3D Printing in Medicine and Its Role in the COVID-19 Pandemic: Personal Protective Equipment (PPE) and other Novel Medical and Non-Medical Devices

This book describes how “makers” with no medical experience became and remain clinically important because they utilized 3D printing to produce supplies for healthcare, including medical and non-medical devices, and to improve the quality of life for patients with COVID-19 and those who care for them. It shows how 3D printing became vital during the pandemic due to its broad availability and the inherently digital nature of the work that enables thriving digital exchanges and work in isolation. 
Subsequent chapters highlight some of the “maker” communities' efforts that made a difference in their part of North America. Each contribution describes the unique experiences, challenges, and successes.
While this book is written and edited mostly from a medical perspective, additional input from medical engineers, administrators, attorneys, and public safety officials enables a broad perspective to highlight some of the ingenuity from the North American 3D printing community who responded to the initial case volumes of COVID-19. 

• Language: English
• Publisher: Springer
• Release date: Jan 11, 2021
• ISBN: 9783030619930

Book preview

© The Author(s), under exclusive license to Springer Nature Switzerland AG 2021

F. J. Rybicki (ed.)3D Printing in Medicine and Its Role in the COVID-19 Pandemic https://doi.org/10.1007/978-3-030-61993-0_1

1. Introduction

Frank J. Rybicki¹  

(1)

Department of Radiology, University of Cincinnati, Cincinnati, OH, USA

Frank J. Rybicki

Email: [e-mail]

Keywords

COVIDCOVID-19Coronavirus3D printingThree dimensional printingAdditive manufacturingRapid prototypingPandemic responsePersonal protective equipmentMedical devicesStop-gap medical devices

The maker culture includes individuals who creatively use 3D printing for a variety of applications. Many of these makers had never before intersected with people using 3D printing to enhance the quality of healthcare [1]. This later group is actively evolving from industry professionals to include healthcare workers from hospitals and medical teaching institutions [2, 3].

This book is a collection of essays and more formal reviews regarding how the COVID-19 pandemic fostered the intersection of individuals who might otherwise not work together; it highlights some of their accomplishments and challenges. The book is very far from comprehensive. The book is written for people in the union, as opposed to the intersection, of the maker scene and those in healthcare. It is also intended to serve as a resource to document efforts in 3D printing of medical and non-medical devices during the pandemic, as of July 2020. Earlier work predates this collection [4], and it is recognized that writing about a timely and dynamic topic has the inherent challenge that material requires frequent update. Every attempt has been made to rapidly deliver this information in book form, including discussion questions at the end of most chapters for use in the classroom. One consequence of the urgency for timely release is that the book remains a work in progress; the mirrors the COVID-19 pandemic response in general.

3D printing has an army of human resources. One theme of this book is that, based on the creativity afforded by design in 3D printing, makers with no medical experience became clinically important because they had a mechanism to manufacture products that made a positive difference during the pandemic. Another theme is that individuals with experience in medical 3D printing—both from industry and hospitals, shifted their roles and responsibilities to better communicate and contribution to the COVID-19 effort.

The book focuses on 3D printing communities that made a difference in their part of North America. This includes the University of Cincinnati in Cincinnati, Ohio; the University of Ottawa School of Medicine in Ontario, Canada; and two sites in New York. Each location had different, valuable experiences. These include the essential collaboration between physicians, medical engineers, and a cross section of the 3D printing community.

References

1.

Rybicki FJ. 3D printing in medicine: an introductory message from the Editor-in-Chief. 3D Print Med. 2015;1:1. https://​doi.​org/​10.​1186/​s41205-015-0001-5.CrossrefPubMedPubMedCentral

2.

Mitsouras D, Liacouras P, Imanzadeh A, Giannopoulos AA, Cai T, Kumamaru KK, George E, Wake N, Caterson EJ, Pomahac B, Ho VB, Grant GT, Rybicki FJ. Medical 3D printing for the radiologist. Radiographics. 2015;35:1965–88.Crossref

3.

Mitsouras D, Liacouras PC, Wake N, Rybicki FJ. RadioGraphics update: medical 3D printing for the radiologist. Radiographics. 2020;40(4):E21–3.Crossref

4.

