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Last updateFri, 05 Jun 2020 6am
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Formlabs Covid19 response: swabs

Formlabs has fielded hundreds of requests, evaluated dozens of potential applications for 3D printed products, and is now supporting a handful of projects with high-impact potential. The current priority areas were selected based on clinical demand, technical feasibility, and regulatory implications. Priority areas for focus include test kit swabs, ventilator splitters, and face shields. Once designs have been tested and validated by the medical community, Formlabs has the resources available to scale production to tens of thousands of parts per week. We are ready to engage our internal resources and community of skilled volunteers to produce parts for healthcare providers all over the world.

Below are the key projects that Formlabs is spearheading, with guidance from medical thought leaders and physician innovators.

There is a nationwide shortage of the nasopharyngeal (NP) swabs needed to collect samples for COVID-19 testing. These swabs are typically used for testing for influenza and other respiratory infections. The current and impending supply chain shortages are serious enough that clinicians are beginning to design and test their own swabs as quickly and safely as possible.

NP swabs are flexible sticks with a bristled end that are inserted into the nose to the back of the nasal cavity and swept around to collect material that sticks to or wicks up the bristles. The swab is then placed into a vial that contains a culture medium. Swab sticks have an intentionally weak point 7–8 cm from the bristled tip, which allows the stick to be broken to the correct length so that the vial can be capped before it is transported to a laboratory for testing.
Solution

Currently we are printing and optimizing swab designs co-created by doctors at USF Health and Northwell Health, as well evaluating designs from other leading hospitals. The entire swab is printed as one piece.
Validation Status

Formlabs has printed hundreds of samples of the test swab using the same biocompatible, autoclavable material as Surgical Guide Resin. These samples have passed a variety of tests at USF Health, which has received an Emergency IRB approval as well as authorization from regulatory, infectious disease, and virology, among others.

These swabs are Class I medical devices exempted from premarket notification requirements and require manufacturers to register and list the products. Formlabs will produce swabs in its FDA-registered, ISO 13485 certified facility in the United States.
www-formlabs.com

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