A medical device is any device that can be used by people alone or in combination (as stated by the maker) for a medical purpose. This includes any equipment, software, materials, or other items. The term “medical device” refers to several items, including breast implants, walking sticks, and contact lenses.
In vitro diagnostic devices are included in the category of medical devices. Examples of medical devices that are used to test samples of tissue, bodily fluids, and blood that have been taken from the body include blood glucose, lateral flow, and pregnancy tests. Medical devices that are implanted, such as cardiac pacemakers, are also included in this category; depending on how they are used, they may or may not require external power sources.
Any apparatus employed in the diagnosis, mitigation, therapy, or prevention of disease and not exerting its effect chemically is referred to as a medical device.
Medical devices come in a wide variety of complex and vary from two tongue depressors to highly advanced computerized medical equipment. Medical devices, as defined by the World Health Organization (WHO), are items whose principal intended mode of action is not immunological, metabolic, or pharmacological in nature.
Medical equipment is classified using several worldwide standards. The WHO is now working to harmonies medical device nomenclature, which is anticipated to have a significant effect on patient safety. Finding reports of unpleasant incidences and recalls depends on doing this.
Several harmonized definitions for medical devices have been proposed by the Global Harmonization Task Force (GHTF). The WHO states that medical devices can be used for one or more of the following particular purposes:
- Disease diagnosis, monitoring, therapy, and/or amelioration
- Identification, mitigation, monitoring, treatment, prevention, or payment for an injury
- study, replace, or encouragement of any anatomical region or physiological process
- Support and sustenance of life
- Controlling conception
- cleaning medical equipment
- Information provided for medical purposes as a result of in vitro evaluation of specimens acquired from human body sites that fail to have the desired effect on the body through immunological, pharmacological, or metabolic activity (but may be assisted in its function by these systems).
Both a category and classification exist for medical devices. There are five different types of devices all, of which are categorized based on their intended use:
- Devices that are non-invasive are not inserted into the body. Walking canes, artificial kidneys, and wheelchairs are among the examples.
- These gadgets are invasive since they are introduced into body orifices. Examples include enemas, exam gloves, contact lenses, and enemas.
- Surgically invasive: These tools are either inserted or utilised during surgery. Scalpels, catheters, and needles are a few examples.
- Active: equipment that needs to be powered by an outside source. Examples include x-ray technology, transcutaneous electrical nerve stimulation, and ultrasound (TENS)
- These gadgets are implantable; they go into the body. Breast implants, intraocular lenses, and orthopedic implants are among the examples.
The four types of general medical devices represent each device’s inherent danger. To classify medical devices according to risk, the risk assessment takes into account a variety of factors, including the anticipated duration of use, composition, and whether the device is implanted or active.
- Class 1 examples include wheelchairs, tongue depressors, stethoscopes, and glasses.
- Dental fillings, tracheotomy tubes, and surgical clamps all fall under class IIa.
- Condoms, bone fixation plates, and lung ventilators are examples of items of class IIb.
- Heart valves, pacemakers, and implanted brain stimulators are examples of Class III devices.
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