Factual Information Regarding UDI Systems That You Should Be Aware Of
One thing about UDI or Unique Device Identification System that you should be aware of is the fact that it is a system that is specifically used in marking as well as identifying medical devices within the supply chain of the healthcare department. 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.
The next thing about Unique Device Identification System that we want you to know of is the fact that it was signed into law on the twenty-seventh day of September, in the year two thousand seven, as part of FDA’s Amendments Act of two thousand seven. It has been said as well that the act includes languages that are related to the establishment of UDI or Unique Device Identification System. The implementation of this law will require the new system to have the following:
It is significant for all the labels of medical devices to have a unique identifier, unless, of course, there is an exception made for a certain device or group 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.
Other than the things we mentioned above, there are still more that you should know of such as the fact that the National Unique Device Identification System is creating a common vocabulary for reporting and enhancing electronic tracking abilities. Nowadays, the examination of the negative event reports are very limited to those certain medical devices that are involved in incidents which are 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. 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.
What we have here are some factual information that you need to know regarding unique device identification.