In the first year of the COVID-19 pandemic, at least 3,607 healthcare workers in the United States died of the disease. One main reason: Many people lacked access to personal protective equipment (PPE). Indeed, desperate doctors and nurses relied on reusing disposable masks, disinfecting gloves for use with multiple patients, and wearing garbage bags instead of gowns. The shortage of other medical devices, from cotton swabs to ventilators, exacerbated the crisis.
But early on, 3D printing emerged as a temporary solution. Between February 15th and July 15th, 2020, about 38 million face shield parts, 12 million used in tests, for companies with 3D printing capabilities, hospitals, and even 3D printing enthusiasts. Printed nasal swabs, 2.5 million mask ear savers, and 241,000 mask parts. And 116,000 ventilation parts.
To understand how 3D printing succeeded and failed during a pandemic, The Pew Charitable Trust gave 19 stakeholders in the 3D printing industry, academic medical centers, medical systems, and government agencies their experience. I interviewed about. The most common theme expressed by the interviewees was gratitude. For the direction provided by regulatory agencies such as the Food and Drug Administration to stakeholders. For flexibility to meet the needs of urgent patients, especially through an Emergency Use Authorization (EUA). This will temporarily allow manufacturers of FDA-regulated products to sell their products without going through a standard review process. Infrastructure built by public and private institutions to facilitate communication. And overall, because of the efforts and sacrifices people have made to bring life-saving equipment to where it is needed, when it is most needed.
When asked ahead of the next pandemic, interviewees consider regulators, designers, manufacturers, and healthcare providers to better enable 3D printing to meet patient needs. We have identified some common issues that should be addressed.
Centralized communication
In the early days of the pandemic, when equipment shortages first occurred, manufacturers relied on various sources, such as news media and word-of-mouth, to determine what healthcare professionals needed most. However, this ad hoc approach turned out to be inefficient. In some cases, manufacturers have overemphasized demanding devices such as N95 masks, but such products may not provide the same level of protection during 3D printing. Also, there is not enough focus on determining the optimal product design, there are many different structures for face shields and other accessories, most of which are safe or effective in design and material. It wasn’t scrutinized to make sure.
To facilitate real-time communication between hospitals and medical systems, designers and manufacturers, and to provide more consistent monitoring of 3D-printed devices, the FDA, National Institutes of Health, Veterans Affairs, and America Makes Information sharing established March 2020 collaboration, now called COVID 3D TRUST. The FDA consulted on best practices and field questions. VA used its printing capabilities to develop and evaluate the design. NIH has adopted 3D Print Exchange to act as a repository for scrutinized design files. and America creates a healthcare provider connected to a manufacturer with 3D printing capabilities. Interviewees said that in the event of another pandemic, a communications platform with federal surveillance would already be in place or would need to be established much more quickly.
Openness
Some healthcare systems and manufacturers can take advantage of open standards to print their devices quickly. However, licensing requirements have created a bureaucratic hurdle that prevents manufacturers, including those in hospitals, from printing the equipment they need. Some companies restrict the use of designs, while others make print files available as open source. Experts seek ways for manufacturers, designers, healthcare providers, and policy makers to balance intellectual property rights during a pandemic with ways to maximize innovation and access to patient needs. I advised that it was necessary. They also recommended the creation of digital stockpiles with scrutinized design files, printing procedures, and quality assurance protocols freely available to manufacturers.
quality assurance
Even for low-risk devices that do not require FDA approval, hospitals and healthcare systems are still wary of using 3D printed products from non-traditional sources. COVID 3D TRUST ultimately enhances end-user confidence in devices such as face shields and nasal swabs printed using verified materials and designs by providing clear guidance on materials and designs. rice field.
Still, interviewees said hospitals need to build a process for procuring equipment outside the normal supply chain. They also from regulators such as the National Institute for Occupational Safety and Health of the US Centers for Disease Control and Prevention and the FDA about the roles, responsibilities, regulatory requirements of each agency, and the types of devices that should and should not be 3D. I asked for clear guidance. -Printed, optimal materials for a variety of devices, and the criteria for designing and printing them. Questions remain as to whether and how a device with EUA will eventually be needed to obtain more formal FDA approval.
Greater printing capacity
Interviewees said healthcare systems need to develop or enhance their 3D printing expertise in-house so that they can respond to the needs of the community as soon as possible in the event of future shortages. In addition to getting the right equipment, hospitals need to hire and train staff who know how to use it properly. Others have advised the federal government to establish and maintain 3D printing facilities (strategic stockpiles of printing capacity) so that government agencies can close supply gaps in the event of a re-emergence. .. Federal law, including the National Manufacturing Security Act, will build and train reserves to bridge the gap between manufacturing-focused workforce and the crisis and mitigate bottlenecks. Federal policy makers also need to develop guidelines when 3D printing is most useful. Like other manufacturing techniques, 3D printing has its limitations. Suitable for developing prototypes and creating specific specialized products such as personalized products for individual patients. However, more complex devices and devices that require faster throughput (the amount of products that can be manufactured within a particular time frame) may be suitable for other manufacturing technologies.
COVID-19 reveals many weaknesses in American society and the economy, including over-reliance on foreign-made medical devices for the healthcare system and inadequate strategic national stockpiles. 3D-printed devices have served as an important temporary solution in a crisis, but they can be a permanent part of the medical supply chain for certain products. By applying the lessons learned during the pandemic and continuing to investigate key issues related to the design, manufacture, testing, regulation, and sourcing of these products, policy makers, healthcare providers, scholars, and others. Stakeholders are preparing for the following public health emergencies that will help secure the US healthcare system.
Zahra Younoszai is working on a Pew Charitable Trust healthcare product project.
