Formlabs Swabs

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 designing and testing their own swabs as quickly and safely as possible.

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PrinterPrezz is a 3D printing medical company offering design, prototyping, mass production and regulation assistance to orthopedic device companies. We help customers at every stage of the innovation life cycle, and specialize in titanium and other medical materials. During this time, we are keeping our facilities open to create test swabs to aid the medical community in fighting this pandemic.

What are NP Test Swabs?

Nasopharyngeal (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 its is transported to a lab for testing.

FAQs

Swab Design

A team from the USF Health’s 3D Clinical Applications Division created an initial test swab design, working with Northwell Health, and collaborating with Formlabs, a 3D printing company. The swabs were tested by clinicians at Northwell Health, USF Health for patient safety and comfort.

Validation Status

Key milestones in testing the swabs were conducted by USF Health faculty researchers in the Departments of Radiology and Infectious Diseases in collaboration with Northwell Health, including validation testing (24-hour, 3-day and leeching), and rapid clinical testing at Northwell Health. All testing showed that the 3D printed nasal swabs perform equally to standard swabs used for testing for COVID-19.

Are the swabs FDA approved?

The FDA has designated the swabs as a Class 1 exempt Medical Device exempted from premarket notification requirements but require manufacturers to register and list their products, IRB approved clinical trial has also been completed. PrinterPrezz has a production license for these unsterilized swabs and is producing them in our FDA registered, ISO 13485:2016 certified facility in Fremont, CA.

NP Swab Regulatory Information

NP Swabs, intended to collect specimens from a patient, are Class I devices exempt from premarket notifications according to 21 CFR 880.6025 Absorbent tipped applicator. The FDA requires medical device manufacturers to register their facility and list their products according to 21 CFR 80720. PrinterPrezz facilities are registered:

1. PrinterPrezz, Inc. Registration Number: 3016580753

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