Transcript Causes of Device Accidents

Causes of Device Accidents
(taxonomy used in MDSR)
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Device Factors
External Factors
Tampering and Sabotage
Support System Failures
User Factors
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Causes: Device Factors
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Device Failure
Design or Labeling Error
Manufacturing error
Packaging Error
Software Deficiency
Random Component Failure
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Causes: Device Factors (cont.)
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Failure of an Accessory
Invalid Device Foundation
Device Interactions
Improper maintenance, testing, repair,
or lack or failure of pre-use incoming
inspection
• Device Interactions
• Improper Modification
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Causes: External Factors
• Power Supply Failure
– Including compressed medical gases
• Medical Gas / Vacuum Systems
• Electromagnetic or Radio Frequency
Interference (EMI or RFI)
• Environmental Conditions
– Temperature, Humidity, Light
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Causes: Tampering/Sabotage (Rare)
• Family Member
• Patient
• Healthcare worker
– Doctor
– Nurse
– Aide
• Enemy
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Causes: Support System Failure
• Poor Device Evaluation During Tendering Process
• Lack or Failure of Incoming and Pre-Use
Inspections
• Using Inappropriate Devices
• Improper Storage
• Failure to Train and Credential
• Poor Incident/Recall Reporting System
• Lack of Competent Accident Investigation
• Failure to Impound Incident Devices
• Error in Hospital Policy
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Mechanisms of Injury Taxonomy
(used in MDSR)
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Overdose
Underdose
Wrong Drug
Infiltration
Extravasation
Barotrauma
Suffocation
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Hemolysis
Coagulopathy
Exsanguination
Hemorrhage
Ischemia
Hypothermia
Hyperthermia
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Mechanisms of Injury
• Failure to Deliver
Therapy
• Monitoring
Failure
• Mis-diagnosis
• Electrical Shock/
Electrocution
• Burn (thermal,
chemical, elec.)
• Pressure Necrosis
• Mechanical (cut,
crush, puncture)
• Embolism (gas or
particulate)
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Mechanisms of Injury
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Infection
Particulates
Anaphylaxis
Fire
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Oops!
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Device
Accidents
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Causes: User Error
• User Error vs. Device Malfunction
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Examine instructions and labeling.
Was device used according to instructions?
Was device properly assembled?
Was the user familiar with the instructions?
Does device design invite user error?
If findings are undecided, consider
idiosyncratic patient reaction to device or
therapy.
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User Error: References
• Institute of Medicine, Committee on Quality of
Health Care in America. Kohn LT, Corrigan JM,
Donaldson MS, eds. To Err is Human: Building a
Safer Health System. Washington, D.C.: National
Academy Press, 1999. Available from National
Academy Press, tel:800-624-6242 or 202-3343313.
• Leape LL. Error in medicine. JAMA 1994, Dec
21: 272(23); 1851-1857.
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Causes: User Error
50 - 70% of Device Accidents
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Pre-use inspections
Labeling
Mis-assembly
Mis-connection
Improper (“bad”)
connection
• Incorrect clinical use
• Incorrect control
settings
• Incorrect
programming
• Spills
• Abuse
• Inappropriate reliance
on automated features
• Failure to monitor
• Maintenance or
incoming inspection
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Causes: User Error (cont.)
• Improper maintenance, testing, repair, or
lack or failure of pre-use incoming
inspection:
– Rare cases
– Infant Incubators: back-up thermostats mis-set
– Pneumatic tourniquet: poor grounding and EMI)
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User Error vs. Device Malfunction
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Examine instructions and labeling.
Was device used according to instructions?
Was device properly assembled?
Was the user familiar with the instructions?
Does device design invite user error?
If findings are undecided, consider
idiosyncratic patient reaction to device or
therapy.
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User Error: Patient
as User
• Homecare Technologies
– Orthopedic Implants, IV & Feeding Pumps,
Ventilators, Glucose Meters, Oxygen
Concentrators, Dialysis
• Mis-Use
• Device design and labeling for lay
user even more important
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Accident Investigation Overview
• Government and Ministry of Health
Role
• Difficulties
• Device Interfaces
• Preservation of Evidence
• Third Party Investigations
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Government’s Role
• Public Safety
• Regulatory oversight of vendors and
importers
• Data Collection
• Data Analysis
• Investigation?
• Recall Authority
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Difficulties
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Diversity of Technologies
Numerous Causes of Injuries
Lines of Communication
Variable Biological System (i.e.,
Patient)
• Limited information available to
manufacturer
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Difficulties: Diverse Technologies
• >5000 Device Types
• Unique Testing and Investigative
Approaches for Each Technology
• The Investigative Process is what is
important
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Difficulties: Lines of Communication
Patient’s
Attorney
Purch. Dept.
