A medical device is basically anything that does not exert its action through chemical means and is used to detect, eliminate, or treat disease or alter biological or biochemical functions. Medical devices range in complexity from simple tongue depressors to sophisticated computerized equipment. The World Health Association (WHO) defines a medical device as any equipment whose primary mode of action isn’t immunological, metabolic, or pharmacological in nature.
Several classification systems are used to label medical devices. The World Health Organization has been working to develop a standardized nomenclature that would help make it easier to identify any risks related to them as well as any adverse events that might occur as a result of using one implant or another, for example. Because this is especially important with regard to learning about patient safety issues and recalls of defective products, the Global Harmonization Task Force has proposed specific classifications for labeling certain features of medical devices. According to the WHO, medical devices can be used for one or more purposes:
Uses of medical devices
Diagnosis, prevention, monitoring, treatment, or alleviation of disease. Investigation, modification, replacement, or support of any anatomical site or a physiological process. Provision of information for medical purposes as a consequence of in vitro examination of specimens taken from sites of the human body and which do not achieve their intended action in or on the human body by immunological, pharmacological, or metabolic action (but may be assisted in its function by these systems).
The World Health Organization does not consider an accessory a medical device. However, in some instances, a maker may mean for an accessory to be used with a parent medical device to help it achieve its intended purpose; In this context, the accessory is subject to the same testing as outlined by the GHTF.
Medical strategies and policies on medical devices…..
The World Health Organization states that there are several strategies, policies, and action plans related to health technologies, particularly medical devices, that any National Health plan needs in place. These include the Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices developed to support member states to develop and implement regulatory controls and regional guidelines to ensure healthcare professionals have affordable access to a safe, quality tool that guarantees its effectiveness when used by a professional as well as recreational use.
classification of medical devices
Categories and classification of medical devices: UK case study. In the United Kingdom, medical devices have both a category and classification. There are five categories in total. Non-invasive devices do not go inside the body. Examples include walking sticks, artificial kidneys, and wheelchairs. Invasive devices are inserted into orifices both in and on the body. Examples include contact lenses, examination gloves, enemas, and enemas. Surgically invasive devices are either used during surgery or inserted into the body. Examples include scalpels, catheters, and needles. Active devices require an external source of power like ultrasound, x-rays equipment, or transcutaneous electrical nerve stimulation (TENS). Implantable implants are placed in the body as opposed to simply being worn as other products might be orthopedic implants, intraocular lenses, and breast implants.
Maintenance of medical devices
Preventive Maintenance or “PM” service is an equipment inspection and functionality test. Due to the vital nature of some medical equipment for extending uninterrupted patient care, it is often the best practice to have the equipment periodically serviced to avoid unexpected equipment failures. which include …..Train and retain staff, Carry out daily routine checks, and Replace Reagents and lubricants,Maintain a clean work environment and keep devices clean, and Turn off devices when not in use, Sterilize and Disinfect devices. avoid multiple users.
