Medical Device Accidents and Their Engineering Analysis

3 credit hours
when offered

Course Organizer:   L.A. Geddes

Guest Lecturers:   To be selected when appropriate

Text:  
	Handbook of Electrical Hazards and Accidents.  L.A.Geddes, CRC Press 1995
	Handout lecture notes and published papers.

Prerequisites
Seniors and graduate students in engineering.  Those not in engineering can be
 enrolled subject to instructor approval, based on background courses taken.

Objective:
This course is designed to train the student the techniques of forensic 
engineering as they apply to  assigning culpability in medical device accidents.
  Selected, real-world cases are presented and analyzed to provide examples.
  The subject material covered appears on the attached list.

General Plan:
	The general plan of the course involves presentations of the relevant
 physiology and pathophysiology associated with the use of a medical device.
  Then the principle of operation of the device is covered, followed by an 
analysis of the evidence related to a medical device accident.  The student
 is required to construct all possible scenarios for the accident.  Finally,
 the student must select the most logical and defend his/her choice and 
assign culpability.

	This is a dual-level course that will meet twice weekly, each lecture
 being 1 1/2 hours long.  The lectures will be supported by demonstrations.
  Homework and outside reading will be required. 

Topics Covered in the Course:

Product Liability and Medical Technology
        Introduction
        Medical Technology
        Product Liability
                Product Defect
                Misuse
                Negligence
                Design Defect
        Medical Device Reports
        The Incident Report
        Minimum Product Liability World

Electromagnetic Interference (EMI) and Electrostatic Discharge (ESD)
        Introduction
        Sources of EMI
                Radio Broadcasting
                Television
                Public Safety and Land Transportation
                Amateur Radio and Citizens Band
                Industrial, Scientific and Medical
                Radar
        Frequency, Wavelength and Antenna Effect
        Skin Depth
        Modulation
        Examples of Malfunction Due to EMI
                Patient Simulator
                Electrical Equivalent for a Subject
                Electroencephalographic Interference
                Electrocardiographic Interference
                Impedance-Based Apnea Monitor Mishap
                Monitor Alarms
                Mechanism of Death Due to Apnea
                Susceptibility to EMI
                Ventilator Mishaps
                Drug-Infusion Mishaps
                Powered-Vehicle Mishaps
        Cellular and Mobile-Telephone Generated EMI
                Infant Radiant Warmer Mishaps

Cardiac Pacemakers
        Introduction
        Closed-Chest Cardiac Pacemakers
        The Cardiac Cycle
        Three-Letter Code
        Communication With an Implanted Pacemaker
        Effect of EMI on Pacemaker Function
        Pacemaker Malfunction Due to Electrosurgery
        Abandoned Pacemaker Lead
        Mobile Telephone-Generated EMI
        Pacemaker Malfunction Due to Cellular Phones
        Pacemaker Malfunction Due to Magnetic Resonance Imagers
        Pacemaker Malfunction Due to Microwave-Oven EMI
        Pacemaker Malfunction Due to Low-Frequency EMI
        Pacemaker  Malfunction Due to Arc-Welding Machines

Ventricular Fibrillation and Cardioversion
        Electrostatic Discharge
                Introduction
                ESD Testing
                Mechanism of Action
                ESD Incidents
                Effect of ESD on Human Subjects

Electrosurgery
        Introduction
        Electrodes
        Dispersive Electrodes
                Conductive Dispersive Electrodes
                Capacitive Dispersive Electrode
                Dispersive Electrode Monitors
                Patient Sentry
                Current Comparator
                Patient Return Monitor
                Performance Standards
        Types of Current
        Isolated Output Electrosurgical Unit
        Tissue Responses
                Cutting
                Desiccation
                Coagulation
                Argon - Enhanced Coagulation
                Current Crowding
        Complications With Electrosurgery
        Muscle Contraction
                Mechanism of Muscle Stimulation

Anesthesia
        Introduction
        Anesthesia Machine
                In-Circuit Vaporizer Machine
                Out-of-Circuit Vaporizer Machine
        Endotracheal Tube
        Auxiliary Equipment
        Monitoring Equipment
                Anesthesia-Machine Monitoring
                Patient Monitoring
                Alarms
        Anesthesia Machine Mishaps
        Carbon-Dioxide Absorber Failure
                Valve Malfunction
                Leaks and Disconnects
        Pulse Oximeter
                Introduction
                Principle of Operation
                Oxygen Saturation
                Hazards and Accidents With Pulse Oximetry
        Impedance Cardiography
        Burns From Warming Devices
        Fire
        Introduction
        Endotracheal-Tube Fire
                Electrosurgically Induced Fire
                Laser Induced Fire

Catheter Accidents
        Introduction
        Intravascular Catheter Incidents
                Catheter Pinchoff
                Conducting Properties of Fluid-Filled Catheter
                Catheter Electrode Pinchoff
                Current Sinks and Sources
                Electrosurgically Induced Ventricular Fibrillation WithFluid-Filled
                                    Catheters
                60-Hz Leakage Current Induced Ventricular Fibrillation

Direct-Current Injury
        Introduction
        Iontophoresis
        Complications With Iontophoresis

Transcutaneous Electrical Nerve Stimulation
        Introduction
        Mechanisms of Pain Inhibition
        Current-Pulse Characteristics of TENS Units
        The Stimulator
        Electrode Placement
        Electrode Types
        Standards of Performance
        Complications With TENS Units

Experiences That May Help Technical Experts
        Introduction
        The Technical Expert
        Attorneys
        Discovery
        The Report
        The Deposition
        The Courtroom
        Payment for Services

For further information regarding the Biomedical Engineering Program at Purdue University contact the Biomedical Engineering Graduate Office at (317) 494-5730 bmeprogram@ecn.purdue.edu