Biomedical Engineeringin Optimizing Patient Outcomes and ControllingClinical Risk

By: Kyril BelleBiomedical Engineer

Department of Health and Human Services State Health Conference 8-9 November 2007

Role of Biomedical Engineer Apply engineering principles to solve medical problems Provide clinical supportDevelop bionics

Biomedical Engineering Departments in Australian hospitals support clinical servicesEnsure safe, reliable, effective commissioning, calibration and maintenance medical equipmentResearch and design of bionicsImproved user interfaces (computers!)Training on equipment and systemsPurchasing and service contract supervision

Increasing Demands for Biomedical Equipment Aging populationIncreasing premature birth survival rateGreater reliance on technology in diagnosis and therapy Move to non-pharmaceutical optionsHigh expectation from the globally informed and aware communities and legal system

Preventable Incidents Due to Incorrect Use of Medical DevicesNSW most recent: Patient death in CCU due to wrong device configurationInfant seriously injured due to wrong infusion pressure settingDefibrillator failed resuscitation attempt to patient as correct device maintenance protocol not followed

SA-12 cases (8 requiring MET intervention, 1 requiring admission to ICU) due to wrong delivery of gasesWA 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?

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.

College of Biomedical Engineers collaboration with ACHS

Identifying responsible approach to risk management within clinical engineering practiceACHS will include and publish updates to Equipment StandardsACHS wants help writing update. NPCE (National Panel of Clinical Engineers) will draft this update due to be released in Feb 2008

Medical Devices Incidents Reported to TGA

Risk Management and LiabilityClinicians 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 tasksClinicians are currently writing and managing technical service contracts that could be done by a Biomedical Engineer, diverting time and attention from core role

How to Manage Risk & Reduce Cost Perform risk assessments on all equipment and systemsConsistent Biomedical delivery Hard to achieve with duplicated servicesRelease Clinicians from Biomedical tasksBiomedical input in purchasing Best technology, ergonomics, function based specification, life expectancy of the equipmentIs safe and meets legal Australian Standard Combined bulk purchases where possibleSpecific action areasMaintain separation of corporate and clinical computer systems

Equipment Capital CostsThe 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 hospitalsIn Tasmanian hospitals and healthcare centres 80% of the Biomedical devices used, costs over $1000 each

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 time10% cost reduction to the latest laser contract by simply running it past the Biomedical EngineerUnnecessary supplier schemes and extras are picked up by the Biomedical Engineer, and more importantly omissions that will cost $1000s in contract variations are identified

Hospital objectives(Corporate plans)Asset Management PlansEstablish new equipment needs and prioritiesKeep equipment maintained Identify procurement options and allocate resourcesReview utilisation and replacement needsAsset RegisterDISPOSALSource: Based on UK National Audit Office Report The Management of Medical Equipment in NHS Acute Trusts in England, 1999.Example: Management Cycle For Medical Equipment

Staffing Biomedical SupportFirst Australian Biomedical support staffing model developed by Royal Prince Alfred Biomedical Engineering DepartmentPresented in the ABEC 2007 in Freemantle, WAThis model is yet to be accepted by College of Biomedical EngineersThe model Is based on number of beds Shows staffing is not linear with size or activityIncludes adequate supervision ratios and leave cover

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

Computer Issues !Computers are simply a powerful, yet highly unreliable toolComputers used for human interface, device control and data manipulation/storageFailure of the computer within a device usually takes out the deviceWorse still it can produce misleading behaviour70% of computer viruses come via the corporate networkSeparation of corporate and medical networks essentialCorporate network response to security is to lock up the system, denying access to all, including those needing itIncreasing computer integration into medical equipment and facilities must be covered by computer up-skilling within the Biomedical Engineering support

Out-sourcingCan provide short term cost savings at expense of control, response time, safety and workload transfer to others within the DHHSOutsourcing maintenance is cost effective only where the amount of work involved cannot support an internal technician or the medical service company has automated test facilitiesThe Biomedical Engineers role cannot be effectively outsourcedClinicians have to take on the role

Is Outsourcing the Best Option ?In-house presents staffing and accommodation problems Uncertainty over effectiveness of outsourcing riskWhere $ involved it will end up in the legal systemWho 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

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 softwareCan only operate within the limits of the available tools

The Way Forward ?Develop improved Biomedical Engineering support strategy for the stateState-wide review of Biomedical Engineering support needs and outsourcing arrangementsSurvey 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 equipmentMatch Biomedical RM to corporate and clinical RM practice

Computer up-skilling within the Biomedical Engineering

Sarah Hedges, LGH Anaesthetics registrar

Kyril Belle, LGH Biomedical engineer

Thank You

Questions?

