Safety Culture and Uncertainty Over Device Behaviour: The Limitations and Hazards of Telemedicine

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Safety Culture and Uncertainty Over Device
Behaviour The Limitations and Hazards of
Telemedicine
Chris Johnson University of Glasgow,
Scotland. http//www.dcs.gla.ac.uk/johnson ISSC
4th August 2003
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• Medical errors in 45,000-100,000 deaths (US).
• RTA43,000, Aids16,000.
• Additional care cost 15 billion
• 45 experience some medical mismanagement.
• 17 suffer events that prolong hospital stay.

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• Retrospective studies of patient records in NY
  State and Utah.

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• SE Virginia medical centres
• 1 nurse monitors system
• 49 remote patients
• 5 ICUs at 3 centres.
• Staff 50-80 of ICU budget.

Courtesy Univ. of Virginia, Office of
Telemedicine
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Courtesy NASA Telemedicine Instrumentation Pack
project
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Motivation
The benefits and costs of this blend of medicine
and digital technologies must be better
demonstrated before today's cautious
decision-makers invest significant funds in its
development. Telemedicine A Guide to Assessing
Telecommunications for Health Care Marilyn J.
Field, Editor Committee on Evaluating Clinical
Applications of Telemedicine, Institute of
Medicine
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Haemofiltration Device
Whats it saying? I dont know its stopped
saying it Ive no idea what was
happening What did you do? I dont know, I
just took it apart
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• That must be a record. I think thats worth
  minutingI think the thing is to reemphasise that
  we did have it working for 30 odd hours
• Sister leading the Renal Core Group

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• You know we said that their kidneys not working
  as well as it should? Well this machine is
  going to do the job of their kidneys

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Findings from MAUDE Safety Culture

• Telemedicine changes relationships
• clinicians and technicians but also
• device suppliers and device manufacturers.
• No common safety culture
• many incidents stem from poor communication.

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Findings from MAUDE System Uncertainty

• Introduction of telemedicine implies
• less clinical staff more technical staff
• technical staff dont understand
  devices/procedures?
• Increasing reliance on vendors guidance
• vendors in turn rely on manufacturers
• communication often breaks down or is too slow.
• So technicians often resort to coping strategies.

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Safety-Culture in Healthcare

• Strong safety-culture implies shared concern
  for safety.
• SINCE PLACEBO TREATMENT IS STILL ACTIVE IN
  REVISION 9 OF SOFTWARE, IT IS POSSIBLE TO
  UNINTENTIONALLY DELIVER PLACEBO TREATMENT.
• IT APPEARS COINCIDENTAL THAT reporter USED THIS
  PARTICULAR PASSWORD
• X-RAY TECH MAY SOMEHOW MISTOOK DEFAULT PHYSICS
  PASSWORD "9999" FOR "4444", WHICH MEANS OPERATOR
  WOULD HAVE ALSO CONFUSED TREATMENT PASSWORD WITH
  PHYSICS
• (MDR TEXT KEY 1490034)
• Complex nature of safety in healthcare
  applications
• Operator error? Physics Department Password?
  Developer neglect?

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Uncertain Diagnosis

• PATIENT HEART RATE OF 71 WITH CONSISTENT QRS (QRS
  waves monitor ventricular contraction on ECG).
• HOWEVER, BEDSIDE AND CENTRAL MONITORS INDICATED A
  Ventricular-Tachycardia ALARM (lower chambers of
  heart beating unusually fast).
• ALARM EXTINGUISHED WHEN BEDSIDE MONITOR
  DISCONNECTED FROM CENTRAL, INDICATING ERROR
  GENERATED BY CENTRAL MONITOR.
• CYCLING POWER ON CENTRAL STATION MONITOR RESTORED
  PROPER OPERATION.
• BIOMEDICAL TECHNICIAN SAYS MANUFACTURER
  ACKNOWLEDGED THIS CAN OCCUR AFTER PERIOD OF
  CONSTANT OPERATION WITHOUT ANY POWER DOWN.
• REPORTER UNDERSTANDS THIS TYPE OF DEVICE FAILURE
  HAPPENED IN 2 ICUs AT DIFFERENT TIMES.
• (MDR TEXT KEY 1505404)

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Uncertain Diagnosis

• Support staff use diagnostic skills to identify
  causes
• selective disconnect finds problem in central
  monitor
• uncertainty shown by previous unreported failures
  in 2 ICUs.
• Further analysis finds
• problem if V-Tach alarm suspended at bedside
• alarm is then set at central monitor and cannot
  be cleared.
• Problem known to manufacturer but not in the
  manual.
• Subsequently corrected by software upgrade.

