Keeping those on the frontlines safe is a constant motivation to share and develop protective supplies. Like so many who have volunteered their time during this crisis, we also want to pool our collective resources and do our part to offer support. So, Intuitive Foundation had in mid-2020 collaborated with Intuitive Surgical on an effort to develop a protective enclosure in compliance with the U.S. FDA’s May 1, 2020 umbrella Emergency Use Authorization (EUA) for protective barrier enclosures that do not use fans, air filters or other features and are not intended to generate negative pressure. Even when healthcare workers are wearing personal protective equipment (PPE), intubation and other aerosol generating procedures can pose some of the greatest contamination risks during the COVID-19 public health emergency. The hope was that, properly used, the protective barrier enclosure may offer some physical barrier/protection while still allowing the visualization and access needed for the procedure.
However, the U.S. FDA revoked this umbrella EUA in August (https://www.fda.gov/news-events/fda-brief/fda-brief-fda-revokes-emergency-use-authorization-protective-barrier-enclosures-without-negative). As a result, the protective barrier enclosures described here are not approved for use, and are not available for purchase.
Therefore, the below is just provided for historical information purposes.
The protective enclosure that Intuitive Foundation and Intuitive Surgical developed together under the now-revoked May 1, 2020 EUA, required one Mayo stand, one clip, and one plastic drape that will form the protective barrier enclosure, and was designed to ONLY be used in conjunction with required PPE (such as face masks, face shields, gowns, etcetera) that are worn by the healthcare provider. The graphics below describe how the protective barrier enclosure was to be set up.
As noted above, the information on this page is provided only to describe the efforts of Intuitive Foundation in response to the COVID-19 public health emergency, and should not be used to provide any protective enclosures.
Please send questions and feedback to: PPE@intuitive-foundation.org
Steps for the Protective Barrier Enclosure*
*Not approved for use. Provided for historical information only.