3D Systems has worked with engineers and clinicians at the Veterans Health Administration to develop an emergency stopgap face mask.
This supplementary face mask was created as an emergency action in the effort to provide protection as a backup Personal Protective Equipment (PPE) option if the traditional PPE devices have become unavailable. This device has not gone through the same regulatory approval process as traditional PPE, but has gone through a special verification process expedited strictly for the response to the COVID-19 pandemic.
The mask consists of two main components (the mask body and the filter cover) and contains features for attaching two elastic straps and receiving a patch of filter material.
The mask comes in difference sizes. The idea is to use a small rectangular piece of filter material, discard it after every use, sterilize the mask and slot in another piece of filter material to use it again. This way you can cut up a single mask and use its filter material multiple times.
Since the mask body component will be in direct contact with the user’s skin for a long duration of time, it is recommended that only materials and processes with existing examples of FDA cleared skin contacting applications should be used. Below are the materials that have been recommended in the manufacturing guidance document for manufacturing of the mask.
All the data necessary to print this mask is available from the download link below. Included are the 3D printable files, the instructions for use, and a manufacturing guidance document for printing these masks on a 3D Systems SLS 3D printer using the Duraform PA 12 bio-compatible material. For SLS printers from other 3D Printing OEM’s please refer to their respective best practices documents to print medical devices.