The Food and Drug Administration (FDA) has issued a special warning describing the risk for patients associated with the protective barrier enclosures without negative pressure used in the context of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus.”

Passive Protective Barrier Enclosures: Regulatory Background

Earlier in May, 2020, the FDA issued an Emergency Use Authorization (EUA) allowing the use of passive protective barrier enclosures for the purpose of protecting healthcare professionals working with COVID-19 patients as an additional measure supplementing the use of the appropriate personal protective equipment (PPE) to mitigate risks associated with the potential transmission of the virus from the patients to healthcare professionals. 

According to the document, a passive protective barrier is a transparent device intended to cover a patient’s head and upper body that incorporates one or more ports through which the healthcare professional’s hands are passed to perform medical procedures, and that does not include fans, air filters, or other features and is not intended to generate negative pressure. 

In accordance with the umbrella EUA, those passive protective barrier enclosures that fall within the scope of authorization and meet the conditions of authorization have been allowed for manufacturing, distribution, and use in the US. When issuing the appropriate EUA, the FDA deemed such devices as useful for the purpose of increasing the level of protection of healthcare professionals providing care and treatment to the patients suspected to be infected with COVID-19. In particular, passive protective barrier enclosures were allowed for use in certain situations, such as:

  • Airway management, 
  • Aerosol generating procedures. 

Emergency Use Authorization in Brief 

At the moment when the appropriate Emergency Use Authorization was initially issued by the FDA, there were FDA-approved barrier protection devices available for healthcare professionals. The FDA also stated that protective barrier enclosures are novel protective devices that could be used in order to create an additional protective layer to enhance the level of protection offered by the personal protective equipment used by healthcare professionals working with coronavirus patients. Such additional protection becomes especially important if there is a high level of exposure to the fluids and airborne particles. 

When issuing the initial authorization, the FDA made its decision based on the following authorization criteria: 

  1. COVID-19 creates hazards for infected persons. Thus, it is important to take all necessary measures in order to reduce the risk of its transmission from patients to healthcare professionals. 
  2. According to the information available to the FDA at that moment, passive protective barrier enclosures could be an effective solution providing healthcare professionals with the additional protective layer.
  3. There were no adequate alternatives to such devices. 

In order to be eligible for marketing and use under the aforementioned EUA, the passive protective barrier enclosure has to meet the following criteria:

  1. The device should bear the labeling indicating the intended purpose of the product, and also the list of body-contacting materials the device contains.
  2. The labeling should also clearly state that the device could not be used instead of personal protective equipment.
  3. The device should be accompanied with the detailed instructions for use necessary for the safe and efficient utilization of the passive protective barrier enclosure by healthcare professionals. 
  4. The materials used to manufacture the device should be fully transparent.
  5. The device should not contain any filters or similar elements. 
  6. The labeling should contain an indication of whether the product is intended for single or multiple uses. 
  7. The device should not contain flammable materials. 
  8. The intended purpose of the device should be indicated in a way excluding any possible misrepresentation.

FDA Warning 

The FDA has published the present document in order to warn healthcare providers and institutions about certain risks associated with the use of passive protective barrier enclosures without negative pressure.

In particular, the FDA has certain evidence stating that in some cases the use of passive protective barrier enclosures could result in complications or other adverse events. The FDA also mentions that still no appropriate adverse events have been reported. However, the FDA deems existing evidence sufficient to revoke the umbrella EUA for passive protective barrier enclosures issued earlier this year.

The document also contains special recommendations to be considered by healthcare facilities, namely:

  • Passive protective barrier enclosures without negative pressure should not be used since they are not only ineffective in reducing the risks of transmission but in some cases are even increasing such risks. In particular, the use of such barriers could result in severe complications since they actually reduce the mobility of healthcare professionals. 
  • If the use of protective barrier enclosures is necessary, the FDA recommends using ones with negative pressures. Some devices of such kind have been already approved by the FDA under the appropriate Emergency Use Authorization. Only for such devices, the potential benefit from their use overweights potential risks associated thereto. However, the FDA still has no reports related to the complications caused by negative pressure devices. 
  • Protective barrier enclosures (irrespectively of their type) should not be used instead of personal protective equipment. 
  • In case if the protective barrier obstructs healthcare professionals when performing medical procedures, such a barrier should be removed.

Further Actions

As it was already mentioned before, the Emergency Use Authorization for passive protective barrier enclosures should be deemed revoked. Thus, any and all medical devices covered by the scope of the present EUA could not be longer marketed in the US. It is also important to mention that such devices would remain allowed for emergency use for creating additional layers of protection for healthcare professionals providing care and treatment to the patients with known or suspected COVID-19. 

If an interested entity is going to apply for the EUA for passive protective barrier enclosures, the appropriate application should be supplemented with the sufficient evidence demonstrating that the device subject to review meets the safety and performance requirements. 

The FDA also states that the policy regarding passive protective barrier enclosures could be subject to changes due to the new information about COVID-19 available to the authority. The FDA also encourages healthcare professionals to notify about any incidents associated with such devices. The whole scope of reports the authority expects to receive includes, inter alia, the following types:

  • Voluntary reports to be submitted under the FDA Safety Information and Adverse Event Reporting program,
  • Reports to be filed by medical device manufacturers in accordance with the Medical Device Reporting regulations, and
  • Reports to be filed by healthcare professionals in accordance with the user facility reporting requirements. 

The FDA additionally emphasizes the importance of reporting since it allows the authority to be aware of the situation, including the risks and potential consequences resulting from the use of medical devices to be able to implement special measures necessary to reduce the exposure to such risks. 

Summarizing the information provided hereinabove, the informational notice published by the FDA is intended to warn healthcare professionals about the risks associated with the passive protective barrier enclosures used under the Emergency Use Authorization, and also notifies that the appropriate EUA has been revoked. 

How Can RegDesk Help?

RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.