Abstract
During the first surge of the coronavirus disease 2019 (COVID-19) there was a tremendous global response from three-dimensional (3D) printing communities and individuals to support local health care systems and staff. The responses involved a range of 3D printer users from amateur makers to conglomerate manufacturers creating personal protective equipment (PPE) and other supplies of which there were shortages. These new supply chains resulted from the democratization of 3D printing, open source file sharing, mass production of desktop machines, and the relatively cheap cost of 3D printers. The democratized state of 3D printing facilitated an altruistic movement of makers with ranging experience, to work alongside traditional manufacturers to make medical supplies. With the critical nature of the shortages and the sharp increase in COVID-19 infections, many standards and regulations were bypassed, and good manufacturing processes disregarded, in cases. The outcomes from this article is a set of six lessons learned from the authors perspective regarding the use of 3D printing during the initial phase of the COVID-19 pandemic. We note challenges experienced around volume manufacturing, infection control requirements of produced parts and the cleanability of devices, mechanical strength considerations, good manufacturing practices, product and intellectual property (IP) liability, and the role of involving clinical stakeholders.
Background
The first cases of coronavirus disease 2019 (COVID-19) were reported by officials in Wuhan City, China, in December 2019. 1 By January 2020, the first cases of COVID-19 were confirmed in Europe and the United States. Italy, Spain, and Germany saw dramatic rises in cases until April 2020, and were then surpassed by rates in the United States, Brazil, and India. By September 2020, the virus spread to 188 countries globally and infected upward of 31,000,000 people, of which >900,000 people are estimated to have died. 2 As the pandemic spread, health care systems ran out of PPE and other medical supplies. 3 With quarantine restrictions in place many manufacturers also struggled to meet demands due to the closure of manufacturing lines and/or submanufacturers/suppliers. 4 Furthermore, as governments issued lockdowns, and in some cases trade embargos on the export of associated equipment, many supply chains froze internationally.
The initial response was largely on the basis that 3D printed devices would be a last resort and were better than nothing.5,6 However, as the infection rate soared, last resort products became more commonplace in some areas.7–9 There was a notable trend regarding communities/individual makers producing 3D printing face visors, face masks, and respiratory equipment, among various other health care devices.3,10 Although there were deeply commendable individual and community efforts during this time of emergency, our experience was that a great many erroneous assumptions were made, such as the extent of shortages of specific products locally and in supply chains. Solutions were produced that had design/production challenges that limited their actual use in the health care settings. Issues such as sterility, consistency, scalability, and product liability were widely overlooked.
Stringent standards and regulations are in place for medical device manufacturing to protect all members of the supply chain, particularly the end user/patient. With the emergency nature of the pandemic and the risk to frontline workers from extreme shortages of supplies, many, if not all, regulatory requirements were ignored by many to deliver solutions (knowingly or otherwise).
The 3D printing community internationally responded rapidly during the first wave of COVID-19. Some responses were more fruitful than others. It is appropriate to now reflect on the responses and consider aspects that affected the utility and success of these efforts, which should be considered through research activities for future emergencies of this nature. This could help ensure that such efforts in the future are optimized and the opportunities for utilizing 3D printing fully exercised. The purpose of this commentary is to detail six lessons learned by the current authors on this topic.
Lessons Learned
Volume manufacturing using 3D printing at required quality levels was a challenge during the pandemic
As the production throughput of 3D printing is low in comparison with traditional manufacturing, many machines must be utilized for the output rate to sufficiently meet moderate demands. Quality control of 3D printed relative to traditionally manufactured devices remains a challenge.11,12 Many nonprofessional maker groups came together to scale up production of some designs, notably visor head bands.3,9 The very nature of multiple disparate makers producing a single design brings with it the potential for large variability in printer technologies, settings, materials, and quality. For example, our experience in Ireland was that many groups donated 3D printed visor headbands to health care facilities, with significant variability in overall quality. As a proportion of these donated units were unsuitable for use, some facilities disregarded 3D printed solutions en masse. The lesson learned is that for volume manufacturing across various makers, there is a need to produce such devices to a minimum acceptable standard, even during emergencies such as a pandemic.
