FDA Alert: Barrier Enclosures
The FDA issued a letter on Aug. 21, 2020, advising that previously EUA approved Protective Barrier Enclosures without Negative Pressure may increase risk to patients and healthcare providers. Therefore, it is revoking the EUA for these types of passive protective devices. Preliminary evidence discovered during simulated intubation procedure models revealed potential adverse events that could occur or complications with protective barrier enclosures that do not have a negative pressure component. Data showed that that these products may not decrease a healthcare provider’s exposure to airborne particles and, in some cases, may increase exposure.