domingo, 23 de agosto de 2020

Protective Barrier Enclosures Without Negative Pressure Used During the COVID-19 Pandemic May Increase Risk to Patients and Providers

https://www.fda.gov/medical-devices/letters-health-care-providers/protective-barrier-enclosures-without-negative-pressure-used-during-covid-19-pandemic-may-increase?utm_campaign=2020-08-20%20CDRH%20-%20LHCP%20Protective%20Barrier%20Enclosures&utm_medium=email&utm_source=Eloqua

Protective Barrier Enclosures Without Negative Pressure Used During the COVID-19 Pandemic May Increase Risk to Patients and Providers

The U.S. Food and Drug Administration (FDA) is alerting health care providers (HCP) and health care facilities that the use of passive protective barrier enclosures (those without negative pressure) when treating patients who are known or suspected to have Coronavirus Disease 2019 (COVID-19) may pose an increased health risk to patients and HCPs.
The Letter to Health Care Providers and health care facilities includes important information about protective barriers enclosures, including:
  • Details on the safety concerns about the passive protective barrier enclosures.
  • Recommendations for health care providers.
  • Actions that the FDA has taken to address the safety concerns about the protective barrier enclosures.
  • Instructions for reporting problems with a device.

Questions?
If you have questions about the safety of protective barrier enclosures, contact the Division of Industry and Consumer Education (DICE).

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