Infection prevention and control practices need to be respected or printed solutions will not be used in health care settings
Health care facilities work under stringent infection protection and control (IPC) considerations. 3D printed components to be used in health care must consider infection/sterilization-related aspects as they may affect their use. 13 These increased significantly during the pandemic. IPC teams require that solutions are clean (not necessarily sterile) before they can be used in a health care facility. Furthermore, reusable devices must be cleanable using conventional methods such as with isopropanol wipes.
The printing technology used can also affect IPC risk. Technologies such as fused deposition modelling (FDM) often have small crevices/spaces between print layers, and in such cases, there may be a risk that surfaces cannot be thoroughly cleaned. 14 For single-use applications in some health care settings this may not be as much a concern as for repeated use in settings where devices require cleaning before reuse.
In our experience, there were cases in which large volumes of devices were produced without any/sufficient IPC team input. Where the IPC team only evaluate devices postmanufacturing through 3D printing there is a significant risk the entire batch will be rejected if a concern emerges. This can lead to negative opinions and low adoption of 3D printed devices in those health care settings.
Emergency 3D printed devices need to consider mechanical strength characteristics
A response during the early stages of the pandemic when supply chains froze was to 3D print devices locally as an alternative production method. 3 There is significant variability in the mechanical characteristics of 3D printed components depending on the 3D printing technology used. Many of the designs available on open source websites were intended for production on specific systems, but may have been printed using alternatives or lower-end 3D printing technologies. A potential concern is that some devices were printed without sufficient consideration for their mechanical strength and performance, which may give rise to product failure and injury during use.3,4
There is a need for guidance on good manufacturing practices for 3D printed devices
Maintaining good manufacturing practice (GMP) in medical device supply chains is central to product safety. This includes protocols regarding sterility, quality control, part validation, and verification. Traceability of parts is also important if devices need to be recalled on safety grounds. 15 Products created and supplied to health care facilities using 3D printing should be subject to appropriate manufacturing standards. Although it is appreciated that in the crisis phase of a pandemic that some supplies are better than none, the devices must still meet minimum safety standards. It is important that GMP guidance for 3D printed emergency medical devices are established, but in particular in response to pandemics, to ensure they are as safe as is reasonably feasible, and above all, safe for clinical use.
Makers may be inadvertent medical device manufacturers and responsible for product liability and IP infringement
The emergency response during COVID-19 was a passionate response of many. Several device designs were shared internationally, some with caveats that they were to be used as a last resort, and others with liability warnings. 4 Makers may have made assumptions that because designs were made available online that they were “approved” in accordance with requisite regulations and standards. In some cases, makers became medical device manufacturers unknowingly, and in so doing, became potentially responsible for product liability. 15 In addition, assumptions may also have been made by some makers that they could reverse engineer and reproduce commercial designs without consideration for IP infringement. Inadvertently or not, the maker could be held liable even if they were unaware of, or believed they were exempt from, certain regulations.
It is crucial to involve clinical stakeholders if making or designing solutions
Involving health care staff in validating requirements for devices and in the design of new devices is crucial. During the initial surge of COVID-19 there were chain reactions whereby devices were 3D printed in response to what was happening on an international level. In many cases this was done without first validating the needs for such devices locally.4,7,9,15 Regarding the design of new solutions, it is imperative that clinical stakeholders are consulted using an iterative design process to arrive at solutions that meet their needs.
Conclusions
The 3D printing community internationally demonstrated how this technology can be mobilized quickly to provide important supports to health care systems during an emergency such as a pandemic. In this article we detail six lessons learned, which, if addressed through research and regulatory/policy guidance, will help optimize the utility of 3D printing during responses to emergency medical disasters in the future, including potential future pandemics.
Footnotes
Author Disclosure Statement
No competing financial interests exist.
Funding Information
This publication has emanated from research supported by Science Foundation Ireland (SFI) under Grant Numbers SFI 16/RC/3918 and SFI 20/COV/0031, co-funded by the European Regional Development Fund.