Clinical Engineering Why do hospitals need engineers?
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Clinical EngineeringEngineers in the Modern Academic Medical Center
Design DisastersConsequences of Blunders, Bad Luck, and Bias
Patrick Norris, Ph.D.Assistant Professor of Surgery,
Biomedical Engineering
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Clinical EngineeringWhy do hospitals need engineers?
• Definition• Past, Present, Future• Examples
– Facility Design– Biomedical Devices– Information and Technology Management
• Clinical Research, Quality Improvement
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Definition
Biomedical Engineering
Biomedical Electronics
Clinical Technology Service
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DefinitionThe American College of Clinical Engineering:
A professional who supports and advances patient care by applying
engineering and management skills to healthcare technology.
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Definition: Hospitals need engineers when technology requires:
• Special (non-trade/craft skills) customization or maintenance
• Complex selection criteria• Modification of existing facilities or
systems, or special design of new ones
• Design and analytic skills, professional credentials, etc. differentiate engineers from technicians, craftspeople, clerical, administrators, etc…
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Examples: Past• Einthoven: EKG, early 1900’s• Other examples:
– Day to day heat, AC, water, electricity, etc.
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Examples: Present• Infrastructure Design
– Typical: Water, Electrical, HVAC, Telecom– Special: Medical Gas, Sample Handling– Structural: Imaging Systems
• Biomedical Devices– Selection, integration, tracking– Maintenance is becoming a sophisticated
trade/craft skill• Information
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Future
Grimes SL, IEEE Engineering in Medicine and Biology Magazine, March/April 2003 p.91-99
• Information– Medical Informatics– 6 VUSE PhDs
• Integration– People– IT Systems– Medical Devices
• Regulation– Privacy, Safety,
Efficacy• Across Multiple
Healthcare Systems
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Clinical Research• SIMON Project
– (Signal Interpretation and Monitoring)– Ongoing since 1994
• Seeks to Advance:– Medical Monitoring Technology– Critical Care– Scientific Knowledge
• Clinical Engineering Component
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Trauma• 5th Leading Cause of Death (1st Under 45)• 8% of Medical Expenditures (rank: 3rd)• All Age and Socioeconomic Groups• VUMC
– Only Level 1 Facility, 65,000 Square Miles– 3500 Annual Admissions– 800 to Trauma ICU, ~10% Mortality
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Patient Monitoring
• Cushing, early 1900’s:– Importance of Monitoring and
Recording Vital Signs• Technology Has Advanced• Fundamentally, Clinical
Strategies Remain Unchanged– Intermittent Recording– Manual Interpretation
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Tools for
Dense Physiologic Data Management
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Four Engineering Challenges• Data Collection
– Interfaces to a Variety of Devices– Remote Locations
• Storage– Clinical Applications - Short-Term– Research Applications - “Forever”
• Processing– Time-Critical Tasks (Clinical Decision Support)– Research Analysis
• Architecture– Integration, Reliability, Scalability, Flexibility…
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SIMON Data Capture
• Philips CareVue– Routine, Automatic Vital
Signs Capture– HR, ABP, PAP, CVP, ICP,
CPP, PAP, SaO2
– Episodic Waveform Capture
• Edwards Vigilance– CI, EDVI, temp, SvO2, etc.
• Alaris IV Pump (near future?)
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SIMON Data Storage
• Relational Database– Time Constraints w/ Limited Resources– Adaptive Sampling, ~0.25-1Hz Storage
• 5500+ TICU Patients– Reliably Identified, Linked to Outcomes
• 450,000+ Continuous Hours• Grows by:
– 2 Million+ Data Points/Day– ~70 Patients/Month
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Daily Reports
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Data Display
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Alerts
• Effective Alerting– Right Information– Right Person– Right Time
• Process– Event– Alert– Notification– Response
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SIMON Architecture
• Modular, Simple Components– Scalable– Reliable– Flexible
• Time-Constrained
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SIMONS1SIMONT1
Digi Driver
Data Collection Modules (1 per device)
•••
Bed 1
Bed 2
Bed 3
Bed 14
Data Collector
SQL 2k
ODBC
Simon Packet Format
System Mgr.
Database Mgr.
