Let's talk about UDIs, the GMDN and the new rules.

UDIs are unique barcodes that we will find on our medical devices, have you ever wondered how and who generates them?

May 10, 2022

In the biomedical and hospital field, much is said about medical devices, maintenance, new medical technology, management, and parts; engineers, technicians, and other staff are also related to the term "nomenclature" specifically to identify medical devices, each medical device in the world regardless of the brand or model has its own identifier code (UDIs), but, who is in charge to establish that codes? Well, the FDA is in charge of that, which is based on the GMDN (The Global Medical Device Nomenclature) that works as an international standard (ISO 15225) and is a non-profit association, whose function is to create a system of agreed descriptors to identify medical devices, which will subsequently receive a UDI.

The GMDN is managed by the GMDN Agency, which is made up of a group of regulators, manufacturers, and providers of medical devices, which are in charge of standardizing the naming and grouping of devices, all in order to improve communication in the hospital environment and help regulators to understand better the use of medical equipment while supporting patient safety.

A UDI is an identifier code created in a readable way for humans and machines that serves to modernize the surveillance of technology and its management, also to facilitate the whole part of marketing and innovation of devices, in order to generate a UDI it is required a GMDN, that is to say, that it is within a very specific category, a UDI, as its name suggests, is unique, however, hundreds of UDIs can share the same GMDN term or code. A GMDN term represents a group of generic medical devices in a database and allows these to be harmonized. A UDI cannot have more than one GMDN term or code, so they try to generate them as detailed as possible.

GMDN term lists and databases are updated daily, new terms are added based on requests from users developing new technology, and some existing terms may be modified to broaden the scope of the term or to indicate that the term became obsolete in case it no longer accurate to describe a product. if you are registered with the GMDN and have a list with the terms that you requested or simply match your interest or products, if they are modified or become obsolete, you will be notified via email. The lists of each licensee or client are private, encrypted with a password, and cannot be seen or accessed by another licensee, likewise, as a user, you do not have access to see the complete list of terms within the GMDN database, rather, it shows you the most relevant codes or that can be useful to you according to your range of products, if you require the more than 24,000 terms within the database, you must request special access, in which you will be granted a 5-digit code to access the full list of terms.

In order to label a medical device with its UDI, the FDA requires that the GMDN term to which the UDI is linked be current, that is, not obsolete. If the equipment was already labeled with its UDI previously and some time has passed and the GMDN term of the UDI becomes obsolete, it is not necessary to relabel the device, it is only necessary to notify the FDA about the new GMDN term in which said medical device is found, In this way, the FDA will update its GUDID (Global Unique Device Identification Database) and the expenses relabeling costs will be avoided.

In the summer of 2021, the FDA released a draft of what would be the final guide for UDIs, after eight years of launching the UDI Rule, aimed at manufacturers (labelers) and issuing agencies accredited by the FDA, the final guide describes the requirements and recommendations so that they meet the objectives of the device identification rule, in the document you will be able to observe the two forms in which a UDI is presented, which are the easy-to-read form and the automatic data capture form through of technology. However, this new guide rejects requests from manufacturers which include changing the way data is displayed and removing data delimiters since the UDI should be the most important data in the label and precede other data. In the new guide, you can also find recommendations for independent software labeling requirements. This restructuring of the guide for IDUs was carried out as a result of hundreds of medical errors that occurred as a result of the incorrect identification of medical devices, which caused confusion about how to use them.

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