August 28, 2020
The following quote is attributed to Suzanne Schwartz, M.D., MBA, Director, Office of Strategic Partnerships and Technology Innovation at FDA’s Center for Devices and Radiological Health:
“As part of our commitment to health care providers and their safe use of personal protective equipment, today we sent an alert to health care providers regarding a potential safety issue with gowns, including surgical gowns, sold by Laws of Motion PPE.
“The FDA investigation is ongoing, but we recommend that health care providers do not use these products at this time.
“We will continue to monitor this situation and will take appropriate action as needed to protect public health. ”
- Today, the U.S. Food and Drug Administration issued an alert to health care providers to not use medical gowns, including surgical gowns, from Laws of Motion PPE after receiving reports that the gowns do not meet the labeling specifications for intended use.
- The FDA encourages health care professionals to report adverse events or quality problems experienced with the use of personal protective equipment to FDA’s MedWatch Adverse Event Reporting program.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.