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Getting Ready for UDI in Medical Devices

Reg Pulse

Unique device identification (UDI) is finally here. On September 24, 2013, the U.S. Food and Drug Administration (FDA), published its long-anticipated regulation1 requiring medical devices and in-vitro diagnostic products to incorporate unique device identification that will allow them to be tracked throughout the distribution chain and all the way to the end user. Some of the benefits:

  • Enable more accurate reporting, review and analysis of adverse event reports, so problem devices can be identified and corrected more quickly
  • Reduce medical errors by enabling healthcare professionals and others to more rapidly and precisely identify a device and obtain information about it
  • Enhance analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries
  • Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls
  • Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion problems and prepare for medical emergencies

This new FDA regulation has considerable impact on the healthcare community from manufacturers to providers and payers. Note that in the final regulation, FDA made some important decisions that some entities in this community may not be aware of:

  • Removed the requirement for direct marking of implantable medical devices but the UDI must still be on the label
  • Special labeling is provided for standalone software that are regulated as devices
  • Finished devices in inventory have three (3) additional years to comply with the UDI regulation, e.g. Class III devices have four years to include UDI codes on labels (one year plus three additional years)
  • Device kit components do not need individual UDI codes provided that those components are not distributed on their own and that the finished device kit has a UDI on the label
  • Granted an opportunity to apply to FDA for a one year extension to meet UDI requirements for Class III devices

Over the long term, the FDA hopes the UDI regulation will lead to development of a medical device identification system that is harmonized and recognized around the world. But the most immediate impact is that the UDI system for high risk devices (designated Class III) must be fully operational by September 24, 2014 (unless an extension is granted), which is less than a year away. The timeline is longer for Class I and Class II devices; however, because such devices are far more numerous, every company involved with medical devices needs to start planning for UDI now.

In preparing to meet the UDI requirements, our clients are realizing the importance of capturing appropriate sources of data and managing it … and how much data there really is. An important question for any medical device company to ask themselves is, "Have we identified all sources of data that could impact our UDI submissions and how are we ensuring the quality of that data?" It’s really all about the data. Operationally, FDA will hold companies accountable for the quality of the data they submit to the Global Unique Device Identification Database (GUDID), which will become a public database that FDA will manage. The amount of data that needs to be catalogued, reviewed and analyzed in order to prepare accurate UDI submissions to the GUDUD can be staggering. The data identification process is a key first step.

To get started, it is useful to perform a gap analysis between the current state of compliance with the specific UDI requirements and what the UDI regulation actually requires. Although the analysis should be thorough, it need not be overly complicated or time consuming and there are tools that can accelerate the process. Some important questions for manufacturers to ask their healthcare provider customers include: Do you currently use unique identifiers such as bar codes for business purposes that could be adapted to UDI? How do your current tracking and recall systems function? What procedures do you have in place governing those functions? Will you need to purchase new equipment and implement new procedures to operate those systems? For those changes, what level of training and validation will be required?

UDI is more than just a labeling or technology regulation. Its impact is far reaching and will require a detailed review of many compliance areas within the business. Also, participation and support from healthcare providers will be crucial if the regulation is to achieve its intended benefits. To maximize the benefits, institutions and other providers will need to have proper procedures in place and trained staff to track and document devices through distribution and use.

There’s a lot to do and the clock is ticking. It’s time to get started.

Larry Spears

Director
Deloitte & Touche LLP

  
1 https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system

As used in this document, "Deloitte" means Deloitte LLP and its subsidiaries. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. Certain services may not be available to attest clients under the rules and regulations of public accounting.

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