Medical devices introduction

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Medical Devices IBasic Principles


Description

This presentation serves as an introduction to the principles of medical device development. It is mainly intended for those beginning in the biomedical engineering career or are new to the field.

Medical Devices Principles


Presentation Contents


Medical Device Definition Product Development Process Biomedical Engineering Overview Medical Device Regulations Bioethics in Product Development Biomedical Instrumentation


What is a Medical Device?


It is an instrument, apparatus, implement, machine, implant, in vitro reagent, a component part, or accessory which is:

Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease or

which does not achieve any of its primary intended purposes through chemical action

DiagnoseDisease

TreatDisease

Manage Disease

Prevent Disease

Medical Device


Discovery, understanding and management of interaction between energy and human body, as well as the understanding or physiological systems and biosignals allows the development of medical devices used to diagnose, monitor, manage or treat physiological organs


Scientific Principles in Product Development


Development Phases


Biomedical Industry Overview

Engineering technology is the part of the technological field that requires the application of scientific and engineering knowledge and methods combined with technical skills in support of engineering activities

ENGINEERING applies knowledge of the natural sciences gained by study, experience, and practice to develop ways to utilize the materials and forces of nature for the benefit of mankind.



Medical Device Industry Overview

Engineering disciplines related include

•Electrical engineering•Mechanical engineering•Biomedical engineering•Chemical engineering•Computer engineering

A Biomedical engineer applies electronic, mechanical, and other engineering principles to design, develop, maintain, repair or upgrade medical equipment.

Most biomedical engineering graduates are employed by medical device manufacturers, research labs, hospital, clinics, and service organizations




Scientific fields applied•Medicine, Healthcare•Physics, Chemistry, Math, Biology•Engineering Disciplines•Manufacturing technologies•Medical Device Regulations•Compliance Engineering

Areas of product development:• Biomedical instrumentation• Medical Devices• Medical Imaging• Biomechanics and rehabilitation engineering• Bioinformatics and telemedicine• Clinical Engineering




Medical Device Regulations

• Devices can benefit patients• Devices can harm patients• Balance between risk and benefit

Products need to be regulated• To ensure patient safety• To ensure maximum benefit• To ensure proper use


Product Approval Requires•Patient Safety•Demonstrated Effectiveness•Validated Intended Use•Labeling Compliance•Risk Management•Quality in Manufacturing


Medical Device Regulations Patients depend on an increasing array of medical devices for the diagnosis and management of disease conditions. Most countries have a regulatory body that regulates the safe and effective development manufacturing, distribution and use of such devices.

FDA In the United States, the Food and Drug Administration (FDA) regulates the medical device industry. The FDA was allowed to regulate medical devices starting in 1976. This year was significant because the conflict of interest between a medical device company and its investors was brought to the forefront with a device (the Dalkon Shield) that compromised the safety of its users.

Product reviewMedical devices are reviewed for safety, effectiveness and labeling compliance within the FDA Center for Devices and Radiological Health (CDRH)


The FDA has established classifications for approximately 1,700 different generic types of devices. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes and the requirements that apply to them are as follows.

Class I: subject to least regulatory controlPresent minimal potential for harm to the patient or medical professional userSimpler in design than Class II or III devices

Class II: subject to special controls (including general controls)Special labeling requirementsMandatory performance standardsPost-market surveillance

Class III: subject to strictest regulatory controlsSupport or sustain lifeOf substantial importance in preventing impairment of human healthPresent a potential, unreasonable risk of illness or injuryPremarket approval (including general controls)


Medical Device Classification

I

2

3


25 MeV Radiotherapy Machine – X-rays & Electrons

200 rad (e) or 25000 rad (x)

Error on selection, Software bug, Beam not reset

Patient received 25000 MeV, “malfunction 54 displayed”

Technician fired 2 more times

4 months later patient died


Patient Safety – Case Example



As per the Biomedical Engineering Society, biomedical engineering is a learned profession that combines expertise and responsibilities in engineering, science, technology, and medicine. Because public health and welfare are paramount considerations in each of these areas, biomedical engineering professionals must uphold those principles of ethical conduct when involved in professional practice, research, patient care, and training.