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Uncertainty over New Technology

• EASITM software provides 12-lead ECG data on
  5-leads to patient.
• TELEMETRY TECH NOTED EASI 12-LEAD DISPLAY ON
  CENTRAL STATION FROM TRANSMITTER THAT WASNT EASI
  CAPABLE.
• CUSTOMER ENGINEER REPLACED TRANSMITTER AND
  RELOADED CENTRAL STATION SOFTWARE, CONFIRMED ALL
  SIGNALS WERE CORRECTLY TRANSMITTED AND LABELED.
• CUSTOMER DID NOT UNDERSTAND DIFFERENCE BETWEEN
  STANDARD ECG AND EASI.
• CUSTOMER WAS RETRAINED TO FURTHER THEIR
  UNDERSTANDING OF DIFFERENCE.
• (MDR TEXT KEY 1379795)
• Less electrodes reduce work for nurses, improves
  patient comfort.

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Uncertainty over New Technology

• Social implications clinicians and support rely
  on suppliers explanations.
• Symptomatic of system safety problems
• manufacturers gain insights that should be
  caught earlier in development.
• Retraining is proposed, no idea of systemic
  causes of human error?
• DURING INVESTIGATION, ENGINEERS CONFIGURED A
  SYSTEM IN SAME SETUP AS CUSTOMER.
• FOUND MAINFRAME RECEIVERS CAN RECEIVE INCORRECT
  BIT TO MISIDENTIFY TRANSMITTER AS EASI CAPABLE
• Report doesnt state how to prevent
  mis-configuration.

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Uncertainty and Reliability

• End-user frustrated by device unreliability and
  manufacturers response
• SEVERAL UNITS RETURNED FOR REPAIR HAD FAN
  UPGRADES TO ALLEVIATE TEMP PROBLEMS. HOWEVER,
  THEY FAILED IN USE AGAIN AND WERE RETURNED FOR
  REPAIR
• AGAIN SALESMAN STATED ITS NOT A THERMAL PROBLEM
  ITS A PROBLEM WITH Xs Circuit Board.
• X ENGINEER STATED Device HAS ALWAYS BEEN HOT
  INSIDE, RUNNING AT 68C AND THEIR product ONLY
  RATED AT 70C.
• ANOTHER TRANSPONDER STARTED TO BURNSENT FOR
  REPAIR. SHORTLY AFTER MONITOR BEGAN RESETTING FOR
  NO REASON (MDR TEXT KEY 1370547)
• Manufacturers felt reports not safety-related
• reports relate to end-user frustration regarding
  product reliability (not safety).

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Uncertainty and Reliability

• Telemedicine applications developed by groups of
  suppliers
• flexibility and cost savings during development,
  manufacture, marketing
• problems if incidents stem from sub-components
  not manufactured by suppliers
• incident reports must be propagated back along
  the supply chain.
• Manufacturer states problems stem from
  subcontractors circuit board
• more problems after faulty board replaced,
  customer returns unit again
• connectors to PCB not properly seated but still
  passes acceptance test?
• connector not seated completely during initial
  repair and gradually loosens over time?

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Uncertainty and Reliability

• Fly-fix-fly approach undermines attempts to
  improve patient safety.
• Confused dialogue between clinician, vendor,
  manufacturer
• End-user may see technical issues as form of
  excuse (eg PCB connectors)
• Device repairs not only rectify problems, they
  introduce new ones
• compounds end-user uncertainty and distrust of
  device reliability
• communication fails and shared safety culture
  erodes over time.