Tino R, Moore R, Antoline S, et al. COVID-19 and the role of 3D printing in medicine. 3D Print Med. 2020;6:1–8. https://​doi.​org/​10.​1186/​s41205-020-00064-7.Crossref

© The Author(s), under exclusive license to Springer Nature Switzerland AG 2021

F. J. Rybicki (ed.)3D Printing in Medicine and Its Role in the COVID-19 Pandemic https://doi.org/10.1007/978-3-030-61993-0_2

2. Literature and Media-Based Review of Personal Protective Equipment 3D Printing Efforts During COVID-19

Prashanth Ravi¹  , Nathan Lawera¹   and Frank J. Rybicki¹  

(1)

Department of Radiology, University of Cincinnati, Cincinnati, OH, USA

Prashanth Ravi (Corresponding author)

Email: [e-mail]

Nathan Lawera

Email: [e-mail]

Frank J. Rybicki

Email: [e-mail]

Keywords

COVIDCOVID-19Coronavirus3D printingThree dimensional printingAdditive manufacturingRapid prototypingPandemic responsePersonal protective equipmentMedical devicesStop-gap medical devicesFace shieldsFace masksN95 respiratorsSurgical masksCommunity masksVentilatorsNational Institutes of HealthTension relief devices

Questions for Further Discussion

1.

How has the literature evolved regarding making personal protective equipment (PPE) available during the COVID-19 pandemic?

2.

What has been the relative impact of the media (including social media) with respect to the peer-review literature?

3.

Has the media been considered a reliable source of medical information regarding 3D printing, or for the COVID-19 pandemic in general?

4.

What are the best search strategies to learn about the literature on 3D printed medical and non-medical devices during the pandemic?

5.

How has the media trended in terms of acceptance of 3D printed personal protective equipment (PPE) as opposed to the same devices made by companies?

2.1 Introduction

The rapid, global spread of COVID-19 caused a shortage of personal protective equipment (PPE) worldwide [1–5]. Some areas, such as New York City in April 2020 had more severe PPE shortages [3]. In areas like Cincinnati, Ohio, USA, where our group is based, the system was taxed but not overwhelmed. Other chapters in this book highlight different regions in North America with vignettes from Ottawa, New York, Cincinnati, and Tampa. The purpose of this chapter is to highlight the work of additional groups based on related published peer-reviewed literature as well as selected non-peer-reviewed sources as of mid-July, 2020. For clarity, each non-peer reviewed reference in this chapter includes meticulous language to identify the source, and the citations themselves include web addresses (url format or preprint DOIs) from the time this book went to press. When we have not specifically included language to identify the source, the readers should assume that the statements are from the cited peer-reviewed literature. Our intent is that the readership will be able to readily comprehend both the format and the content. While it is not possible to be comprehensive, we hope to clearly summarize the large and growing body of work that demonstrates the impact of 3D printing during the COVID-19 pandemic.

2.1.1 Medical 3D Printing and PPE

PPE is the reference standard in personal protection against airborne infection [6]. The pandemic created opportunities for the manufacturing of a number of devices such as: door openers to reduce contact spread of the virus, ear tension relievers to enable hospital staff to wear surgical masks for extended time periods without the risk of pressure ulcers, and UV units for disinfecting PPE for safe reuse. In addition to the chapters in this book, these devices are discussed in two papers [7, 8] and a non-peer reviewed manuscript [9]. The acute shortage of ventilator components and deficiencies in the production and supply chain [10] are described in other chapters within this book.

This review includes our study of the free and open source scientific and medical hardware (FOSH). Individuals engaged in 3D printing are encouraged to share device designs online to accelerate innovation [11]. Several industry 4.0 technologies have played an important role during COVID-19 [12]. 3D printing proved highly valuable in April and May 2020 because volunteer makers could manufacture products virtually anywhere and on a moment’s notice [13], particularly under relaxation of some regulatory guidelines by the United States (US) Food and Drug Administration (FDA) [14]. Generally, ventilator parts and N95 respirators are medical devices that require emergency use authorization; whereas, surgical/community masks, mask frames and face shields are within the class of devices that are not formally cleared [15]. More details regarding these algorithms can be found in chapter 4 of this book dedicated to the National Institutes of Health (NIH) Print Exchange.

