3D printing faces hurdles in coronavirus response

Shortages of medical devices and protective equipment driven by the coronavirus pandemic have led medical workers and manufacturers to turn to 3D printing to fill the void.

However, the new technology still faces technical and legal hurdles before it can be fully deployed to address the shortfall.

Supplies of medical equipment and devices have been depleted in recent weeks by COVID-19, the respiratory disease caused by the novel coronavirus. Hospitals have faced shortages of potentially life-saving ventilators as well as personal protective equipment, such as masks, to keep their doctors safe. The rollout of coronavirus testing, crucial to identifying those with the virus and containing its spread, has also been slow, with the government scrambling to acquire more kits.

But the 3D printing industry and those with the technology are eager to help fill that void. The technology has been used to produce face masks, test kit swabs and some of the key components of ventilators.

Joseph Hanna, an acute care surgeon at Rutgers Robert Wood Johnson Medical School, told The Hill that he has managed to produce face masks in less than three hours using a printer he already owned.

Working with Rutgers University and other 3D printing hobbyists in the area, Hanna has produced crucial protective equipment for dozens of doctors working on the front lines of the pandemic in New Jersey, one of the hardest-hit states.

Hanna is not the only one to use 3D printing for masks — examples of similar efforts can be found across the country, and the world. Italian volunteers in Lombardy, a coronavirus hot spot, used 3D printing to make 100 valves after some breathing machines keeping people alive started to fail.

3D printing has been particularly critical in helping to boost the production of test swabs, many of which were originally made in China and Italy, two of the countries hardest hit by the pandemic.

Companies with 3D printers have been joining forces to design and ramp up production of needed supplies during the public health crisis.

In one case, Formlabs Inc., a Somerville, Mass.-based company, worked with Northwell Health in New York and the University of South Florida to develop and manufacture swabs using 3D printing.

Tim Osswald, a professor of mechanical engineering at the University of Wisconsin-Madison and an expert on the technology, told The Hill that 3D printing speeds up manufacturing much more than traditional production methods.

But Osswald also said there were limits to the new technology. For example, 3D printers alone will not be able to quickly create ventilators, which are complex machines. However, the printers can be used to make splitters, devices that could allow more than one person to use ventilator, and other crucial parts.

“Printing is the perfect solution so we can fix a ventilator,” Osswald said, even if there are limits to making one from scratch.

But despite the early successes of 3D printed parts and the demand for medical supplies, regulators have urged caution.

Relevant authorities, including the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), have not had a chance to approve many of the potential applications for 3D printing.

The FDA last week issued updated guidance for health care providers around 3D printing specific medical devices and personal protective equipment.

In a Q&A section, the agency expressed support for using 3D printing for components of medical devices if originals are unavailable. But the agency also urged caution over using 3D printed protective equipment, which it said might not be as safe as equipment made by traditional methods.

“3D-printed PPE (personal protective equipment) are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators,” the FDA note said.

The agency is also working with the National Institutes of Health, Veterans Affairs and 3D manufacturers to help create designs for needed medical supplies that can be quickly approved.

“FDA recognizes that many stakeholders are interested in designing and producing 3D printed devices during the COVID-19 public health emergency. We are also aware that stakeholders often do not know what device designs to choose or how much to print,” the agency said in late March about the effort.

Other countries have similarly ramped up their efforts.

Hanna, for example, used a model developed by Czech designer Jo Prusa that has been approved by the Czech Republic’s Ministry of Health.

There is pressure for U.S. regulators to catch up.

“All of these things that are being designed and printed have not gone through FDA, CDC approval processes,” the doctor told The Hill. “So there’s some uncertainty in what we’re doing now.”

But the lack of formal guidance on 3D printing is also encouraging many to move forward.

Hanna told The Hill that there remains a “gray area” around protective medical shields.

“When you look at FDA and CDC guidance, there are no clear strict definitions and guidelines for how to produce a face shield, or how to design a face shield, specifically as a splash shield,” he said.

And there are questions about how all the agencies are coordinating their efforts.

Another agency, the National Institutes of Health, released a face shield design, which was reviewed in a clinical setting.

Some manufacturers have been able to get formal approval for nonprotective equipment. Formlabs and Carbon, for example, received FDA approval for their tests swabs, but health experts warn that the approval process takes more time than medical professionals can afford.

While those potential legal and regulatory issues are being resolved, 3D printing will continue to help fill in key gaps in medical devices and protective equipment, Hanna said.

Experts like Hanna and Osswald have high hopes for the technology.

Hanna predicted the current pandemic “is going to likely crystallize” the importance of 3D printing to medicine.