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Matrix IT - Tracking Direct Part Marked Hospital-Sterilized Medical Implants

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2017 AIM Case Study Competition Winner (AIDC Category)


Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. New federal laws require medical device companies to place permanent Unique Device Identifier (UDI) marks onto hospital-sterilized surgical implants, which must be electronically traced through the product’s lifecycle. Further, mandated UDI adoption is required in most developed countries. This Case Study evaluates the effectiveness of placing a high speed, high resolution camera into the sterile field of the operating room.

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