EEE-3107: Industrial and Medical Instrumentation
Shekh Md Mahmudul Islam, Ph.D.
Assistant Professor
Department of Electrical and Electronic Engineering
University of Dhaka
Email: mahmud@du.ac.bd
https: sites.google.com/a/du.ac.bd/mahmudul-islam
Course Outline
Faculty Instructor: Dr. Shekh Md Mahmudul Islam (SMMI)
Tel: 01818402137
Office: 216
Office Hours (Only by Prior Appointments through E-mail): Monday & Wednesday
E-mail: mahmud@du.ac.bd
Join the Google Classroom with your DU E-mail ID using the code:
Recommended Textbooks:
1. “Medical Instrumentation: Application and Design,” Edited by John Webster,
Fourth Edition, Wiley
2. “Introduction to Biomedical Engineering,” Enderle and Bronzino, Elsevier
Course Objective
This course will cover principles, applications, and design of medical instrumentation:
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Basic Concepts of Medical Instrumentation
Basic Sensors and Principles
Amplifiers and Signal Processing
The Origin of Biopotentials
Biopotential Electrodes
Biopotential Amplifiers
Blood Pressure and Sound
Measurement of Blood Flow and Volume of Blood
Measurements of the Respiratory System
Chemical Biosensors
Clinical Laboratory Instrumentation
Medical Imaging Systems
Therapeutic and Prosthetic Devices
Electrical Safety
Evaluation Process
Tests and Evaluation:
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Class Attendance: 5%
Project Presentation: 5%
Mid Term: 20% (after week 6)
Term Final: 70%
Total: 100%
Grading: DU standard
Evolution of Health Care Systems
A sick child brought to the Temple of Aesculapius.
Courtesy of
http://www.nouveaunet.com/images/art/84.jpg.
A portrait of Florence Nightingale.
Courtesy of
http://ginnger.topcities.com/cards/
computer/nurses/765x525nighteng
ale.gif.
Modern Health Care Systems
•Advances in medical practice
• Advances in pharmaceuticals: penicillin, vaccines, …
•Advances in technology: ECG, X-ray…
•Advances in cellular and molecular research: tissue engineering, stem
cells,…
Evolution of Health Care Systems: ECG
(a) An early electrocardiograph machine and (b) a modern ECG setup. Computer technology and
electronics advances have greatly simplified and strengthened the ECG as a diagnosis tool.
Evolution of Health Care Systems: OR
Changes in the operating room: (a) the surgical scene at the turn of the century, (b) the surgical scene
in the late 1920s and early 1930s, and (c) the surgical scene today
From J. D. Bronzino, Technology for Patient Care, St. Louis: Mosby, 1977; The Biomedical Engineering
Handbook, CRC Press, 1995; 2000; 2005.
Modern Imaging Systems
(a) A modern fMRI medical imaging facility and (b) fMRI scan images.
http://neurophilosophy.wordpress.com.
Transplantations Performed Today
http://www.transplant.bc.ca/images/what_organs.gif.
Stem Cell Research
https://stemcells.nih.gov/info/basics/stc-basics/#stc-I
Biomedical Engineering Fields
Clinical Engineering
The range of interactions that a clinical engineer may be required to
engage in a hospital setting.
Recent Advances in
Biomedical Engineering
•Orthopedic Prosthetics
•Neural Prosthetics
•Tissue Engineering
•Stem Cell Research
Orthopedic Prosthetics
Paralympic sprinter Oscar Pistorius with a prosthetic leg. Designing for overall function, as
opposed to mirroring the human body, is often the more practical approach.
Compliments of http://www.thefinalsprint.com/images/2008/05/oscar-pistorius-doubleamputee-sprinter.jpg.
Neural Prosthetics
Dean Kamen's Luke Arm, the most advanced neural prosthetic to date,
which uses myoelectric signals. Clinical trials are presently underway.
Courtesy of http://medgadget.com.
Human Organs Grown in the Lab
•Stem cell derived for organ transplant, drug testing
and disease research
Moral and Ethical Issues
•Two Moral Norms: Beneficence and Nonmaleficence
•Beginning of Life
•Onset of Death
•Euthanasia
•Human Experimentation
•Regulation of Medical Devices
Beginning of Life
Using the inner cell mass to form pluripotent stem cells. Courtesy of
http://www.nih.gov/news/stemcell/primer.htm.
Beginning of Life
A Neonatal Intensive Care Unit.
