The additive community has really stepped up to help healthcare workers who are facing shortages of Personal Protection Equipment (PPE), such as face masks, and components for ventilation systems. While professional engineers and hobbyists alike are either creating designs or using CAD files available on various sites, it’s important that these efforts are done using the right materials. Healthcare workers need to feel safe and protected using these solutions. Safe improvised alternatives do exist.
According to 3D Systems, 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.
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 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. Included with the 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.