FDA warns to stop using gowns, including surgical gowns, from Laws of Motion PPE
The U.S. Food and Drug Administration (FDA) published an alert to healthcare facility risk managers, procurement staff, and healthcare providers that gowns sold as medical gowns, including surgical gowns, sold by Laws of Motion PPE (LawsofMotionPPE.com) have potential quality issues that affect the level of fluid barrier protection.
The FDA is recommending that gowns manufactured or sold by Laws of Motion PPE should not be used as personal protective equipment at this time while the FDA continues our investigation.
The FDA recommends healthcare facility risk managers, procurement staff, and healthcare providers:
· Stop using gowns, including surgical gowns, purchased from Laws of Motion PPE until further notice.
· Identify the supplier or manufacturer of the gowns in your inventory.
· Report any issues with the quality or performance of gowns, including surgical gowns, to the FDA. See “Reporting Problems to the FDA” below.
The FDA has become aware that gowns, including surgical gowns, purchased from Laws of Motion PPE may not provide protection, including fluid barrier protection, at the level for which the gowns are labeled.
Personal protective equipment (PPE) refers to protective clothing, helmets, gloves, face shields, goggles, respirators, or other equipment designed to protect the wearer from injury or the spread of infection or illness. A surgical gown is a personal protective garment intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate matter.
The FDA is assessing the extent of the concerns and is working with Laws of Motion PPE to understand and address the issue. The agency will continue to keep healthcare providers and the public informed as significant new information becomes available.