E: kyril.belle@dhhs.tas.gov.auP: 03-63487492 M: 0437070870

Thank you Peter. Good Afternoon everyone. After listening to all the speakers yesterday and this morning I feel honoured to be presenting amongst them. I do not bring the wealth of experience like most speakers do but I would like to bring your attention to the importance of biomedical engineering in healthcare. Word Bionics is an invention of mine which categorises parts of human body that can be replaced by mechanical or electrical engineering systems. Education/ training on equipment and system Getting the best out of the medical devices Users are often unwilling to acknowledge needResearch ProjectsWith support equipment and instrumentationTesting equipment itselfPurchasing SupportOverwhelming Technology Choices bristling with features, sometimes too many features taking the attention out of the function: Its like wanting a microwave and all it will ever be used is as a microwave there is no use if it comes with a mp3player and cappuccino feature We try to bring the focus of choosing based on clinical functional need. It is sometimes difficult to differentiate the two. Consistent specifications Purchase for maintenance (not just good the day of purchase) Improved user interfaces (computers!)

I think this demand is driven by clinical pull" (ie identification of problems that need to be solved) and by "technology push"(ie invention of new tools and means Most speakers touched on this. And its clear it not a Biomedical specific listIncrease in Equipment introduces a factor for errors and incidents related to them. Most of you are must have come across similar examples in health bulletins and alerts.

These examples and alike stress the risk and need to do manage and reduce that risk. The step towards that is collaboration of cbme and achsThe risk associated with medical devices is also reflected in quartely reports from TGA on incidents reported. Note the table only shows the reported incidents not all incidents. The first column shows the causes that were identified against those incidents. The worrying bit is the unknowns the ones TGA investigation could not point to. We have identified there is element of risk associsted with medical devices Among the primary ergonomics issues are errors in the use of diagnostic and therapeutic equipment. Improper use of medical devices is frequent and so is the misinterpretation of diagnostic information from complex instruments Calibration of calibrating equipment how can you be assured the reading the devices are giving are correct. False reading leads to false diagnosis. Managing risk is a continuous process of evaluation, action and re-evaluation, rather than a one-off event . Undertaking a risk assessment is an important step in identifying areas where practices are performing well and areas where changes would be beneficial. To reduce the errors and incidents we need to manage the risk and at the same time find ways to reduce costs. Some things that Biomedical Engineering can do is For public hospitals, effectively maintained medical equipment is an important asset central to patient care. Hospitals hold a vast array of medical equipment ranging from small inexpensive items, such as infusion pumps each costing less than $5 000, to complex items, such as linear accelerators which typically cost over $4 million and involve substantial ongoing costs.

Equipment costs contributes significantly to the overall healthcare costs. For example.

How does Biomedical Engineering reduce these costs. Biomedical Engineering contribution in targeting costs is at tender/contract level , some of the simple examples have saved DHHS significantly.For Biomedical Engineering to provide quality support it needs proper assett management programs , Here is a good example and an area we can improve and need to continuously review it. It is an area we can improve and need resources to keep it to the acceptable standard. There has been need for a long time for an Australian model to identify Biomedical Engineering staff numbers for hospitals. RPH has recently

Adequate staffing is crucial for safe and quality service. I am sure you all have had that experience in your working and personal life.In healthcare they are used for human interface, device control data manipulation and storage.

Biomedical Engineering staff cannot be expected to know about Engineering, Medical and computers all the same time. But I think upskilling in computing can it could mean in future we might have to dedicated expertise in this area.

Now we talked about the problems we face but How can Dept of health get Biomed support and manage risk ? One of the option is Outsourcing IS IT BEST THOUGHYes its true like any other in house service it presents Before I end I would like to show you two photos I have borrowed from a presentation our director of anaesthetics Dr. George Merridew gave about a project we did with Australian Army. From this conference I am getting working together and building great teams is the key. Working together on this project from my early days in health certainly helped me build some great professional relationships