What is a respirator?
A respirator is a personal protective device that is worn on the face or head and covers at least the nose and mouth. Respirators, including those intended for use in healthcare settings, are certified by the CDC/NIOSH and should be fit tested prior to use.
How does an N95 respirator work?
An N95 filtering facepiece respirator (FFR) is a type of respirator which removes particles from the air that are breathed through it. These respirators filter out at least 95% of very small (0.3 micron) particles, including bacteria and viruses.
Does Owens & Minor sell facial protection to prevent transmission of the coronavirus?
Infection control procedures including administrative rules and engineering controls, environmental hygiene, correct work practices, and appropriate use of personal protective equipment (PPE) are all necessary to prevent infections from spreading during healthcare delivery. Reference the website Interim Infection Prevention and Control Recommendations for Patients with Confirmed Coronavirus Disease 2019 (COVID-19) or Persons Under Investigation for COVID-19 in Healthcare Settings (https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html) for information on infection prevention and control regarding COVID-19.
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.
What is Owens & Minor’s position on selling expired respirators?
Owens & Minor’s position is that we will not sell expired respirators. Owens & Minor has no data to support the use of respirators beyond the expiration date printed on the package and does not recommend using our products past its expiration date. The FDA and CDC have not provided an exemption for manufacturers to sell expired respirators.
What is Owens & Minor’s position on selling other personal protective equipment that has expired?
Owens & Minor’s position is the same for respirators. We only recommend using products that conform to the product labelling and will not sell product that is expired.
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Does Owens & Minor have a position on using expired respirators?
Owens & Minor does not recommend using expired HALYARD brand respirators. Owens & Minor only has data to support the 5-year expiration date described on the product labelling for HALYARD* N95 Particulate Filter Respirators and Surgical Masks. This data supports the functionality of the respirator including the straps and nose bridge, which can affect the quality of the fit and seal. Additionally, it supports certification requirements set by NIOSH to ensure filtration of small particles, including bacteria and viruses.
For non-proprietary brands, HCPs should be referred to the manufacturer of the brand for their position on using expired respirators.
Does Owens & Minor have a position on other expired products?
Owens & Minor only recommends using medical devices products only as described by its label claims.
Where are HALYARD* N95 respirators manufactured?
Owens & Minor proprietary HALYARD* N95 Respirators are manufactured in our internal North American manufacturing sites. If asked about non-proprietary respirators, refer them to the manufacturer of that brand.
Can you reuse a HALYARD* N95 respirator?
No. HALYARD* N95 respirators are labeled as single use. The respirators are designed to be disposable and should be removed and discarded after exiting the patient’s room or care area and closing the door. We are aware that the CDC has published a guidance document that recommends practices for extended use and limited reuse of NIOSH-certified N95 filtering facepiece respirators (commonly called “N95 respirators”). The recommendations are intended for use by professionals who manage respiratory protection programs in healthcare institutions to protect health care workers from job-related risks of exposure to infectious respiratory illnesses.
Can you clean a HALYARD* N95 Respirator?
O&M Halyard recommends using our HALYARD branded N95 respirators as intended in the product labeling. Our HALYARD branded N95 respirators are non-cellulose and are labelled as disposable and single use based on scientific data that supports the product’s design and intended use as stated on the labeling to ensure its safe and effective use in the healthcare setting.
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:
Due to the shortage of PPE like facial protection, can any other Owens & Minor proprietary products be used to make facial protection?
O&M Halyard manufactures sterilization wrap under our HALYARD brand. The intended use of the product is for the sterilization of medical instruments and devices by healthcare professionals through various sterilization methodologies, and to maintain the sterility of its contents until use. HALYARD branded sterilization wrap is cleared for this specific use by the FDA.
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.
Can surgical gowns be used as isolation gowns?
Surgical gowns and isolation gowns have different intended use claims. Owens & Minor recommends only using products as described by the products label claims. The CDC provides the following guidance on the types of gowns available for healthcare personnel to protect from COVID-19?
- 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. Isolations gowns should not be worn during surgical or invasive procedures, or for medium to high risk contamination patient care activities.