Courtesy of http://www.pediatrics.ucsd.edu/Divisions/Neonatology/Pictures/Image%20Library/NICU%20Bed.jpg.
Basic Concepts of Medical
Instrumentation
Medical Instrumentation Application
and Design
EEE-3107
Medical Instrumentation System
Design Process
Simplified ECG System
Biostatistics
Sensitivity, Specificity and Prior Probability
Medical Measurement Constraints
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Low Frequency (DC-10kHz)
Low Power (V, 100mmHg)
Prone to Interference
Prone to Motion Artifacts
Safety Concerns
Regulation of Medical Devices
• FDA is a federal agency has been regulating food and
drugs since 1906
• FDA has been regulating medical devices to ensure
safety and effectiveness since 1938
• 1976 Medical Device Amendment:
– requires FDA approval before new devices are marketed
– requires human testing
Human Testing
• Clinical Research: medical research combined with
professional care (practice)
• Nonclinical Research: nontherapeutic (research)
• Governed by “Common Rule” outlined in Belmont report
Historical Reasons
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Nuremberg War Tribunal (1947)
Tuskegee Study (1932-1972), Clinton apology in 1997
Guatemala syphilis study (1946-1948), Obama apology in 2010
Thalidomide use (1950s-1960s), Gruenenthal apology in 2012
Radiation experiments (1940s – 1970s), Clinton apology in 1995
Reaction and Regulations
• Nuremberg code (1948): voluntary consent
• "Kefauver Amendment" (1962) to the Food, Drug and
Cosmetic Act, requiring drug manufacturers to prove to
the FDA the safety and effectiveness of their products
and physicians to obtain informed consent from
potential subjects before administering investigational
medications
• The Declaration of Helsinki drafted by the world Medical
Association in 1964 (most recently updated in 2000)
builds on the Nuremberg Code and is the basis for Good
Clinical Practices
Declaration of Helsinki
• Research with humans should be based on the results
from laboratory and animal experimentation
• Research protocols should be reviewed by an
independent committee prior to initiation
• Informed consent from research participants is
necessary
• Research should be conducted by medically/scientifically
qualified individuals
• Risks should not exceed benefits
US Regulations
• Due to the publicity from the Tuskegee Study, the
National Research Act of 1974 was passed
• The National Research Act created the National
Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research
• The Commission was to identify the basic ethical
principles that should underlie the conduct of biomedical
and behavioral research involving human participants
and to develop guidelines
Belmont Report
• The Belmont Report is a statement of basic ethical
principles and guidelines that provide “an analytical
framework to guide the resolution of the ethical problems
arising from research with human subjects.”
• The framework of the Belmont Report is presented in
three discussion topics:
– boundaries between practice and research
– basic ethical principles
– applications
Practice vs. Research
• The distinction between practice and research is blurred;
often because they occur together.
• The IRB must ensure that the researcher (and the
participant) distinguishes practice from research in both
social science and biomedical research
• Minimize the potential for therapeutic misconception –
when one believes the purpose of clinical research is to
treat rather then to gain knowledge
Basic Ethical Principles
• Respect for Persons
– Individuals should be treated as autonomous agents
– Individuals with diminished autonomy are entitled to protections
• Beneficence
– Do not harm
– Maximum possible benefits, and minimize potential harms
• Justice
– Fair distribution of burdens and benefits of research
Respect for Persons
• Treat individuals as autonomous persons; allow
individuals to choose for themselves
• Persons with limited autonomy need additional
protection, even to the point of excluding them from
activities that may harm them. The extent of protection
should depend upon the risk of harm, and the likelihood
of benefit.
• The judgment that any individual lacks autonomy should
be periodically re-evaluated, and will vary across
situations.
