How Standards Can Facilitate the Global Fight Against Pandemics and Improve Preparedness

The medical community encountered enormous challenges during COVID-19, including facing significant shortages of emergency medical supplies such as nasal swabs and personal protective equipment that are critical for testing and treating patients. When COVID-19 shattered the global manufacturing supply chain, and hospitals and caregivers were overwhelmed, many turned to additive manufacturing, also known as 3D-printing, for rapid development and mass production of critical medical products. Designs of these conventionally fabricated products were revised on an ad-hoc basis to suit the additive manufacturing requirements. The crisis-response additive manufacturing efforts helped us to tackle disruptions in manufacturing supply chains and transportation. However, many of these efforts faced challenges from a lack of standard approaches in the selection of design, material, process, and equipment. Appropriate use of the existing standards and development of some missing additive manufacturing-specific standards can enable us to exploit the full potential of additive manufacturing in tackling future production needs during emergencies. These standards include product and material specifications, performance requirements, design, process selection, quality control, and testing and evaluation of final products. We can transform the lessons we have learned with the shortages of medical supplies during COVID-19 into better preparedness for future pandemics. In this work, we investigate how standards can enable agile productions of emergency medical supplies using additive manufacturing. We also identify some available standards that can be leveraged in designing, producing, and evaluating medical products. Finally, we recommend some additional standards for AM to ensure secure and responsive manufacturing operations, assure product quality and performance, and importantly, support rapid production of on-demand medical supplies for future pandemics.