There is a new website in town relevant to all medical devices called AccessGUDID. You decide if it is a catchy, memorable name or not. Just think, you would like to Access the Global Unique Device Identification Database, but that’s not enough as its own identifier isn’t so easy. http://accessgudid.nlm.nih.gov/ Wouldn’t it have been nice to have ended in a simple “.gov”?
The U.S. Food and Drug Administration (FDA) announced today that, in partnership with the National Institutes of Health National Library of Medicine, their AccessGUDID will provide public access to all medical devices with unique device identifiers (UDI). However, it will take several years for all information to become available as various UDI compliance elements are phased in.
The FDA’s Final Rule to establish a UDI system was issued in 2013. This system is designed to adequately identify medical devices throughout distribution and use. To date, only data on the highest risk medical devices (specifically implantable, life-supporting and life-sustaining devices) is being submitted to the database. However, there is a compliance timeline that spans out to September 24, 2020. In general, here is the timeline:
- 9/24/2014 – The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI.
- 9/24/2015 – The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database.
- 9/25/2016 – Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database.
- 9/24/2018 – A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database. Class I stand-alone software must provide its UDI.
- 9/24/2020 – Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. (See the compliance timeline for additional requirements and information.)
In the future, the label of most devices will include a UDI in human- and machine-readable form. In addition to identification, device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID).
The UDI system, which will be phased in over several years, offers a number of benefits that will be more fully realized with the adoption and integration of UDIs into the health care delivery system. According to the FDA, UDI implementation is intended to improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.
A small entity is defined as a medical device manufacturer with 500 or fewer employees, or a medical device relabeler or repackager with 100 or fewer employees. Here is the FDA’s Unique Device Identification System- Small Entity Compliance Guide 2014.
Time will tell whether the public will use the information in this database, or if it will be beneficial primarily to the FDA, US Customs and Border Patrol, doctors, manufacturers and lawyers. Certainly, the system is being designed to help everyone access the information they need. It should allow for easier recall of devices when a problem arises. The hope it that it will also fight against counterfeiting and improve patient safety.
We can expect that it will enhance the ability of US medical device manufacturers to remain competitive globally as a similar system has been in development in the EU. The European Commission leads an Ad Hoc Working Group at the Global Harmonisation Task Force. As they say, the “idea is to promote a global approach in order to avoid discrepancies between the different UDIs produced by” different members of the Task Force.
