facebook linkedin twitter

FDA Warns Health Care Providers of Certain N95 Respirators from China

September 1, 2021 by Reece Nations
A worker handles filter material for face masks in Seattle. (Gerardo Villalobos/Outdoor Research via AP)

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 by the company. 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 personal protective equipment 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.

Health

September 17, 2021
by Dan McCue
FDA Panel Backs COVID-19 Boosters Only for Elderly, Those at High-Risk

WASHINGTON - A Food and Drug Administration advisory panel voted unanimously Friday to recommend emergency use authorization of a booster... Read More

WASHINGTON - A Food and Drug Administration advisory panel voted unanimously Friday to recommend emergency use authorization of a booster dose of Pfizer-BioNTech COVID-19 vaccine six months after full vaccination in people 65 and older and those at high risk of severe Covid-19. But the same... Read More

September 15, 2021
by Reece Nations
CDC Interim Estimates Find Moderna Vaccines Most Effective Against Delta Breakthroughs

WASHINGTON — Data collected by the Centers for Disease Control and Prevention on COVID-19's delta variant found that vaccine efficacy... Read More

WASHINGTON — Data collected by the Centers for Disease Control and Prevention on COVID-19's delta variant found that vaccine efficacy was higher among recipients of the Moderna vaccination at 95%, higher than both the Pfizer-BioNTech and the Johnson & Johnson vaccines. The CDC collected data in... Read More

September 15, 2021
by Alexa Hornbeck
U.S. Health System Trails Far Behind Other High-income Countries

The COVID-19 pandemic has shown that no nation has the perfect health system, but a report from the Commonwealth Fund... Read More

The COVID-19 pandemic has shown that no nation has the perfect health system, but a report from the Commonwealth Fund finds the U.S. trails far behind other high-income countries on measures of health care affordability, administrative efficiency, equity, and outcomes. By analyzing 11 high-income countries and... Read More

September 15, 2021
by Alexa Hornbeck
Study: Getting Vaccinated Against COVID-19 Can Improve Mental Health

LOS ANGELES, Calif. -- A year-long study conducted by researchers from the University of Southern California finds that getting vaccinated... Read More

LOS ANGELES, Calif. -- A year-long study conducted by researchers from the University of Southern California finds that getting vaccinated against COVID-19 can actually improve mental health. “We were interested to see what the short-term effects of getting a COVID-19 vaccination would be on people’s mental... Read More

President, CEOs, Biz Leaders Meet on COVID-19 Vaccine Mandates

WASHINGTON (AP) — President Joe Biden was meeting Wednesday with the CEOs of Walt Disney and Columbia Sportswear, and other... Read More

WASHINGTON (AP) — President Joe Biden was meeting Wednesday with the CEOs of Walt Disney and Columbia Sportswear, and other business executives and leaders leaders to discuss  his recently announced vaccine requirement for companies  that employ at least 100 people.  The White House meeting comes less... Read More

Biden: Nearly 3M Get Health Coverage During COVID-19 Sign-Up

WASHINGTON (AP) — Nearly 3 million consumers took advantage of a special six-month period to sign up for subsidized health... Read More

WASHINGTON (AP) — Nearly 3 million consumers took advantage of a special six-month period to sign up for subsidized health insurance coverage made more affordable by the COVID-19 relief law, President Joe Biden said Wednesday. He called that number encouraging and urged Congress to help keep... Read More

News From The Well
scroll top