IVDs and Combination products
IVDs are abbreviations for in vitro diagnostic product (IVD), which is a device applicable in the diagnosis of disease or other conditions. Combination products are the medicinal products and services used in execution of a given medicinal role. The operations of these devices are determined by the regulations that are set by the health organization of a given region. IVD and combination products are among the devices, which have been regulated exclusively following the sensitivity that they possess in the execution of their roles in the health facilities.
There are various changes in regulations that have been identified on how these devices should be used. The first element that has been considered vital in the regulations is determination of the state of health. The regulation states that the devices used should have the ability to give accurate results of the problem being tested.
The second element of regulation is identification of the most outstanding mitigation process. This is the process by which the problem that has been identified is resolved. The regulations dictate that the mitigation should take the shortest time possible. Proper mitigation ensures the patient is treated as fast as possible.
In addition, the device should be highly reliable in execution of treatment processes. This defines the other regulation that has been developed in a bid to execute exclusive role of the devices. The devices must be driven by their ability to detect diseases accordingly and assist the physician plan for necessary treatment processes to follow.
It is also required that all devices used in the treatment process must work together for the benefit of the patient. There is no device, which should surpass others in an execution of the treatment process, which is a regulation defined by use of IVDs and combination products.
