Modalities to Study the Efficacy of UVC Devices

EP: 1.FDA UV Authorization Introduction

EP: 2.When Did the FDA Begin Regulating UVC Robots?

EP: 3.What Separates Those Companies That Have Been FDA Authorized and Those That Haven’t?

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EP: 4.Modalities to Study the Efficacy of UVC Devices

EP: 5.FDA’s UV Performance Testing and Emergency Use Authorization for the COVID-19 Pandemic

EP: 6.Value Analysis Committees for UVC and What They Need

EP: 7.EPA Does Not Regulate Medical Devices, and UV Are Medical Devices

EP: 8.What Are the Differences Between Medical Devices and Nonmedical Devices?

EP: 9.Are These EPA-Regulated Since These Devices Are Dangerous to Staff?

EP: 10.What Is the Process to Get the FDA Authorization, and Is the FDA Enforcing this Industry?

EP: 11.Loopholes in the UV Device Industry

EP: 12.Where Can These Products Be Used if They Are Not (Yet) Authorized?

EP: 13.What Is Your One Piece of Advice to Health Care Leaders Evaluating These Devices?

EP: 14.Will the FDA Allow UV Companies to Market While Working on Getting the Authorization?

EP: 15.Educating the UV Device Purchaser

EP: 16.Panel Members’ Final Thoughts

Next, the panelists dig into why “efficacy” claims cannot be compared apples-to-apples. Before the pandemic, researchers showcased wildly different test methods, including carrier materials and inoculum, device-to-surface distance, exposure time, and the log-reduction targets, making it difficult for clinicians to interpret results across UV systems. Our panelist explains how that inconsistency pushed her to scrutinize study design and ultimately partner with one of the FDA-cleared device makers.