Imagine that you are a parent, concerned about surging pediatric Covid-19 hospitalizations due to the highly transmissible new Omicron variant. Perhaps your child can’t be vaccinated for medical reasons, or perhaps they have been vaccinated, but you are still concerned about the potential risks that remain such as long Covid and want a way to protect your child while still allowing them to attend school and other normal activities.
If you live in South Korea, you can simply go to any drugstore and purchase a KF94 respirator for your child. This respirator will have been tested by the Korean FDA to a filtration standard comparable (actually considerably more rigorous than) the N95 standard and also tested to provide a reasonable fit and comfort during moderate activity (albeit with looser fit than the Korean medical respirator standard, but still protective).
If you live in the United States; however, no government standard for children’s respirators exists. On the surface, the reason is obvious, respirators in the United States are regulated by the National Institute of Occupational Safety and Health and the Occupational Safety and Health Administration; children are not supposed to be working, especially not in hazardous jobs that require respirators! The reality, however, is respirators are useful not only in hazardous occupations, but also during wildfires, sandstorms, and most pertinently respiratory disease epidemics. This has lead to companies making de-facto respirators for children to try to dance around the fact that they’re making a respirator to avoid getting in trouble with regulators while publishing filtration data or in one bizarre case an American company actually getting their mask certified to a Chinese standard to sell in the United States.
The lack of a children’s respirator has been perhaps the greatest criticism levied by mask activists against the CDC and FDA for their refusal to endorse a respirator standard for the general public. Laboratory studies have found time and again and again that respirators provide not only superior respiratory protection, but actually dramatically superior source control and, while some early epidemiological studies have found cloth masks significantly reduce the transmission of Covid-19, later larger-scale studies, computer modeling, and the advent of the more infectious Delta and Omicron variant have lead to public health experts to recommend the use of respirators or a surgical mask with fitter over cloth masks. The White House even requires N95 respirators to meet senior officials and there are reports the CDC may follow California in recommending respirators for the general public, but the lack of a non-occupational respirator standard (for adults anyway) could always be justified to some degree by the increasing availability of N95 respirators.
Recently, KN95 respirators (a Chinese standard similar to Europe’s FFP2) have been distributed to members of congress to protect them against a surge of Covid cases amongst legislators. Many have raged about the political optics of congress getting respirators while the general public get cloth masks, but in my view this misses the greater issue and true absurdity of the situation. The legislative branch of the United States is depending on a Chinese standard to protect itself against the ongoing pandemic because there is no appropriate US standard against which to certify these respirators. This is not just bad optics, this is a serious national security issue. Perhaps congress decided it was important to keep N95 for healthcare and essential workers, that headstraps were impractical for politicians, or some other consideration. Whatever the case, representatives have been issued a respirator that a Chinese company largely self-regulates to meet certain filtration, fit, safety, and breathability standards. While the NPPTL has tested a sampling of respirators to evaluate filtration efficiency and found a large number of legitimate KN95 respirators with excellent filtration, many (perhaps the majority) do not meet filtration standards and even those tested by the NPPTL can’t be fully trusted in terms of fit or other parameters because these were not tested (and because China requires filtration media be certified independently of the final product).
If the CDC does endorse respirators for the general public, the lack of a standard will be even more problematic. The general public can’t navigate around fakes like congress can and South Korea and 3M (whose Chinese and Singaporean-made KN95 are reliably legitimate) alone can’t possibly supply the entire world. The US needs its own standard equivalent to KF94 or KN95 against which American-made respirators can be certified. This also would provide a basis for US regulators to certify and remove fake Chinese respirators from the market allowing cost-conscious consumers to safely purchase the many legitimate KN95 that are available with confidence that they are effective and it would help ensure panic buying does not disrupt supplies of N95 to healthcare workers by providing an effective alternative for the general public. Most importantly, it will finally give the US a standard for children’s masks that is competitive with the rest of the word.
Thursday, Jan 13, 2022 · 12:29:05 AM +00:00 · rufe
The White House is reportedly considering distributing KN95 or N95 masks to the general population. If this is true, particularly if KN95 are being considered, it is especially pressing that the US not depend on Chinese companies to self-regulate and establish a domestic standard for non-occupational respirators prior to having the federal government distribute them.