Introduction to biomedical devices

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UNIT 1
Introduction to biomedical devices
Biomedical Devices
Biomedical Engineering
INDEX
➢ Biomedical Engineering Events
➢ Introduction to Biomedical Devices
➢ Categories of Medical Devices 
➢ Classes of Medical Devices (FDA)
➢ Classification of Medical Device 
equipment and tools
INTRODUCTION
(460 B.C.) (335)(1000 B.C)
BIOMEDICAL ENGINEERING EVENTS
Big toe prosthesis
Hipócrates in medicine
First hospital
(1485)
Leonardo Da Vinci
(1508)
Iron hands
(1696)
First below-knee prosthesis
(1895) (1903)(1700)
X - Rays
Electrocardiogram
(1924)
Electroencephalography
(1944) (1953)
First artificial heart-lung
Electrical conduction in living 
beings
First artificial kidney
(1972)
Magnetic
Resonance
BIOMEDICAL ENGINEERING EVENTS
(2011) (2017)(2001)
Robotics and bionics
Diagnosis of Atrial 
Fibrillation SMARTWACHT
Glucowatch
(1980)
Graphite Fiber Prosthesis
(2001)
Conferences in Latin America
BIOMEDICAL ENGINEERING EVENTS
INTRODUCTION
▪ Biomedical Engineering is a scientific and technological discipline that applies electronic, mechanical,
chemical or other engineering principles to understand, modify or control biological systems and to
design and manufacture products capable of monitoring physiological functions and assisting in the
diagnosis and treatment of patients (Bronzino, 2000).
INTRODUCTION TO BIOMEDICAL DEVICES
INTRODUCTION TO BIOMEDICAL DEVICES
▪ Biomedical devices, are considered to be any in vitro instrument, apparatus, implement,
machine, reagent or calibrator, computer application, material or other similar or related
article, intended by the manufacturer to be used on humans, alone or in combination, for
one or more of the following specific purposes:
• Diagnosis, prevention, monitoring, treatment or relief of a disease.
• Diagnosis, monitoring, treatment, relief or compensation of an injury.
• Investigation, replacement, modification or support of anatomy.
• Life support or maintenance.
• Control of conception.
• Disinfection of medical devices.
INTRODUCTION TO BIOMEDICAL DEVICES
Types of biomedical devices:
▪ MEDICAL INSTRUMENT: Instrument intended for surgical use, to cut, drill, saw, scrape, curettage, hold,
remove, immobilize without any connection to another active medical device.
▪ MEDICAL EQUIPMENT OR SUPPLIES: Substance, article or material used for the diagnosis, treatment or
prevention of diseases that do not require energy sources for their use.
▪ BIOMEDICAL EQUIPMENT: Operational and functional medical device that brings together electrical,
electronic and hydraulic and/or hybrid systems and subsystems, which for their use require a source of
energy; including computer programs involved in their proper functioning.
▪ IN VITRO DIAGNOSTIC MEDICAL DEVICE: Products intended by the manufacturer for the examination
of samples derived from the human body, used alone or in combination for in vitro examination of
samples.
INTRODUCTION TO BIOMEDICAL DEVICES
• Before medical devices can be introduced on the market, the safety of a device has
to be demonstrated for its intended use.
• Therefore, a number of tests have to be performed under laboratory conditions.
• For the development and in vivo testing of
medical devices, international regulations have
become important tools of the European
Commission and the US Food and Drug
Administration to control the quality of the
product.
CATEGORIES OF MEDICAL DEVICES
CATEGORIES OF MEDICAL DEVICES
According to document 10 993 of the International Organization of Standardization 
(ISO), medical devices can be divided in to FOUR CATEGORIES:
Noncontact 
devices
Surface-
contacting 
devices 
External 
communicating 
devices
Implant 
devices
CATEGORIES OF MEDICAL DEVICES
CATEGORIE 1:
Noncontact 
devices
Surface-
contacting 
devices 
External 
communicating 
devices
Implant 
devices
CATEGORIES OF MEDICAL DEVICES
Noncontact 
devices
These include 
medical 
devices (or 
components) 
That have 
neither direct 
nor indirect 
contact with 
the body
Were 
biocompatibility
CATEGORIE 1:
CATEGORIES OF MEDICAL DEVICES
Noncontact 
devices
EXAMPLES
. .
