UDI? No, it’s not the next super virus; it's Unique Device Identification "UDI" and it is something that medical device and pharmaceutical manufacturers need to be prepared for now. Here’s the scoop:
The FDA’s mandate
In September 2013, the FDA released a rule requiring devices to have an individual barcode that uses AIDC (Automatic Identification and Data Capture) technology. The move is intended to increase patient safety as part of the electronic medical record transformation. To implement, AIDC technology attaches device identifier codes to patient records and other automatic tracking systems. This creates the ability to track devices throughout their use in the clinical theatre. In the unfortunate event that a defective batch or recall is required, the new system allows for faster identification, thus reducing the number of patients affected. This obviously helps contain the effects of a number of potential negative impacts across the board.
What it means and why it matters
Does your organization have a plan to incorporate these requirements into your existing processes? If not, start planning to integrate UDI into your medical or pharmaceutical product pipeline now so you don’t get caught unprepared. Here’s why it matters:
- The new UDI rule is being rolled out in phases, based on different classes of devices. As of June 2015, only Class III devices are required to comply with the new UDI rule.
- Next on the list are labels and packages of implantable, life-supporting, and life-sustaining devices. This product category must comply with the new rule by September 24, 2015.
- Noncompliance comes with steep penalties. Manufacturers found to be out of compliance risk being barred from selling their product or device across state lines in the U.S. In addition to lost sales, there are stiff fines and even possible federal prosecution. Even these pale in comparison to your company’s reputation if your products do not comply in time.
See all FDA UDI Compliance Dates
What it takes to be in compliance
UDI requires three distinct elements:
- UDIs must meet recognized standards like GS1, HIBC, ICCBBA and must also be ISO compliant. To meet these standards, the device must have a static “Device Identifier” and dynamic “Production Identifier” that includes lot/batch number, serial number, production date or expiration date.
- The UDI must be BOTH machine readable (barcode) and human readable.
- The UDI must incorporate the new Us By Date (YYYY-MM-DD) and the existing Lot Number with symbols.
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