and appropriately cleaned. (refer Attachment 6 Decision Flowchart for Inadequate Reprocessing Instructions) - Ensure appropriate reporting and documentation of contaminated loan sets is completed through: PRIME TGA for Medical Device Adverse Event Clinical Resource manager &/or SOA Manager as per local product complaint process. Ensure all electrical loan equipment has a safety and function test in accordance with manufacturer s instructions, performed prior to its use on/for a patient 1 Instrument trays are to be reprocessed in accordance with AS/NZS 4187 and manufacturers instructions Ensure the loan sets are delivered to the Operating Rooms (OR) with all documentation i.e. tray lists, sterilization records. During use: Operating Rooms OR staff are to check the instrumentation prior to the surgical procedure to confirm the contents of the loan set are correct and all appropriate documentation is present i.e. tray list, sterilization record Ensure all instruments are documented in OR count by using the loan set tray lists Record all used implants and associated consumable items such as saw blades, guide wires and other single use items, in the patient record Remove gross soil from instruments during the time of surgery Handle instruments with care to maintain their integrity Any damaged instruments or those requiring repair are to be labelled and reported to the shift supervisor. Instruments damaged as a result of improper use may incur a cost Instruments are returned to the CSD as soon as the procedure is completed. Page 7 of 21

8 After use- Central Sterilizing Department responsibilities Cleaning of loan set instruments is to be a priority task within CSD Multi-component instruments are disassembled and appropriately cleaned Any damaged instruments or those requiring repair are to be labelled and reported to the company immediately using the company contact details on the Decontamination Declaration Form (refer Attachment 7 Decontamination Declaration Form, formerly know as Green Form) The instruments are cleaned, thermally disinfected and dried prior to loading the transport cases. If instruments cannot be thermally disinfected e.g. due to manually washing or the facility washer disinfector does not have a print out feature, the instruments will have to be cleaned and sterilized prior to dispatch Package instruments in an orderly manner in the original containers for return to the provider Complete the Decontamination Declaration Form (refer attachment 7) to identify the cleaning, disinfection and (if applicable) sterilising process on completion of the procedure. Attach a copy of the Form to the transport cases prior to dispatch Notify medical industry should any instrument be difficult to clean or to reprocess 1 Ensure the instruments are checked out of the health care facility against the original inventory, to ascertain all equipment is accounted for and that any used or damaged equipment is reported to medical industry 1 Notify the company when the loan set is ready for dispatch Consideration shall be given to couriers and vendors in relation to: - occupational health and safety issues during the lifting and transporting of loan set instruments; and - infection control issues if loan sets are still contaminated during transportation. Role of medical industry Medical industry plays an integral role in the management of loan sets. The following points have been prepared in consultation with Medical Industry and are to be included when developing service agreements: Instruments provided in loan sets should comply with the specifications of Queensland Health Standing Offer Arrangement 705 ARTG certificates for all equipment/prosthesis contained in the loan sets Superseded instruments shall be decommissioned and replaced There should be sufficient inventory to meet demand without reducing delivery time. Receive a Purchase Order Number from facility prior to the dispatch of the Loan Set Provide assurance that the instruments supplied in the loan set are clean, functional and in optimal working order Ensure that the instrument trays are designed and loaded so that they weigh no more than 5 7 kg each 1 - in the event that the instrument tray exceeds this weight it shall be labelled to alert staff handling the instrument case 1 - avoid over-filling of transport cases. 1 Provide transport cases that: - are portable on wheels (where weight of the loan set including the transport case is greater than 10kg) - provide access for staff to remove heavy trays from horizontal layered cases without the need to bend and with minimal forces - are delivered in a clean and well maintained state Page 8 of 21

