The coronavirus pandemic which has infected more than half a million people and killed at least 25,000 has been an obstacle for the global supply chain following the shutdown in China.
Though China has begun to restart its factories, in other countries closed borders and lockdowns have thrown the supply chain into flux, prompting the FDA to allow alternatives and forcing health systems to get creative— especially as demand for testing equipment rises with the increased testing in the U.S.
As the U.S. case count surges past 100,000, the dire situation unfolding for frontline health workers includes shortages of personal protective equipment (PPE) and medical equipment.
It’s why Northwell Health, New York’s largest health-care provider, took matters into its own hands and started 3-D printing nasal swabs used for COVID-19 testing.
“First it was the kits, then it became the reagents [in short supply], then it became the swabs. Clearly, we couldn’t print the kits or the reagents,” Todd Goldstein, director of design and innovation at Northwell, told Yahoo Finance. “Its tough, everyone wants the same supplies at the same time.”
Northwell came up with the design and began testing patients with them within days. To test the accuracy of the printed swabs, the clinicians used both industrial swabs and 3D-printed swabs on each patient and then sent them both to the lab to compare the results. On Friday, the results came back — both swabs produced similar results.
The high risk of outbreak in the New York region led to a shuttering of the health system’s research institute, which resulted in the pre-clinical testing relying on a partnership with the University of South Florida in Tampa.
Working through conference calls, video calls and screenshots, the swab was developed using Formlabs printers.
Northwell can now produce up to 1,500 swabs per day using eight printers, and is offering the product’s code for free to any health system or lab with the same printer to use, according to Goldstein.
“This is an unprecedented time and unprecedented level of exposure to the entire world. We are a hospital system, we know we all need to band together,” Goldstein said. “We want this out there so anyone in the country can use it and be able to test. This isn’t about making money on a product.”
He also said Formlabs has a large network of printers in Ohio, known as a print farm, that are FDA-approved for printing medical devices and ready to contribute to the production.
It’s something Dr. Bon Ku, director of the Health Design Lab atThomas Jefferson University in Philadelphia, is keenly interested in.
The emergency-room doctor told Yahoo Finance that with 3D printers lying around idle right now, there is a lot of enthusiasm from the “maker” community. And the potential to solve a shortage problem efficiently is appealing.
“We are seeing supply shortages across the board not only in PPE but also in testing. I think this a great idea that can be manufactured cheaply and very quickly,” Ku said, noting that it also addressed a cost problem often faced during shortages.
And since the FDA has already issued guidance about 3D-printed medical device equipment, it opens the door for more production.
“Entities should use original parts or those with the same specifications, dimensions, and performance, if available. While it is possible to use 3D printing to print certain accessories, components, and parts, some complex products (e.g., working pumps, electronics) are not easily 3D printed. It may help to use plans from original parts when available and verify that any 3D-printed products fit and work properly before they are used in a clinical setting. Entities engaged in 3D printing are encouraged to work with relevant medical device manufacturers,” according to the FDA’s website.
Ku noted there is already an FDA approved hack for much-need ventilators — a printed piece of hardware used to split one ventilator to supply oxygen for two patients. And he is inundated with emails and phone calls and texts hourly about 3D printing ideas and codes— which all need to be weighed carefully since it’s all open source.
“It’s a lot cheaper and needed to be done yesterday,” Ku said of PPE and other necessary supplies being printed.
He noted it was important for any lab to link up with a clinician so that there is some sort of clinical testing before products are used on patients. But as the virus continues to spread and overwhelm emergency rooms across the country, time may be a luxury they cannot afford.
“The situation is so dire that sometimes, if there is no other option, then we are going to get desperate and we may implement unproven technologies,” Ku said