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Uncertainty and Complexity

• IN SOFTWARE RELEASE VF2, IF PATIENT IN
  "AUTOADMIT" MODE, PARAMETER DATA AUTOMATICALLY
  COLLECTED AND STORED IN THE SYSTEMS DATABASE,
• IF THE PATIENT LATER REMOVED (BUT NOT DISCHARGED)
  FROM ORIGINAL BED/NETWORK LOCATION, DATA
  COLLECTION TEMPORARILY DEACTIVATED (EG DURING
  MOVE FOR TREATMENT).
• PROBLEM PRESENTS WHEN NEW PATIENT ADMITTED TO
  SAME BED/NETWORK LOCATION, BUT ORIGINAL PATIENT
  WAS NEVER DISCHARGED WHILE CONNECTED TO THAT
  LOCATION.
• NEW PATIENT ADMISSION BEGINS STORING DATA IN
  DATABASE APPROPRIATELY. HOWEVER, IN PARALLEL,
  DATABASE INCORRECTLY APPENDS NEW PATIENT DATA ON
  TOP OF OLD PATIENT'S DATA RECORD
• (MDR TEXT KEY 1340560)

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Uncertainty and Complexity

• Wicked problem difficult to recreate
  conditions for failure to occur.
• No problem occurred if
• patient data entered in AUTOADMIT not MANUAL.
• patient returned to monitor after treatment if no
  new patient used it in meantime.
• original patient reconnected to another monitor
  then no problem.
• Even once company found context of incident, hard
  to trace causes
• In previous versions, no more data collected
  until patient re-connects to new monitor
• new distributed monitoring function creates
  relatively complex hazard.
• Company recodes software for all deployed
  monitoring systems.

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Conclusions

• Clinicians increasingly rely on technicians who
  are often
• Extremely uncertain about device behaviour
• Poorly trained and equipped to identify causes of
  adverse events.
• On the supply side, manufacturers and
  distributors often
• Cannot recreate the failures that are reported
• Rely upon incident reporting to debug aspects of
  their systems.
• Fly-fix-fly and basic unreliability of devices
• undermines communication and shared safety
  culture
• may ultimately erode clinical confidence in many
  aspects of telemedicine.

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Conclusions

• No quick fixes but
• Regulators need to focus on dialogue between
  manufacturers and users
• Consider detailed training requirements for
  telemedicine before approval
• Especially look at end-user maintenance and
  configuration issues
• Introduce training in safety and risk management
  for support staff?
• Things are only going to get worse

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Da Vinci, 1st robotic aid approved by the FDA
New York Presbyterian Hospital uses it on atrial
septal defects. Fly-by-wire technology,
enhanced 3D virtual display of site. Ave.
hospital stay 7-10 days (traditional) now 3 days
(N17).
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• Roboscope
• Removing deep-seated brain tumours.
• Robot holds endoscope and allows constrains
  surgeons motions to a specific region.
• Involves MRI processing, ultrasound guidance,
  robotics and visualisation. (http//www.me.ic.ac.u
  k/case/mim/)

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Questions?

• Thanks are due in particular to
• David Wright,
• Intensive Care Unit,
• Edinburgh Western General Hospital.
• Barbara Holland,
• Paediatric Intensive Care Unit,
• Yorkhill Hospital, Glasgow.
• Clinical Negligence and Other Risks Scheme,
• Scottish Executive.

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bad
good
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bad
Scenario 1 Weight Dose Error (Human-Factors)
good
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bad
Scenario 2 Infusion (Technological)
good
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bad
Scenario 5 Doppler (FHR)
good
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Low-Tech Reports

• A TECHNICIAN FOUND THAT TABLE WAS WORKING
  ACCORDING TO SPECIFICATIONS, NO COMPONENTS WERE
  BROKEN
• CAUSE APPEARS TO BE USER ERROR IN IMPROPERLY
  TIGHTENING HEAD SECTION THUMB SCREWS.
• TECHNICIAN DISCUSSED IMPORTANCE OF PROPERLY
  TIGHTENING THUMB SCREWS WITH HOSPITAL BIOMEDICAL
  DEPARTMENT.
• (MDR TEXT KEY 1506987)

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Higher-Tech Reports

• DOSE CALCULATOR FUNCTION FOR A NITROGLYCERIN DRIP
  PROGRAM CHANGES FROM Micrograms (MCG) ON ONE
  SCREEN TO milligrams (MG) ON THE NEXT.
• DECIMAL POINT IS NOT EASY TO READ AND DOSING
  ERROR MAY NOT BE NOTICED.
• ALLOWS 10 OF THE DESIRED DOSE TO BE DELIVERED.
• SOFTWARE CHANGES RELEASED THIS SUMMER.
• (MDR TEXT KEY 1128586)