The U.S. medical stockpile is looking for companies that can make disposable isolation and surgical gowns in the U.S. or Canada.
The Strategic National Stockpile issued a request for information to find companies that can deliver gowns over the next 18 months and meet stringent safety requirements.
The gowns will need to be registered with the Food and Drug Administration, cover the back of the wearer, not be flammable, and meet standards set by the Association for the Advancement of Medical Instrumentation—the same ones used by the FDA—and standards organization ASTM International.
The gowns are among the many types of protective equipment that doctors struggled to get earlier in the Covid-19 pandemic. If workers wear a gown without the correct level of protection for a procedure, it puts them at risk of exposure to a virus like the one that causes Covid-19.
The federal government previously turned to companies that began making PPE during the pandemic. However, those companies may be untested in terms of their ability to deliver quality gowns.
The surgical gowns must also have been approved by the FDA and be made of woven or nonwoven fabric, but not the plastic material polyethylene.
The stockpile is looking for Level 2 isolation gowns and Levels 3 and 4 surgical gowns. The different levels of the gowns tell a worker what amount of protection the garment will provide based on the anticipated risk of exposure to a fluid. A Level 1 gown is intended for basic patient care or transport, a Level 2 for procedures like drawing blood or inserting an IV, a Level 3 for trauma patient care, and a Level 4 for surgery.
The federal government is planning to purchase more gowns, an administration official said on condition of anonymity. The hope is that all aspects of those gowns will be American-made, and the government is discussing purchasing an additional 80 million to get closer to the stockpile’s initial goal of 265 million gowns, the official said.
The stockpile bought more than 80 million isolation gowns from a variety of untested companies in September 2020. The gowns delivered from that contract, awarded by the Defense Logistics Agency, “have not been deployed,” a Health and Human Services Department spokesperson said, attributing the lack of distribution to a lower demand for gowns from states and localities.
The U.S. medical stockpile removed 25 million out of 26 million isolation gowns purchased from those companies from its inventory in March while experts determined if they adequately protect health workers.
An independent health safety nonprofit found last November that half of a set of disposable hospital gowns it tested didn’t meet the level of protection they claimed according to standards set by the Association for the Advancement of Medical Instrumentation.
Responses to the request for information are due June 14.