This webinar discusses key factors to help buyers make informed procurement decisions when making a respirator purchase. The information will help to maximize the likelihood of obtaining safe and effective products that will keep workers safe.

When a respirator has been approved by the National Institute for Occupational Safety and Health (NIOSH), the user can be confident that the device will provide the expected level of protection, as long as it fits properly and is worn correctly. But when there is a shortage of NIOSH-approved filtering facepiece respirators (FFRs), as we are experiencing during the coronavirus disease 2019 (COVID-19) pandemic, other reliable options must be found. When possible, NIOSH recommends the use of NIOSH-approved reusable elastomeric respirators and powered air-purifying respirators (PAPRs) as alternatives to FFRs.

When a facility still needs additional FFRs, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) have determined that other options may be appropriate to protect workers during the pandemic. One of these options is to purchase respirators that meet the regulatory requirements of the countries listed in the FDA’s Emergency Use Authorizationexternal icon (EUA)*. However, due to the current demand, buyers should be aware that an unprecedented number of products on the market do not perform as advertised. The three most common “pitfall” scenarios include:

1. Documents are altered so FFR models appear to comply with a particular standard, but they do not.
2. Certification marks are counterfeit.
3. Manufacturers’ names, logos, and model numbers are counterfeit.

Key Factors

The key factors described below should assist potential purchasers of international respirators in making informed procurement and distribution decisions to keep their workers safe. Due diligence should be done to apply all factors to maximize the possibility of obtaining safe and effective products.

Potential purchasers of international respirators should evaluate the device they plan to purchase, the manufacturer, any third-party intermediary (if applicable), and the contract terms before making purchasing decisions.

Evaluation of the Device

• Considerations when purchasing any filtering facepiece respirator
  1. The overall protection afforded by an FFR is a combination of the filter efficiency of the filtering material and the ability of the product to form a tight seal on the face of the wearer, commonly referred as the fit.
  2. As part of an overall respiratory protection program in the workplace, OSHA requires initial fit testing in which a particular product is tested by the wearer using a recommended method.
  3. When formal fit testing cannot be performed for each product on each person, such as when procuring an emergency supply, assessing a product’s ability to fit multiple people prior to purchase is important.
  4. Overall quality of construction should also be considered, especially if your facility is practicing the extended use of respirators.
• Evaluation of samples of the product prior to making a purchase
  1. Obtain samples from the manufacturer.
  2. Evaluate the respirator yourself by conducting a fit test with multiple people in your organization per the requirements of your respiratory protection program.
• Filtration efficiency
  1. During the COVID-19 response, NIOSH is conducting modified filtration efficiency assessments of respirators not certified by NIOSH. You can check the test results for products that have been evaluated to date to see if the model(s) you are interested in are included. Note that the test results listed on the page linked above are for FFR samples submitted to NIOSH’s modified test program. NIOSH does not have information on how the tested samples’ performance relates to the performance of other products marked with similar model numbers.
     1. Do NOT purchase any model that achieved filtration efficiency results <95% efficient during a NIOSH evaluation.
     2. For models that achieved filtration efficiency results >=95% efficiency during a NIOSH evaluation, continue to follow the steps below prior to purchasing the product.
  2. Interested parties can send a small sample size of respirators received from other countries to be tested at the NIOSH National Personal Protective Technology Laboratory. This is a point-of-use assessment and is not to be used by manufacturers, distributors, suppliers, or importers attempting to sell products in the United States.
• Head harness design
  1. Use caution when purchasing a respirator with ear loops as the head harness. Preliminary NIOSH assessments indicate it is difficult to achieve an adequate fit when wearing respirators with ear loop designs. (NIOSH-approved respirators generally do not have ear loops.)
  2. NIOSH strongly recommends against purchasing a respirator with ear loops without conducting a fit test with multiple people (with varied facial structures) in your organization per the requirements of your respiratory protection program.

Source: https://tools.cdc.gov/api/embed/downloader/download.asp?m=403372&c=406845