May 14, 2020

CDC, NIOSH Address Pitfalls of Purchasing Respirators Manufactured Abroad

As healthcare facilities in the United States face respirator shortages during the COVID-19 pandemic, some employers and local health departments are seeking to replenish supplies by purchasing respirators manufactured in other countries. But careful vetting is necessary to ensure these respirators are as protective as NIOSH-certified devices, according to new guidance released by CDC.

High demand has led to what CDC calls an “unprecedented” number of counterfeit or deficient respirators on the market, the guidance says. One common problem noted by the agency is the alteration of documents intended to falsely suggest a respirator meets a particular performance standard. In addition, many devices have counterfeit certification marks or manufacturers’ names, logos, and model numbers.

The counterfeits can be exceedingly difficult for potential buyers to spot if they don’t know what to look for. At a NIOSH webinar on the topic held May 7, Christina Baker, CEO of a Florida-based company that specializes in emergency response services, discussed examples of counterfeit markings she has encountered while evaluating respirators manufactured in other countries. Her presentation displayed two versions of the common “CE” certification mark. The legitimate version of the mark is found on products approved for sale in the European Union. But some respirators have another version of the CE mark, identical to the EU version except for narrower spacing between the letters, which stands for “China Export” and indicates that the respirator was manufactured in China.

Respirators that meet a European standard should have a four-digit number next to the CE mark, Baker said. The number is the designation of an EU “notifying body” that is designated to assess products’ conformance to a standard. Researching the number on the EU’s Nando Information System will indicate whether the body is approved for conformity assessment of personal protective equipment.

Fake Documents, Concerns About Fit

Baker warned listeners that disreputable sellers are providing “certificates of compliance” that have no legal authority. She estimated that she has found fraudulent information related to approximately 90 percent of the respirators she has evaluated.

The CDC guidance lists several steps buyers should take to evaluate respirator manufacturers, third-party sellers, and the devices themselves. The first step is to verify that a device meets the regulatory requirements of the jurisdictions listed in the Food and Drug Administration’s March 28 Emergency Use Authorization (PDF) or the May 7 update of the April 3 EUA (PDF). Other considerations include the respirator’s quality of construction and assessing its ability to fit multiple people prior to purchase. CDC also recommends caution when purchasing respirators that have ear loops instead of the head straps featured on most NIOSH-approved respirators.

“It is difficult to achieve a proper fit with ear loops,” said John Powers, chair of the Evaluation and Testing Branch of the NIOSH National Personal Protective Technology Laboratory, during the agency’s May 7 webinar. “NIOSH strongly recommends that users do not purchase a respirator with ear loops without first conducting a fit test using multiple people with varied facial structures following the requirements of the approved respirator protection program.”

During the COVID-19 pandemic, NIOSH has evaluated the filtration efficiency of several non-NIOSH-approved respirators. According to Powers, the agency has evaluated more than 90 products since the beginning of April. Only about two-fifths of those respirators achieved a filtration efficiency greater than 90 percent. The results posted to the NIOSH website identify the manufacturer of the respirator, the model number or product line, the international standard the product claims to meet, and filtration efficiency. The results also include a NIOSH test report.

“I encourage everyone to not just focus on the filtration efficiency numbers, but to really look at the reports,” Powers told webinar attendees.

When evaluating manufacturers who are not current NIOSH approval holders, Powers advised listeners to determine whether the manufacturer can provide a test report for their product from a laboratory that is accredited to ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories. Reports for Chinese manufacturers are available from the China National Accreditation Service for Conformity Assessment, or CNAS. Accredited laboratories in Europe are listed on the European Union Commission website.

Reports from other sources should be treated with skepticism, Powers suggested. “International manufacturers like to include test reports with their products,” he said, but “it can be difficult to know which documents are real and which are fabricated.”

A Crisis Strategy

Maryann D'Alessandro, director of the NIOSH National Personal Protective Technology Laboratory, reminded listeners that non-NIOSH-approved respirators should be used only as a last resort. CDC has published guidance on ways that healthcare facilities can optimize their supply of N95 filtering facepiece respirators. Facilities should first employ the CDC’s conventional and contingency strategies before trying to purchase respirators manufactured in another country.

Buyers should be wary of purchasing respirators from third-party sites such as eBay and of accepting donations of respirators from well-meaning nonprofits, D’Alessandro said. Many of these devices may be of questionable quality. D’Alessandro said that respirators whose authenticity cannot be verified may be used as masks or source control, but not as personal protective equipment.

The NIOSH website identifies standards for respirators manufactured in other jurisdictions that have similar performance requirements to NIOSH-approved devices. Many companies that manufacture NIOSH-approved respirators for the U.S. also produce respirators that meet the standards of other jurisdictions. Buyers can be confident that respirators made by these companies will meet the requirements of those jurisdictions, D'Alessandro said. To identify NIOSH approval holders, buyers can search the agency’s certified equipment list.