mdi ConsultantsThe EUA is causing havoc in the medical industry and for the FDA. Now there is a gown that does not meet specification and the FDA is warning on it discontinued use. The faster the FDA can stop this EUA the faster the FDA can get a better control on these PPE products and manufacturing operations.
On August 28, 2020, the FDA made aware that gowns sold as medical gowns, including surgical gowns, sold by Laws of Motion PPE have potential quality issues that affect the level of fluid barrier protection. The FDA is making this alert aware to health care facility risk managers, procurement staff, and health care providers and is recommending that gowns manufactured or sold by Laws of Motion PPE not be used as PPE at this time while the investigation continues.
FDA recommends that health care facility risk managers, procurement staff, and health care 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.
To read the full update, please visit the FDA’s website.
For any further questions about this update, please email mdi Consultants at [email protected] RE: MedWatch.