Frequently Asked Questions Concerning COVID and PPE
Covid 19 PPE Frequently Asked Questions
Respirators alone do not protect against the coronavirus. We do not claim that wearing our respirators prevents coronavirus. Owens & Minor sells proprietary HALYARD* brand and non-proprietary NIOSH-certified N95 filtering respirators.
For non-proprietary brands, HCPs should be referred to the manufacturer of the brand for their position on using expired respirators.
Currently, O&M Halyard does not have sound scientific data regarding the safety and effectiveness for any decontamination method(s) of our HALYARD branded N95 respirators. O&M Halyard is actively working with leading sterilization companies and organizations that are investigating in several decontamination methods to identify processes that can expand the life of HALYARD branded N95 respirators while ensuring the product performs as intended.
The Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUA) for certain decontamination systems of N95 respirators during the COVID-19 pandemic. Under EUA, the FDA allows non-cleared/regulated medical products or unapproved uses of cleared medical products to be used in an emergency situation such as the COVID-19 pandemic.
FDA has granted the following EUAs for the decontamination of N95 respirators constructed of non-cellulose materials. There are specific directions and requirements under each EUA that provide guidance on the position and use of the decontamination cycles. Healthcare providers considering the use of these systems should consult with the manufacturer of the decontamination system to determine which N95 respirators are compatible.
For the details on those cycles/modalities please refer to the EUA links below:
- Battelle Decontamination System
- STERIS Sterilization Systems for Decontamination of N95 Respirators
- Advanced Sterilization Products (ASP) STERRAD Sterilization System
We are aware of the recent reports regarding sterilization wrap material being used to make face masks. The use of sterilization wrap for facial protection has not been cleared by the FDA. O&M Halyard does not endorse the off-label use of our products.
O&M Halyard only recommends using our medical devices as described in the indications for use included in the product labeling. O&M Halyard does not have data to support the safety of products used beyond the indications for use including modifications of the product to make facial protection.
- While the transmissibility of COVID-19 is not fully understood, gowns are available that protect against microorganisms. The choice of gown should be made based on the level of risk of contamination. Certain areas of surgical and isolation gowns are defined as “critical zones” where direct contact with blood, body fluids, and/or other potentially infectious materials is most likely to occur. (ANSI/AAMI PB70).
- If there is a medium to high risk of contamination and need for a large critical zone, isolation gowns that claim moderate to high barrier protection (ANSI/AAMI PB70 Level 3 or 4) can be used.
- For healthcare activities with low, medium, or high risk of contamination, surgical gowns (ANSI/AAMI PB70 Levels 1-4), can be used. These gowns are intended to be worn by healthcare personnel during surgical procedures.
If the risk of bodily fluid exposure is low or minimal, gowns that claim minimal or low levels of barrier protection (ANSI/AAMI PB70 Level 1 or 2) can be used. Isolation gowns should not be worn during surgical or invasive procedures, or for medium to high risk contamination patient care activities.