Beneficence
• The IRB should determine whether the risks to subjects
are reasonable in relation to anticipated benefits
• Obligations of beneficence affect both the researcher
and society –
– investigators are required to give forethought on maximization of
benefits and reduction of risk that may be involved in the
research
– society should recognize the longer term benefits and risk that
may result from the improvement of knowledge, and from the
development of novel medical, psychological, and social
processes and procedures
Justice
• Treat people fairly
• Do not exploit those who are readily available or
malleable
• Fair distribution of the risks and the benefits of research
based upon the problem/issue under investigation
Applications of Basic Principles
• Consideration of the three general principles in the
conduct of research lead to the consideration of:
– Informed Consent process
– Risk/Benefits assessment
– Selection of research participants
Medical
Instrumentation
Development
Process
Regulation of Medical Devices
• FDA is a federal agency within the Department of Health
and Human Services that has been regulating food and
drugs since 1906
• FDA has been regulating medical devices to ensure
safety and effectiveness since 1938
• 1976 Medical Device Amendment:
– requires FDA approval before new devices are marketed
– requires human testing
• http://www.fda.gov/MedicalDevices/ResourcesforYou/def
ault.htm
FDA Regulates
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Food
Drugs
Medical Devices
Radiation-Emitting Products (RF, laser, X-ray)
Vaccines, Blood & Biologics
Animal and Veterinary
Cosmetics (FDA regulated, not FDA approved, except
for color additives)
• Tobacco (since 2009)
FDA Program Centers
• Center for Biologics
• Center for Drug Evaluation and Research
• Center for Food Safety and Applied
Nutrition
• Center for Veterinary Medicine
• Center for Devices and Radiological
Health (CDRH)
Center for Devices and Radiological Health (CDRH)
• Ensure Safety and Effectiveness of
medical devices
• Eliminate unnecessary human exposure to
man-made radiation from man-made
medical, occupational, and consumer
products
Center for Devices and Radiological Health (CDRH)
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Office of Systems and Management
Office of Compliance
Office of Science and Technology
Office of Health and Industry Programs
Office of Surveillance and Biometrics
Office of Device Evaluations (ODE)
Market Submission Options
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Premarket notification 510(k)
Premarket approvals (PMAs)
Class I/II Exemptions
Humanitarian Device Exemptions (like
PMA without effectiveness requirement)
Clinical Trials
• Investigational Device Exemptions
Device Classification
(based on risk)
• Class I: General Controls
– -most exempt from Premarket Notification 510(k)
• Class II: General Controls and Special Controls
– most require Premarket Notification 510(k), may
require human testing
• Class III: General Controls and Premarket Approval
– most require Premarket Approval, which require
human testing
• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/
PCDSimpleSearch.cfm
General Controls
• Apply to all three classes
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registration
record keeping
labeling
reporting of adverse experiences
good manufacturing practices
Device Categories
• Preamendment: on the market prior to May 28, 1976
• Postamendment: automatically placed in Class III
• Substantially equivalent (to preamendment): same as
preamendment
• Implanted (assumed to be Class III)
• Custom: subject to general controls
• Investigational: undergoing clinical trial
• Transitional: used to be regulated as drugs
Premarket Notification 510(k)
• Requires companies to notify FDA 90 days before
marketing
• FDA determines:
– If the device is novel
– Safety and efficacy
– Substantially equivalent
• FDA has discretion to decide whether product requires
510(k) or PMA
Premarket Notification 510(k)
Required for:
• A limited number of special Class I devices
• All Class II devices, unless specifically exempted
• Preamendment Class III devices for which PMAs are not
currently required
Substantial Equivalence
• Same intended use and similar indications of use
• Same or similar technological characteristics
• SE must be based on comparison to a legally marketed
device
Substantial Equivalence
• Same intended use and similar indications of use
• Same or similar technological characteristics
• SE must be based on comparison to a legally marketed
device
Predicates:
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Legally marketed Class I or Class II device
Preamendment devices
Predicate cleared via “de novo”
Combination of predicates
De Novo Review
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Since 1997
Novel, but low risk device
Legally marketed Class I or Class II device
No predicates
First De Novo Action
• On December 16,1996, Cranial Technologies submitted
a 510(k) for the DOC Band Cranial Orthosis
• An alternative to surgery for the treatment of positional
plagiocephaly, meaning deformation of the head caused
by persistent positioning in one orientation.
• Device applies pressure and restricts growth persuading
a more symmetrical shape of the head.
First De Novo Action
• Predicate Devices:
– Boston Body Jacket - Used to correct scoliosis, employs
similar technology and identical materials.
– Halo Systems - Used as traction to stabilize the vertebrae
in the neck via metallic pins set in the skull.
First De Novo Action
• FDA disagreed and rated the DOC Band NSE
– Placed in Class III requiring premarket approval because there was no
predicate.
• After an unsuccessful appeal the company submitted a de novo request for
reclassification into Class II
• The company provided extensive data backing its position and suggested
several possible special controls to provide for safe and effective use of the
device
• Included outcome data from major clinical trials, protocols, summary data,
discussions, conclusions, new description of the device, refinement of
treatment ages and a revision of labeling
• The reclassification of the DOC Band (Cranial Technologies: Phoenix) into
Class II was ordered on May 29, 1998 via letter from ODE.