Biomedical engineering professionals in the fulfillment of their professional duties shall use their knowledge, skills, and abilities to enhance the safety, health, and welfare of the public; and strive by action, example, and influence to increase the competence, prestige, and honor of the biomedical engineering profession.

Biomedical engineering professionals involved in healthcare activities shall regard responsibility toward and rights of patients, including those of confidentiality and privacy, as their primary concern; and consider the larger consequences of their work in regard to cost, availability, and delivery of healthcare.


Bioethics Within the Field of Biomedical Engineering


Biomedical engineering professionals must follow principles of ethical conduct when involved in professional practice, research, patient care, and training. Biomedical engineering professionals in the fulfillment of their professional duties shall

•Use their knowledge, skills, and abilities to enhance the safety, health, and welfare of the public

•Regard responsibility toward and rights of patients, including those of confidentiality and privacy, as their primary concern; and

•Consider the larger consequences of their work in regard to cost, availability, and delivery of healthcare.


Bioethics Within the Field of Biomedical Engineering


Diagnostic Medical Devices generally capture signals from the human body or signals as a result of interaction of energy sources with the body, and convert these signals into useful information to diagnose or treat disease conditions


Biomedical Instrumentation in Medical Devices


Biomedical signals contain important information about the health, as well as anatomical or physiological condition of human beings. The signals are measured to assess the presence of abnormal events, commonly associated with diseases or abnormal conditions. Biomedical signals can be obtained:

•Capturing signals produced by physiological processes in the human body. Interfaces are developed with sensors to capture signals and convert them to appropriate electrical or mechanical signals

•Capturing signals produced by energy sources after they have interacted with the human body. Signals include attenuation signals, radiated heat profiles, etc.


Biomedical Instrumentation - Signals


Biomedical instrumentation systems in medical devices deal with the measurement and conditioning of the body's current and voltage signals for further analysis. Most of these systems measure currents very small in magnitude and require several stages of signal conditioning and processing in order to convert them into signals that can analyzed by humans with the use of computer systems. The block diagram below depicts the basic components of a biomedical instrumentation system.


Biomedical Instrumentation

Subject

Applied energy

Sensor

Calibration Signal

Signal conditioning Analog to Digital Data acquisition

Signal Processing

Control & Feedback

Output Display

Data Transmission


Measurand—what is being measured or analyzed (i.e., ECG, EEG, EMG, temperature, blood pressure).

Sensor—The physical element that senses the signals and converts them to an electrical signal.

Signal conditioning—The signal is prepared and improved for interpretation, either through amplification or filtering.

Output display—The physiological signal or its transformed signal is displayed for the end user’s interpretation.


Definitions


Calibration signal—It is a signal with the properties of the signal to be measured. It is used to test the output of the processing stages and device functionality, with a known signal.

Control and feedback—To adjust the sensor and signal conditioner, and to direct the flow of output for display, storage, or transmission. Control and feedback may be automatic or manual.

Data storage and transmission—Data may be stored briefly to meet the requirements of signal conditioning or to enable the operator to examine data that precede alarm conditions. Alternatively, data may be stored before signal conditioning, so that different processing schemes can be utilized. Conventional principles of communications can often be used to transmit data to remote displays at nurses’ stations, medical centers, or medical data-processing facilities.


Definitions


ValidityHow well an instrument measures the signal it is supposed to measure

ReliabilityConsistency in the measurement results on multiple trials

RepeatabilityAbility of an instrument to return to the same value when repeatedly exposed to the same signal

AccuracyHaving minimal error with respect to the true value.

PrecisionRelating to the ‘exactness’ of findings from multiple trials.

ResolutionThe smallest to be distinguished magnitude from the measured value


Measurement Factors



Factors in Making Measurements



Factors in Making Measurements

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