Opinion: the role of design, risk management and 3D printing during the COVID-19 pandemic
In this post from Dominic Eggbeer, Professor of Healthcare Applications of Design at PDR, (Cardiff Metropolitan University, UK), Eggbeer discusses a safe and regulated approach to 3D printing critical components and devices for use during the COVID-19 pandemic.
I am Professor of Healthcare Applications of Design at PDR, Cardiff Metropolitan University (UK). My research focuses on the design and development of personalized medical devices. I apply my knowledge to surgical implants, facial prosthetics, dental devices and other areas of rehabilitative medicine. In addition to my academic research, I manage a small, ISO 13485 compliant commercial team in the design of patient specific implants and other devices. I also take a leading role in collaboration, dissemination and in supporting broad uptake of novel design engineering approaches in healthcare.
I have previously written on the COVID-19 pandemic about the role and responsibilities of designers and makers producing Personal Protective Equipment (PPE) and medical device components. In my short LinkedIn article, I referenced ISO 14971:2012 'Medical devices — Application of risk management to medical devices'. Part of this standard is etched in my brain since my team spent many an hour pouring over it in the development of our ISO 13485 quality management system. This particular part is 6.2 – Risk Control Option Analysis. This states that:
"The manufacturer shall use one or more of the following risk control options in the priority order listed:
a) inherent safety by design;
b) protective measures in the medical device itself or in the manufacturing process;
c) information for safety.”
I particularly like the concept of inherent safety by design. ISO 14971 has now been updated and this term has been removed (which I think is rather sad) and replaced with inherently safe design and manufacture (part 7.1a in the 2019 edition). The meanings are, however, pretty much the same – when it comes to medical devices, designers and manufacturers have a responsibility to ensure their products are as safe as possible before they are made available. Although PPE falls under different regulations and guidelines that do not require ISO 14971 to be followed to the letter, I believe the same principles should apply. My concern when drafting that first short article was that in the rush to provide solutions to the PPE shortage, lack of ventilators and other medical devices, safety was not being considered in sufficient detail, especially by those rushing to deploy 3D printing.
The COVID-19 pandemic has spawned innovative ways of approaching the UK’s shortfall in essential medical and PPE equipment. The 3D printing community has been right at the forefront and was one of the first to react when reports of shortages were broadcast across the media. Companies, such as Prusa Research a.s. (Prague, Czech Republic) were quick to design face shield components that could be 3D printed on low-cost machines available around the world. 3D-printed components were complemented with relatively easy to acquire elastic straps and clear sheet plastic to complete the design. Numerous other face shield designs sprung up and were quickly adopted by the maker community who did what they do best – make things based on a perceived need. Other companies have produced non-medical or PPE devices, such as no touch door openers, which are not subject to stringent regulations, but could play an important role in infection control. On the whole, it has been fantastic to see how people can be united in a common cause to address the perceived shortfall for PPE in the UK’s National Health Service (NHS).
I work closely with specialists in the NHS and, like most other people in the UK, appreciate their hard work often undertaken in difficult situations. They also rely on PPE since the very essence of doing their job effectively means that they often have to take protective measures rather than avoid an unsafe situation all together. In the COVID-19 situation, PPE must protect the wearer and/or others around them against a potentially deadly virus. Therefore, whether you’re selling PPE or gifting it to the end users, you are essentially making a claim that it offers protection.
We are fortunate in Wales. As a relatively small country that’s part of the UK, we have a degree of autonomy in healthcare since it is a devolved area from the UK government. This means experts are relatively easy to get hold of. As with other parts of the UK, working groups were established to create a conduit between industry, the NHS and Welsh Government. I was able to take advice from these Welsh working groups. Similar set ups were also created across the UK. The maker community, who were the fastest to react to perceived demand, started operating in parallel to the official routes. This potentially created confusion in the system. People who were not used to making PPE or medical devices, but were agile and extremely enthusiastic, started producing product that had not undergone proper testing and were not being supplied via official registered routes. As stories of 3D printing PPE hit mainstream media, even more joined the cause. Inspired and motivated by research groups and companies, numerous groups were set up on Facebook, some using 3D printing to fabricate masks, ventilators and other medical devices that are normally subjected to stringent testing (for very good reasons).
