Single Use Medical Device Reprocessing
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Single Use Medical Device Reprocessing
Single-use medical device reprocessing is the disinfection, cleaning, remanufacturing, testing, packaging and labeling, and sterilization among other steps, of a used, (or, in some cases, a device opened from its original packaging but unused), medical device to be put in service again. All reprocessed medical devices originally labeled for single use in the United States are subject to U.S. Food and Drug Administration (FDA) manufacturing requirements and must meet strict cleaning, functionality, and sterility specifications prior to use. Although first regulated in the U.S., the reprocessing of medical devices, particularly those that are labeled "Single Use Device" (SUDs), is a global practice with countries in Europe, Asia, Africa, and North America actively engaged in reprocessing. Currently, approximately 2% of all SUDs on the U.S. market are eligible for reprocessing by a qualified commercial vendor. Reprocessing industry estimates indicate the amount of revenue saved by ...
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Disinfection
A disinfectant is a chemical substance or compound used to inactivate or destroy microorganisms on inert surfaces. Disinfection does not necessarily kill all microorganisms, especially resistant bacterial spores; it is less effective than sterilization, which is an extreme physical or chemical process that kills all types of life. Disinfectants are generally distinguished from other antimicrobial agents such as antibiotics, which destroy microorganisms within the body, and antiseptics, which destroy microorganisms on living tissue. Disinfectants are also different from biocides—the latter are intended to destroy all forms of life, not just microorganisms. Disinfectants work by destroying the cell wall of microbes or interfering with their metabolism. It is also a form of decontamination, and can be defined as the process whereby physical or chemical methods are used to reduce the amount of pathogenic microorganisms on a surface. Disinfectants can also be used to destroy mi ...
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Electrophysiological
Electrophysiology (from Greek , ''ēlektron'', "amber" etymology of "electron"">Electron#Etymology">etymology of "electron" , ''physis'', "nature, origin"; and , ''-logia'') is the branch of physiology that studies the electrical properties of biological cells and tissues. It involves measurements of voltage changes or electric current or manipulations on a wide variety of scales from single ion channel proteins to whole organs like the heart. In neuroscience, it includes measurements of the electrical activity of neurons, and, in particular, action potential activity. Recordings of large-scale electric signals from the nervous system, such as electroencephalography, may also be referred to as electrophysiological recordings. They are useful for electrodiagnosis and monitoring. Definition and scope Classical electrophysiological techniques Principle and mechanisms Electrophysiology is the branch of physiology that pertains broadly to the flow of ions (ion current) in biol ...
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American College Of Cardiology
The American College of Cardiology (ACC), based in Washington, D.C., is a nonprofit medical association established in 1949. It bestows credentials upon cardiovascular specialists who meet its qualifications. Education is a core component of the college, which is also active in the formulation of health policy and the support of cardiovascular research. History The American College of Cardiology was chartered and incorporated as a teaching institution in 1949, and established its headquarters, called Heart House, in Bethesda, Maryland, in 1977. In 2006, the college relocated to Washington, D.C.'s West End neighborhood. Past papers for the institution are held at the National Library of Medicine in Bethesda, Maryland. Leadership The college is governed by its officers, including the president, president-elect, vice president, secretary, treasurer, chief executive officer and board of trustees. The current ACC Board of Trustees (BOT) consists of 14 College members who took offic ...
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Polyurethane
Polyurethane (; often abbreviated PUR and PU) refers to a class of polymers composed of organic chemistry, organic units joined by carbamate (urethane) links. In contrast to other common polymers such as polyethylene and polystyrene, polyurethane is produced from a wide range of starting materials. This chemical variety produces polyurethanes with different chemical structures leading to many List of polyurethane applications, different applications. These include rigid and flexible foams, varnishes and coatings, adhesives, Potting (electronics), electrical potting compounds, and fibers such as spandex and Polyurethane laminate, PUL. Foams are the largest application accounting for 67% of all polyurethane produced in 2016. A polyurethane is typically produced by reacting an isocyanate with a polyol. Since a polyurethane contains two types of monomers, which polymerize one after the other, they are classed as Copolymer#Alternating copolymers, alternating copolymers. Both the isocy ...
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Polycarbonate
Polycarbonates (PC) are a group of thermoplastic polymers containing carbonate groups in their chemical structures. Polycarbonates used in engineering are strong, tough materials, and some grades are optically transparent. They are easily worked, molded, and thermoformed. Because of these properties, polycarbonates find many applications. Polycarbonates do not have a unique resin identification code (RIC) and are identified as "Other", 7 on the RIC list. Products made from polycarbonate can contain the precursor monomer bisphenol A (BPA). Structure Carbonate esters have planar OC(OC)2 cores, which confers rigidity. The unique O=C bond is short (1.173 Å in the depicted example), while the C-O bonds are more ether-like (the bond distances of 1.326 Å for the example depicted). Polycarbonates received their name because they are polymers containing carbonate groups (−O−(C=O)−O−). A balance of useful features, including temperature resistance, impact resistance and o ...
