Medical products can be manufactured and distributed illegally beyond regulatory and safety channels. Patients can be harmed by these unregulated devices, including through injury, infection, and device malfunction. Nurses and other healthcare providers play an essential role in identifying counterfeit, falsified, or substandard medical products and then understanding how to report these products to protect others. Having a clear understanding of the sources of safe versus unsafe medical products and the steps to be taken when finding these products can help protect patients and strengthen a safer medical supply chain.
Learning Objectives:
Describe the differences between authorized sellers and original equipment manufacturer (OEM) vs. unauthorized sellers and OEM (gray market) medical products and the risks each poses to patient safety and clinical operations
Identify potential warning signs of counterfeit or unauthorized medical supplies and understand the risks they pose to patients and healthcare facilities
Apply best practices for preventing counterfeit or gray market products in the clinical setting, including proper procurement, reporting, and chain of custody procedures