Factors to Consider When Planning to Purchase Respirators from Another Country

Factors to Consider when Purchasing Respirators From Another Country

This webinar discusses key elements to assist patrons make knowledgeable procurement choices when making a respirator buy. The info will assist to maximise the chance of acquiring protected and efficient merchandise that may maintain staff protected.

When a respirator has been approved by the National Institute for Occupational Safety and Health (NIOSH), the consumer will be assured that the system will present the anticipated stage of safety, so long as it matches correctly and is worn accurately. But when there is a shortage of NIOSH-approved filtering facepiece respirators (FFRs), as we’re experiencing in the course of the coronavirus illness 2019 (COVID-19) pandemic, different dependable choices should be discovered. When doable, NIOSH recommends the usage of NIOSH-approved reusable elastomeric respirators and powered air-purifying respirators (PAPRs) as options to FFRs.

When a facility nonetheless wants further 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 those choices is to buy respirators that meet the regulatory necessities of the international locations listed within the FDA’s Emergency Use Authorizationexternal icon (EUA)*. However, because of the present demand, patrons must be conscious that an unprecedented variety of merchandise in the marketplace don’t carry out as marketed. The three commonest “pitfall” situations embody:

  1. Documents are altered so FFR fashions seem to adjust to a specific commonplace, however they don’t.
  2. Certification marks are counterfeit.
  3. Manufacturers’ names, logos, and mannequin numbers are counterfeit.

Key Factors

The key elements described beneath ought to help potential purchasers of worldwide respirators in making knowledgeable procurement and distribution choices to maintain their staff protected. Due diligence must be completed to use all elements to maximise the potential for acquiring protected and efficient merchandise.

Potential purchasers of worldwide respirators ought to consider the system they plan to buy, the producer, any third-party middleman (if relevant), and the contract phrases earlier than making buying choices.

Evaluation of the Device

  • Considerations when buying any filtering facepiece respirator
    1. The general safety afforded by an FFR is a mixture of the filter effectivity of the filtering materials and the flexibility of the product to kind a good seal on the face of the wearer, generally referred because the match.
    2. As a part of an general respiratory safety program within the office, OSHA requires preliminary match testing wherein a specific product is examined by the wearer utilizing a advisable methodology.
    3. When formal match testing can’t be carried out for every product on every individual, equivalent to when procuring an emergency provide, assessing a product’s potential to suit a number of folks prior to buy is essential.
    4. Overall high quality of development also needs to be thought-about, particularly in case your facility is practising the prolonged use of respirators.
  • Evaluation of samples of the product prior to creating a purchase order
    1. Obtain samples from the producer.
    2. Evaluate the respirator your self by conducting a match check with a number of folks in your group per the necessities of your respiratory safety program.
  • Filtration effectivity
    1. During the COVID-19 response, NIOSH is conducting modified filtration effectivity assessments of respirators not licensed by NIOSH. You can check the test results for products that have been evaluated to this point to see if the mannequin(s) you have an interest in are included. Note that the check outcomes listed on the web page linked above are for FFR samples submitted to NIOSH’s modified check program. NIOSH doesn’t have info on how the examined samples’ efficiency pertains to the efficiency of different merchandise marked with related mannequin numbers.
      1. Do NOT buy any mannequin that achieved filtration effectivity outcomes <95% environment friendly throughout a NIOSH analysis.
      2. For fashions that achieved filtration effectivity outcomes >=95% effectivity throughout a NIOSH analysis, proceed to observe the steps beneath prior to buying the product.
    2. Interested parties can send a small sample size of respirators received from other countries to be tested on the NIOSH National Personal Protective Technology Laboratory. This is a point-of-use evaluation and isn’t for use by producers, distributors, suppliers, or importers trying to promote merchandise within the United States.
  • Head harness design
    1. Use warning when buying a respirator with ear loops as the top harness. Preliminary NIOSH assessments point out it’s tough to realize an satisfactory match when sporting respirators with ear loop designs. (NIOSH-approved respirators typically should not have ear loops.)
    2. NIOSH strongly recommends in opposition to buying a respirator with ear loops with out conducting a match check with a number of folks (with various facial buildings) in your group per the necessities of your respiratory safety program.

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