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Titanium
Titanium is a chemical element with the symbol Ti and atomic number 22. Found in nature only as an oxide, it can be reduced to produce a lustrous transition metal with a silver color, low density, and high strength, resistant to corrosion in sea water, aqua regia, and chlorine. Titanium was discovered in Cornwall, Great Britain, by William Gregor in 1791 and was named by Martin Heinrich Klaproth after the Titans of Greek mythology. The element occurs within a number of minerals, principally rutile and ilmenite, which are widely distributed in the Earth's crust and lithosphere; it is found in almost all living things, as well as bodies of water, rocks, and soils. The metal is extracted from its principal mineral ores by the Kroll and Hunter processes. The most common compound, titanium dioxide, is a popular photocatalyst and is used in the manufacture of white pigments. Other compounds include titanium tetrachloride (TiCl4), a component of smoke screens and catalysts; and ...
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Stainless Steel
Stainless steel is an alloy of iron that is resistant to rusting and corrosion. It contains at least 11% chromium and may contain elements such as carbon, other nonmetals and metals to obtain other desired properties. Stainless steel's corrosion resistance, resistance to corrosion results from the chromium, which forms a Passivation (chemistry), passive film that can protect the material and self-healing material, self-heal in the presence of oxygen. The alloy's properties, such as luster and resistance to corrosion, are useful in many applications. Stainless steel can be rolled into Sheet metal, sheets, plates, bars, wire, and tubing. These can be used in cookware, cutlery, surgical instruments, major appliances, vehicles, construction material in large buildings, industrial equipment (e.g., in paper mills, chemical plants, water treatment), and storage tanks and tankers for chemicals and food products. The biological cleanability of stainless steel is superior to both alumi ...
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Raw Materials
A raw material, also known as a feedstock, unprocessed material, or primary commodity, is a basic material that is used to produce goods, finished goods, energy, or intermediate materials that are feedstock for future finished products. As feedstock, the term connotes these materials are bottleneck assets and are required to produce other products. The term ''raw material'' denotes materials in unprocessed or minimally processed states; e.g., raw latex, crude oil, cotton, coal, raw biomass, iron ore, air, lumber, logs, water, or "any product of agriculture, forestry, fishing or mineral in its natural form or which has undergone the transformation required to prepare it for international marketing in substantial volumes". The term ''secondary raw material'' denotes waste material which has been recycled and injected back into use as productive material. Ceramic While pottery originated in many different points around the world, it is certain that it was brought to light mostly ...
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Landfills
A landfill site, also known as a tip, dump, rubbish dump, garbage dump, or dumping ground, is a site for the disposal of waste materials. Landfill is the oldest and most common form of waste disposal, although the systematic burial of the waste with daily, intermediate and final covers only began in the 1940s. In the past, refuse was simply left in piles or thrown into pits; in archeology this is known as a midden. Some landfill sites are used for waste management purposes, such as temporary storage, consolidation and transfer, or for various stages of processing waste material, such as sorting, treatment, or recycling. Unless they are stabilized, landfills may undergo severe shaking or soil liquefaction of the ground during an earthquake. Once full, the area over a landfill site may be reclaimed for other uses. Operations Operators of well-run landfills for non-hazardous waste meet predefined specifications by applying techniques to: # confine waste to as small an area as ...
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Product Life Cycle
In industry, Product Lifecycle Management (PLM) is the process of managing the entire lifecycle of a product from its inception through the engineering, design and manufacture, as well as the service and disposal of manufactured products. PLM integrates people, data, processes and business systems and provides a product information backbone for companies and their extended enterprises. History The inspiration for the burgeoning business process now known as PLM came from American Motors Corporation (AMC). The automaker was looking for a way to speed up its product development process to compete better against its larger competitors in 1985, according to François Castaing, Vice President for Product Engineering and Development. Lacking the "massive budgets of General Motors, Ford, and foreign competitors … AMC placed R&D emphasis on bolstering the product lifecycle of its prime products (particularly Jeeps)." After introducing its compact Jeep Cherokee (XJ), the vehicle tha ...
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Recycled
Recycling is the process of converting waste materials into new materials and objects. The recovery of energy from waste materials is often included in this concept. The recyclability of a material depends on its ability to reacquire the properties it had in its original state. It is an alternative to "conventional" waste disposal that can save material and help lower greenhouse gas emissions. It can also prevent the waste of potentially useful materials and reduce the consumption of fresh raw materials, reducing energy use, air pollution (from incineration) and water pollution (from landfilling). Recycling is a key component of modern waste reduction and is the third component of the "Reduce, Reuse, and Recycle" waste hierarchy. It promotes environmental sustainability by removing raw material input and redirecting waste output in the economic system. There are some ISO standards related to recycling, such as ISO 15270:2008 for plastics waste and ISO 14001:2015 for enviro ...
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