Does Red Tape delays the COVID-19 response? Why is US having problems with ventilators shortage?

More hands are rapidly coming on deck to make ventilators for American coronavirus victims. Faced with the ventilator shortage, president Donald Trump used government authority to compel a private business to help a country in crisis.

Trump announced March 27 that he is using the Defense Production Act (DPA) to force General Motors (GM) to carry out federal contracts to make ventilators and give those contracts priority over any other orders. While this may make more ventilators available sooner, it still doesn’t guarantee that America will have enough ventilators by the time patients across the country need them.

The FDA is already easing rules for importing needed products, including personal protective equipment like N95s, into the U.S, but now an online petition is started asking that FDA lifts restrictions on life-saving Ventilators, but also other protective equipment.

„American doctors and nurses desperately need more personal protective equipment (PPE), diagnostic tests and ventilators to keep us all safe from the novel coronavirus (SARS-CoV-2). In addition first responders, key government employees and those who work in essential services like grocery, pharmacy, utilities and logistics need PPE so that they can continue working in a way that is safe for all of us. But unnecessary red tape is keeping all of them from getting these critical supplies. This is putting everyone’s lives at risk“, explains John Craig.

He claims the problem is that US only allows FDA-certified protective equipment, diagnostic tests and ventilators to be imported and used with a stated policy and enforcement system of “FDA does not recognize regulatory authorizations from other countries.”

„We could immediately access a lot more equipment if we relaxed changed this so that at least temporarily during a crisis, or more generally whenever supply of FDA-certified equipment is even slightly low“, he claims.

Craig started a petition asking that US federal government allow for protective equipment, diagnostic tests and ventilators that have been certified by other reputable bodies besides the FDA to be EASILY imported and used in the United States.

„As an example, just one supplier in China I found (via onsite inspection by relatives in China) has the following supplies available for immediate purchase:

500,000 surgical masks

100,000 N95 masks

500,000 COVID-19 rapid test kits

These products are currently available today in inventory—but no one in the US can import them, as they only have EU’s CE certification and are not FDA-approved!“, wrote Craig in his petition.

1 thought on “Does Red Tape delays the COVID-19 response? Why is US having problems with ventilators shortage?

Leave a Comment