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Chapter 20: Product Issues. Design of Biomedical Devices and Systems By: Paul H. King Richard C. Fries. Product Safety & Legal Issues. Risk Assessment What failure could cause harm to the patient or user? What misuse of the device could cause harm? Liability Assessment

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chapter 20 product issues

Chapter 20: Product Issues

Design of Biomedical Devices and Systems


Paul H. King

Richard C. Fries

product safety legal issues
Product Safety & Legal Issues
  • Risk Assessment
    • What failure could cause harm to the patient or user?
    • What misuse of the device could cause harm?
  • Liability Assessment
    • Have all possible failure modes been explored and designed out?
    • Have all possible misuse situations been addressed?
  • Freedom from accidents or losses
  • A function of the situation in which it is measured
    • Drinking water & kidney failure
  • A measure of the degree of freedom from risk in any environment
  • Accident – unwanted or unexpected release of energy
  • Mishap – unplanned event or series of events that result in death, injury, occupational illness, damage to or loss of equipment or property, or environmental harm
  • Multiple factors that flow in series until the system is out of control and a loss is produced
    • Anticipation simpler problems
    • Opportunities for interruption
how do engineers deal with safety problems






How Do Engineers Deal With Safety Problems?
  • Operational or Industrial Safety
    • Examination during operational life
    • Correcting unacceptable hazards
  • Goal: design an acceptable safety level into the system before actual production or operation
safety and reliability
Safety and Reliability
  • Safety – only concerns itself with failures that introduce hazards
  • Reliability – probability of failure of a device to meet its requirements
safe system
Safe System
  • One in which damage to persons or property doesn’t happen often or, when it does, the damage is minor
  • Small damage potential
    • Able to occur more often
    • Still considered Safe
  • Large damage potential
    • Chance for mishap small
  • System that fails all the time can still be safe
  • System can be up and running all the time and consistently put people at risk
    • Reliable system, but not Safe
example pacemaker
Example: Pacemaker
  • Pacemaker that paces at 110 beats per minute continuously no matter what is very RELIABLE
  • If patient is in cardiac failure, high pacing rate is medically inappropriate. UNSAFE
  • Reliable but Unsafe device
mttf mtbf
  • Mathematical laws of probability used to estimate reliability
  • Published values for reliability measures:
    • Mean Time To Failure
    • Mean Time Between Failure
legal aspects of safety
Legal Aspects of Safety
  • 3 Most Common Theories of Liability:
    • Negligence
    • Strict liability
    • Breach of warranty
  • One should pay for injuries that he causes when acting below the standard of care of a reasonable, prudent person participating in the activity of the action in question
  • People have the right to be protected from unreasonable risks of harm
  • A manufacturer that does not exercise reasonable care or fails to meet a reasonable standard of care in the manufacture, handling, or distribution of a product may be liable for any damages caused.
strict liability
Strict Liability
  • Focus on product
  • One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer or to his property if the seller is engaged in the business of selling such a product, and it is expected to and does reach the user or consumer without substantial change to the condition in which it is sold.
  • Risk/benefit analysis
breach of warranty
Breach of Warranty
  • 3 Types
    • Breach of implied warranty of merchantability
    • Breach of the implied warranty of fitness for a particular purpose
    • Breach of an express warranty
system safety
System Safety
  • Fail-safe – designed to fail into a safe and harmless state
  • Enter safe states by terminating or preventing hazardous conditions (lockouts or shutdown systems)
  • Should be able to work despite failure of other functions
hardware safety
Hardware Safety
  • Techniques for reducing failure of component:
    • Component derating
    • Safety margin
    • Load protection
software safety
Software Safety
  • Safety is a concern when used to control potentially unsafe systems
verification validation of safety
Verification & Validation of Safety
  • Proof of Safety
  • Verification – capture the semantics of the hardware, software code, and the system behavior
  • Fault-tree analysis
effective safety program
Effective Safety Program
  • Implementation of internal hazard analysis procedures, a firm grasp of regulatory and other standards, and an awareness of the current industry practice regarding safety controls
  • Figure 20-1 Safety Analysis Checklist
accident reconstruction forensics
Accident Reconstruction & Forensics
  • Biomedical Engineers may be used to analyze accidents
  • Analysis of Medical Device accidents
  • Discussion on biomechanics and accident investigation
medical device accidents
Medical Device Accidents
  • Process for a medical device accident investigation

p. 456

  • Case: Pressure Limited Pump
biomechanics traffic accident investigations
Biomechanics & Traffic Accident Investigations
  • Data Collection
    • National Highway Transportation Safety Administration (NHTSA)
  • Injury Estimation
    • Abbreviated Injury Scale (AIS)
  • Impact Analyses
    • Accident report, crush patterns, etc to estimate probable outcome