Basic Concepts about Medical Device or Equipment Engineering
Medical devices or equipments are required to operate the process diagnosis, prevention, mitigation, medication, treatment of disease and imbalanced health conditions. The modern technology has invented numerous effective and essential equipments applying the knowledge and expertise of medical device engineering.
These medical devices might range from simple structured device that are used and maneuvered by the patients in the home to high level professional use by the surgeons in the operation theater. Some of the most popular and essential inventions of contemporary medical device engineering include: dental implants, pacemakers, somato prosthetics, infusion pumps, facial prosthetics, heart-lung machine, ocular prosthetics, dialysis machines, cochlear implants, artificial organs, corrective lenses, artificial limbs and organ implants, etc.
Medical device engineering is a branch of Bio-medical Engineering study. This branch of Bio-medical engineering not only deals with modeling human-organs, but also carries research and development applying the modern techniques and knowledge of engineering to invent efficient medical devices for providing innovative and effective therapies, medical treatments, 24/7 patient monitoring, quick diagnosis of diseases, etc to save human lives from the life threatening diseases and injuries.
Regulation and classification of the medical devices or equipments vary from country to country. In the following the Medical device engineering products are classified into three categories depending on their structural design and use. They are described below:
- Class I category medical devices represent medication for the primary level health-threat. Devices under this category check minimum vulnerability to human body. Usually, these devices are built with simpler designs with lighter weight in comparison with the devices of Class II and Class III. Medical devices of this category include elastic bandages, hand-operated surgical instruments, tongue depressors, examination gloves, bedpans, etc.
- Class II category medical devices represent medication for the medium level health-threat. Devices under this category check vulnerabilities to human body at a significant level. These devices undergo special monitoring besides the broad-spectrum controls. Special controls might include particular labeling requirements, obligatory performance standards, post market observation, etc. Though medical devices under this category possess complex design, they are usually non-invasive. Medical devices of this category include powered wheelchairs, surgical drapes, x-ray machines, PACS, infusion pumps, etc.
- Class I category medical devices represent medication for the primary level health-threat. Devices under this category check minimum vulnerability to human body. Class III devices generally require premarket approval (PMA) or premarket notification, a scientific review to ensure the device’s safety and effectiveness, in addition to the general controls of Class I. Medical devices of this category include replacement heart valves, hip and knee joint implants, silicone gel-filled breast implants, implanted cerebellar stimulators, implantable pacemaker pulse generators, endosseous (intra-bone) implants, etc.
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