I was recently interviewed for a PodCast by Joris Peels from 3Dprint.com, where we discussed the AM/3DP industry response to the Covid-19 crisis. Like many people, I have been watching closely how 3D Printing has been used to respond to the global pandemic. I have been in awe at the level of innovation and commitment made by so many people. From the great work on the rapid design of emergency respirators by my good friend Magi Galindo at Laitat, through to the fantastic job of the FabLab in Milan to manufacture replacement oxygen control valves.
However, I have also been concerned with several press reports relating to the manufacture of Personal Protective Equipment (PPE) including face shields, visors and masks. The problem I have is that many of these well-intentioned uses of AM/3DP fail to consider the regulatory environment and the vital role that standards and CE marking play in keeping people safe. Let me expand?
Within Europe (and Post Brexit UK) all PPE must carry a CE mark. CE marking is not as simple as many people would think. Just placing the letters CE onto an item doesn’t make it conform. To achieve a CE mark, a product needs designing and manufacturing according to stringent standards. CE marking is not as some would suggest there to drive up the cost, but to keep the wearer safe. After all, what is the point of unsafe PPE?
During the COVID crisis, there have been numerous stories of non-CE market PPE finding its way into hospitals and onto healthcare professional and patients alike, and I fear that 3D printed PPE may be no different. Much of the 3D Printed PPE that I have seen has been designed around the constraint of the manufacturing processes rather than the applicable standards. To this end, it could be argued that it is inherently unsafe. But it doesn’t need to be!
There has been some fantastic work on the rapid design, development and manufacture of 3D Printed PPE, which considers all applicable standards while maximising the global availability of AM/3DP capacity. Take, for instance, the great work of the guys at Nottingham University who were approached by their local NHS trust to help with face visors.
The Nottingham approach was to identify an open-source visor designed for manufacture using the HP MJF process. They then reviewed the appropriate British Standards for PPE before making the necessary design modifications. By locking the design to manufacture using Nylon PA 12 (MJF or LS) and fully documented the manufacturing processes, they were able to satisfy the PPE for Healthcare Professionals 2020/403 – Eye protection Technical Specification within just 10-days. The University and several industrial partners have now delivered over 5,000 approved face shields to Nottingham NHS trust.
What I find interesting is that although we talk about AM/3DP disrupting supply chains, there has, until now been very little evidence of this happening, mainly because there has been no need. However, what COVID has shown us, is that with good engineering practice and an awareness of appropriate standards, AM/3DP can be a highly effective and positive supply chain disruptor.
If you want to know more, why not give the PodCast a listen.