Clinicians
Risk Manger
Biomedical Eng.
Third Party
Investigator
Suppliers
/Mfrs.
Administration
Regulators
Insurer
Attorneys
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ECRI Case Histories
• Accident Investigator
–Fatal Misconnection
–Hazards of New Technology
–Junk Science and Expert
Testimony
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Cardiopulmonary Bypass Accidents:
Involved Devices
• Reusable
– Bypass Pump
Consoles
– Gas Blenders
– O2 Saturation Mon.
– Anesth. Vaporizers
– Gas Regulators
– Gas Flowmeters
– Bubble Detectors
• Disposable
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Tubing Circuits
Oxygenators
Arterial Blood Filters
Cardiotomy
Reservoirs
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Cardiopulmonary Bypass Accidents:
Mechanisms of Injury
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Gas Embolism
Coagulopathy
Exsanguination
Anoxia
Hypersensitivity
Haemolysis
Others
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Gas Embolism Accidents
• C-P Bypass Units
• Haemodialysis Units
• Blood Recovery
Systems (Cell Savers)
• Gas-Cooled Laser
Fibers
• Insufflators
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Laparoscopic
Hysteroscopic
Ophthalmic
Arthroscopic
• Central Venous Cath.
• Ruptured Balloons:
– Intra-Aortic Pumping
– PTCA Balloons
• Nitrogen Gas
Powered Surgical
Instruments
• Infusion Devices
• Radiographic Dye
Injectors
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Electrosurgical (ESU) Accidents
• Return electrode (“grounding pad”)
– Poor Site Preparation
– Non-uniform Conductivity
– Repositioning (pad or patient)
• Alternate Current Pathways (injury away from
operative site or pad)
• Malfunction of ESU Active Pencil
• Failure to use holster
• Failure to use activation tone
• Organ Perforations
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Physiologic Monitoring Accidents:
Risk/Accident Considerations
• Alarm Design
• Accessory Transducers
– Blood pressure
– Intra-cranial Pressure
– Intrauterine pressure
• Accessory Cables and
Leads
• Software
– Arrhythmia Detection
– Patient Data Systems
– Memory/Trending
• Telemetry Systems
• Equipment Interfaces
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Bedside Monitors
Central Stations
Telemetry Transmitters
Patient Data Systems
• Human Factors
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Ventilator Accidents:
Risk/Accident Considerations
• Alarm Design
• Accessories
– Breathing Circuits
– Bacterial Filters
– Humidifiers
– External Monitors
• Software
– Version
– Patient Data Systems
• Equipment Interfaces
– Central Stations
– Patient Data Systems
• Human Factors
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Device Interfaces
• Device - User
• Device - Patient
• Device - Accessories (Including
disposable devices)
• Device - Environment
– Hospital
– Ambulance
– Home
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Device Interfaces
Environment
Hospital / Home
• Electric Power
• Medical Gas
• Heat, Humidity, Light
Device
Patient
Ventilator
User
• Breathing Circuits
• Heated Humidifier
• Exhalation Filter
Accessories/Disposables
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Medical Device Problem Recognition:
Based on Patient-Centered Concept
Users:
Many devices used for
diagnosis, treatment,
monitoring, and care
Accessories/Disposables
Breathing Circuit
Heated Humidifier
Exhalation Filter
Tracheal Tube
Water Trap
Patient
Medical Devices and
Equipment
Medications
Reagents
Solutions
Dyes
User Facility/Home Environment
Medical Gas
Electric Power
Heat, Humidity, Light
Support Systems
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Preservation of Evidence
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Disposables - Save all!!
Photographs
Control Settings
Error Codes in Device Memory!!!
Cleaning/Processing
Sequestering Devices
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Preservation of Evidence
• For Non-Serious Event:
– Hospitals do own investigation
– Return device to vendor (see form letter in AI
book chapter)
• Specify no destructive testing
– Document correspondence & shipping
documents
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Preservation of Evidence
• For Serious Event:
– Hospitals typically never give up the device
• Vendor
• Regulatory Authority?
– Investigate in-house (or with 3rd party)
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Third Party Investigation:
When is it indicated?
• Serious Events
• Augment, parallel or substitute your
investigation
• If high probability of litigation
• Insufficient workforce, expertise, or test
equipment
• Expert qualifications needed
• Elimination of bias
• Political considerations
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Accident Investigation Guidelines:
Getting Started
• Immediate Action Plan (hospital or vendor)
• Investigation Team
– Members (each with own responsibilities):
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Clinical Department Head
Clinical Staff Members
Risk Manger
Biomedical Engineering
Legal Counsel
Safety Committee
– Not on Team: Anyone responsible for patient or
device.
