Fillat-Gomà et al. BMC Health Services Research (2020) 20:1035 https://doi.org/10.1186/s12913-020-05891-2 RESEARCH ARTICLE Open Access Integrated 3D printing solution to mitigate shortages of airway consumables and personal protective equipment during the COVID-19 pandemic Ferran Fillat-Gomà1,2* , Sergi Coderch-Navarro1, Laia Martínez-Carreres1,2, Núria Monill-Raya1,3, Toni Nadal-Mir4, Cristina Lalmolda5,6, Manel Luján5,6, Candelaria de Haro5 and Lluís Blanch5,6 Abstract Background: To cope with shortages of equipment during the COVID-19 pandemic, we established a nonprofit end-to-end system to identify, validate, regulate, manufacture, and distribute 3D-printed medical equipment. Here we describe the local and global impact of this system. Methods: Together with critical care experts, we identified potentially lacking medical equipment and proposed solutions based on 3D printing. Validation was based on the ISO 13485 quality standard for the manufacturing of customized medical devices. We posted the design files for each device on our website together with their technical and printing specifications and created a supply chain so that hospitals from our region could request them. We analyzed the number/type of items, petitioners, manufacturers, and catalogue views. Results: Among 33 devices analyzed, 26 (78·8%) were validated. Of these, 23 (88·5%) were airway consumables and 3 (11·5%) were personal protective equipment. Orders came from 19 (76%) hospitals and 6 (24%) other healthcare institutions. Peak production was reached 10 days after the catalogue was published. A total of 22,135 items were manufactured by 59 companies in 18 sectors; 19,212 items were distributed to requesting sites during the busiest days of the pandemic. Our online catalogue was also viewed by 27,861 individuals from 113 countries. Conclusions: 3D printing helped mitigate shortages of medical devices due to problems in the global supply chain. Keywords: 3d printing, Airway consumables, Personal protective equipment, Medical device, Impact analysis * Correspondence: drfillat@gmail.com 1 3D Surgical Planning Lab. Parc Taulí Hospital Universitari. Institut d’Investigació i Innovació Parc Taulí (I3PT), Universitat Autònoma de Barcelona, Par Taulí 1. Santa Fe Building 2nd floor, 08208 Sabadell, Spain 2 Department of Orthopaedic Surgery and Traumatology. Parc Taulí Hospital Universitari. Institut d’Investigació i Innovació Parc Taulí (I3PT), Universitat Autònoma de Barcelona, Sabadell, Spain Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Fillat-Gomà et al. BMC Health Services Research (2020) 20:1035 Page 2 of 8 Background Methods The SARS-CoV-2 pandemic overwhelmed healthcare sys- Identifying medical equipment in potential short supply tems, leaving many centers without essential equipment to During the first 2 weeks of the pandemic in Spain (March prevent the spread of the virus or to treat COVID-19 pa- 2020), our team worked with pulmonologists, intensive tients [1]. Most of the products in short supply were con- care physicians, and hospital purchasing managers to sumables, such as connectors for invasive and noninvasive identify potentially unavailable medical equipment that mechanical ventilation and personal protective equipment could be manufactured using 3D printing. To determine (PPE) [2, 3]. The companies that usually supply these prod- the health system’s needs, we also considered news, other ucts were unable to meet the high demand during the pan- online information, and proposals from other health cen- demic; many items were out of stock and inaccessible ters. Items that could not be validated in terms of know- through the usual channels. The lack of equipment limited ledge or available facilities were excluded. therapeutic options for many patients and contributed to the spread of the infection and collapse of the system by Design failing to protect healthcare professionals. After the identification phase, two reengineering strategies 3D printing technology has been widely used in industrial were used to design items: 1) optical scanning and 2) de companies around the world for years to create detailed novo design referencing the dimensions of the original item. models, customized parts, jigs and fixtures, end-use parts, For optical scanning, we used a hand-held 3D scanner concept models and visualization aids. Its rapid expansion (HandySCAN Black™ Elite, Creaform Inc.; Lévis, Canada) is now revolutionizing some aspects of the medical field as with dedicated software for reverse engineering and me- well [4, 5]. The establishment of in-house specialized trology (Geomagic® Design X, 3D Systems Inc.; Rock Hill, hospital-based 3D services has facilitated it. Nowadays, per- SC, USA or VxModel™, Creaform Inc.; Lévis, Canada). For sonal specific instruments (PSI) such as anatomical models de novo design, we used computer-aided design software and surgical guides, are used in the clinical practice [6, 7]. (SOLIDWORKS®, Dassault Systèmes; Vélizy-Villacoublay, To cope with shortages and disrupted supply chains, France). various initiatives worldwide undertook to design and When optical scanning could not detect specific areas manufacture medical equipment with 3D printing in rec- of the product, we combined the two strategies. ord time to supply hospitals [8, 9]. Designs for 3D print- All digital designs were exported as STL files (the most ing have been made available online for many items, common file type for 3D printing). including airway consumables, facial masks and screens, and even entire ventilators [10, 11]. However, the impact