Factual Information Regarding UDI Systems That You Should Be Aware Of
When we say UDI or Unique Device Identification System, we are referring to a system that is used in making and identifying medical devices within the supply chain of the healthcare industry. If you are wondering why FDA is using unique device identification, well, that is due to the fact that this system enables them to effectively identify medical devices that are sold in the market, beginning from manufacturing, to distribution, and to patient use as well. When this mandate is implemented, the label of all devices will have a unique device identifier that comes in human as well as machine-readable form, and this eventually improve the safety of the patient, while, modernizing device post-market surveillance, and facilitates innovation on medical devices.
Another thing about Unique Device Identification System that we want you to know of is the fact that this system was signed into law on the twenty-seventh of September, in the year two thousand seven, being part of FDA’s Amendments Act of two thousand seven. The act was said to have included languages that are related to the establishment of UDI or Unique Device Identification System. When this act will be implemented, the new system will ask for the following:
It is crucial for labels of medical devices to bear unique identifiers, unless, there is an exception made for a specific device or groups of devices, or if an alternative location is specified by the Food and Drug Administration. In addition to that, we want you to know that it is vital for every unique device identifier to be able to identify medical devices through use and distribution. Moreover, it is integral for every unique device identifier to include the serial number or the lot number, if noted by FDA.
Aside from that, we want you to know as well that the national Unique device identification system will create mutual vocabulary for reporting and enhancing electronic tracking abilities. In this present day and time that we live in, study of adverse reports are very limited by certain devices that are involved in an incident, which are often not known with the necessary level of specificity. Experts claim that when a person do not possess any common vocabulary regarding medical devices, it will be impossible for them to gather meaningful analysis based on data that come from already existing vocabulary. As a matter of fact, reliable as well as consistent identification of medical devices are vital and essential as this will lead to safety surveillance, and safety surveillance means that the FDA and manufacturers can identify device defects or potential problems, while enhancing patient care.
These and more are what you need to know when it comes to unique device identification system.