Who was responsible pre-Covid? Why aren’t they being held accountable?
The shortage of PPE across the country means the days of rocking up to a local distributor or pharmacy for supplies are gone, at least for now.
With much skinnier supply chains now, you have to go directly to a local or overseas manufacturer or through groups like us.
But how did it used to work?
The Food & Drug Administration (FDA) approves all products whether that may be gowns, masks or respirators. It is the FDA which orders the country’s supplies from registered manufacturers based on national forecasts of PPE sales.
For goods purchased overseas, they are imported into the US and sent into the national supply chain, with the first stop usually distributors such as Cardinal, Medline, McKesson or Owens and Minor. The next stop are hospitals, private clinics and practitioners and doctors.
All medical products including health tests and PPE are regulated by the FDA. Some PPEs are reviewed by the FDA before they can be legally sold in the United States. This is known as Premarket Notification or 510(k) clearance.
Supermarkets and high-street shops buy non-medical products like sanitisers from their own manufacturers. There are few regulations surrounding these products.
A medical insider told ActionPPE that up to 30 percent of hospitals and clinics are not prepared and have insufficient PPE supply at any one time.
“There are many reasons for this, and this could be due to large numbers of COVID-19 patients or a lack of funds to buy in bulk,” he said.
And that is also how many not-for-profit and volunteer groups and bulk-buy teams like us have banded together overnight to coordinate bulk purchases and/or help to direct the distribution of PPE to groups in need.
Of those who are not PPE-ready, our medical insider says the majority are clinics – about 60 per cent – and the rest, hospitals.
Interestingly, these unprepared institutions are in big cities and states like California, Florida, New York and Pennsylvania. Most of them are excellent providers with good medical credentials but they have limited relationships with major buying groups, he adds.
He also points to a very recent plea by the President of American Medical Association Susan Bailey, who says in an article the “persistent shortage of N95 masks, gowns and other forms of PPE continues to impede the ability of physicians, nurses and other health care workers serving on the front lines during the COVID-19 pandemic”.
“Particularly hard-hit are physicians seeking to reopen their practices and resuming care for patients who have delayed or foregone care for chronic conditions. A lack of PPE, and in particular shortages of N95 masks and gowns, has prevented physicians in ambulatory settings from seeing new and established patients,” Bailey said.
Unfortunately there hasn’t been a concerted effort by President Donald Trump and his administration to coordinate a federal response to the PPE shortage.
He has adamantly refused to increase imports of PPE from places like China and have left it to the states to fend for themselves.
Importing PPE on your own is still a very onerous exercise, see the rules here. You can however count on groups like us for help.
Here is also an in-depth guide on the right kind of PPE and medical devices to use, by the FDA.