Validation system of those initiatives has never been analyzed. Validation was based on the ISO13485 quality standard Our 3D surgical planning laboratory, a point-of-care 3D for customized medical device manufacturing [13, 15]. printing unit focused on personalized surgery, [7, 12] estab- In the validation phase, we used 3D modeling software lished a nonprofit integrated (end-to-end) solution to meet (Materialise 3-matic; Leuven, Belgium) for mesh analysis, hospitals’ needs during the pandemic by supplying 3D-printed optimization, and correction of the STL file. We printed products. This solution included the identification, reengineer- small quantities of the items with polylactic acid on 3D ing, validation, and supply of potentially lacking consumables printers (Ultimaker 3 or Ultimaker S5; Ultimaker B.V.; Ut- based on our usual method of manufacturing customized recht, the Netherlands or MakerBot Replicator+; MakerBot medical devices in accordance with the ISO 13485 quality Industries, LLC; New York, NY, USA), ensuring the dimen- standard [13–15]. The initiative was co-managed with the sions of 3D-printed pieces with certified vernier calipers. College of Physicians and Surgeons of Barcelona (COMB) Afterward, pieces were tested in real clinical scenarios and the College of Industrial Engineers of Catalonia (EIC). To (Fig. 1). Devices that needed additional considerations or enable regional hospitals to request supplies, we created an calibrations (3DPT21, 3DPT22, 3DPT23, and 3DPT33: see online catalogue of 3D-printed consumables, including the the Additional file 1) were tested in an experimental model files necessary to manufacture them so that any hospital using a polygraph (PowerLab 16 SP; ADInstruments, Dun- worldwide with a 3D printing system could benefit. edin, NZ) equipped with an S300 pneumotachograph (dead To enable other regions to benefit from our experience, space, 80 ml) and a pressure transducer [18]. we describe the process of identifying, validating, regulating, Once the design was validated, a technical documenta- and supplying 3D-printed medical equipment. We analyze tion form was completed for each item, including informa- the products identified as potentially lacking, the products tion regarding its use, technical design, and manufacturing validated, manufacturers’ characteristics, requests for prod- specifications as well as schematic diagrams and pictures ucts, distribution, and regulatory requirements, [16, 17] as of the products. well as the impact of this system during the peak of the To ensure the items’ functionality, we asked manufac- SARS-CoV-2 pandemic in our region. turers to supply units for testing made with different Fillat-Gomà et al. BMC Health Services Research (2020) 20:1035 Page 3 of 8 Fig. 1 Prototype design approaches for producing 3D-printed medical devices 3D-printing technologies and different materials (only supply these products during the COVID-19 pandemic biocompatible materials fulfilling the ISO 10993 / USP health emergency, European in-house manufacturing class VI quality standards for at least skin and mucous regulations allow them to be manufactured as custom contact). medical devices with appropriate safety guarantees by Specific cleaning procedures were defined for each 3D printing for hospitals’ exclusive use, waiving the need material to prevent thermal deformation and alteration for CE marking [22] and assigning the responsibility for of chemical properties. the use of these products to the health centers. Hospital executives accepted the responsibility for using the Online catalogue products. Validated items were included with their STL files and technical documentation in an online catalogue on our Impact measurements institution’s open website [19]. Data regarding the number of individual visitors and the total number of visits to the catalogue were extracted Local manufacture and distribution from Google Analytics. In parallel with the publication of the catalogue, we de- The number of deaths due to COVID19 and number signed a system to supply the items to health centers in of infections in each Spanish region were extracted from our region. Orders were placed through a form on our the Spanish Ministry of Health’s website [23]. institutional website [20] and transmitted to COMB and Information regarding orders, manufacturers, and 3D- EIC, who coordinated the manufacture, storage, and dis- printed items was collected in a dedicated database. tribution (Fig. 2). Manufacturing companies from different sectors willing Statistical analysis to collaborate in the context of the COVID-19 crisis were We compiled descriptive statistics, reporting frequencies grouped and organized through a citizens’ initiative plat- and percentages. To evaluate the relationship between visits form [21]. Companies received no financial compensation to the online catalogue and incidence of COVID-19 in for these actions. Spain, we used Pearson correlation, considering P < 0·05 Items for which full details about manufacture were significant. unavailable were excluded from centralized distribution channels. All items were washed, disinfected, and dried Results before distribution. A total of 33 necessary items that were potentially lacking during the COVID-19 (March–April 2020) were identi- Regulatory requirements fied; 26 (78·8%) of these were validated and included in The 3D-printed items produced are consumables or dis- the online catalogue [23/26 (88·5%) components for inva- posable components necessary for the proper function sive or noninvasive ventilation and 3 (11·5%) PPE