Solutions Being Explored
The following table provides a summary view of current applications being explored
Category | Part | Current Activity | Status | In Clinical Use | Next Steps |
PPE - Face Shield High Capacity | High capacity frame without visor | Manufacturing | Released | Yes | Released |
PPE – Face Shield w/ visor | Frame with visor | Optimization for SLS nylon | Active | Yes | Verification |
PPE – Face Mask | Stopgap Face Mask | Manufacturing | Released | Yes | Released |
Surgical Mask1 | Approval | Active | No | Manufacturing | |
Surgical N95 Respirator1 | Prototyping | Active | No | Bench Testing | |
Ventilator Solutions | Various | Support of ventilator OEMs | Active | Yes | Continue collaborative efforts |
Splitter | HCP Evaluation | Released | Yes | Contact to participate in clinical validation | |
Diagnostics | Swabs | HCP Evaluation | Released | Yes | Contact to participate in clinical validation |
Medical Education | Lung Ultrasound COVID-19 Training Module | Available | Active | Yes, for clinical training | Contact to participate in clinical validation |
Materials | All | Material Technology Overview Chart2 created for download for Printer-material section | View | The overview below may change based on continued results. The table will be updated regularly to reflect these changes. |
1 View FDA Guidance and Definitions
2 3D Systems Material Technology Overview Chart
We have prepared a Material Technology Overview Chart to identify the best candidates for printer-material combinations for which either Class VI and/or ISO 10993 certifications are possible for COVID-19 applications, including potential solutions to the COVID-19 applications in emergency situations though the materials are not Class VI and/or ISO 10993 certified and customers should conduct their own testing to determine whether certification is possible.
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Disclaimer
The production of medical parts requires conformance with certain regulations. The parts and designs shown above do not have regulatory clearance at this time. Any required validations and regulatory approvals are not the responsibility of 3D Systems.
Any design files referenced or provided by 3D Systems are provided “as-is” without any warranties or guarantees of any kind, including but not limited to, warranties of fitness for particular purposes, merchantability, or non-infringement. Design files for the manufacture of parts for medical use do not include any registrations or certifications. Users of the design files are solely responsible for their use of the design files and any applicable regulatory approvals (or exceptions thereto) and any claims of liability, including but not limited to products liability or intellectual property infringement, and will indemnify 3D Systems for any liability that may result from use of the design files.