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Why not start a medical device traceability program before you have to?

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John Keating, 08-30-2011

If you make hospital supplies, medical devices, or medical technology products, you know that quality is critical to success. You are held accountable for defective products and inconsistent quality while rapidly changing costs, increased global competition, and pending regulations all challenge your profitability.

For the sake of patient safety, medical device traceability at a global level is vital. Currently there is no single global regulation for uniquely identifying medical devices in the supply chain. This makes the handling of recalls less efficient and more complex than it could be, negatively impacting patient safety and confidence. How can you get a head start while achieving peace of mind and a competitive advantage?

You can ensure compliance and provide recall efficiency with end-to-end traceability by reading 2-D codes marked directly on parts (DPM), devices, and surgical instruments. Advanced image-based barcode readers (like our DataMan) can read these marks on all surface types.

1-D barcodes can be printed on rolls of labels and flexible products or packaging such as solution bags.  Image-based barcode readers are perfect for high-speed scanning of such 1-D barcodes to help detect errors without slowing the speed of your production lines.

If you do not already have a traceability program in place, you should be preparing for upcoming FDA regulations by placing Unique Device Identification (UDI) in human readable and Auto ID formats on each device or product, its label/packaging, or both.

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