Becoming a Prepared Partner for UDI Compliance
In 2013, the Food and Drug Administration (FDA) issued a rule requiring the label of medical devices to include a unique device identifier (UDI). The rule also mandates that each UDI be provided in a plain-text version and in a form that uses automatic identification data capture (AIDC) technology. The goal is to be able to track medical devices from manufacturing to distribution, to taking care of patients in clinics and hospitals.
Why? Ideally, universal tracking of devices will:
- Improve patient safety by helping identify counterfeit products and allow medical staff to distinguish between devices that are similar in appearance, but serve different functions
- Enhance the ability to track devices to improve the recall process
- Facilitate medical device innovation and efficiency
Because UMC’s objective is to be an informed, connected, and proactive partner for our customers as they integrate UDIs to improve their businesses, we’ve already been taking steps to be a ready, valuable partner in UDI compliance. Here’s how:
Stepping into Implementation
The FDA’s UDI rule will be rolled out in stages based on each class of medical device until September 2020. As the industry prepares to adopt UDIs, there are new processes and procedures to master, and a new set of rules and regulations to learn.
Investing in Equipment and Technology
UMC invested in laser marking equipment more than two years ago. We’ve built expertise in programming and operating the equipment that is used to add UDIs to parts. We also went through the extensive process of obtaining validations for different materials and finishes.
UMC has also purchased a verifier that allows us to evaluate barcodes accurately on criteria and parameters defined by international standards.
Diving into Regulations and Requirements
Partnering with our first customers adopting UDIs has meant supporting them in understanding and accurately implementing the FDA, ISO, and GS1 requirements. Depending on which of the three classes a medical device falls into, there are different dates for required UDI implementation. The current compliance date for Class I devices is September 24, 2020.
We’ve also had a firsthand look at how to submit device information to the Global Unique Device Identification Database (GUDID). We’ve been part of discussions around what other information, in addition to the manufacturer code, can and should be put on a device (i.e., batch or lot numbers, expiration dates, etc.)
Mastering Measurements and Grading
According to FDA regulations, you must be able to prove that the UDIs you use are graded out to the desired level. Verification measures the key aspects of the barcode symbol and quality of the code, which includes how well the code is marked. It then assigns the code a grade (A-F). To be compliant with the standards, UMC strives for a grade C or better.
UMC has received training on verification so we can evaluate the barcode accurately on criteria like print contrast, magnification, light margins, and bar width. Verification requires strict lighting and positioning of the code to comply with standards. We are practicing using verification to diagnose problems and propose how to improve the quality of barcodes so we can efficiently and effectively guide our clients through this process.
Developing and Expanding Partnerships
As we venture further into the world of unique device identifiers, we are focused on building strategic relationships with key players and innovators. We’re excited to partner with our customers who are exploring UDIs and helping maximize the impact they will have on their business.
There are still a lot of unknowns when it comes to the full rollout of the new unique device identifier requirements, but UMC thrives on change and challenge. With a coordinated, proactive approach, we can actualize the potential of UDIs to enhance the industry and improve patient safety together.
Are you ready to discuss how UMC’s capabilities could be the right fit for your next project?