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Topics Medical, Materials, Materials Suppliers, Plastics in Medical Devices
Companies & Associations PolyOne Corp.
CLEVELAND — Traceability is becoming a bigger factor for medical devices and other plastic products, largely because of the rise of the Internet, which has made it easier for counterfeit goods to be made and sold.
“Bad things can happen if counterfeit goods get into your supply chain,” James Petrie said May 7 at Plastics in Medical Devices, a conference hosted by Plastics News in Cleveland. Petrie serves as North American color and additives marketing director for PolyOne Corp., a leading compounding and distribution firm based in Avon Lake, Ohio.
“Counterfeiting continues to grow, fueled by the Internet, which gives counterfeiters direct entry to the market,” he added. “Tracking and traceability can put safeguards in place to avoid this outcome.”
Counterfeiting has affected a wide range of products from folding bicycles to athletic jackets to medical products such as glucose test strips, Petrie said. The counterfeit test strips became a safety issue when patients used their results to determine how much insulin they needed.
PolyOne had a recent experience in this area when a customer used a third-party manufacturer in Asia to make an industrial application. When problems with the product arose, PolyOne found the problem to be with a cheaper component of the part that was used to improve the customer’s profit margin. The cheaper part did not use PolyOne material.
“We worked with the customer on track and trace solutions,” Petrie said. “You have to be aware of your supply chain and supply chain management.”
Common track and trace methods include overt ones such as inks, labels, lasermarking or holograms, but these sometimes offer little protection because they can be duplicated by counterfeiters. Covert track and trace methods aren’t obvious to the naked eye. These include methods such as microprinted or energy-sensitive taggants. Forensic track and trace methods go even deeper into the material itself.
The medical industry will face another challenge in this area later this year, Petrie said, when the U.S. Food & Drug Administration requires certain medical devices to be permanently marked with unique numeric or alphanumeric codes.