When the COVID-19 pandemic earlier this year, additive manufacturing vendors and users rallied to manufacture much-needed personal protective equipment (PPE), ventilator components and swabs, setting up printer farms, lending production facilities to hospitals and repurposing lone desktop 3D printers to plug supply chain gaps for vital equipment. Yet, despite the technology’s ability to react quickly to this rising demand, there was cause for concern around how viable and reliable these 3D printed alternatives could be.
In an effort to address this, German testing and certification outfit, TÜV SÜD has introduced a range of checklists addressing the key standards and regulations required for the additive manufacture of COVID-19 related products. The guidelines are designed to help manufacturers implement regulatory requirements and are being provided free of charge to manufacturers, testing labs and healthcare specialists.
Typically, medical products and equipment are made by a select number of contract manufacturers and qualified under strict quality and legal requirements to ensure safety and performance before being placed on the market. For example, PPE must comply to regulations which protect the wearer from particles or droplet aerosols (Regulation (EU) No. 2016/425) and those used in healthcare settings must undergo rigorous conformity and safety standards testing. This process takes time and we saw during the crisis how organisations like America Makes worked with the FDA, VA and NIH, to fast track the review process for COVID-19 related devices, and how stereolithography leader Formlabs quickly received emergency use authorisation (EUA) from the FDA for a series of plastic adapters designed to convert sleep apnoea equipment into mechanical ventilators.
Read more on the 3D printing industry’s response to COVID-19:
Desktop 3D printer manufacturer Ultimaker is said to have been one of the first collaborators on TÜV SÜD’s checklist following the creation of a COVID-19 online portal to assist healthcare centres in sourcing local production capacities. Meanwhile, AM software provider 3YOURMIND has developed a platform for efficiently coordinating and organising supplies of essential products during the pandemic and has embedded TÜV SÜD’s checklist, integrating evaluation of the manufactured products in the process.