The issue with 3D printing, like any manufacturing process is quality control and management of risk. The proliferation of 3D printing in recent years has been spawned by decreasing prices. Schools, colleges and individuals (I have a few at home) can afford extrusion or even photopolymer machines and materials. Materials are also readily available. In parallel, the regulatory sector has struggled to keep pace with innovation; task groups are frantically working to ensure the technology is fit for purpose in safety critical situations. Manufacturers using 3D printing for medical device production must have an appropriate quality management system (typically ISO 13485), which dictates a risk-based approach and tight controls on the materials and processes. I am not as familiar with PPE production and quality control requirements, but there are regulations and guidelines in place that should ensure products are fit for purpose. Companies supplying class iii PPE or medical devices must also be registered with the government as doing so. This creates traceability and makes post market surveillance possible.
From what I can understand, the maker community largely operates outside of these regulations and quality management systems. Even worse, it has not always been evident that 3D-printable designs of things like face shields were undertaken in collaboration with end users or in reference to the necessary specifications. Designs in the maker community evolved as mistakes were ironed out and people became more aware of essential specification details (for example, many original face shield designs left a gap between the forehead and shield, which was not suitable. Many designs also used straps with latex in them. Latex causes an allergic reaction in many people and is avoided in PPE for this reason). However, many of these inappropriate designs had already been hastily made and sent to hospitals with limited ability to trace them back to the original manufacturer or feedback on quality. The concern with supplying healthcare workers with unproven PPE (or even worse, life supporting medical devices like ventilators -that’s another story) is the false sense of security it could give them.
3D printing is often used to add value - people feel good if they think time, effort and a cool technology has gone into making a product they're using. Great, but if that product hasn't been through testing and certification to the regionally appropriate standards, is this fair to the staff who are using it? Would they perhaps take more risks since they were wearing PPE (even if it’s not proven effective)? That is against the essence of risk management. I am aware that locally, many 3D-printed pieces of PPE have been rejected by hospitals who could not conclude that the designs met safety requirements. There have also been many successes, mostly where a more considered, risk-based approach has been taken from the outset, then scaled up.
Although industry has been slower to react to the need for PPE than the maker community, they have done so in a way that is legal, more scalable and has greater potential to guarantee user safety. For example, in Wales, the Royal Mint quickly ramped up production of visors that avoided 3D printing as a production method. After all, 3D printing is still relatively slow and inefficient compared to laser cutting, injection moulding and other mass manufacturing methods.
So what are the implications for the future? The ideal solution would incorporate the agility of distributed design and manufacturing with the rigour of regulatory compliance. The COVID-19 situation has particularly highlighted the issues with local supply chain resilience (I also recommend reading an article by Alastair Parvin (Open Systems Lab, London, UK) that discusses the issues around procurement in much greater detail). 3D printing as a mass production tool is still slow, inefficient and expensive (particularly at the lower cost end of the spectrum), but has proven potentially useful to serve local needs or in the production of specialist lower volume pieces of equipment to adapt medical devices.
In-hospital production of medical devices adds another dimension to the discussion. During the COVID-19 situation, numerous hospital facilities across the UK and worldwide have redirected their 3D printing capability from the production of anatomical models and tools for teaching and communication to PPE and medical devices. I have spoken to medical specialists that have been able to fabricate critical pieces of medical equipment suddenly unavailable through traditional routes. They may only be able to produce stopgap solutions, but there is a strong argument to support this approach if the benefits can be shown to outweigh any residual risk (a nod to ISO 13485 and the Medical Device Regulations). Operating 3D printing and other manufacturing processes in-hospital provides a direct link between supply and demand. In-hospital facilities therefore have the potential to react faster than industry. However, this opportunity requires more detailed consideration to ensure it is not simply used as a way to avoid regulatory scrutiny.
Part of my team’s job is to work with medical specialists to ensure advanced design and production methods, such as 3D printing, are introduced into the NHS safely and effectively. In-hospital production of custom-made medical devices are subject to different regulations under the Medical Device Directive. It is important to note that elements of this will change with the introduction of the Medical Device Regulations – hospitals will need to implement much greater levels of quality management that are more closely aligned to what industry must adhere to at the moment and in the near future.
Our research has identified that in the rush to implement 3D printing as an in-hospital tool, the importance of good design practice and quality management can be been neglected. I therefore propose that greater collaboration and integration of design engineering and regulatory expertise is required to ensure that in-hospital 3D printing hubs are better coordinated to meet local supply chain demands for medical device and PPE products. Coordination would ensure that appropriate specifications are developed, quality requirements defined, and risk mitigation methods are implemented prior to rushing into making a solution. Enabling greater levels of in-hospital device fabrication will inevitably shake up the current way of working and will require liaison with industry and the research sector to ensure the latest technologies and services meet end user needs safely.