More than 2,500 healthcare providers have requested protective gear for their employees via Project N95, one of the latest volunteer-based efforts to mitigate equipment shortages spurred by COVID-19.
Project N95 aims to connect healthcare facilities, manufacturers and distributors to arm frontline workers with personal protective equipment like N95 respirators, which are in short supply. As of March 24, around 1,700 healthcare institutions requested more than 70 million units of PPE via the website. That has grown to nearly 2,550 facilities and more than 341 million units.
"Healthcare providers are risking their lives on front line, so we are trying to increase the availability of PPE as quickly as we can," said Andrew Stroup, one of Project N95s founding members and CEO of LVRG, a supply chain software company.
Project N95 sources PPE like masks, gloves, wipes, hand sanitizer, face shields and gowns as well as respiratory devices like ventilators and CPAP machines from more than 1,750 suppliers. It is also working with around 30 government agencies and community partners to distribute the supplies where it is most needed.
It is one of many informal collaborations that have materialized to combat COVID-19. Demand for N95s respirators—most of which are manufactured in China—has increased 17-fold, according to a new survey from Premier, a group purchasing and consulting organization that compared demand before and after hospitals reported COVID-19 cases. Demand for face shields has nearly increased ninefold, sixfold for swabs to do testing, fivefold for isolation gowns and threefold for surgical masks.
As a result, hospitals are relying on donations to protect their workers.
A group of Chicago medical students launched a crowd-sourcing campaign to secure PPE for area hospitals. Dozens of 3D-printing enthusiasts in Santa Clara County, Calif. have pledged to build more than 3,000 face shields for caregivers at Santa Clara Valley Medical Center. the University of Maryland Medical Center put out a call for hand-sewn surgical masks, yielding 400 masks over the period of a week.
"The response from the community has been overwhelming," Susan Dorsey, a professor at the university and chair of the pain and translational symptom science department at the University of Maryland School of Nursing, said in prepared remarks. "To see everyone come together to support frontline clinicians and staff who care for patients during this difficult time has been incredibly inspiring."
But as more suppliers flood the market, the Food and Drug Administration must toe a delicate balance between trying to meet the unprecedented demand and ensuring products are safe.
The FDA issued an Emergency Use Authorization on March 27 for certain imported non-NIOSH-approved respirators that essentially haven't been vetted as thoroughly to expedite distribution.
"The FDA is more or less saying that we don't want people making unsubstantiated therapeutic claims about products, but we want to make it as easy as possible to get additional supply," said Jonathan Havens, a partner at Saul Ewing Arnstein & Lehr and former FDA regulatory counsel. He added that the agency has been very responsive.
While Project N95 has a due diligence process that checks FDA clearance, licensure, referrals and other measures, it has had to turn away many new suppliers that are not able to deliver on their claims, Stroup said.
Havens said some of his clients are opting to not work with any new manufacturing facilities because of quality concerns.
The Department of Justice has cracked down on individuals who have hoarded PPE and inflated prices.
The DOJ and HHS recouped about 192,000 N95s this week during an investigation by the DOJ's COVID-19 Hoarding and Price Gouging Task Force. The agencies distributed the N95s, 598,000 medical grade gloves and 130,000 surgical masks, procedure masks, N100 masks, surgical gowns, disinfectant towels, particulate filters, bottles of hand sanitizer, and bottles of spray disinfectant to the New Jersey Department of Health, the New York State Department of Health and the New York City Department of Health and Mental Hygiene, as mandated by the Defense Production Act.
N95s usually cost about $1 before COVID-19—that has increased to $5 to $7 per respirator, Stroup said.
As the federal government continues to watch for price gouging and fraud, it is also doling out supplies via the National Strategic Stockpile. Although, critics have questioned if the equipment has been distributed equitably. Part of the problem is that demand and supply levels change by the hour and "severity" can be subjective as it relates to the hardest-hit areas.
Still, real-time, data-driven transparency is needed to mitigate those concerns and build trust, Stroup said.
"We need a data-driven approach to information sharing," he said.
