3D Systems has seen concerns expressed regarding medical devices being created using materials that are not biocompatible. The company is a recognized leader in medical device design and manufacturing. The company’s deep experience and expertise in 3D printing, engineering, quality control, and regulatory requirements have enabled production of nearly 1 million medical devices. For all medical devices, 3D Systems complies with guidance from the FDA – testing the safety and efficacy of all devices. Recently, the FDA has issued several emergency use authorizations for things such as PPE for healthcare providers that are allowing companies to get clearance more quickly than previously possible. Additionally, FDA, VA, America Makes & CDC have all published guidance and 3D Systems is collaborating with all these organizations in our response efforts.
Over the weekend, 3D Systems released a Material Technology Recommendation Chart on its COVID-19 response page. This chart was prepared to identify the best candidates for printer-material combinations for which either Class VI and/or ISO 10993 certifications are possible, including potential solutions to applications in emergency situations although the materials are not Class VI and/or ISO 10993 certified and customers should conduct their own testing to determine whether certification is possible.
PPE – Face Shield Frame File
The Face Shield Frame file made available on the website March 27 has been downloaded more than 1,000 times.
3D Systems On Demand engaged in 50 COVID-19 projects
3D Systems’ On Demand is currently involved with approximately 50 different projects to support healthcare workers and medical device manufacturers during the pandemic. The agile supply chain is enabling the designers to work with private enterprises, NGO’s, and hospitals to fulfill prototyping and volume manufacturing requests, as well as bridging gaps in the traditional supply chain. Projects the company is working on include face shields for hospitals in the UK, Italy and US, face masks, ventilator components, disposable valves to convert scuba masks to emergency ventilators, as well as door openers. In its Pinerolo, Italy facility alone, the 3D Systems team produced more than 700 components in just one week. One of the best examples of this in action is how quickly they were able to deliver the disposable valves for emergency ventilator masks for an Italian Hospital. They received a request at 11 AM, designed a brand new design, printed 30 parts, packaged them and delivered to the hospital in 8 hours.
3D Systems
www.3dsystems.com
