In COVID-19 Crisis, FDA Bends Rules to Bring More Equipment to Facilities

The FDA is loosening the rules for the manufactures of certain air purifiers disinfectant devices so that more can be made available.

The FDA is continuing its efforts to make vital equipment available to hospitals and other healthcare institutions in the midst of the coronavirus (COVID-19) outbreak causing nationwide shortages of personal protective equipment (PPE), ventilators, and more.

Most recently, the agency issued a guidance to expand the availability and capability of sterilizers, disinfectant devices, and air purifiers during — and only during – the COVID-19 outbreak. Once the pandemic is ruled to be over by the US Department of Health and Human Services (HHS), the guidance will no longer stand.

“In the context of the COVID-19 public health emergency, it is necessary to maintain adequate supply of sterilizers, disinfectant devices, and air purifiers that can facilitate rapid turnaround of sterilized or disinfected medical equipment and that help reduce the risk of viral exposure for patients and healthcare providers to SARS-CoV-2,” the agency wrote in the guidance.

Manufacturers of these devices typically must submit a marketing application to FDA before putting the items on the market. After the FDA Oks the application, additional clearance is needed by the FDA to modify the device or the way it is used.

“However, to help ensure the availability of equipment that might offer some benefit to healthcare providers and the general public during the COVID-19 outbreak, during the declared public health emergency, FDA does not intend to object to limited modifications to the indications or functionality of FDA-cleared or FDA-approved sterilizers, disinfectant devices and air purifiers…” the FDA wrote.

Additionally, the FDA stated that they have no intention of objecting to the distribution and use of these type of devices that don’t already have marketing authorization granted by the agency.

These new are coming after a previous statement by the FDA, saying that they are working to expedite imports of PPE to get them to the healthcare providers that need them most.

“The FDA is continuously examining the global supply chain to identify any concerns and assess the availability of the products Americans need most,” the FDA said in a Marc 28 statement. “We are also partnering with the Federal Emergency Management Agency (FEMA) on supply chain issues, including importation of needed medical products to support U.S. response.”

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