Census AgentCensus Monitor
Event Engine
Alert Engine
Notify Engine
Report Engine
SIMONW1(Secure WWW Server)
trauma.mc.vanderbilt.edu
VUMC Census
VUMC StarPanel
sFTP
sFTP
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Research Hypotheses
• Identify failure of communication pathways (uncoupling)
• Linking systems, organs, cells, proteins, and genes
• Illuminate underlying control mechanisms
• …especially in the critically ill
New measurements, available through techniques of dense data capture and analysis, will:
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Short-Term HRV - SurvivalP
erce
nt T
ime,
ent
ire s
tay
5-minute HR Standard Deviation
00
0.5
0.5
1.0
1.5
1.0 1.5 2.0 2.5 3.0 3.5
N = 825
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Short-Term HRV - DeathP
erce
nt T
ime,
ent
ire s
tay
00
0.5
0.5
1.0
1.5
1.0 1.5 2.0 2.5 3.0 3.5
N = 98
5-minute HR Standard Deviation
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Short-Term HRV - Combined
Time normalizedwithin outcome
group
Per
cent
Tim
e, e
ntire
sta
y
00
0.5
0.5
1.0
1.5
1.0 1.5 2.0 2.5 3.0 3.5
N = 923
5-minute HR Standard Deviation
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Design DisastersConsequences of Blunders,
Bad Luck & Bias
• What is a Design Failure?• Why Do They Happen?• Examples
– “Recipes for Design Disasters”– Space Program– Transportation– Medical
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What is a Design Failure?
• Elements of Establishing Defect:– Identify the design defect– Establish a causal link to harm or cost– Identify alternate designs (correctable)– Compare to similar products
• “A product does not have a design defect when it is safe for any reasonably foreseeable use and meets all applicable functional specifications.”
Geddes, Medical Device Accidents With Illustrative Cases
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Example Design Defect(probably from urban legend)
Nurses in Pelonomi Hospital, South African hospital were baffled that every Friday morning the patient in one particular bed would be found dead! Investigation revealed that the cleaning person would unplug that bed’s life support equipment, in order to plug in her floor polisher when she did the floors each Friday. When finished, she would plug the equipment back in unaware that the patient was now dead.
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Example Design Defect
Definition• Identify defect
• Causal link
• Alternate designs• Comparison
Pelonomi Hospital Legend• Life support equipment
could be unknowingly unplugged
• Staff were not alerted when machine unplugged, patient died
• Alarms and batteries• All life-critical equipment
offered by vendors X,Y,Z have alarm & battery backup
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What is a Design Failure?
• There are plenty of definitions• Numerous example cases• In the end, failures are debatable
– Ultimately, court may have to decide– With testimony from experts– Sometimes difficult to separate liability
from design flaw– Negligence is a legal, not technical, term
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Why Do Designs Fail?At least three types of factors
• Blunders (Human Error)– “Everyone makes mistakes”
• Bad Luck (Random Effects)– “S*** happens”
• Bias– People sometimes believe what they
want to, irrespective of facts– Especially when money, power,
relationships are involved
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Example: $125M Blunder• 1999 Mars Orbiter• JPL, Lockheed• Metric vs. English
units• Erroneous orbital
entry calculation – engine burn time
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Example: Bad Luck (?)• Weather: A random effect• Dense fog on I-75
– 99 vehicle pile-up in TN – Killing 12, injuring 56
• Initially weather blamed• Then local paper mill
– $13.5M settlement– Once = bad luck– Many times = negligence?
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Example: Bad Luck
• Tacoma-Narrows bridge• Unforeseeable consequence of
lightweight design, wind profile• No human deaths• $5.2M in 1940,
~$70M today• (Insurance paid)
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Types of Bias
• “Statistical”– Sampling– Multiple comparisons– Repeated measurements
• Psycho-Social– Groupthink– “Corpthink”
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Examples: Statistical Bias
• More people die in hospitals than anywhere else, therefore don’t go to the hospital! (unfair sampling)
• Similar situation: A medical device designed only for the critically ill
• Randomized, controlled trials are part of the answer
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Examples: Statistical Bias
• Suppose you design a device that will roll a six every time – how many times do you need to test it?
