Essential Facts That You Have To Know Regarding UDI Systems
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 becomes fully implemented, the label of every device will have a unique device identifier in both machine and human readable form, eventually improving the safety of the patients, and at the same time, facilitating medical device innovation, and modernizing device post-market surveillance.
There are other things that you have to be aware of when it comes to Unique Device Identification System such as the fact that it was signed into law on the twenty-seventh of September, in the year two thousand seven, as part of the 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. The following will be asked for the new system when this act will be implemented:
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. And also, it is crucial for all unique device identifiers to include the lot number or the serial number, particularly if stated 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. According to experts, when you do not have any idea about medical devices, most notably on meaningful analysis that are based on data that comes from existing vocabulary systems, this will be problematic. The truth of the matter is that, consistent and reliable identification of medical devices will allow safety surveillance, and this will enable both manufacturers and the FDA to better identify possible problems or device defects, and enhance patient care as well.
Everything stated here is about unique device identification.