Diagnostic
software
An in vitro 
diagnostic device
CATEGORIE 1:
CATEGORIES OF MEDICAL DEVICES
Noncontact 
devices
EXAMPLES
.
blood-collection
tube
CATEGORIE 1:
CATEGORIES OF MEDICAL DEVICES
Noncontact 
devices
Surface-
contacting 
devices 
External 
communicating 
devices
Implant 
devices
CATEGORIE 2:
CATEGORIES OF MEDICAL DEVICES
Surface-
contacting 
devices 
1. Skin 
surfaces 
only.
2. Mucosal 
membranes
3. Breached 
or otherwise 
compromised 
body 
surfaces.
Medical devices 
that contact 
intact 
CATEGORIE 2:
CATEGORIES OF MEDICAL DEVICES
1. Skin 
surfaces 
only.
EXAMPLES
. .
Fixation
tapes
External
prosthesesElectrodes
Compression
bandages
CATEGORIE 2:
CATEGORIES OF MEDICAL DEVICES
2. Mucosal 
membranes
EXAMPLES
. .
Contact lenses Urinary catherter
CATEGORIE 2:
CATEGORIES OF MEDICAL DEVICES
2. Mucosal 
membranes
EXAMPLES
. .
Intravaginal devices
Intra-intestinal devices
(stomach tubes)
CATEGORIE 2:
CATEGORIES OF MEDICAL DEVICES
2. Mucosal 
membranes
EXAMPLES
Endotracheal tubes Bronchoscopes
CATEGORIE 2:
CATEGORIES OF MEDICAL DEVICES
2. Mucosal 
membranes
EXAMPLES
Dental prostheses Orthodontic devices
CATEGORIE 2:
CATEGORIES OF MEDICAL DEVICES
3. Breached 
or otherwise 
compromised 
body 
surfaces.
EXAMPLES
Dressings or healing
devices
Occlusive patches for
ulcers
CATEGORIE 2:
CATEGORIES OF MEDICAL DEVICES
3. Breached 
or otherwise 
compromised 
body 
surfaces.
EXAMPLES
Burn patche Granulation tissue
CATEGORIE 2:
CATEGORIES OF MEDICAL DEVICES
Noncontact 
devices
Surface-
contacting 
devices 
External 
communicating 
devices
Implant 
devices
CATEGORIE 3:
CATEGORIES OF MEDICAL DEVICES
External 
communicating
devices 1. Blood
path
indirect
2. Tissue/bo
ne/dentin
3. Circulating
bloodcategorized according 
to their contact with 
the following 
application sites.
CATEGORIE 3:
CATEGORIES OF MEDICAL DEVICES
1. Blood
path
indirect
EXAMPLES
Solution
administration sets
Extension sets
CATEGORIE 3:
CATEGORIES OF MEDICAL DEVICES
1. Blood
path
indirect
EXAMPLES
transfer sets blood administration
sets
CATEGORIE 3:
CATEGORIES OF MEDICAL DEVICES
2. Tissue/
bone/
dentin
EXAMPLES
Dental filling
materials
skin staples
CATEGORIE 3:
CATEGORIES OF MEDICAL DEVICES
3. 
Circulating
blood
EXAMPLES
Intravascular 
catheters
Temporary pacemaker
electrodes
CATEGORIE 3:
CATEGORIES OF MEDICAL DEVICES
3. 
Circulating
blood
EXAMPLES
oxygenators dialysers
CATEGORIE 3:
CATEGORIES OF MEDICAL DEVICES
Noncontact 
devices
Surface-
contacting 
devices 
External 
communicating 
devices
Implant 
devices
CATEGORIE 4:
CATEGORIES OF MEDICAL DEVICES
Implant 
devices 1. Tissue
/bone
2. Bloodcategorized according 
to their contact with 
the following 
application sites.
CATEGORIE 4:
CATEGORIES OF MEDICAL DEVICES
1. Tissue
/bone
EXAMPLES
Orthopaedic pins replacement joints
CATEGORIE 3:
CATEGORIES OF MEDICAL DEVICES
2. Blood
EXAMPLES
heart valves ventricular assist
devices.
CATEGORIE 3:
CLASSES OF MEDICAL DEVICES ACCORDING FDA
CLASSES OF MEDICAL DEVICES ACCORDING FDA
The term medical device can mean anything from a tongue depressor to a pacemaker.
Sophisticated medical devices require a
very strenuous regulatory procedure, and
understanding different classes of medical
devices as determined the Food and Drug
Administration may help streamline the
process.
