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Jurisdiction Definition Legislation Australia A medical device that: (a) is made specifically in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and (b) is intended: (i) to be used only in relation to a particular individual; or (ii) to be used by the health professional to meet special needs arising in the course ...
[DEC] Device Enterprise Communication - supports publication of information from point-of-care medical devices to applications such as clinical information systems and electronic health record systems, using a consistent Health Level Seven version 2 (HL7 v.2) messaging format and device semantic content or DICOM profile.
The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...
The term medical device, as defined in the Food and Drugs Act, is "any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in: the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in a human ...
The American Society of Healthcare Engineering (ASHE), established in 1962, [4] was one of the first to publicize the term healthcare engineering.ASHE, as well as its many local affiliate societies, is devoted to the health care physical environment, including design, building, maintenance, and operation of hospitals and other health care facilities, which represents only one sector of ...
A nurse operating medical equipment in an ambulatory care setting. Ambulatory care services typically consist of a multidisciplinary team of health professionals that may include (but is not limited to) physicians, nurse practitioners, nurses, pharmacists, occupational therapists, physical therapists, speech therapists, and other allied health professionals.
Health Level Seven, abbreviated to HL7, is a range of global standards for the transfer of clinical and administrative health data between applications with the aim to improve patient outcomes and health system performance.
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.