Biomedical Engineering in Optimizing Patient Outcomes

and Controlling Clinical 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 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

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

Preventable Incidents Due to Incorrect Use of Medical Devices

• 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?

• 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.

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

Medical Devices Incidents Reported to TGA Total Received: 206

(Jan07March07)Total Received: 280 (April 07-June07)

Component failure 16 21

Contamination 1 10

Design 12 11

Electrical 15 16

Inadequate Instructions 2 3

Labelling 9 2

Maintenance 3 2

Manufacture 12 18

Material/Formulation 9 12

Mechanical 11 20

Not Device Related 19 23

Other 38 26

Packaging/Sterility 1 2

Quality Assurance 3 6

Unknown 66 77

Wear/Deterioration 9 9

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

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

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

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

Hospital objectives(Corporate plans)

Asset Management Plans

Establish new equipment needs and priorities

Keep equipment maintained

Identify procurement options and allocate resources

Review utilisation and replacement needs

Asset Register

DISPOSAL

Source: 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 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

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

0.0

2.0

4.0

6.0

8.0

10.0

12.0

0 100 200 300 400 500 600 700 800 900 1000

Available Beds

Pro

po

sed

FT

E

North & North West (Approx 5FTE)

RHH (Approx 4.1 FTE)

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

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

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

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

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

Sarah Hedges, LGH Anaesthetics registrar

Kyril Belle, LGH Biomedical engineer

Thank You

Questions?

E: kyril.belle@dhhs.tas.gov.au

P: 03-63487492

M: 0437070870