• 3D Systems Pledges Its Support

    The rapid spread of COVID-19 has put many healthcare providers under great strain as they provide treatment and care to affected patients. 3D Systems is offering its services, and we’re looking for our customers and partners to join us in sharing resources to help overcome this pandemic. It’s in these times that we see selflessness at its finest as people come forward to help one another in time of great need.

    If you are able to offer your engineering team’s time and expertise, or access to 3D printers, we would greatly appreciate your support. Conversely, if you are a medical device manufacturer, hospital, or healthcare provider that needs help to bridge a supply chain gap, please let us know of your needs. We will do everything possible to fulfill your request.

  • Support for Medical Device Manufacturers

    We are committed to supporting medical device manufacturers with 3D printed components in either plastic or metal materials to help ease supply chain issues for critical care devices such as ventilators and certified face masks.  3D Systems has a wide network of capabilities including GMP manufacturing facilities and validated print processes.  Learn more.

  • Support for Point of Care / Hospitals

    We are providing solutions to unmet and urgent needs at the point of care.  Examples include:  engineering and printing support for personal protective items, manufacturing capabilities for ventilator venturi valves, and medical education resources for lung ultrasound procedures.  Learn more.

  • Italian Minister for Technology, Innovation and Digitization

    Venturi Ventilator Valves - Photo Credit - Christian Fracassi and team - Isinnova and Lonati SpA - Printed in Italy on a ProX 6100 in Medical Grade Nylon

Solutions Being Explored

Last updated - June 10, 2020 11:00 am PST

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. 

  • Mass-Producing Nasopharyngeal Swabs

    • Mass-Produced Nasal Swabs FLEX-CLR 20

      Single row of 20 swabs linked together for ease of cleaning and removal. 240 swabs were printed in 5 hours 10 minutes with our FLEX-CLR 20 material. Material available upon request.

    • 3D printed, mass-Produced Nasal Swabs in progress on a Figure 4

      NP swabs print in progress on Figure 4.

  • The Need

    There is a shortage of nasopharyngeal (NP) swabs to test COVID-19 patients as large-scale testing ramps up. Most test kits are limited to those who show severe symptoms. As such, it’s hard to determine who is asymptomatic in order to curb community spread through other methods than shelter-in-place policies.

    The Solution

    We are working with clinicians to test the materials and print process of NP swabs printed on our systems. We believe that Figure 4 and its autoclavable, biocompatible materials will be a great fit mass-producing large quantities of swabs in a short amount of time.

    The Outcome

    Through clinical testing and validation, we have established a custom NP swab design and a medical-grade, clear material for this application that will meet clinical standards. Our medical grade material, FLEX-CLR 20, is a flexible, bio-compatible and autoclavable material that is chemically safe, can produce parts that bend at least 180 degrees without breaking and gather viral material for testing. This material is available upon request, contact us for more information. Based on our capacity analysis of a single Figure 4 system running FLEX-CLR 20, we can print 240 swabs in 5 hours and 10 minutes or 84 seconds per swab. We also have several ISO 13485 certified facilities that can produce medical parts.


  • Face Mask Application

    • 3D Systems Stopgap Face Mask

      Stopgap Face Mask from SLS ProX 500 equipment in Duraform ProX PA material

    • 3D Systems Stopgap Face Mask diagram

      Schematic of a Stopgap Face Mask

  • The Need

    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. 

    The Solution

    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 Outcome

    The Stopgap Face Mask is to be used for medical purposes when standard PPE is unavailable or for less critical non-medical environments that does 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. 

    3D Systems would like to thank all the collaborators on this project.  Additional information can be found at the NIH 3D Print Exchange.


  • Reusable Face Shield Frame

    • Face Shield and a cap for greater protection.

      Two-piece face shield frame printed on a Selective Laser Sintering printer with Medical Grade Nylon 12 (Duraform PA).

    • Render of the 3D Systems face shield design

      Diagram showcasing the two sections of the SLS face shield frame assembled together.

    • A face shield mask 3D printed using SLA technology

      A face shield frame printed on a Stereolithography printer with Accura ABS White (SL 7810).

  • The Need

    There is a shortage of Face Shields at hospitals for medical responders who are testing and treating COVID-19 patients. Medical responders need to be protected from respiratory droplets from coughing and sneezing. Even though many individuals and groups are designing and manufacturing face shield frames for these responders, many of the designs are not optimized for high-density optimized additive manufacturing and cannot be accessed locally.

    The Solution

    We have designed a face shield frame that is:

    • A downloadable file to enable local production using any Selective Laser Sintering (SLS)  or Stereolithography (SLA) printer
    • Optimized for high-density nesting
    • Reusable design made of medical-grade nylon that is autoclavable and compatible with disinfectant cleaners
    • Comfortable due to its flexible, non-rigid, form-fitting design
    • Compatible with bonnets and bouffants for protection of the forehead and eyes due to the retention tabs

    The Outcome

    This face shield frame has been manufactured using medical grade nylon on our SLS ProX 6100 machine. The design is a two-part flat pack design that will clip into each other to provide structure while minimizing material usage and maximizing the density of parts that can be manufactured on an SLS machine. They can be disassembled for cleaning.

    The SLA face shield design was optimized and manufactured using medical grade Accura ABS White (SL 7810) on our SLA ProX 500 machine. It was designed for flexibility, robustness, comfort, field of view and efficiency while printing. 216 frames were printed in about 70 hours, the frames were cleaned and post-processed in two days.


  • Ventilator Splitters

    • Ventilator Splitter parts printed in MED-AMB/SG

      2 splitters can be printed in 90 minutes on the Figure 4 with MED-AMB/SG material.