9 - can be moved and handled with available lifting equipment. Provide Manufacturer Instructions for cleaning and sterilizing of instruments in accordance to AS/NZS 4187 (refer Attachment 8 Reprocessing Instruction) Ensure that the medical industry reprocessing instruction (Refer Attachment 8), tray lists and graphic photos are accurate and correspond with trays provided - update tray lists as instruments are replaced or new instruments are added - identify on tray lists instruments requiring specific attention e.g. disassembly, special cleaning instructions. To eliminate the need for decanting (when more than 5 instruments are being loaned to facility): - provide instrument trays and containers that are not damaged and suitable for Australian CSD health technology and in a layout which is appropriate for use by the OR - ensure instrument trays and containers are able to be cleaned, sterilized and dried following sterilization in Australian CSD health technology without the necessity for decanting. Provide the following documentation to the facility: - an up to date medical industry Reprocessing Instruction (refer attachment 8) for each loan set - Two copies of original tray lists that are accurate, legible and clear, with photographic or graphic outline of the tray lists 1 - photographs of tray and contents and or graphic outline of tray and contents, identifying the placement of each instrument on the tray - tray lists that easily identify instruments which require special attention e.g. complex instruments and number of parts for disassembled instruments - Decontamination Declaration Form (refer attachment 7) - indemnity form to be provided by medical industry to those facilities who do not have a current service agreement with the provider. Ensure a system is in place for tracking the loan set back to a facility and/or a patient for review or evaluation purposes Provide inservice education to: - Surgeons in use of instruments - Peri-operative nursing staff - CSD staff in the disassembly/assembly and reprocessing of instruments. Provide written/electronic instructions on the disassembly, assembly, cleaning and processing of complex instruments Ensure instruments are returned to the warehouse or audited at the health care facility as part of the companies regular checking, replacement and maintenance program Provide a feedback mechanism to the facilities when issues arise related to loan sets and any other quality issues. Page 9 of 21

10 URL links Shortcut Workplace Health and Safety Regulation 2011 Manual Handling of Surgical Loan Sets PRIME TGA for Medical Device Adverse Event URL pdf 9_38_ergo.pdf Bibliography Australia/New Zealand. Standards Australia. AS/NZS 4187:2003 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities. EN I.S. ISO17664 :2004 Sterilization Of Medical Devices Information To Be Provided By The Manufacturers For The Processing Of Resterilizable Medical Devices. Henderson, D.K. Patient-to-Patient Transmission of bloodborne Pathogens in health Care: The Price and Perils of Progress. Infection Control and Hospital Epidemiology Apr; 29(4): Page L. Deconstructing loaners. Materials Management in Health Care Jul; 14(7): Ricupito G. Consignment trays and the hidden costs of sterilization. Materials Management in Health Care Dec; 15(12): Sabroskby, P. Spiraling instrument costs present many challenges. Materials Management in Health Care Jul; 16(7):66. Winthrop, T.G., Sion B.A., Gaines C. Loaner Instrumentation: Processing the Unknown. AORN Journal Mar; 85(3): Wales. Welsh Assembly Government. Welsh Health Circular: effectively managing On Loan surgical instruments; 2008 Jul. [cited 2013 May 6]. Available from: WorkSafe. Orthopaedic Surgical Instrument Sets Reducing Risks of Musculoskeletal disorders [Internet] [cited 2013 May 6]. see: References ACORN Standards for Perioperative Nursing. Adelaide: The Australian College of Operating Room Nurses Ltd; Page 10 of 21

11 Revision History Version Number Date of Issue Date of Next Revision /11/2011 Rescinded /07/2013 July 2014 Document Custodian Director & Tuberculosis Control Approving Officer Dr Jeannette Young Chief Health Officer Approval Date 25 / 07 / 2013 Page 11 of 21

12 Attachment 1 Loan Set Decision Table LOAN SET DECISION TABLE To be used when services are contemplating procuring a new loan set PART A: Decision Making YES NO DATE COMMENT/SIGNATURE Identification of Need: Reason for New Equipment: New technology (New to market) Addition to inventory Replacement product New service Review of work practice Service to be Provided Number of Lists: Weekly Monthly Yearly Number of Procedures: Weekly Monthly Yearly Number Number Length of Time Tenure/Contract of Surgeon Requesting Equipment 6 months or less 12 months More than 12 months Funding for Service Funding available Recurrent budget Health Technology Equipment Replacement Programme Business case required and completed Extraordinary funding Costs & Purchase Life cycle costs Cost to purchase instruments Lead time for availability of instruments Weeks Will be used with implants Are instruments available on SOA/Bulk Purchase Will cost be >$100,000 Loan Set Instruments: Available from company immediately Number of Instrument Trays in Set Costs for instruments + Implants $ Costs of delivery $ Costs associated with late ordering $ Page 12 of 21