CLASSES OF MEDICAL DEVICES ACCORDING FDA
Class I
• Class I medical devices require the least
amount of regulatory control.
• These devices have a long history of safe
use and are simple in design.
CLASSES OF MEDICAL DEVICES ACCORDING FDA
Class II
• Class II medical devices require a little more
regulatory control to ensure safety and
effectiveness.
• They must complywith special controls set by
the FDA, such as special labeling
requirements, performance standards, and
more.
CLASSES OF MEDICAL DEVICES ACCORDING FDA
Class III
• These devices are under the most stringent
regulatory controls due to their high-risk
nature.
• They are often used to support or maintain
human life and / or can potentially pose an
unreasonable risk to a patient and require
the highest safety precautions.
CLASSES OF MEDICAL DEVICES ACCORDING FDA
What is 510(k)?
• 510(k), or premarket notification, is the procedure that the FDA mostly requests
from medical device manufacturers for marketing in the U.S. market.
• The 510(k) is different from the PMA process (premarket approval) and through the
identification of the most appropriate product code for the medical device to be
sold in the U.S., it is possible to establish whether the U.S. regulations require a
510(k) or a PMA.
CLASSES OF MEDICAL DEVICES ACCORDING FDA
What is 510(k)?
• The 510(k) procedure is based on the demonstration of substantial equivalence
between the medical device subject to FDA clearance and at least one medical
device with the same intended use and similar technical characteristics (predicate
device) already on the U.S. market.
• Demonstrating substantial equivalence means demonstrating to the FDA that the
device sought to be registered is as safe and effective as the predicate device.
CLASSES OF MEDICAL DEVICES ACCORDING FDA
CLASSIFICATION OF MEDICAL DEVICES
CLASSIFICATION OF MEDICAL DEVICES
Funcional Diagnosis Devices
• Electrocardiography
• Spirometry
• Body Plethysmography
• Ergospirometry
• Metabolic Activity Monitoring
• Electroencephalography
• Electromyography
• Sleep diagnosis devices
• Nystagmography
CLASSIFICATION OF MEDICAL DEVICES
Funcional Diagnosis Devices
• Audiometry
• Ocular Tonometry
• Optical Coherence Tomography (OCT)
• Keratometry
• Ultrasound
• Corneal Topography
• Fluorescence Angiography of the Retina
• Skeletal Muscle Force Assessment
CLASSIFICATION OF MEDICAL DEVICES
• Electrocardiography
https://www.youtube.com/watch?v=ygsvAZVA6sc&ab_channel=LUXSONTube
CLASSIFICATION OF MEDICAL DEVICES
• Electroencephalography
https://www.youtube.com/watch?v=2iCVzOlaKRA&ab_channel=CognitiveBrainLaboratory
CLASSIFICATION OF MEDICAL DEVICES
• Electromyography
https://www.youtube.com/watch?v=Mu_p6IgVFG0&ab_channel=TrainingWall
• Ergospirometry
CLASSIFICATION OF MEDICAL DEVICES
https://www.youtube.com/watch?v=g3msO9bLODg&ab_channel=SCHILLERGroup
• Nystagmography
CLASSIFICATION OF MEDICAL DEVICES
https://encyclopedia2.thefreedictionary.com/audiometric
https://www.slideserve.com/kordell/pure-tone-audiometry
• Audiogram
CLASSIFICATION OF MEDICAL DEVICES
https://encyclopedia2.thefreedictionary.com/audiometric
https://www.slideserve.com/kordell/pure-tone-audiometry
Tonometry is the procedure eye care
professionals perform to determine
the intraocular pressure (IOP)
https://en.wikipedia.org/wiki/Ocular_tonometry
CLASSIFICATION OF MEDICAL DEVICES
• Ocular Tonometry
https://en.wikipedia.org/wiki/Ocular_tonometry
https://learnbiomedengine.blogspot.com/2018/05/optical-coherence-tomography-oct.html
• Optical coherence tomography (OCT)
CLASSIFICATION OF MEDICAL DEVICES
