Specialty Label Substrates for UDI Debut
As the medical device industry begins to prepare for Unique Device Identification, FLEXcon has launched FLEXcon MedFLEX, a line of label substrates designed to meet FDA’s performance requirements. The FLEXcon MedFLEX line can support unique coding as well as comply with rub tests, the company reports. Specifically, the line is UL-certified in accordance with UL/IEC 60601-1 3rd edition marking durability rub tests, the company reports, and three of the products are UL-recognized with inks and ribbons.
“As the FDA seeks to publish the UDI Rule to increase patient safety and more accurately process medical device recalls, FLEXcon recognizes the need to support that effort. This is why we developed the MedFLEX product line to facilitate the UDI rule,” Ken Koldan, new business development manager, FLEXcon, told PMP News. “In addition, we looked to make the product meet the performance specifications, but also make it easy for the OEM and converter to use it through the UL Adoption program.”
FLEXcon MedFLEX products use FLEXcon’s high-performance acrylic adhesives and thermal-transfer printable topcoats. Products include:
· FLEXcon MedFLEX PM2C15K, PM2W15K and MM2SM15K, 2 mil gloss topcoated polyesters in clear, white and silver matte
· FLEXcon MedFLEX PM2W22K, a 2 mil white gloss topcoated polyester
· FLEXcon MedFLEX PM2W36K and PM2W36G, 2 mil white matte topcoated polyesters
· FLEXcon MedFLEX OM1C05P and OM1CM05P, 1 mil clear and clear matte overlaminating polyesters
The UDI rule will require Class II and III medical devices distributed in the United States to carry a unique numeric or alphanumeric code with an identifier specific to each device or model as well as an identifier with current production information, FLEXcon reports.
“The Institute of Medicine (IOM) report showed the inadequacy of the current post-marking surveillance system and the resulting lack of data makes it impossible to confidently draw broad conclusions about the safety and effectiveness of products that are on the market. This statement made me get involved with the UDI effort from a non-profit industry trade association,” Koldan told PMP News. “AIM North America UDI Committee was the avenue for technical discussions. Out of that forum the need for a labeling material was made clear and the product development effort was launched.”
FLEXcon offers assistance to printers and converters to help them understand new regulations and standards. For specific product information, visit www.FLEXcon.com/MedFLEX or follow FLEXcon on Twitter at @FLEXcon.
For more information on FDA’s UDI rule, join Ken Koldan and other industry leaders in the Unique Device Identification LinkedIn group.