PALADIN MEDICAL UDI CONSULTING

As with every industry, the only constants in the healthcare industry are change and change. Rising costs, new regulations and more continually offer a new take on the industry. One of these new changes brought upon by the FDA is unique device identification or UDI.

 

The Basics & The Differences Of Unique Device Identification

The FDA has created UDIs in an attempt to adequately identify medical devices through the lifetime of the device, whether in distribution or use. The unique device identification system will be phased in over the course of many years. Once completed, the program will offer many benefits to the health care system.

Once fully implemented, UDIs will help to improve patient safety, facilitate innovation in the medical device marketplace, provide postmarket surveillance and much more.

As well, UDIs will allow for more accurate reporting, analyzing and reviewing of a number of events. Medical errors will by reduced through ease of access to precise information. The improved analyzing abilities UDIs provide will allow for a clear and concise way to track data.

 

What is GUDID and why will customers benefit from it?

Once a device is uniquely identified, there will be a label on most machines. Each label will be readable by humans and machines alike. Individuals who label each device will also submit information about certain aspects of each device to the FDA’s Global Unique Device Identification Database or GUDID.

This allows customers access to the information they would not have had otherwise, as GUDID is available to the public. Anyone can search and download information from GUDID at any time through AccessGUDID.

 

How do I get a UDI and where can I go to get more information?

All UDIs must be issued through a system that is operated by an FDA-accredited issuing agency. There is a process any applicant would go through when seeking a UDI. There are certain exceptions and alternatives to this fairly new rule, as the UDI system will take around 7 years to fully implement.

To get more information about UDIs and how they may change things, you can visit the UDI homepage on the FDA’s website.

 

What is the effective date for my device and how can I find that out?

As the UDI system is going to take 7 years to fully implement, the compliance dates for the system is fairly complicated. Each year certain classes of devices will require labeling, due to different sections of the legislation.

As the legislation was passed in September 2013, each year on September 24 different devices will be required to be properly labeled. Each device will be classified on a certain scale, usually consisting of the type of device it is. The main devices the FDA is looking at are implantable, life-saving and life-sustaining devices.

To find out more information about the types of devices, you can search the CDRH Product Classification Database here. If that doesn’t help you find the information you’re looking for, you can also find a list of how the FDA classifies these types of devices here.