The FDA continues to exert regulatory pressure on OEM’s and Contract Manufactures which supply complete medical implant products or components. A common area of scrutiny is the requirement to maintain material traceability for the life of the device. Material traceability (and other critical supply chain and process information) is recorded and maintained in a document package named the Device History Record (DHR). Per the FDA, all medical implant devices and select instrument products must have recorded material tractability throughout the supply chain and production process. Specifically, FDA 820.60 states “each manufacturer shall establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mix-ups.” Furthermore, FDA 820.65 states “manufacturers shall maintain procedures for identifying with a control number each unit, lot, or batch of finished devices.”
Similar regulatory standards exist globally through the World Health Organization, ISO 13485, and most recently ISO 14971 (applies to OEM’s selling product into Europe) which calls for the implementation of a risk management system that requires the manufacturer to determine the safety of the medical device during the life cycle of the product. A key element in this risk mitigation system is the ability to track raw material to melt source and all the way through the manufacturing process.
While the vast majority of material suppliers strive to provide 100% traceability to the melt source, few offer the capability of physically marking and labeling each piece of material in addition to providing the material certifications of compliance required. For round bar and flat type material, this process is known as “Line Marking.”
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