Friday, September 9, 2016

Should Implantable Medical Device Manufacturers be Working on a Direct Marking Solution?

There is no regulatory requirement for direct marking the UDI on implantable devices.  However, for some implants, the DM UDI will provide a way of identifying a device at the point of implantation.  However, the inability to DM an implant is not an exception to the overarching requirement to provide the UDI at the point of implantation.
1. Individually labeled sterile implants
2. UDI tag – remains on the individual implant until use
3. Direct Part Marking (DPM) – 2D barcode etched on implant
4. Inventory control sheets – use sheets to map and recording sheets contain the DI in barcode and human readable lot number may be directly marked on implant (can be recorded or photographed)
5. Mobile application – to support field replenishment – ties specific implant’s UDI to each tray/caddy and guides replenish activities
USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

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