The potential benefits of a traceability solution for surgical trays in the Irish Health Service Alana McMahon A dissertation submitted to the University of Dublin, in partial fulfilment of the requirements for the degree of Master of Science in Health Informatics 2012 MSc in Health Informatics Declaration I declare that the work described in this dissertation is, except where otherwise stated, entirely my own work, and has not been submitted as an exercise for a degree at this or any other university. Signed: ____________________________________________ Alana McMahon Date: [2] MSc in Health Informatics Permission to lend and/or copy I agree that Trinity College Library may lend or copy this dissertation upon request. Signed: ____________________________________________ Alana McMahon Date: [3] MSc in Health Informatics Acknowledgements The author would like to thank the following for their contribution and support in making this dissertation possible. My supervisor Frank Bannister for his advice and guidance. The MSc Course Director Lucy Hederman and all course lecturers who made the course a memorable experience. GS1 for their invaluable support throughout the year, in particular, Alan Gormley. The stakeholders of the traceability project who took part in interviews, in particular, Simon Jackson from Medical Standards 1, Karl Holmes from Synthes and Alan Murphy from Irish Process and Power. The CDU managers who shared their knowledge and gave their time, in particular, Andrew Smith from St. James Hospital and Michael Cleary from Tullamore Hospital. The CDU staff in St. James Hospital and Tullamore Hospital who took part in the interviews. My parents, Michael and Aileen McMahon for their support, pots of tea and green juices. My aunt, Beryl Conroy, who leveraged her nursing experience in NYC to support the completion of this dissertation. My friends, Helen Brosnan and Bobbi Costello for their encouragement and supplies of chocolate. [4] MSc in Health Informatics Summary Surgical Site Infections (SSI) are a major cause of Hospital Acquired Infections (HAI). SSIs can have an impact on both patient safety (e.g., development of a serious illness) and hospital costs (e.g., additional treatment). There are three ways in which patients can contract SSIs; by direct contact, by airborne dispersal and by self-contamination. Direct contact refers to contact from the surgical instruments or from the hands of operating theatre staff. The decontamination process of surgical instruments is therefore critical for patient safety. A nationally funded pilot traceability solution has been implemented in the Central Decontamination Unit (CDU) of eight hospitals in Ireland for surgical trays. The solution utilises GS1 standardised barcodes for device identification. GS1 are a global not- for-profit non-governmental organisation. GS1 has over 30 years of experience in the development and implementation of standards. GS1 identification numbers and barcodes allow organisations to fight the proliferation of counterfeit medicines, to establish robust recall solutions, and simply to uniquely identify products to enable traceability solutions. This dissertation examines this pilot solution and identifies its potential benefits, focussing on two of these hospitals: St James Hospital and Tullamore Hospital. The research question is: What are the potential benefits of a traceability solution for surgical trays in the Irish health service? Methods Used A literature review, case study research, interviews with the project stakeholders, semi-structured interviews with the hospital staff, and development of a financial model to quantify the potential cost benefits of implementing a traceability system. Major Findings A number of benefits were realised in the two case study hospitals including less administration, the ability to recall which instruments were used on a patient, knowing the location of the surgical instruments and quality assurance of the washer and steriliser cycles. The main issues identified in operating the system include the preparation work involved in barcoding all the surgical trays in the hospital with MS1 and GS1 barcodes. The financial model illustrates a substantial potential return on investment for the system if all SSIs associated with surgical instruments are eliminated. Conclusion The evidence found from literature review, case study research and the financial model strongly supports the implementation of a traceability solution for surgical trays in Irish hospitals. [5] MSc in Health Informatics Table of Contents Chapter 1. Introduction and Background ....................................................................................... 10 Chapter 2. Literature Review ......................................................................................................... 14 2.1 Traceability ................................................................................................................... 14 2.2 Traceability of Medical Devices .................................................................................... 16 2.3 Decontamination Standards ......................................................................................... 19 2.4 Impact of Hospital Acquired Infections ......................................................................... 23 2.5 Conclusion of Literature Review .................................................................................. 27 Chapter 3. Methodology ................................................................................................................. 29 3.1 Research Strategy ........................................................................................................ 29 3.2 Case Study ................................................................................................................... 30 3.3 Sample ......................................................................................................................... 31 3.4 Interviews ..................................................................................................................... 31 3.5 Data Analysis ............................................................................................................... 32 Ethical Considerations ....................................................................................................................... 33 3.6 Limitations .................................................................................................................... 33 Chapter 4. Findings and Analysis .................................................................................................. 35 4.1 Background to the project ............................................................................................ 35 4.2 Project Stakeholders .................................................................................................... 36 4.3 Case Study Research .................................................................................................. 41 4.4 Walkthroughs of the Hospital CDUs ............................................................................. 41 4.5 Analysis and Results .................................................................................................... 45 4.6 Financial Model of Cost Benefits .................................................................................. 60 Chapter 5. Discussion and Conclusions ........................................................................................ 69 Chapter 6. References ................................................................................................................... 72 Appendices ........................................................................................................................................... 76 Appendix A: GS1 Standards ................................................................................................................. 76 Barcodes and RFID tags ................................................................................................................... 76 GS1 Data Carriers and identification Keys ........................................................................................ 78 Element String ................................................................................................................................... 81 GS1 Application Identifiers in Numerical Order ................................................................................. 82 Appendix B: Ethics ................................................................................................................................ 89 Ethics Approval from Trinity College Dublin ...................................................................................... 89 Appendix C: CDUs ................................................................................................................................ 93 Appendix D: As-Is and To-Be in the CDUs ........................................................................................... 96 Appendix E: Surgical Tray Checklists and Production Labels ............................................................ 106 Appendix F: Sample Reports .............................................................................................................. 110 [6] MSc in Health Informatics Index of Figures and Tables Figures: Figure 1.1; A breakdown of the most common Hospital Acquired Infections in Irish hospitals – Health Service