Challenge
Astute Medical manufactures biomarkers that are used to identify high-risk, acute medical conditions in critically ill patients. The Federal Drug Administration (FDA) issued a mandate that medical devices must carry a Unique Device Identifier (UDI), which requires a greater volume of information than had been previously required.

Astute Medical sought a compliance labeling solution that would meet UDI requirements in accordance with GS1 Standards. The manufacturer also wanted to receive accurate and repeatable verification results and a solution that included a Validation Protocol to document compliance with these requirements. We needed to not only comply with federal regulations, but also ensure that we were sending out our medical devices with a high-quality barcode, “to avoid returns,” explained Susan Shelton, Materials Management and Procurement Manager of Astute Medical.

Analysis

Astute Medical designs, engineers, and manufactures novel biomarkers that enable clinicians to identify acute conditions in their critically ill patients before the symptoms become evident. Products like the NephroCheck Test and Astute140 Meter fall under the guidelines of the FDA’s Unique Device Identification rule. This system was established to identify medical devices throughout their distribution and use, providing critical traceability that benefits the patient, caregiver, manufacturer, and distributor.

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