This is an extremely broad category—essentially covering all health care products that do not achieve their intended results through predominantly chemical (e.g., pharmaceuticals) or biological (e.g., vaccines) means, and do not involve metabolism.
A medical device is intended for use in:
- the diagnosis of disease or other conditions, or
- in the cure, mitigation, treatment, or prevention of disease,
Some examples include pacemakers, infusion pumps, the heart-lung machine, dialysis machines, artificial organs, implants, artificial limbs, corrective lenses, cochlear implants, ocular prosthetics, facial prosthetics, somato prosthetics, and dental implants.
Stereolithography is a practical example of medical modeling being used to create physical objects. Beyond modeling organs and the human body, emerging engineering techniques are also currently used in the research and development of new devices for innovative therapies, treatments, patient monitoring, and early diagnosis of complex diseases.
Medical devices are regulated and classified (in the US) as follows (see also Regulation):
- Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Devices in this category include tongue depressors, bedpans, elastic bandages, examination gloves, and hand-held surgical instruments and other similar types of common equipment.
- Class II devices are subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance. Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, and surgical drapes.
- Class III devices generally require premarket approval (PMA) or premarket notification (510k), a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I. Examples include replacement heart valves, hip and knee joint implants, silicone gel-filled breast implants, implanted cerebellar stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants.
Other articles related to "medical devices, medical":
... Mems-ID is a technology company developing a tracking system for medical devices ... technology allows the Mems-ID chips to be integrated directly into individual medical devices, such as surgical instruments, and survive high-temperature ... regulatory compliance and infection control by electronically identifying use of medical devices, including when they are associated with an adverse event improving inventory control and supply chain ...
... The use of DEHP in certain medical devices ... whether there may be any risk from the use of DEHP in certain medical applications (children and neonates undergoing long-term blood transfusion and adults undergoing long-term haemodialysis) ... on Emerging and Newly Identified Health Risks (SCENIHR) reviewed the safety of DEHP in medical devices ...
... DEHP has been used as a plasticiser in medical devices such as intravenous tubing and bags, catheters, nasogastric tubes, dialysis bags and tubing, and blood ... the tolerable daily intake in some specific population groups, namely people exposed through medical procedures such as kidney dialysis ... The American Academy of Pediatrics has advocated not to use medical devices that can leach DEHP into patients and, instead, to resort to DEHP-free alternatives ...
... Other major health care related firms include Accellent – Medical devices American Biosystems – Direct-fed microbials used in waste treatment, feed ...
... This Standard gives general requirements for medical devices carried in road ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions ...
Famous quotes containing the words devices and/or medical:
“There is nothing in machinery, there is nothing in embankments and railways and iron bridges and engineering devices to oblige them to be ugly. Ugliness is the measure of imperfection.”
—H.G. (Herbert George)
“If science ever gets to the bottom of Voodoo in Haiti and Africa, it will be found that some important medical secrets, still unknown to medical science, give it its power, rather than the gestures of ceremony.”
—Zora Neale Hurston (18911960)