Medical Devices

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The instruments and equipment used in the diagnosis, treatment, and monitoring of medical conditions.

Anatomy and Physiology: Understanding the basic structure and function of the human body is essential when studying medical devices. It includes knowledge of the skeletal, muscular, nervous, respiratory, circulatory, digestive, and endocrine systems.
Medical Terminology: Learning the language of medicine and knowing how to use medical abbreviations, prefixes, suffixes, and root words is crucial for interpreting medical records and understanding medical device instructions.
Biomechanics: Understanding how the human body moves and functions is essential for designing medical devices that are safe and effective. It involves knowledge of physics and materials science.
Biomaterials: Materials used in medical devices must be biocompatible, safe, and durable. Understanding the properties and characteristics of materials such as metals, polymers, ceramics, and composites is critical.
Design and Manufacturing: Knowing the design and manufacturing process is crucial for ensuring that medical devices meet safety and efficacy standards. It involves knowledge of CAD software, 3D printing, and sterilization techniques.
Regulatory Requirements: Medical devices are heavily regulated, and it is essential to have knowledge of FDA regulations, ISO standards, and other requirements to ensure that devices are safe and effective.
Quality Control: Quality control measures are necessary to ensure that medical devices meet safety and efficacy standards, and it involves knowledge of statistical analysis, testing methods, and risk management.
Human Factors: Medical devices must be user-friendly to ensure that they are used correctly and safely. Human factors involve understanding human behavior, ergonomics, and usability testing.
Clinical Trials: Clinical trials are necessary to evaluate the safety and efficacy of medical devices. Understanding the design and execution of clinical trials is essential.
Post-market Surveillance: Once a medical device is on the market, ongoing monitoring is necessary to ensure that it remains safe and effective. Post-market surveillance involves knowledge of adverse event reporting, risk management, and post-market clinical studies.
Diagnostic imaging devices: These devices are used to create images of the inside of the body using various technologies, such as X-rays, ultrasound, magnetic resonance imaging (MRI), and computed tomography (CT).
Surgical instruments: These devices are used during surgical procedures to perform specific tasks, such as cutting, dissecting, grasping, or holding tissues or organs.
Implantable devices: These devices are surgically implanted into the body to perform a variety of functions, such as supporting or replacing damaged tissues, monitoring bodily functions, or delivering medication.
Monitoring devices: These devices are used to monitor a patient's vital signs, such as heart rate, blood pressure, and temperature.
Prosthetic devices: These devices are designed to replace a missing or damaged body part, such as an artificial limb, joint, or hearing aid.
Therapeutic devices: These devices are used to provide various forms of therapy to patients, such as electrical stimulation, radiation therapy, or oxygen therapy.
Diagnostic tests: These devices are used to perform various diagnostic tests, such as blood tests, urine tests, and genetic tests.
Respiratory devices: These devices are used to help patients breathe, such as oxygen inhalers, nebulizers, and CPAP machines.
Cardiac devices: These devices are used to monitor or regulate the heart, such as pacemakers, defibrillators, and catheters.
Rehabilitation devices: These devices are used to assist patients in recovering from injuries or disabilities, such as mobility aids, vibrating plates, and TENS units.
- Quote: "A medical device is any device intended to be used for medical purposes."
- Quote: "Significant potential for hazards are inherent when using a device for medical purposes."
- Quote: "Medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country."
- Quote: "As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases."
- Quote: "Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan."
- Quote: "Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome."
- Quote: "In the United States it was not until the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938 that medical devices were regulated."
- Quote: "On May 26, 2017, the Medical Device Regulation (MDR) replaced the MDD."
- Quote: "Examples range from simple, low-risk devices such as tongue depressors, medical thermometers, disposable gloves, and bedpans."
- Quote: "One example of high-risk devices are those with embedded software such as pacemakers, and which assist in the conduct of medical testing, implants, and prostheses."
- Quote: "The global medical device market was estimated to be between $220 and US$250 billion in 2013."
- Quote: "The United States controls ~40% of the global market."
- Quote: "Japan has the second largest country market share."
- Quote: "The largest market shares in Europe (in order of market share size) belong to Germany, Italy, France, and the United Kingdom."
- Quote: "The rest of the world comprises regions like (in no particular order) Australia, Canada, China, India, and Iran."
- Quote: "The design of medical devices constitutes a major segment of the field of biomedical engineering."
- Quote: "Further, as associated risk increases the potential benefit to the patient must also increase."
- Quote: "Later in 1976, the Medical Device Amendments to the FD&C Act established medical device regulation and oversight as we know it today in the United States."
- Quote: "The largest market shares in Europe (in order of market share size) belong to Germany, Italy, France, and the United Kingdom."
- Quote: "One example of high-risk devices are those with embedded software such as pacemakers, and which assist in the conduct of medical testing, implants, and prostheses."