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COVID-19 Update: N95 Masks and PPE: Guidelines for Use And Importation

March 27, 2020

We know that right now most providers are in great need of N95 masks and other personal protective equipment (“PPE”). We also know that many providers are asking questions about what alternatives they can use during this COVID-19 public health emergency, and or how they may go about importing N95 masks and other PPE. Part 1 of this alert addresses current CDC guidance regarding N95 masks, and Part 2 summarizes the considerations for importing N95 masks/PPE and identifies potential hurdles you may encounter once you have connected with a manufacturer or supplier in a foreign country.

Part 1: CDC N95 Guidelines

The CDC recognizes that the realities of this current public health emergency makes it necessary for most providers to consider alternatives to PPE that are not commensurate with current standards. The following sets forth some of the basics relating to N95 respirators.

N95 Basics

Surgical N95 respirators are considered the gold standard for use by health care practitioners (“HCPs”) who need protection from both airborne and fluid hazards, and in the United States such items must be approved by the National Institute for Occupational Safety and Health (“NIOSH”) and regulated by the FDA. According to the CDC, Surgical N95 respirators are recommended for use while working in a sterile field or when an individual may be exposed to high-velocity splashes, sprays or splatters of blood or body fluids. NIOSH approves other filtering face-piece respirators that are at least as protective as the N95 and include N99, N100, P95, P99, P100, R95, R99, and R100. NIOSH also approves N95 respirators that are not for surgical/sterile uses (e.g., construction, painting). According to the CDC, standard N95 respirators may be used if Surgical N95 respirators are not available. If Surgical N95 respirators are not available, and there is a risk that the worker may be exposed to high-velocity splashes, sprays, or splatters of blood or body fluids, CDC recommends that a face-shield should be worn over the standard N95 respirator.

Use of N95 Respirators Beyond Their Designated Shelf Life

The CDC states that in times of shortage, consideration may be given to using N95 respirators beyond the manufacturer-designated shelf life. Studies conducted by the CDC of certain models of N95 masks indicate that many of these N95 respirators still function as intended after their designated shelf life has passed. Notwithstanding, CDC warns that due to the potential of degradation, there is no guarantee that expired respirators will perform to the requirements for which they were certified. Accordingly, CDC recommends that decisions regarding extended use of N95 respirators be made by your institutional infectious disease and respiratory experts. A list of the studied models can be found here. If your organization decides to use N95 respirators beyond their designated shelf life, CDC recommends the following:

Users should take the following precautionary measures prior to using the respirator in the workplace:

  • Visually inspect the N95 to determine if its integrity has been compromised.
  • Check that components such as the straps, nose bridge, and nose foam material did not degrade, which can affect the quality of the fit, and seal and therefore the effectiveness of the respirator.
  • If the integrity of any part of the respirator is compromised, or if a successful user seal check cannot be performed, discard the respirator and try another respirator.
  • Users should perform a user seal check after they don each respirator and should not use a respirator on which they cannot perform a successful user seal check.

Extended Use of N95 Respirators

The CDC also recognizes that extended use (i.e., the practice of wearing the same respirator for repeated close contact encounters with several different patients, without removing the respirator between patient encounters) may be necessary in medical emergencies or when supplies are limited. It is noted that the CDC recommends that decisions relating to extended use “be made by the professionals who manage the institution’s respiratory protection program, in consultation with their occupational health and infection control departments with input from the state/local public health departments.” It is also noted by the CDC that extended use may be best suited to situations wherein multiple patients with the same infectious disease diagnosis. CDC guidance for extended use of N95 respirators can be found here.

If neither of these options are enough, it may become necessary for your institution to consider importing N95 respirators from one of the countries recognized by the CDC as having quality standards comparable to the United States. Specifically, the CDC has come up with a list of products from other countries that have been tested by NIOSH and found to be equivalent and suitable alternatives to provide protection during the COVID-19 response when supplies are short. The country, conformity assessment standards, acceptable product classifications, standards and guidance documents, and protection factor determination can be found here.

