A shortage of PPE for protective face masks is creating a hazardous situation for frontline workers and secondary support service health care professionals. Face masks that are 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.
3D Systems 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 – Duraform PA or Duraform ProX PA, 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 Stopgap Face Mask is to be used 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. You can view the instructions for use (IFU) document here.