• Which results do you report?• Increasingly an issue in medical drug
and device trials• 95% significance (p<.05) means that 1
in 20 studies is a false-positive
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Psycho-Social Biases
• Individual– Primacy: The first option mentioned
seems best– Recency: The last option seems best
• Group– Groupthink: Consensus rules– “Corpthink”: Desire to please those
higher in the chain of command
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NASA: Ripe for Disaster?• Huge shift in corporate culture
– Space race: Do it at any cost– Increasing cost concerns, cuts,
downsizing, resource pressure, etc.• Feynman, Challenger Disaster Report
– Engineer estimate of catastrophic failure: 1 in 100
– Management: 1 in 100,000– “What is the cause of management’s
fantastic faith in the machinery?”
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More Design Failures
• “Recipes for Disaster”– Ignition Source + Flammable Material– …
• More Examples– Transportation– Space Program– Software
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Hindenburg
• German airship• Caught fire while
landing in 1937• Design defect:
– Hydrogen?– Skin?
http://www.youtube.com/watch?v=F54rqDh2mWA
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Apollo 1
• Pad fire during test• Killed 3 astronauts• Design defects:
– 31 miles of electrical wire– Pressurized pure oxygen
environment– Flammable materials– Substandard wiring
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Medical Devices & Fire
Ignition Source• Electrocautery• Nerve stimulators• Short-circuit• Electrostatic discharge• Cigarettes• …
Flammable Materials• Anesthetic gas
– not so much today, ex. O2• Gases in the body,
especially GI system– Geddes reports ~10 cases of
GI explosions during procedures, some lethal!
• Bedding, clothing• Bandages• Cleaning solutions,
solvents, etc.
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Medical Software Design
• What type of [medical] technology is least regulated?– Software– There is no professional-level (i.e. PE)
certification for software engineering– Less regulation than devices/drugs
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Medical Software Design
• Design failures are being publicized• Computerized Physician Order Entry
– Cedars-Sinai software rollout– Multi-million dollar project scrapped– Software “endangered patient safety”– This story is not unique
• Privacy issues• Will software design failures increase?
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Summary – Clinical Engineering
• Definition of clinical engineering• Engineers’ role in the hospital?
– Technology design, management– Increasingly, information management– Clinical research, i.e. VUMC Trauma
• Differences between engineering and trade/craft skills (design & analysis)
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Summary – Design Disasters
• Geddes definition of design failure:– Identified defect– Causal link to harm– Available alternative– Deficiency w/ respect to other products
• 3 factors in design disasters:– Human error (blunder)– Random effects (bad luck)– Bias
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Sample Questions
Which is not an aspect of establishing design failure (according to Geddes)?
A. Identified defectB. Causal link to harmC. NegligenceD. Feasible alternative
design
What factor best differentiates engineers from trades/craftspeople?
A. Design and analytic skillset
B. Professional ethicsC. Ability to work in
highly regulated fieldsD. Salary
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Sample Questions
What kinds of bias is most likely encountered by an individual doing statistical analysis of complex data?
A. Unfair samplingB. GroupthinkC. RecencyD. All of the above
According to Feynman’s appendix to the Challenger disaster report, NASA engineers estimate probability of failure at about 1 in ________, compared to management’s 1 in ________ .
A. 10, 10000B. 1000, 1000C. 100, 100000D. 10000, 100
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References/Sources• clinicalengineering.duhs.duke.edu/• cms.clevelandclinic.org/anesthesia/body.cfm?id=124• www.healthsystem.virginia.edu/internet/clinical-eng/• www.wikipedia.org• www.ceasa-national.org.za/• www.mc.uky.edu/clinicalengineering/• cms.clevelandclinic.org/anesthesia/body.cfm?id=156• www.uams.edu/ClinEng/default.aspx• simon.project.vanderbilt.edu/• tafkac.org/medical/hospital_cleaning_lady.html• www.cnn.com/TECH/space/9909/30/mars.metric.02/• mars.jpl.nasa.gov/msp98/orbiter/• www.douglasjfeeslaw.com/achievements.jsp• gtresearchnews.gatech.edu/reshor/rh-ss01/fog.html• www.ralentz.com/old/space/feynman-report.html• youtube.com