Part 2: Importation of Alternative N95 Respirators from Other Countries

Most healthcare systems are, understandably, not in the business of importing their own supplies and, under normal scenarios, utilize trusted supply chain partners to handle much of the transport and logistic requirements. However, given the present shortage of supplies, many healthcare systems are interested in finding and working with any supplier of PPE and arranging direct imports where appropriate.

Standard items are imported through U.S. Customs and Border Protection (“CBP”). Certain PPE, namely those that meet the definition of “medical devices,” may also trigger Food and Drug Administration (FDA)-specific import requirements, trigger certain import duties/tariffs and elevate the bribery/corruption risk of a transaction, as summarized below.

FDA Requirements for Standard Medical Device Imports

FDA, through its Center for Devices and Radiological Health (“CDRH”), verifies and enforces applicable medical device requirements at the time a medical device is imported or offered for import into the United States. Foreign companies must comply with applicable FDA regulations before, during, and after the medical device is imported into the United States or territory. Products that do not meet FDA regulatory requirements may be detained upon entry.

Imports of medical devices must clear CBP and FDA requirements before entry. Typical information necessary includes:

  • Country of origin
  • Importation product code
  • Importer product description
  • Manufacturer
  • Shipper
  • Applicable affirmations of compliance codes
  • Harmonized Tariff Schedule (HTS) code
  • Manufacturer of the masks (full name and address)
  • FDA registration number of the manufacturer and exporter
  • End Use Letter

Non-Medical Device Exemption

As noted above, NIOSH regulates/certifies PPE for occupational settings, including standard N95 masks. Indeed, according to NIOSH, the FDA has no role in the approval or clearance of N95 respirators that are not intended for use as a medical device. Thus if a health care provider’s intended use of the N95 masks does not meet the definition of a “medical device,” the complexities of the import can be reduced when exempt from FDA requirements.

Emergency Use Authorization

Based on the current public health emergency, the Secretary of Health and Human Services (“HHS”) declared that circumstances exist to justify the authorization of emergency use of personal respiratory protective devices during the COVID-19 outbreak. By law, the FDA Commissioner may (and did) allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives. Manufacturers and “strategic stockpilers” are able to submit a request to FDA in order to have their products added to the Emergency Use Authorization (“EUA”) list.

Several N95 models that would not otherwise satisfy all standard FDA requirements have been authorized under this option. Information on approved products with EUA can be found here.

Tariffs

Under the “Section 301” Tariffs, a wide variety of imports, including medical supplies, from China carried tariffs over and above any applicable customs duties. In March 2020, the U.S. government implemented relief for many Chinese medical supply imports by waiving the 7.5% tariff. To inform the full, landed cost of such transactions, importers should be aware that the relief is likely not permanent and that other potential duties and tariffs may nevertheless stay in play.

Anti-Corruption/Bribery

Lastly, any time the demand for a product far exceeds the supply, businesses and operations should be aware of and manage elevated corruption/bribery risks. Pursuant to the anti-bribery provisions of the U.S. Foreign Corrupt Practices Act (“FCPA”), it is a crime for any US individual, business entity or employee of a US business entity to offer or provide, directly or through a third party, anything of value to a foreign government official with intent to influence, gain or continue business. The terms “anything of value” and “foreign government official” have been interpreted very broadly. Therefore, when dealing with suppliers in economic sectors that are largely state-owned, as are many in China, the risk of violating the FCPA is heightened because certain suppliers and employees thereof may meet a broad interpretation of “foreign government official.

Conclusion

The desire to best protect dedicated health care professionals and patients during this global moment has, of course, increased the demand for the most appropriate PPE, a demand that seemingly dwarfs the current supply. Health care systems are encouraged to leverage their collective networks to find new sources of “less than perfect” PPE, but must maintain a full grasp on practical effectiveness and legal/regulatory requirements.

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