FDA Warns Health Care Providers of Certain N95 Respirators from China

WASHINGTON — The Food and Drug Administration is alerting health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co. due to “serious concerns with [their] quality.”

In a letter released last week, the FDA announced that the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health had revoked approval issued to Shanghai Dasheng N95 respirators because the Chinese manufacturer did not implement or maintain a system of quality management. The FDA published the revoked label references from NIOSH on its website.

“As a clinician who has been working throughout the pandemic, it is very important for my colleagues and other health care professionals to be confident in any products that are meant to protect our health and safety,” Felix Khusid, president of the New York Downstate Association for Respiratory Therapists, said in a written statement. “I strongly believe that every attempt should be made to manufacture essential PPE in the United States to ensure it undergoes strict quality assessments that are overseen by our own government.”

Khusid continued, “By relying on overseas manufacturers, we are putting ourselves in a vulnerable position when it comes to quality control, just as we have seen with the recent recall of certain Chinese-manufactured N95s. Protecting health care workers who are fighting COVID-19 on the frontlines starts with making sure that they are given PPE that meets the highest safety and quality standards.”

The FDA recommended that health care facility risk managers, procurement staff and health care personnel stop using N95 respirators manufactured by Shanghai Dasheng, including those with other brand names, and to replace them with respirators found on NIOSH’s certified equipment list. Shanghai Dasheng responded to the revocation on its website by stating the issues with the respirators were due to counterfeit masks using its company’s NIOSH approval numbers.

In the letter, the FDA also encouraged health care personnel to report any issues with the protective equipment through “MedWatch,” the administration’s program for reporting adverse events. As a result of the NIOSH rescinding its approval for the products, all previously authorized Shanghai Dasheng respirators are no longer authorized for emergency use.

“I think that’s one of the great hallmarks of the American health care system, is that we do have a government regulatory agency like the FDA and the CDC … to determine which products meet the kinds of standards that American citizens deserve,” Giles Kyser, retired United States Marine Corps colonel and CEO of American PAPR, said. “Clearly, this does not. When it comes to the United States’ health care system, the [research and development] and quality management, quality control that is insisted upon by our government matters. And when you’re an American company, you go into that market understanding that, appreciating it and recognizing that you’re not going to be able to compromise.”

The reasons why American health care personnel are still using imported equipment at this stage in the COVID-19 pandemic range from American products generally having a higher price point, an unwillingness to switch from existing supply chains and the persisting mindset of desperation to protect doctors and nurses regardless of where the equipment had been sourced.

However, Kyser said the lack of foresight exercised at the onset of the pandemic ignores the opportunity for American innovation to step in and remedy existing issues with domestic supply chains and manufacturing capabilities. Committing health care personnel to foreign supply chains that were volatile to begin with doesn’t just put hospital workers at risk, it equates to lost economic opportunity.

“But now we need to think beyond that, we need to think more strategically about how we’re going to shore up the American capability to look after its own citizens,” Kyser said. “And to do that you need companies like American PAPR. But frankly, I will tell you, we are still fighting an uphill battle. The companies that make their products in foreign countries still dominate the market.”

Existing issues with the lack of reliance on American products throughout the pandemic represent a two-pronged concern for Kyser, he said. First, the ability to exert influence over quality management systems is “severely constrained,” and secondly, manufacturers inside the U.S. ought to be looked at first.

For instance, should the FDA want to inspect American PAPR’s facilities located in Brooklyn for quality assurance, Kyser said they would be welcomed. American PAPR products are NIOSH-approved and are also less expensive than comparable foreign-made products on the market.

Lawmakers could intervene by insisting that entities purchasing PPE must use American manufacturers that have verifiable safety standards. In a situation as complicated as a still-evolving pandemic, one variable that can be controlled is quality control and management ensured by governmental agencies.

“If I had a lawmaker in front of me, I’m going to tell [them] that there needs to be specific language in appropriations that requires any and all federal dollars — whether they’re spent directly or indirectly — to first be used for American manufacturers down that tiered approach,” Kyser said.