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FDA signals PPE shortage, issues EUA for more

2020-06-04

The FDA has issued a call for manufacturers to produce more non-surgical gowns and other personal protective equipment (PPE) as the coronavirus pandemic makes its way across the country.

The emergency use authorization issued Friday also listed conductive shoes and shoe covers, operating room shoes and shoe covers, surgical helmets and caps and other surgical accessories.

The FDA said it issued the EUA in response to concerns about shortages of gowns and other apparel for use by healthcare personnel. Earlier this month, the agency said that healthcare organizations had informed the agency that some distributors may be allocating PPE basing on a health system’s previous use rather than its projected use.

Shortages of PPE prompted a recent article in The Lancet, based on a study by GetUsPPE, a volunteer organization connecting healthcare providers with supplies of PPE during the COVID-19 pandemic.

That study showed that most of the 6,169 hospitals, healthcare and other facilities — including nursing homes — that made PPE requests through GetUsPPE asked for N95 respirators (74%), surgical masks (64%), gowns (61%), and face shields (60%).

Metropolitan areas comprised 5,416 (88%) of the requests. The data show significant disparities between PPE availability and income levels, with requests equaling 3,990 (65%) coming from counties with the highest quartile of median income. This may be because requesters in those areas are more aware of the GetUsPPE Demand Data Hub, the organization said.

Hospitals topped the list of facility types requesting PPE at 27%, with outpatient clinics at 15% and skilled nursing facilities at 9%. Facilities in the South made the most requests at 32%, followed by the West at 26%, the Northeast at 23%, and the Midwest at 16%. The organization called for a significant increase in PPE manufacturing.

Earlier this month, the FDA issued conservation strategies for gowns, including using:

  • Reusable gowns instead of disposable, single-use gowns.
  • Sterile surgical isolation gowns for surgery/invasive procedures with a medium to high risk of contamination.
  • Non-sterile gowns.
  • Isolation gowns for routine care of patients that are suspected or confirmed to be infected with COVID-19.

From:mass device