Biomedical Engineering in Optimizing Patient Outcomes and Controlling Clinical Risk By:

1. Biomedical Engineering  in Optimizing Patient Outcomes and Controlling Clinical Risk By: Kyril Belle Biomedical Engineer Department of Health and Human Services State Health Conference 8-9 November 2007

2. Role of Biomedical Engineer • Apply engineering principles to solve medical problems • Provide clinical support • Develop bionics • Biomedical Engineering Departments in Australian hospitals support clinical services • Ensure safe, reliable, effective commissioning, calibration and maintenance medical equipment • Research and design of bionics • Improved user interfaces (computers!) • Training on equipment and systems • Purchasing and service contract supervision

3. Increasing Demands for Biomedical Equipment • Aging population • Increasing premature birth survival rate • Greater reliance on technology in diagnosis and therapy • Move to non-pharmaceutical options • High expectation from the globally informed and aware communities and legal system

4. Preventable Incidents Due to Incorrect Use of Medical Devices • NSW most recent: • Patient death in CCU due to wrong device configuration • Infant seriously injured due to wrong infusion pressure setting • Defibrillator failed resuscitation attempt to patient as correct device maintenance protocol not followed • During 1984-1992 US government documented 8000 cases in which patient had been injured or killed due to human error in the use of therapeutic and medical devices • Decade later the number has not changed! • With much greater computer integration this is even more worthy of reflection. • SA-12 cases (8 requiring MET intervention, 1 requiring admission to ICU) due to wrong delivery of gases • WA – 140 different hip stems, 120 acetabular component, and 50 knee prostheses available in Australia. WA BME tracking and evaluation found that “poor microstructure and/or sub optimum design factors are commonly featured in recurrent failures”. • Tasmania currently does not track implants! • Are our patients getting inappropriate joint replacements because biomedical currently does not provide this support?

5. College of Biomedical Engineers collaboration with ACHS • Identifying responsible approach to risk management within clinical engineering practice • ACHS will include and publish updates to Equipment Standards • ACHS wants help writing update. NPCE (National Panel of Clinical Engineers) will draft this update due to be released in Feb 2008

6. Medical Devices Incidents Reported to TGA

7. Risk Management and Liability • Clinicians act to minimise risks to patient and hospital. Decisions assume all equipment • Is functioning reliably and accurately • Is safe and meets legal Australian Standard • Release Clinicians from Biomedical Eng tasks • Clinicians are currently writing and managing technical service contracts that could be done by a Biomedical Engineer, diverting time and attention from core role

8. How to Manage Risk & Reduce Cost • Perform risk assessments on all equipment and systems • Consistent Biomedical delivery • Hard to achieve with duplicated services • Release Clinicians from Biomedical tasks • Biomedical input in purchasing • Best technology, ergonomics, function based specification, life expectancy of the equipment • Is safe and meets legal Australian Standard • Combined bulk purchases where possible • Specific action areas • Maintain separation of corporate and clinical computer systems

9. Equipment Capital Costs • The total value of medical equipment in 91 Victorian public hospitals was $507 million representing 13% of non-current assets (Auditor General Health Report 30 June 2003) • ratios to $84 Million Equipment in Tasmanian hospitals • In Tasmanian hospitals and healthcare centres 80% of the Biomedical devices used, costs over $1000 each

10. Contracts control costs! • A recent state-wide equipment contract had calibration equipment included by the Biomedical Engineer allowing a 30% reduction in support costs and an 50% reduction in down time • 10% cost reduction to the latest laser contract by simply running it past the Biomedical Engineer • Unnecessary supplier schemes and extras are picked up by the Biomedical Engineer, and more importantly omissions that will cost $1000s in contract variations are identified

11. Example: Management Cycle For Medical Equipment Hospital objectives (Corporate plans) Asset Management Plans Establish new equipment needs and priorities Asset Register Identify procurement options and allocate resources Review utilisation and replacement needs DISPOSAL Keep equipment maintained Source: Based on UK National Audit Office Report – The Management of Medical Equipment in NHS Acute Trusts in England, 1999.

12. Staffing Biomedical Support • First Australian Biomedical support staffing model developed by Royal Prince Alfred Biomedical Engineering Department • Presented in the ABEC 2007 in Freemantle, WA • This model is yet to be accepted by College of Biomedical Engineers • The model • Is based on number of beds • Shows staffing is not linear with size or activity • Includes adequate supervision ratios and leave cover

13. ABES Model – Relationship between the number beds and the FTE (Courtesy Royal Prince Alfred Hospital NSW)

14. Computer Issues ! • Computers are simply a powerful, yet highly unreliable tool • Computers used for human interface, device control and data manipulation/storage • Failure of the computer within a device usually takes out the device • Worse still it can produce misleading behaviour • 70% of computer viruses come via the corporate network • Separation of corporate and medical networks essential • Corporate network response to security is to ‘lock up’ the system, denying access to all, including those needing it • Increasing computer integration into medical equipment and facilities must be covered by computer up-skilling within the Biomedical Engineering support

15. Out-sourcing • Can provide short term cost savings at expense of control, response time, safety and workload transfer to others within the DHHS • Outsourcing maintenance is cost effective only where the amount of work involved cannot support an internal technician or the medical service company has automated test facilities • The Biomedical Engineers role cannot be effectively outsourced • Clinicians have to take on the role

16. Is Outsourcing the Best Option ? • In-house presents staffing and accommodation problems • Uncertainty over effectiveness of outsourcing risk • Where $ involved it will end up in the legal system • Who takes responsibility of quality control if Biomedical Engineer is not on staff? • Difficult to write and administer outsourcing specification to deliver quality service meeting all required standards to which private enterprise can deliver at less cost than doing it in house • Biomedical engineer best placed to write and administer service contracts after evaluating cost effectiveness

17. The Tasmanian Situation • Biomedical Engineering in Tasmania is currently significantly behind all other Australian States • The North is currently better placed due to the Department of Biomedical Engineering • Where requested BME (North/NW) contributes at a state-wide level • The performance of health professionals increasingly dependant on Biomedical Engineering hardware and software • Can only operate within the limits of the available tools

18. The Way Forward ? • Develop improved Biomedical Engineering support strategy for the state • State-wide review of Biomedical Engineering support needs and outsourcing arrangements • Survey Clinicians’ satisfaction with BME support • Recommend completion before design of RHH is completed • Improved Risk Management • Need consistent testing priorities for management of clinical medical equipment • Match Biomedical RM to corporate and clinical RM practice • Computer up-skilling within the Biomedical Engineering

19. Sarah Hedges, LGH Anaesthetics registrar

20. Kyril Belle, LGH Biomedical engineer

21. Thank You Questions? E: kyril.belle@dhhs.tas.gov.au P: 03-63487492 M: 0437070870