13 PART A: Decision Making cont. YES NO DATE COMMENT/SIGNATURE HHS Processes and Resources for Management of Loan Sets HHS has formalised documented process for the management of Loan Sets Safe, dry delivery area for loan sets Loan Set coordinator to cover all shifts Central Sterilizing Department Capacity Health Technology available to reprocess loan sets in line with manufacturers instruction Adequate number of Washers/disinfectors Adequate number of sterilizers Sufficient staff Hours of operation Budget Knowledge and skills in staff Assessment/Evaluation of Product: Have all stakeholders participated in the evaluation of product/s (eg Equipment/Consumable Committee) Executive Member Service approved Expert end User/s Clinical Suitability (Nurse, Surgeon) CSSD staff Ability to reprocess if required Clinical Products Advisor Contracts/SOA expertise Infection Control Practitioner Able to be appropriately cleaned Finance/ Business Manager /Corporate Funding available Services Biomedical Technology Services TGA, Design & Servicing Supply Services Contract management/ ordering All potential products have ARTG certificates (Ensure documents available) Design of product: Product has been trialled? Performs required function? Education/Training has been identified Risk assessment been undertaken using Queensland Health Risk Management Framework Contractual Agreement set up between supplier and district/facility. Company Support: Company demonstrates consistent provision of maintenance and support Company service & repair agreement is available for perusal Education/Training on use is available to: Surgeons Operating Room Nursing Staff CSD staff (cleaning and reprocessing) Recommend product for purchase? Authorisation to Purchase Printed Name: Signature: Date: Page 13 of 21

14 PART B: Post Purchase YES NO DATE COMMENT/SIGNATURE Introduction plan developed & includes: Education & training plan Revision/New Standard Operating Procedure Communication plan Asset Register updated (>$5,000) Relevant workplace documentation updated Inventory management systems Maintenance Plan Life cycle management plan Page 14 of 21

15 Attachment 2 Loan Set Usage Report Loan Set Usage Report District Period Ending (?Monthly) Committee HHS/Facility (Date) (eg Finance, Clinical Products Advisory, Executive, Clinical Governance, Peri-operative Management) USAGE Loan Set Reprocessing Number of Loan sets Ordered for (period) Number of Surgical specialities using loan sets (orthopaedics, microsurgical etc) Number of suppliers of Loan sets to facility Number of trays reprocessed Number of Loads required for reprocessing Washer disinfector only (A) Number of Loads required for reprocessing Sterilizer (B) Number of hours of reprocessing Number of trays returned opened but unused Number of trays returned unopened/unused TOTAL TRAYS REPROCESSED SUMMARY of COSTS Total Costs of Washing Only: ($400 x A) Total Costs of Sterilisation: ($500 x B) Cost of Unused/Unopened Trays: $400 (No. Trays/Load washer) $500 (No. Trays/Load sterilizer) Cost of Extra fees: (late ordering) $(late ordering) TOTAL COSTS $ ANY REPORTABLE ISSUES Late Delivery of Loan Sets Contaminated Loan Sets Arrival of new Loan Sets CSD not notified, not inserviced Company documentation inadequate Any other identified issues Please note that this format is a guide only Page 15 of 21

16 Attachment 3 Loan Set Management Checklist LOAN SET MANAGEMENT CHECKLIST Section A: To be completed by the person ordering the Loan Set Equipment Patient Detail (attach patient identification label here) UR Number: DOB: / / Surname Surgical Detail Procedure: Consultant: Given Names Address: Post code: Male Female Registrar: Speciality: Phone (H) (W) Site: Loan Set Name Company Booked by: Purchase Order Yes No Date of Surgery: Purchase Order No Date of Delivery: A/H Urgent Order Time of Delivery FAMMIS entry Yes No Copy sent to Loan Set Yes No Coordinator Date Received No. of Boxes delivered Checked by: Print Name and Sign Decontamination Certificate present Section B: To be completed at time of Loan Set Receipt by Loan Set Co-ordinator Time Received No. of trays for reprocessing Yes No Checklists Correct Yes No Missing Instruments Yes No Contaminated Instruments Yes No Missing/Contaminated Yes No Company Representative Yes No Instruments Documented Notified Reprocessing Instructions Available Yes No Instruments required to be decanted into green trays Yes No Section C: To be completed in CSSD Prior to Dispatch to Company Instruments Disassembled & Yes No Trays reprocessed Yes No Cleaned Missing/Damaged Instruments Company Notified Yes No (not identified prior to use) Yes No Trays return unused & not Checklist present for Yes No reprocessed Yes No dispatch Decontamination Certificate attached Yes No Date and Time ready for dispatch Hospital Representative Releasing Loan Set Date Dispatched: General Comments: Print Name and Sign Courier Receiving Loan Set Time Dispatched: Print Name and Sign This form is to be kept by the facility ordering and managing the loan set Page 16 of 21

