Rapid Convergence: The Outcomes of Making PPE During a Healthcare Crisis

The U.S. National Institute of Health (NIH) 3D Print Exchange is a public, open-source repository for 3D printable medical device designs with contributions from clinicians, expert-amateur makers, and people from industry and academia. In response to the COVID-19 pandemic, the NIH formed a collection to foster submissions of low-cost, locally manufacturable personal protective equipment (PPE). We evaluated the 623 submissions in this collection to understand: what makers contributed, how they were made, who made them, and key characteristics of their designs. We found an immediate design convergence to manufacturing-focused remixes of a few initial designs affiliated with NIH partners and major for-profit groups. The NIH worked to review safe, effective designs but was overloaded by manufacturing-focused design adaptations. Our work contributes insights into: the outcomes of distributed, community-based medical making;the features that the community accepted as "safe"making;and how platforms can support regulated maker activities in high-risk domains. © 2023 Copyright held by the owner/author(s).

Development and Implementation of a Biometrics Device Design Project in an Introductory BME Course to Support Student Wellness.

Mental health challenges have been rising across college campuses. To destigmatize wellness practices and promote student mental health, we present a novel technical project in an introductory bioengineering course that explores stress management techniques through physiology, biosensors, and design. We hypothesize that if students measure objective, physiologic impacts of stress management techniques on themselves, they may be more likely to realize the benefits and use those techniques when needed. Additionally, through this data-driven project, we aim to appeal to engineers' critical thinking nature. To support students in selecting stress management techniques for themselves, mindfulness is introduced and practiced in the course. Initial student feedback on the introduction of mindfulness into the classroom is positive. The COVID-19 pandemic has emphasized the need to focus on student wellbeing in addition to physical health. Integration of wellness into the core curriculum can normalize the use of these resources within engineering departments and colleges and equip students with stress management tools for their careers. Ultimately, this curricular development lays the groundwork for institutional enhancement of undergraduate STEM education by supporting student wellness through the engineering curriculum. Supplementary Information: The online version contains supplementary material available at 10.1007/s43683-021-00060-1.

Development and efficacy testing of a portable negative pressure enclosure for airborne infection containment.

OBJECTIVES: To overcome the shortage of personal protective equipment and airborne infection isolation rooms (AIIRs) in the COVID-19 pandemic, a collaborative team of research engineers and clinical physicians worked to build a novel negative pressure environment in the hopes of improving healthcare worker and patient safety. The team then sought to test the device's efficacy in generating and maintaining negative pressure. The goal proved prescient as the US Food and Drug Administration (FDA) later recommended that all barrier devices use negative pressure. METHODS: Initially, engineers observed simulations of various aerosol- and droplet-generating procedures using hospital beds and stretchers to determine the optimal working dimensions of the containment device. Several prototypes were made based on these dimensions which were combined with filters and various flow-generating devices. Then, the airflow generated and the pressure differential within the device during simulated patient care were measured, specifically assessing its ability to create a negative pressure environment consistent with standards published by the Centers for Disease Control and Prevention (CDC). RESULTS: The portable fans were unable to generate any airflow and were dropped from further testing. The vacuums tested were all able to generate a negative pressure environment with the magnitude of pressure differential increasing with the vacuum horsepower. Only the 3.5-horsepower Shop-Vac, however, generated a -3.0 pascal (Pa) pressure gradient, exceeding the CDC-recommended minimum of -2.5 Pa for AIIRs. CONCLUSION: A collaborative team of physicians and engineers demonstrated the efficacy of a prototype portable negative pressure environment, surpassing the negative pressure differential recommended by the CDC.

De Novo Powered Air-Purifying Respirator Design and Fabrication for Pandemic Response.

