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This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
Single-use medical devices include any type of medical equipment, instrument, or apparatus that is disposed of after a single-use in a medical facility. The Food and Drug Administration defines this as any device entitled by its manufacturer that it is intended use is for one single patient and one procedure only. [1]
The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be ...
The Arctic Sun has adhesive gel pads which stick to a patient's body, and cover only a portion of a patient's body to leave most of the body free for augmenting medical procedures. The device operates under negative pressure and circulates water through the adhesive pads at a temperature between 4–42 °C (39–108 °F).
Electrotherapy is the use of electrical energy as a medical treatment. [1] In medicine, the term electrotherapy can apply to a variety of treatments, including the use of electrical devices such as deep brain stimulators for neurological disease. [2]
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 ...
Negative pressure wound therapy device. Negative-pressure wound therapy (NPWT), also known as a vacuum assisted closure (VAC), is a therapeutic technique using a suction pump, tubing, and a dressing to remove excess wound exudate and to promote healing in acute or chronic wounds and second- and third-degree burns.
Durable medical equipment (DME) is a category of medical devices designed to assist individuals with disabilities, injuries, or chronic health conditions. [1] These devices are prescribed by healthcare professionals and intended for repeated use over an extended period. [2]