The race to produce and distribute N95 masks seems to intensify each day. And unfortunately, the shortage of PPE for protective face masks is creating a hazardous situation for frontline workers and secondary support service health care professionals. Understandably, face masks intended for a medical purpose in the United States are regulated by FDA (see guidance). When FDA-cleared masks or respirators are unavailable, healthcare professionals may choose to improvise PPE. Similar situations are likely to arise in jurisdictions not regulated by FDA.
Of course, the reality is that not every medical application requires a N95 mask. With this in mind, 3D Systems recently worked with engineers and clinicians at the Veterans Health Administration to develop an emergency Stopgap Face Mask (SFM). The SFM is available in multiple sizes and is printed from a biocompatible nylon material using selective laser sintering technology. The SFM is comprised of the 3d printed mask and filter cover, two elastic strips, and a rectangular patch of filter material. The SFM can be reprocessed using disinfectants and/or autoclaved.
The SFM is intended for medical purposes when standard PPE is unavailable, or for less critical non-medical environments that do not require compliant PPE. The SFM design has undergone review in a clinical setting and is recommended for use when manufactured according to the guidance and used as instructed in the IFU. Included with download are the 3d printable files, the instructions for use (IFU), and a manufacturing guidance document for printing from a 3D Systems Selective Laser Sintering machine in Duraform PA or Duraform ProX PA. Selective laser sintering can be used to manufacture volume quantities of the mask and filter cover.