The rapid spread of COVID-19 and disruption of normal supply chains has resulted in severe shortages of personal protective equipment (PPE), particularly devices with few suppliers such as powered air-purifying respirators (PAPRs). A scarcity of information describing design and performance criteria for PAPRs represents a substantial barrier to mitigating shortages. We sought to apply open-source product development (OSPD) to PAPRs to enable alternative sources of supply and further innovation. We describe the design, prototyping, validation, and user testing of locally manufactured, modular, PAPR components, including filter cartridges and blower units, developed by the Greater Boston Pandemic Fabrication Team (PanFab). Two designs, one with a fully custom-made filter and blower unit housing, and the other with commercially available variants (the "Custom" and "Commercial" designs, respectively) were developed; the components in the Custom design are interchangeable with those in Commercial design, although the form factor differs. The engineering performance of the prototypes was measured and safety validated using National Institutes for Occupational Safety and Health (NIOSH)-equivalent tests on apparatus available under pandemic conditions at university laboratories. Feedback was obtained from four individuals; two clinicians working in ambulatory clinical care and two research technical staff for whom PAPR use is standard occupational PPE; these individuals were asked to compare PanFab prototypes to commercial PAPRs from the perspective of usability and suggest areas for improvement. Respondents rated the PanFab Custom PAPR a 4 to 5 on a 5 Likert-scale 1) as compared to current PPE options, 2) for the sense of security with use in a clinical setting, and 3) for comfort compared to standard, commercially available PAPRs. The three other versions of the designs (with a Commercial blower unit, filter, or both) performed favorably, with survey responses consisting of scores ranging from 3 to 5. Engineering testing and clinical feedback demonstrate that the PanFab designs represent favorable alternatives to traditional PAPRs in terms of user comfort, mobility, and sense of security. A nonrestrictive license promotes innovation in respiratory protection for current and future medical emergencies.

A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic.

The disruption of conventional manufacturing, supply, and distribution channels during the COVID-19 pandemic caused widespread shortages in personal protective equipment (PPE) and other medical supplies. These shortages catalyzed local efforts to use nontraditional, rapid manufacturing to meet urgent healthcare needs. Here we present a crisis-responsive design framework designed to assist with product development under pandemic conditions. The framework emphasizes stakeholder engagement, comprehensive but efficient needs assessment, rapid manufacturing, and modified product testing to enable accelerated development of healthcare products. We contrast this framework with traditional medical device manufacturing that proceeds at a more deliberate pace, discuss strengths and weakness of pandemic-responsive fabrication, and consider relevant regulatory policies. We highlight the use of the crisis-responsive framework in a case study of face shield design and production for a large US academic hospital. Finally, we make recommendations aimed at improving future resilience to pandemics and healthcare emergencies. These include continued development of open source designs suitable for rapid manufacturing, education of maker communities and hospital administrators about rapidly-manufactured medical devices, and changes in regulatory policy that help strike a balance between quality and innovation.

Hands-on engineering courses in the COVID-19 pandemic: adapting medical device design for remote learning.

The COVID-19 pandemic has challenged the status quo of engineering education, especially in highly interactive, hands-on design classes. Here, we present an example of how we effectively adjusted an intensive hands-on, group project-based engineering course, Medical Device Design & Innovation, to a remote learning curriculum. We first describe the modifications we made. Drawing from student pre and post feedback surveys and our observations, we conclude that our adaptations were overall successful. Our experience may guide educators who are transitioning their engineering design courses to remote learning.

MADVent: A low-cost ventilator for patients with COVID-19.

The COVID-19 pandemic has produced critical shortages of ventilators worldwide. There is an unmet need for rapidly deployable, emergency-use ventilators with sufficient functionality to manage COVID-19 patients with severe acute respiratory distress syndrome. Here, we show the development and validation of a simple, portable and low-cost ventilator that may be rapidly manufactured with minimal susceptibility to supply chain disruptions. This single-mode continuous, mandatory, closed-loop, pressure-controlled, time-terminated emergency ventilator offers robust safety and functionality absent in existing solutions to the ventilator shortage. Validated using certified test lungs over a wide range of compliances, pressures, volumes and resistances to meet U.S. Food and Drug Administration standards of safety and efficacy, an Emergency Use Authorization is in review for this system. This emergency ventilator could eliminate controversial ventilator rationing or splitting to serve multiple patients. All design and validation information is provided to facilitate ventilator production even in resource-limited settings.