17 Attachment 4 Decision Flowchart for Incomplete Loan Sets Decision Flowchart Incomplete Loan Sets Notify Shift Supervisor / Loan Set Coordinator No Is the loan set complete? Yes Shift Supervisor / Loan Set Coordinator to contact the provider Continue Standard Reprocessing Procedures No Will all the instruments be available in time for the operating list? Yes Notify Operating Theatre about missing items and delay Notify Operating Theatre about missing item/s and when it/they are expected to arrive OT Manager to discuss with Surgeon Negotiate with OT reprocessing timeframes for the set & the missing item/s & inform they will be wrapped separately Decision to continue or reschedule made & communicated to CSD Document & Report Report using local Critical Incident Management Tool (PRIME / AIMS) Complete IRIS and Product complaint Note: CHRISP&TB should be included as a contact Escalated to Clinical Resource Manager and / or SOA Manager as per local product complaint process Complete HSPL performance report complaints/index.htm report/index.htm Forward to Biomedical Technology Services (BTS) Forward to CHRISP&TB for Collate & Review Send to HSPL contract manager Theraputic Goods Administration (TGA) notified Page 17 of 21

18 Attachment 5 Decision Flowchart for Contaminated Loan Sets Decision Flowchart Contaminated Loan Sets Instruments are soiled / contaminated No Are instruments checked and clean? Yes Clean and Reprocess Notify Shift Supervisor / Loan Set Coordinator Continue Standard Reprocessing Procedures Shift Supervisor / Loan Set Coordinator to complete the documentation Report using local Critical Incident Management Tool (PRIME / AIMS) Complete IRIS and Product complaint Note: CHRISP&TB should be included as a contact Escalated to Clinical Resource Manager and / or SOA Manager as per local product complaint process Complete HSPL performance report complaints/index.htm report/index.htm Forward to Biomedical Technology Services (BTS) Forward to CHRISP&TB for Collate & Review Send to HSPL contract manager Theraputic Goods Administration (TGA) notified Page 18 of 21

19 Attachment 6 Decision Flowchart for Inadequate Reprocessing Instructions Decision Flowchart Inadequate Loan Set Reprocessing Instructions Notify Shift Supervisor / Loan Set Coordinator No Are instrument reprocessing instructions available and adequate? Yes Shift Supervisor / Loan Set Coordinator to contact the loan set provider Continue Standard Reprocessing Procedures No Can the provider supply adequate reprocessing instruction in a suitable timeframe? Yes Complete a risk assessment with all relevant stakeholders. E.g. NUM OT / NUM CSD / Peri Op / Surgeon to determine action Document & Report Report using local Critical Incident Management Tool (PRIME / AIMS) Complete IRIS and Product complaint Note: CHRISP&TB should be included as a contact Escalated to Clinical Resource Manager and / or SOA Manager as per local product complaint process Complete HSPL performance report complaints/index.htm report/index.htm Forward to Biomedical Technology Services (BTS) Forward to CHRISP&TB for Collate & Review Send to HSPL contract manager Theraputic Goods Administration (TGA) notified Page 19 of 21

20 Attachment 7 Decontamination Declaration Form (Green Form) DECONTAMINATION DECLARATION FORM A copy of this form MUST accompany Loan Set on Dispatch From (CSD): Hospital/Facility: Order No: Emergency Telephone: To (Provider): Address: Emergency Telephone: Loan Instrument or Set Name: Provider / Manufacturer: Missing / Damaged Instrument Identified: Yes No Don t Know Missing / Damaged Instrument Reported to Company: Yes No Don t Know Has this set/item been decontaminated? Yes No Don t Know If NO, please explain why the set/item has not been decontaminated: Method of decontamination Used: Cleaning Thermal/Chemical Disinfection Sterilisation Contaminated items should not be returned without prior agreement of the recipient We guarantee that the items mentioned above have been thoroughly cleaned and terminally disinfected in accordance with the current edition of As/NZS 4187 Name: Position: Signature: Telephone Number: Date: Acknowledgements: Logan Beaudesert Health Service District Medical Industry Association of Australia Sterilising Research & Advisory Council of Australia Page 20 of 21

21 Attachment 8 Reprocessing Instruction Loan Set Name: Loan Set Provider: (Company) Number of Trays: TEMPLATE: REPROCESSING INSTRUCTION FOR THE MANAGEMENT OF LOAN SETS for CSD s Contact No: Description Ultrasonic Cleaning required Manual Cleaning (hand) required Instructions Tick what is applicable Yes No* All Some* Yes No* All Some* Mechanical Cleaning required Yes No Instrument/s in the loan set require disassembly prior to cleaning Yes* No Instrument disassembly instructions provided Yes* No Instrument reassembly instructions provided Yes* No Are there any instruments that can be reassembled prior to packaging and sterilization? If yes, please indicate: Yes* No Recommended chemical ph for reprocessing Alkaline Yes No Acidic Yes No Neutral Yes No * Indicates special instructions are to be supplied to CSD by Supplier Date Information Developed: Date Information Updated: This form is to be completed by Medical Industry, laminated and is to follow each loan set as it moves form site to site Page 21 of 21