VHA Innovation ...
The Veterans Health Administration is evaluating the safety and functionality of a variety of commercially available 3D printed nasopharyngeal (NP) swabs for their use in acquiring samples to test for the SARSCoV-2 virus. As part of our risk assessment, we are considering bending flexibility and general maneuverability to be important factors in whether the swab can safely reach the sampling location without breaking. The ‘Go / No-Go’ gauge was created to complement the more quantitative results from the mechanical bending test and dimensional analysis report and provide a ‘sanity check’ that the swab has appropriate geometric and mechanical characteristics to meet this requirement. The gauge is not intended to be an absolute indicator for the safety of a swab, but rather to provide feedback on the swab design’s mechanical & dimensional properties in a form that is more obviously related to its clinical application than a mechanical testing machine. Data obtained from the gauge is intended to be followed up with a formal clinical trial during less critical times to establish safety and efficacy more rigorously.
see protocol
Please reference the protocol number, name and revision