NP swabs are flexible sticks with a bristled end that are inserted into the nostril to the back of the nasal cavity and swept around to collect material that sticks to or wicks up the bristles.
ROE Dental Laboratory has partnered with Formlabs (using a patented design from USF Health and Northwell Health) to become a contract provider of 3D printed alternative Nasopharyngeal test swabs.
ROE has been granted a production license for these swabs and is ready to immediately produce them in their FDA-registered, DAMAS-certified facility in Independence, Ohio.
The nasal swabs have cleared all testing hurdles and are now being produced. All testing by these institutes showed that the 3D printed nasal swabs perform equally to standard swabs used for testing of COVID-19.
NP swabs, intended to collect specimens from a patient, are Class I devices exempt from premarket notifications according to 21 CFR § 880.6025. FDA requires medical device manufacturers to register their facility and list their products according to 21 CFR § 807.20.
Disinfection and Sterilization Instructions
- The swab may be cleaned, disinfected, and sterilized according to facility protocols. Tested methods of disinfection include: soaking the finished swab in fresh 70% IPA for 5 minutes. Note: Do not leave the part in an alcohol solution for an extended period.
- Swabs may be steam sterilized according to CDC recommended cycles (132 °C / 270 °F for 4 minutes in a pre-vacuum steam sterilizer or 30 minutes at 121 °C / 250 °F in a gravity displacement autoclave), or according to facility/autoclave manufacturer’s protocols, as long as the cycle does not exceed 20 minutes for 134 °C / 273 °F or 30 minutes at 121 °C / 250 °F.
- Autoclave cycles should include a dry cycle to best maintain accuracy. For example, wrapped instruments sterilized in a prevacuum autoclave should be dried for 20-30 minutes according to CDC recommendations. Longer or hotter autoclave cycles than those listed above may result in degradation of physical properties and accuracy. Note: A color shift will be observed after autoclaving, this is normal.
- After disinfection and sterilization inspect the swab for cracks to ensure the integrity of the swab.
Made in America.