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Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare purposes. BME is also traditionally logical sciences to advance health care treatment, including diagnosis, monitoring, and therapy. Also included under the scope of a biomedical engineer is the management of current medical equipment in hospitals while adhering to relevant industry standards. This involves procurement, routine testing, preventive maintenance, and making equipment recommendations, a role also known as a Biomedical Equipment Technician (BMET) or as clinical engineering.
Risk management is the identification, evaluation, and prioritization of risks followed by coordinated and economical application of resources to minimize, monitor, and control the probability or impact of unfortunate events or to maximize the realization of opportunities.
In modern Western body piercing, a wide variety of materials are used. Some cannot be autoclaved, and others may induce allergic reactions, or harbour bacteria. Certain countries, such as those belonging to the EU, have legal regulations specifying which materials can be used in new piercings.
A microchip implant is an identifying integrated circuit placed under the skin of an animal. The chip, about the size of a large grain of rice, uses passive radio-frequency identification (RFID) technology, and is also known as a PIT tag. Standard pet microchips are typically 11–13 mm long and 2 mm in diameter.
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
Biocompatibility is related to the behavior of biomaterials in various contexts. The term refers to the ability of a material to perform with an appropriate host response in a specific situation. The ambiguity of the term reflects the ongoing development of insights into how biomaterials interact with the human body and eventually how those interactions determine the clinical success of a medical device. Modern medical devices and prostheses are often made of more than one material so it might not always be sufficient to talk about the biocompatibility of a specific material. Even the same materials, such as diamond-like carbon coatings, may show different levels of biocompatibility based on the manufacturing conditions and characteristics.
PLGA, PLG, or poly(lactic-co-glycolic acid) is a copolymer which is used in a host of Food and Drug Administration (FDA) approved therapeutic devices, owing to its biodegradability and biocompatibility. PLGA is synthesized by means of ring-opening co-polymerization of two different monomers, the cyclic dimers (1,4-dioxane-2,5-diones) of glycolic acid and lactic acid. Polymers can be synthesized as either random or block copolymers thereby imparting additional polymer properties. Common catalysts used in the preparation of this polymer include tin(II) 2-ethylhexanoate, tin(II) alkoxides, or aluminum isopropoxide. During polymerization, successive monomeric units are linked together in PLGA by ester linkages, thus yielding a linear, aliphatic polyester as a product.
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks, M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products. Not all biologics are regulated by CBER. Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER).
A biomaterial is a substance that has been engineered to interact with biological systems for a medical purpose, either a therapeutic or a diagnostic one. The corresponding field of study, called biomaterials science or biomaterials engineering, is about fifty years old. It has experienced steady and strong growth over its history, with many companies investing large amounts of money into the development of new products. Biomaterials science encompasses elements of medicine, biology, chemistry, tissue engineering and materials science.
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Integration verification and validation" can be abbreviated as "IV&V".
Tygon® is a brand name for a family of flexible polymer tubing consisting of a variety of materials to be used "across a range of specialized fluid transfer requirements". The specific composition of each type is a trade secret. Some variants have multiple layers of different materials. Tygon is a registered trademark of Saint-Gobain Corporation. It is an invented word, owned and used by Saint-Gobain and originated in the late 1930s. Tygon products are produced in three countries, but sold throughout the world. Tygon tubing is used in many markets, including food and beverage, chemical processing, industrial, laboratory, medical, pharmaceutical, and semiconductor processing. There are many formulations of clear, flexible, Tygon tubing. The chemical resistance and physical properties vary among the different formulations, but the tubing generally is intended to be "so resistant to chemical attack that it will handle practically any chemical", whether liquid, gas, or slurry. While largely non-reactive, Tygon has been reported to liberate carbon monoxide and is listed among carbon monoxide-releasing molecules.
Nitinol biocompatibility is an important factor in biomedical applications. Nitinol (NiTi), which is formed by alloying nickel and titanium, is a shape-memory alloy with superelastic properties more similar to that of bone, when compared to stainless steel, another commonly used biomaterial. Biomedical applications that utilize nitinol include stents, heart valve tools, bone anchors, staples, septal defect devices and implants. It is a commonly used biomaterial especially in the development of stent technology.
Medical grade silicones are silicones tested for biocompatibility and are appropriate to be used for medical applications. In the United States, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) regulates devices implanted into the body. It does not regulate materials other than certain dental materials. The FDA regulate silicones used in food contact under the auspices of the Center for Food Safety and Nutrition (CFSAN) and for use in pharmaceuticals under the auspices of the Center for Drug Evaluation and Research (CDER).
Package testing or packaging testing involves the measurement of a characteristic or property involved with packaging. This includes packaging materials, packaging components, primary packages, shipping containers, and unit loads, as well as the associated processes.
CEBEC is a private Belgian rating label for the quality assurance of electrical appliances. Use of this label indicates that a piece of equipment conforms to European safety standards. The label is issued by SGS-CEBEC, now part of the SGS group. CEBEC has its own electrical testing laboratory located in Brussels. It is an approved laboratory for the purpose of certifications granted by SGS.
Surgical mesh is a medical implant made of loosely woven mesh, which is used in surgery as either a permanent or temporary structural support for organs and other tissues. Surgical mesh can be made from both inorganic and biological materials and is used in a variety of surgeries, although hernia repair is the most common application. It can also be used for reconstructive work, such as in pelvic organ prolapse or to repair physical defects created by extensive resections or traumatic tissue loss.
References
- ↑ "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (blue book memo)" (PDF). fda.gov. FDA. Retrieved 23 January 2017.