Educating the UV Device Purchaser

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?

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?

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EP: 15.Educating the UV Device Purchaser

EP: 16.Panel Members’ Final Thoughts

Our panelists urge hospitals to start with education by helping purchasers and leaders understand the difference between a “product” and an FDA-regulated medical device and use the FDA’s public listings to verify status before buying. If the indications for use sound like a medical device claim, check FDA clearance/approval and recall history, and remember these UV systems are adjuncts—they come after manual cleaning and disinfection.