3 challenges with UDI Compliance for Medical Devices

by Maureen Perroni, on March 6, 2017

There are challenges with becoming UDI compliant, but manufacturers must overcome them.

The first deadlines for unique device identification in the medical sector have come and gone, but challenges remain. Adoption and effective usage of UDI labeling are far from universal, and device-makers today face a variety of issues keeping them from making the switch completely. It's important to note what these blockages are and find ways around them.

"The following issues could prove especially troublesome for organizations."

It's no secret that UDI labeling has rolled out slowly among medical device manufacturers. The following issues could prove especially troublesome for organizations as they've scrambled to comply.

1. A lack of standardized software
In August 2016, just over a month before the deadline passed for implementation of UDI requirements, Modern Healthcare reported more than 70 percent of device-makers did not possess a single, unified labeling solution for all their operations. Using a disorganized or patchwork labeling solution could keep organizations from comfortably meeting UDI standards.

2. Cost concerns
Manufacturers may be holding back their programs because of a worry about the immediate costs. Medical Device and Diagnostic Industry noted that the potential price tag attached to ensuring compliance has the ability to frighten company leaders. This is a fear they must overcome, however, as the news provider pointed out that the long-term price of noncompliance is larger.

3. Physical challenges
If the actual codes comprising a UDI system aren't up to standards, the whole project may be disappointing. Packaging Digest reported that printing and reading barcodes can prove problematic, especially because of the wide variability of devices that need codes applied to them. High-quality tech will be required to bridge this gap.

While the aforementioned issues are a persistent problem for many medical device manufacturers, these companies should resist the urge to put together slapdash or half-formed solutions. A much better approach is creating a fully formed and standardized program that will act as a long-term solution. Register for Loftware's webinar on this topic to learn more.

Topics:Medical DevicesRegulatory