The problem of having way too much bureaucratic red tape, and too much reliance on Red China for obtaining these critical products…
Masks, Masks, Where Are the Masks?
Ask Obama, the FDA, the CDC, and China.
Wed Mar 25, 2020 Daniel Greenfield
The media is full of stories of mask rationing and shortages. Health care professionals are reusing masks, slathering them with sanitizer, or substituting scarves in place of surgical masks. Democrats demand that President Trump make more masks immediately using the Wartime Production Act.
But why aren’t there any masks?
Surgical masks, like anything in the medical field, are tightly regulated. You can’t just make a mask. Some masks have to be certified by the FDA and others by the CDC. Some are certified by both the FDA and the CDC.
Until recently, the public had no problem buying N95 respirators for use in construction. These masks are certified by the CDC. Why is the CDC in the business of certifying industrial masks, you may wonder? Because, as discussed previously, the CDC does every possible thing except what people think it does. The component of the CDC that does this is the National Institute for Occupational Safety and Health.
NIOSH is not to be confused with OSHA, even though they were created at the same time, through the same law, and serve a very similar function: making this another skein in the infinitely tangled web of the federal bureaucracy.
The Open PPE Project launched an effort to quickly create N95 masks only to be told by NIOSH that approving a new mask production facility would take between 45 and 90 days.
Meanwhile there are reports of large stockpiles of masks sitting around waiting for an FDA inspector.
The United States government has a stockpile of 12 million NIOSH approved masks and 5 million that are expired, and are therefore not approved by NIOSH. Except it may approve some conditionally for use.
The FDA and CDC bureaucracy are not up to speed with the current crisis. There aren’t enough inspectors and the Wuhan Virus won’t wait on inspectors from the FDA or NIOSH to do their job.
Instead of streamlining its approvals and inspection process, the CDC lowered its mask protection recommendation for health care workers on the front lines.
The CDC is willing to tell health care professionals to use scarves, rather than accelerate approvals.
Meanwhile N95 mask manufacturers feared being sued if masks meant for industry were used in surgical settings, which meant that they wouldn’t sell those masks to health care providers. At least not until a law protecting them against lawsuits was passed. All this, of course, took even more time.
Smaller manufacturers have tried to get in the game, only to discover the regulatory challenges of it. Fashion businesses that tried to jump in have settled for trying to make surgical masks that they hope will be FDA certified. Meanwhile the big manufacturers were making masks in the People’s Republic of China. And those masks are not leaving ChiCom territory except by the express will of its government.
