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COVID-19 ISO Insights

FDA Holds Virtual Townhall on 3D Printed Nasal Swabs

June 8, 2020

By: Christopher Sirota, CPCU

3D Printing, or additive manufacturing, is generally a production technology that can produce actual components, parts, and products from a digital image blueprint.

In April 2020, we noted that during the COVID-19 crisis across the globe, 3D Printing technology was being used to develop components that are vital for the production of crucial medical equipment that have seen shortages including face shields, valves for reanimation devices, and test kit swabs.

We subsequently posted about challenges faced by some 3D printed components that were related to their effectiveness, and whether they provided protection equal to traditionally manufactured equipment.

Now, on May 15, 2020, the Food and Drug Administration (FDA), together with the Department of Veterans Affairs’ (VA) Innovation Ecosystem and the National Institutes of Health’s (NIH) 3D Print Exchange, has held a virtual townhall about the production and use of the NIH's 3D printing web resource, and information about 3D printed nasal swabs.

NIH's 3D Print Exchange Proves Effective During Crisis

According to the transcript of the townhall, the NIH has leveraged its 3D printing resource web page during the crisis to accommodate the increased need for information sharing regarding the 3D printing of various medical and personal protective equipment (PPE). Known as the NIH 3D Print Exchange, it reportedly supports collaboration among 3D blueprint designers (who can upload designs), producers (who can download designs for printing) and users (who can connect with producers based on equipment need). The NIH explains that some designs have been assessed for "appropriate use in clinical or community settings, but they are not approved by the NIH, FDA, VA, or other authority." The NIH underscores that, although the FDA has issued "Emergency Use Authorizations (EUAs) that waives some requirements, once the emergency is over, the requirements must be met by the manufacturers.

Regarding the usage of this exchange during the COVID-19 crisis, per the transcript:

[the NIH has received] almost 460 designs, of which 18 have passed a clinical assessment and 14 other designs have been found appropriate for community use. And so far there have been 34 devices with significant warnings based off of their performance. In terms of the NIH print exchange, the repository, that COVID-19 page, has been viewed almost 200,000 times since launch. A total collected view of all models has exceeded 1 million views. And the top ten designs have been downloaded over 70,000 times.

Some Concerns with 3D Printed Nasal Swabs

The virtual townhall meeting reportedly introduced a new web page dedicated to information related to 3D printing nasal swabs. Nasal swabs are reportedly used to collect specimens from the back of the nasal cavity (for a demonstration, see this short Centers for Disease Control and Prevention (CDC) video).

A related Fast Company article noted that swabs have been in great demand during the COVID-19 crisis, estimating that the U.S. will need tens of millions of swabs to test enough people before completely reopening the economy. The article also explained the difference between a traditional swab design and one 3D printed design as follows:

Traditional swabs are made of different materials to form a soft swab tip and a stiff handle. Origin’s [a 3D printing company] swabs are made from a single material with a Voronoi lattice design, which is typically used for other medical applications. The structure has a composition that allows it to become quite rigid when it’s printed densely but flexible if the lattice has room to breathe. So the 3D-printed design is thin at the top and gets gradually thicker throughout the neck and handle. That means it’s firm enough for a medical professional to grip but also feels soft and (relatively) comfortable as it moves through a patient’s nasal passage.

(the article also has a photo of an example design)

Regarding 3D printed swab designs, the NIH transcript notes that:

the [NIH's] intent is not to endorse any specific swab design. Instead [the NIH is] looking to create a framework for assessment of all swabs that fit into this unique category. We also recognize that swabs are made with different printing technologies, materials, designs and sterilization processes.

The NIH's dedicated web page, entitled COVID-19 Supply Chain Response: 3D-Printed Nasal Swabs lists some concerns with safety and effectiveness.

For example, the NIH notes that there currently is no standard for nasal swabs and limited clinical data comparing the effectiveness of non-traditional swabs, like 3D printed swabs, to capture enough specimen from the correct anatomic location and with the effectiveness of traditionally manufactured swabs. Furthermore, steam sterilization has reportedly been suspected to cause some 3D printed swab sticks to become brittle and break during transport or handling, posing the potential for sharp edges that could cause injury. Of additional quality control consideration, the NIH suggests that materials used in the manufacturing process could be "non-cytotoxic, non-irritating, and non-sensitizing, as well as compatible with testing assays."

Despite these concerns, it appears that there is a high level of capacity to 3D print these nasal swaps quickly. Fast Company noted that one 3D printing company stated that they could produce 450 swabs per day per printer and that they had 200 printers; another company stated their printers could produce up to 1,500 swabs every eight hours per printer.

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