https://learnbiomedengine.blogspot.com/2018/05/optical-coherence-tomography-oct.html
CLASSIFICATION OF MEDICAL DEVICES
• Keratometry
https://www.molex.com/chinese/AppIn/ultrasound
_equipment.htm
• Ultrasound
CLASSIFICATION OF MEDICAL DEVICES
https://www.molex.com/chinese/AppIn/ultrasound_equipment.htm
• Fluorescence angiography of the retina
CLASSIFICATION OF MEDICAL DEVICES
• Skeletal muscle force assessment
CLASSIFICATION OF MEDICAL DEVICES
CLASSIFICATION OF MEDICAL DEVICES
Therapeutic Devices
• X-ray
• Tomography
• Thermography
• Magnetic Resonance Imaging
• Endoscopy
• Long-Term Ventilators
CLASSIFICATION OF MEDICAL DEVICES
• X-RAY
https://www.youtube.com/watch?v=hTz_rGP4v9Y&ab_channel=NIBIBgovNIBIBgov
• Tomography
CLASSIFICATION OF MEDICAL DEVICES
https://www.youtube.com/watch?v=l9swbAtRRbg&ab_channel=NIBIBgov
https://www.youtube.com/watch?v=1CGzk-nV06g&ab_channel=NIBIBgov
• Magnetic resonance imaging
CLASSIFICATION OF MEDICAL DEVICES
video
https://www.youtube.com/watch?v=vE3DVtJSmx4&ab_channel=NIBIBgovNIBIBgov
• Thermography
CLASSIFICATION OF MEDICAL DEVICES
file:///C:/Users/gsalum/Downloads/100 MICRON MRI OF THE HUMAN BRAIN - SAGITTAL.mp4
• Endoscopy
CLASSIFICATION OF MEDICAL DEVICES
https://www.youtube.com/watch?v=sIiaSuCWpgo&ab_channel
=ApolloEndosurgery%2CInc.
• Cochlear implant
CLASSIFICATION OF MEDICAL DEVICES
• Defibrillators and cardiac pacemaker
CLASSIFICATION OF MEDICAL DEVICES
• Laser systems
CLASSIFICATION OF MEDICAL DEVICES
• Anesthesia devices
CLASSIFICATION OF MEDICAL DEVICES
• Dialysis machine
CLASSIFICATION OF MEDICAL DEVICES
• Heart–lung machines
CLASSIFICATION OF MEDICAL DEVICES
Linear Accelerators
• Medical radiation therapy
CLASSIFICATION OF MEDICAL DEVICES
• Brachiherapy
http://roswebsite.wpengine.com/medical-equipment/radiation-therapy/linear-accelerators
• Mechanical circulatory support systems
CLASSIFICATION OF MEDICAL DEVICES
• Neuroprosthetics
CLASSIFICATION OF MEDICAL DEVICES
• Neonatal monitoring
CLASSIFICATION OF MEDICAL DEVICES
• Fetal monitoring
CLASSIFICATION OF MEDICAL DEVICES
Telemedicine (OMS)
• The provision of health care services, in which distance is a critical factor, by professionals who use infor
mation and communication technologies in order to exchange data to make diagnoses, recommend treat
ments and prevent diseases and injuries, as well as for the permanent training of health care professional
s and in research and evaluation activities, in order to improve the health of people and the communities 
in which they live.
CLASSIFICATION OF MEDICAL DEVICES
EQUIPMENT AND TOOLS
• Operating tables – the surgeon’s workplace
EQUIPMENT AND TOOLS
• Medical robotics
EQUIPMENT AND TOOLS
• Sterilizer
EQUIPMENT AND TOOLS
• Intelligent textiles and trends
EQUIPMENT AND TOOLS
• Electronics for wireless health monitoring
EQUIPMENT AND TOOLS
BIBLIOGRAPHY
BIBLIOGRAPHY
Books:
▪ Nashelsky, B., & Boylestad, R. L. (2003). Electrónica: teoría de circuitos y dispositivos
electrónicos. Editorial Pearson Educación
▪ Sawhney, G. S. (2007). Fundamental of biomedical engineering. New Age International.
▪ Donglu Shi (Ed) - Biomedical Devices and Their Applications – 2004
▪ Chapter 5 Medical Devices - Verkerke G.J., H.F. Mahieu, A.A.Geertsema., I.F.Hermann, J.R.van Horn,
J.M.Hummel, J.P.van Loon, D.Mihaylov, A.van der Plaats, H.Schraffordt Koops, H.K.Schutte, R.P.H.Veth, M.P.
de Vries and G.Rakhorst
▪ Springer Handbook of Medical Technology - Rudiger Kramme, Klaus-Peter Hoffmann, Robert S. Pozos
(Eds.) – 2001
UNIT 1
Introduction to biomedical devices
Biomedical Devices
Biomedical Engineering