Peer-reviewed literature [16, 17] highlighted the creation of a citizen supply chain for relative ease of access, particularly using fused deposition modeling (FDM) 3D printers; this was supported by the media [18]. Social media included more than 100 individual designs of 3D-printable PPE by May 2020 [19]. In Canada, Ontario Health developed a comprehensive set of guidelines for facilitating the safe reuse of PPE during shortages in the form of a non-peer reviewed report [20]. Researchers have summarized recommendations for PPE conservation and management [2] and described algorithms for the efficient use of PPE for operating room and routine clinical care use [21]. Precautionary notes were included in pre-validated designs that can be short-run manufactured via 3D printing to solve time-sensitive shortages for critical care needs and protect healthcare workers [22]. Although 3D printing is important to produce stopgap products during the pandemic, care must be taken to monitor quality [23]. 3D printing is best suited for PPE and devices that can be reused due to the inherently low throughput of the technology [24].

PPE includes gloves, face masks, air purifying respirators, goggles, face shields, and gowns [2]. 3D printing made the greatest impact in face shields, with face masks being second, despite the limitation of quality filtering media and sealing material for 3D printed masks. 3D printed face shields for frontline healthcare workers has been discussed in both peer-reviewed [17] and non-peer reviewed literature [25].

This chapter is organized into four parts: face shields, face masks, other medical devices (e.g., ventilator parts), and non-medical devices.

2.2 3D Printing of Face Shields During COVID-19

Face shields must provide effective protection against droplets, they must be easy to disinfect (if reusable), and, during circumstances requiring extended wear, such as the ongoing COVID-19 pandemic, they must be both durable and comfortable. Ideally, face shields would be rapidly produced and inexpensive [26]. In a simulation study, face shields were shown to reduce immediate viral exposure by 96% when worn within 18 in. of a person coughing [27]. A news article reported that Prusa Research, a Czech-based 3D printing company, shared their face shield design to enable anyone with a 3D printer to download it and manufacture face shields [28]. Another media article reported that a US company produced 1,000,000 face shields per week [29].

There are a wide variety of face shield designs—many are closely related to the open sourced Prusa design. Many desktop 3D printed face shields are based on this design, for example, one with a dual stripped headband requiring straps to fit around the head [30]. A modified open-source face shield design was developed, and a Human Research Committee approved research protocol was devised so that clinicians could iterate designs after real-world testing [31]. The scaled manufacturing of a simple face shield design was described using raw materials from an assortment of existing alternative supply chains to circumvent the disrupted supply chains during COVID-19 [32]. The 3D-printable Prusa face shield design was customized for interventional radiology; it was well accepted for various interventions, although the protection offered was not tested quantitatively [33]. Four popular 3D-printable face shield designs were evaluated, and one face shield was found to be the most effective in terms of its printability, ease of assembly, space for additional PPE and protection, although it lacked scalability by stacking [34]. Media coverage [35] highlighted how a non-profit organization 3D printed a design with a horseshoe shaped headband.

Other face shield designs were either very simplistic, intended to enhance rapid manufacturing, or had unique features to improve the performance of the shields. A unique neck mountable face shield had a throughput of 115,000 per day by mid-May 2020, with over three million units total as discussed in a news article [36]. Two types of simple head gear using locally sourced materials were reported for use during aerosol generating procedures like an emergency tracheostomy [37]. There were larger scale manufactured face shields and generally these were not 3D printed. For example, the State of Ohio sourced over one million face shields for which 3D printing was used in the design, but not the large scale production. A university website released information regarding four different face shields designed in collaboration with partners [38]. Another news article reported that a company designed its own face shield and shipped two million units in April 2020 [39]. Scientists from an academic center designed a disposable, die cut face shield that was innovative because it was delivered flat and then assembled as described in a news article [40]. This design was unique because a large number of units could be shipped in a small space, providing an attractive solution for some first responders.

2.3 3D Printing of Face Masks During COVID-19

There were large 3D printing efforts to create potential N95 respirator equivalents, surgical masks, and community masks. Designs came from academic, commercial and open source communities [11, 13, 41] and was also described in a news report [42]. Researchers have highlighted the need to develop efficient processes for scientifically vetting such designs before they are used by healthcare workers [43–47].