Laser-markable compounds can help medtech OEMs comply with FDA’s UDI systemLaser-markable compounds can help medtech OEMs comply with FDA’s UDI system
The compounds have been formulated to allow laser-based high-contrast marks and images, eliminating the need for inks, paints and dyes.
June 14, 2017
Custom compounder RTP (Winona, MN) has developed laser-markable thermoplastic compounds, including clear substrates, that can benefit medical device manufacturers that are required to comply with FDA’s Unique Device Identification (UDI) program. The compounds have been formulated to allow laser-based high-contrast marks and images, eliminating the need for inks, paints and dyes. In some cases, the compounds can be formulated with biocompatible ingredients. RTP showcased this and other technologies at the co-located PLASTEC East and MD&M East event in New York City this week.
“This is a ready-made solution for a real need going forward,” Josh Blackmore, Global Healthcare Manager, told PlasticsToday from the show floor. Noting that laser marking on clear resins can be challenging, Blackmore added that RTP is able to compound additives into clear resins that absorb specific wavelengths of energy and create high-contrast marks while the resin remains clear. Laser-markable compounds are also available in white, black or custom colors.
All medical devices will be required to comply with the UDI system by September 2018. When it is fully implemented, UDI will improve patient safety and modernize postmarket surveillance of medical devices, according to FDA.
RTP also featured its biocompatible colored thermoplastic compounds at its booth. The medical-grade materials are available as pre-colored compounds, masterbatch concentrates, and cube blends in 18 standard colors as well as custom blends color-matched to customer specifications.
The compounds are made with raw materials that have been tested for cost effectiveness and supply chain security, the company said. A proprietary resin carrier and groups of colorants are pre-tested to comply with ISO 10993-1 by a well-respected third-party lab.
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