ASTM International Approves New National Standard for Barrier Face Coverings

On February 15, 2021, ASTM International, a voluntary standards-setting organization, approved a new national standard for barrier face coverings that establishes minimum design, performance, labeling and care requirements for disposable and reusable face masks. Manufacturers should take full advantage of this new guidance as it implements a universal standard for the evaluation of barrier face coverings utilized by a majority of Americans every day.

To read the full text of this Duane Morris Alert, please visit the firm website.

U.S. Food & Drug Administration Takes Steps to Allow Availability of PPE

Over the past week, the U.S. Food & Drug Administration (FDA) has taken a number of steps to enable manufacturers and distributors of face masks to more efficiently make their products available to the marketplace. FDA has accomplished this by establishing criteria that would allow manufacturers to bypass normally required (and often time-consuming) regulatory review.

To read the full text of this Duane Morris Alert, please visit the firm website.

PPE and Other Medical Devices from 3D Printing

During the COVID-19 pandemic, the demand for personal protective equipment (PPE) has significantly outpaced the capabilities of the traditional supply chain. Gowns, gloves, facemasks, and face shields are valued commodities that even many healthcare providers cannot secure in this environment. While traditional supply and manufacturing chains struggle to keep up with production, industry leaders have turned to 3D printing, or additive manufacturing technology, to address this dire need. Unlike traditional manufacturing methods, companies with already established additive manufacturing technologies can more readily and efficiently adapt their productions to manufacture such PPE. 3D printing manufacturers may already have the powder or fabric necessary to manufacture PPE. They also have versatile printers. These companies simply need software and product design specifications, which allows them to begin production much more quickly than companies relying on traditional manufacturing methods that require additional raw materials and even machines and equipment.

For example, Superfeet, a shoe insert manufacturer, which typically uses 3D printing for manufacturing its products, was contacted about its ability to assist with a shortage of powered air purifying respirators (PAPR) hoods to hospitals in Washington state. The company had printers and fabric already. In just a few short days, Superfeet was making PPE.

To read the full text of the article by Duane Morris , visit the MD+DI website.

© 2009- Duane Morris LLP. Duane Morris is a registered service mark of Duane Morris LLP.

The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

Proudly powered by WordPress