  • The Need

    A ventilator splitter is a device that allows a single ventilator to support two or more patients during this crisis. Approximately 2.4% of all COVID-19 patients in this pandemic will require mechanical ventilation.

    The Solution

    The ventilator sharing concept was first written by Dr. Neyman and Dr. Irvin in 2006 (Ac Emergency Medicine 2006). By using T-tubes and adapters, a circuit could be divided so four patients can share a single ventilator in an emergency. One group, Ventsplitter.org has released an open-source file for emergency POC uses along with flow limiters when pairing different patients (body weight, lung compliance, etc). 

    The Outcome

    Additive manufacturing presents the opportunity to rapidly produce splitters for hospitals. We have several sterilizable and biocompatible materials available on all of our systems that can be used to print these parts along with several ISO 13485 certified facilities that can produce medical parts.

Resources

Case Studies

  • Venturi Ventilator Valve

    Venturi Ventilator Valve

    Challenge

    For severe cases of COVID-19, patients require intensive care and oxygenation through the use of ventilators. With cases growing everyday around the world, venturi valves for ventilators are in short supply at hospitals.

    Solution 

    1. Although there were venturi valves printed in Italy on the SLS ProX 6100 as a last minute solution, more testing is required to validate with newer open-source designs.

    2. We are exploring alternative materials and technologies that can be used for this application that are biocompatible and not reactive.

    Outcome

    There was a clinical case where valves were 3D printed and used at a hospital in Chiari, Italy. Traditional OEMs were not able to supply them in such a short amount of time. Parts were reverse-engineered, prototyped, tested and printed in the span of 3 days on a SLS ProX 6100 with medical grade nylon.

  • Simbionix

    Lung Ultrasound

    Challenge

    Lung Ultrasound is considered an alternative to chest radiography or CT scanning in COVID-19 patients. It is safe, easy and quick for use at point-of-care, repeatable, low cost and radiation-free. Therefore, training physicians to rapidly acquire lung ultrasound skills can be critical for the success of COVID-19 management.

    Solution

    Simbionix simulation allows for training to the full extent of the examination and includes practicing of the various lung zones, documentation and clinical reporting in a full clinical environment.

    Outcome

    Our team is working around the clock to develop COVID-19 education and training content on the Simbionix U/S Mentor simulator. If you are a physician with relevant experience, we encourage you to join our development efforts.

  • a woman in scrubs working on a laptop showing medical software

    Bedside Cardiac ICU

    Challenge

    The COVID-19 pandemic can make traditional cath lab activities difficult.  Transportation of patients to and from the lab provides an increased risk of spreading infection.  Cardiology Societies now recommend that these procedures be conducted beside instead of in a catheterization laboratory. 

    Solution

    The Bedside Cardiac ICU module on the Simbionix ANGIO Mentor is designed to provide practice for interventions that are being performed at the bedside of suspected/confirmed COVID-19 patient with no fluoroscopic guidance.

    Outcome

    As a result of 3D Systems’ quick and realistic development of the Bedside Cardiac ICU module, institutions are able to provide hands-on training of these very timely skills, and thus limit exposure of COVID-19.

How the 3D Systems Community is Helping


  • Frequently Asked Questions

    Is it possible to 3D Print a N95 Face Mask or Respirator?

    3d printed N95 face masks or respirators require qualification and compliance to the N95 standard.

    Is it possible to 3D Print Face Shield Frames?

    • Yes - We are exploring several 3D Printed Face Shield Frame designs that can be printed with a variety of our technologies.
    • SLS machines like the ProX SLS 6100-3D Printer running a DuraForm PA (SLS) or DuraForm EX Natural (SLS) are the best options for quickly producing face shields from current designs. 
    • We are currently working with our On Demand Division to begin ramping up a bridge manufacturing effort to help get face shields to area hospitals.
       

    Is it possible to 3D Print Nasal Swab Test Kits?

    We are currently testing various materials and designs to see if they meet the CDC standards for nasal swabs.
     

    Is 3D Systems printing parts for COVID-19?

    We are currently manufacturing parts per requests from OEMS and other certified medical device manufacturers.
     

    Are 3D Systems OEM customers printing parts for COVID-19?

    Yes, 3D Systems OEM customers are printing parts for COVID-19. We are partners with service bureaus and OEM customers that utilize our technology to print parts.
     

    Are there any 3D Systems medical education solutions?

    Simbionix has created a lung ultrasound simulation module that helps train users performing lung examinations. Learn more

    As institutions change to distance learning programs during the coronavirus, 3D Systems is offering educators and learners an abundance of resources via our MentorLearn Cloud platform.  These videos, curricula and other online materials are available free-of-charge for three months during the COVID-19 pandemic.  Remote learning tools span a wide range of medical specialties, tasks and procedures.

    Register and request e-learning access by emailing [email protected].

    Simbionix is also posting clinical recommendations from professional organizations to their website. View COVID-19 clinical recommendations

    Does 3D Systems have medical-grade materials?

    Yes, we have a broad range of material across many technologies that can meet medical-grade specifications and biocompatibility. A 3D Systems Material Technology Overview Chart is available 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.
     

    Where is 3D Systems based?

    We have facilities around the world. Locations in the U.S., Europe, Asia, South America and Australia.

  • COVID-19 Support Webform

    Se você tiver dúvidas ou puder oferecer o tempo e a experiência de sua equipe de engenharia, ou acesso às impressoras 3D, agradeceríamos muito o seu apoio

    Procurando suporte

    De qual tipo de suporte você mais precisa?

    Oferecendo suporte

    Quais serviços você e/ou a sua organização podem fornecer para outras pessoas?
    Questões 0 1 a 3 4+
    Você fabricou peças ou sistemas para ventiladores?
    Para uso veterinário ou em clínicas?
    Você fabricou dispositivos médicos ou peças?

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.