COVID-19: Worldwide Respirator Buy | CDC
This webinar discusses key factors that will help buyers make informed sourcing decisions when purchasing a respirator. The information will help maximize the likelihood of obtaining safe and effective products that will keep workers safe.
When a respirator is approved by the National Institute for Safety and Health at Work (NIOSH), the user can be assured that the device will provide the expected level of protection as long as it is properly seated and properly worn. However, when there is a shortage of NIOSH Approved Respirators (FFRs), as we are experiencing during the 2019 Coronavirus Disease (COVID-19) Pandemic, other reliable options need to be found. When possible, NIOSH recommends using NIOSH approved reusable elastomeric respirators and motorized air-purifying respirators (PAPRs) as alternatives to FFRs.
If 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 to protect workers during the pandemic may be appropriate. One of these options is to purchase respiratory protective equipment that meets the legal requirements of the countries used in the FDA emergency approvalexternal symbol (EUA) *. However, due to current demand, buyers should be aware that an unprecedented number of products on the market are not performing as advertised. The three most common "pitfalls" scenarios include:
- Documents are modified so that FFR models appear to conform to a certain standard, but they do not.
- Certification marks are fake.
- Manufacturer names, logos, and model numbers are faked.
Key factors
The key factors described below should help prospective buyers of international respiratory protective equipment make informed sourcing and sales decisions to ensure the safety of their workers. Careful examination should be carried out to apply all factors and to maximize the possibility of obtaining safe and effective products.
Potential buyers of international respiratory protective equipment should evaluate the device they intend to purchase, the manufacturer, a third party supplier (if applicable), and the terms of the contract before making any purchase decisions.
Evaluation of the device
- Considerations when buying a respirator with a filter face piece
- The overall protection that an FFR provides is a combination of the filtering efficiency of the filter material and the product's ability to form a tight seal on the front of the wearer, commonly referred to as a fit.
- As part of a comprehensive workplace respiratory protection program, OSHA requires an initial fit test, during which a particular product is tested by the wearer using a recommended method.
- When formal fit tests cannot be performed on every person for every product, e.g. When sourcing an emergency supply, it is important to evaluate a product's ability to fit multiple people before purchasing it.
- The overall build quality should also be considered, especially if your facility practices the expanded use of respirators.
- Evaluation of product samples before purchase
- Obtain samples from the manufacturer.
- Evaluate the ventilator yourself by performing a fit test with multiple people in your company according to the requirements of your respiratory protection program.
- Filtration efficiency
- During the COVID-19 response, NIOSH performs modified filtration efficiency assessments on respiratory protective devices that have not been NIOSH certified. You can review the test results for products that have been evaluated so far to see if they include the models you are interested in. Note that the test results listed on the linked page above apply to FFR specimens submitted to NIOSH's modified test program. NIOSH has no information on how the performance of the samples tested will affect the performance of other products marked with similar model numbers.
- DO NOT purchase any model that has obtained <95% filtration efficiency results during a NIOSH evaluation.
- For models that showed Filtration Efficiency Results> = 95% during a NIOSH evaluation, complete the following steps before purchasing the product.
- Those interested can send a small sample of respirators from other countries to the NIOSH National Personal Protective Technology Laboratory for testing. This is an on-site assessment and should not be used by any manufacturer, dealer, supplier, or importer attempting to sell products in the United States.
- During the COVID-19 response, NIOSH performs modified filtration efficiency assessments on respiratory protective devices that have not been NIOSH certified. You can review the test results for products that have been evaluated so far to see if they include the models you are interested in. Note that the test results listed on the linked page above apply to FFR specimens submitted to NIOSH's modified test program. NIOSH has no information on how the performance of the samples tested will affect the performance of other products marked with similar model numbers.
- Head harness design
- Use caution when purchasing a breathing apparatus with ear loops as a head harness. Preliminary NIOSH evaluations show that it is difficult to achieve a proper fit when wearing respirators with an ear loop design. (NIOSH-approved respirators generally do not have ear loops.)
- NIOSH strongly advises against purchasing an earloop ventilator without performing a multi-person (with different facial structures) fit test at your company as per the requirements of your respiratory protection program.
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