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Responsibilities
• Clinicians (Doctors, Nurses): Do’s
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Respond to the injury
Preserve evidence
Record information
Instruct witnesses to temporarily withhold
comments
– Report incident to Risk Manager, etc.
– Notify Biomedical Engineering
– Help determine if device caused or contributed
to incident
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Responsibilities
• Clinicians (Doctors, Nurses): Do Not’s
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Contact vendors/suppliers
Contact Government Agencies
Release equipment
Test equipment independently
• These “Do Not’s” apply immediately after
the incident but may become “Do’s” later.
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Responsibilities
• Biomedical Engineers: Do’s
– Impound devices
– Consult with clinicians to determine device
contribution to incident
– Help determine if 3rd party investigation is
needed
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Responsibilities
• Biomedical Engineers: Do’s
– Help collect information
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Serial Numbers
Model Numbers
Inspection records
Software revisions
Displayed data
Instrument settings
Alarm settings
Maintain device memory data!!!
Other relevant parameters
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Responsibilities
• Biomedical Engineers: Do’s
– List other involved equipment (disposables too)
– Determine sources of power, compressed gases,
and vacuum
– Collect service information
• Who serviced last
• When last services
• What modifications made, before or after incident
– Research other reported problems
(information resources)
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Responsibilities
• Biomedical Engineers: Do’s
– When Asked to:
• Examine equipment
• Test to determine if device caused or contributed to
incident
• Prepare report
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Responsibilities
• Biomedical Engineers: Do Not’s
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Contact vendors/suppliers
Contact Government Agencies
Release equipment
Test equipment independently
• These “Do Not’s” apply immediately after
the incident but may become “Do’s” later.
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Responsibilities
• Risk Manager - Hospital:
• QA/Reg Affairs Manager - Vendor:
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Develops investigation strategy
Coordinates investigation
Collects information about the incident
Consult with clinicians to determine device
contribution to incident
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Responsibilities
• Risk Manager - Hospital:
• QA/Reg Affairs Manager - Vendor:
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Controls communication with outside parties
Helps determine liability
Takes steps to to prevent similar incidents
Liaison with Insurer
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Responsibilities
• Risk Manager:
• QA/Reg Affairs Manager - Vendor:
– Takes steps to minimize damage to
hospital’s/vendor’s reputation
– Helps determine need for 3rd party
investigation
– Communicates with all departments regarding
conclusions of the investigation
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Responsibilities
• Risk Manager:
• QA/Reg Affairs Manager - Vendor:
– Helps determine whether device(s) caused or
contributed to incident
– Communicates with regulatory agencies
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Guidelines: How to Investigate
• Time is critical
• Elements of an Investigation
– Preserve and impound evidence
– Collect and review information-patient and
device related
– Interview personnel
– Assess the injury
– Inspect and test devices
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Guidelines: How to Investigate Approaches
• ECRI References
– Technology and Systems Related Information
• Root Cause Analysis (RCA)
– Joint Commission on Accreditation of
Healthcare Organizations (JCAHO)
– Airline Industry
– Why, Why, Why….
• Remember: Examine the “Big Picture”
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Guidelines: How to Investigate Approaches
• “Root Cause” Analysis (RCA)
– “A process for identifying the basic or causal
factors that underlie variation in performance.”
• Applies to Devices, Systems, Policies, and
Procedures
• Causal Tree Analysis Handout
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Guidelines: How to Investigate Approaches
• “Root Cause” Analysis (RCA) Seeks:
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Proximate cause
Systemic Cause
Common Cause Variation
Special Cause Variation
Risk Points
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Guidelines: How to Investigate Approaches
• “Root Cause” Analysis (RCA) Tools:
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Flow Charts
Cause and Effect Fish-bone Diagrams
Pareto Charts
Scatter Diagrams
Failure Mode, Effect, and Criticality
Analysis
– Fault Tree Analysis
– Barrier Analysis
– Change Analysis
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Guidelines: How to Investigate Approaches
• RCA
• Root “Canal” Analysis
(can be a painful experience)
• Why, Why, Why…
–Why me?
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Guidelines: How to Investigate Approaches
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Causal Tree Analysis (handout)
Reasoning from general to specific
Working backwards in time
Several sub-events need to occur for a
negative event (accident) to occur
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Medical Device Accident
Investigation Seminar
QUESTIONS?
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