Health Law & Business News

FDA Expands Access to Surgical Gowns, Gloves, Sterilizers (1)

March 30, 2020, 3:18 PMUpdated: March 30, 2020, 4:07 PM

The FDA is taking steps to expand the availability of surgical gowns, gloves, and medical device sterilizers to help shield health-care providers and patients against Covid-19, the disease caused by the novel coronavirus.

The Food and Drug Administration issued final guidance Monday to increase the supply of personal protective equipment used by surgeons to examine patients. The agency also released final guidance Sunday to help device makers keep a reasonable supply of medical equipment cleaners and air purifiers.

Masks are in such short supply that hospitals nationwide have asked people with sewing machines and cotton cloth to make them. Many U.S. governors have also complained they’re unable to obtain sufficient supplies of ventilators, respirator masks, and even basic medical supplies like gloves and gowns.

Both guidances will remain in effect only until the end of the public health emergency related to the coronavirus, the agency said.

The guidance on personal protective equipment clarifies when gowns and other apparel qualify as medical devices subject to agency review. It also says the agency won’t object to the distribution and use of equipment that doesn’t comply with certain regulatory requirements, if it doesn’t create undue risks.

The guidance on sterilizers includes recommendations on how manufacturers can design, evaluate, and check for their products’ performance. That guidance covers products used to clean medical devices such as endoscopes, the equipment that uses ultraviolet light to kill germs, and purifiers that kill pathogens in the air by filtering them away.

The FDA says it doesn’t plan to object to the use of sterilizers and air purifiers that claim to be effective at killing the new coronavirus but don’t already have FDA marketing approval, if such devices don’t create undue risks.

(Updated with additional reporting throughout)

To contact the reporter on this story: Ayanna Alexander in Washington at aalexander@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Alexis Kramer at akramer@bloomberglaw.com

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