items of electromedical equipment, but not considered critical (“hands-free” doorknobs, protective visors, and ear protec- by manufacturers. Given the manufacturers’ inability to tors for masks)]. Other PPE items (e.g., facemasks) could Fillat-Gomà et al. BMC Health Services Research (2020) 20:1035 Page 4 of 8 Fig. 2 Scheme of the organization of the system established to supply hospitals in Catalonia with 3D-printed medical equipment not be validated, as we could not guarantee their safety. manufacture 1847 (8·3%) items; these associations pro- Table S1 presents the complete catalogue published duced only PPE items that did not require such a thorough online. validation process. Nearly half the companies (n = 25; Our hospital’s consumption of specific products allowed 42·4%) had more than 250 employees; 7 (11·9%) had from us to gauge demands at other centers. We received orders 51 to 249 employees, 13 (22%) had from 11 to 49 em- for 15,699 items from 25 health centers in the region [19 ployees, and 14 (23·7%) had 10 employees or fewer. Nearly (76%) hospitals, 2 (8%) primary care centers, and 4 (16%) half of all companies 27 (45%) had international import or nursing homes]. A total of 19,212 items were distributed export relations or international headquarters or branches. to the health centers that ordered them. The difference Table S2 provides information about the types of de- between the number of items ordered through the website vices and material used to manufacture them. and the number distributed (3513) is due to some hospi- To determine when interest in 3D-printed projects was tals reordering directly from COMB after receiving the greatest, we analyzed the dates of visits to the online cata- first order submitted through the website. logue according to the number of hospitalizations for A total of 60 companies and 10 manufacturers associa- COVID-19. Most visits took place during the expansion tions from a diverse range of sectors participated in produc- phase of the epidemic in Spain (Fig. 3). The number of tion (Table 1). Companies specialized in 3D technology visits increased again at the peak of the country’s epidemic provided the most units (n = 5234; 23·6%), followed by and gradually decreased thereafter as the number of new automotive companies (n = 2854; 12·9%). The 10 manufac- cases decreased. At the peak, 21% of all the items pro- turers associations used non-industrial 3D printers to duced had been delivered, although orders and deliveries Fillat-Gomà et al. BMC Health Services Research (2020) 20:1035 Page 5 of 8 Table 1 Companies involved in the manufacture of 3D medical continued through late April. Thus, before the peak, hos- devices, number of items and number of companies per pitals were already seeking alternative sources of medical industry type equipment, anticipating or even already suffering short- Company Type 3D printed units number of companies ages, and 3D printing provided a fast, reliable solution. N (%) N (%) From March 11 through April 30, 2020, our online 3D-printing Industry 5234 (23·6%) 13 (18·6%) catalogue of validated 3D-printed medical equipment re- Automotive Industry 2854 (12·9%) 3 (4·3%) ceived 58,904 views from 27,861 unique users from 113 Dental Industry 2641 (11·9%) 9 (12·9%) countries. Due to proximity and outreach effects, most Manufacturers associations 1847 (8·3%) 10 (14·3%) (76%) visitors were from Spain; however, the countries with the most visitors also included distant lands such as Universities 1579 (7·1%) 3 (4·3%) Argentina (4·68%), the USA (2·87%), Mexico (2·48%), Chemical Industry 1483 (6·7%) 2 (2·9%) and Colombia (1·37%) (Fig. 4a). Naval and railway Industry 1193 (5·4%) 1 (1·4%) We analyzed the distribution of visitors from different Plastic Industry 1053 (4·7%) 4 (5·7%) regions of Spain. Most visitors were from Catalonia, where Engineering Consulting 781 (3·5%) 6 (8·6%) our center and the distribution network are located, and Electric Industry 686 (3·1%) 4 (5·7%) Madrid, the two Autonomous Communities with the highest incidence of COVID-19. Pearson correlation coef- Metal Industry 473 (2·1%) 3 (4·3%) ficient (r) showed a strong positive linear association (r = Biomedical Industry 469 (2·1%) 1 (1·4%) 0·71; P < 0·001) between the total number of visits to the Jewelry 403 (1·8%) 1 (1·4%) online catalogue and the cumulative incidence of SARS- Social Organizations 353 (1·6%) 3 (4·3%) CoV-2 infection in the different regions of Spain (Fig. 4b). Medical Industry 284 (1·3%) 1 (1·4%) Food Industry 284 (1·3%) 2 (2·9%) Discussion The speed, availability of material, and maneuverability Packaging Industry 240 (1·1%) 2 (2·9%) of 3D printing made it useful in mitigating the shortage Medical Center 69 (0·3%) 1 (1·4%) of medical equipment during the emergency situation Unknown 267 (1·2%) 1 (1·4%) generated by the SARS-CoV-2 pandemic. TOTAL 22,193 (100%) 70 (100%) Numerous initiatives worldwide have proved the use- fulness of this technology, sharing designs for potentially lacking products online that can be manufactured by 3D printing (e.g., facemasks and connectors for snorkeling masks to be used with noninvasive ventilators). Yet, at Fig. 3 Timeline showing the numbers of COVID-19-related deaths, COVID-19 cases detected, web visits, and accumulated 3D-manufactured items Fillat-Gomà et al. BMC Health Services Research (2020) 20:1035 Page 6 of 8 Fig. 4 a Top 10 countries with the most visitors to the website www.tauli.cat/institut/. b Spain Autonomous Comunities maps showing the total number of visis to the online catalogue (left) and the number of COVID-19 detected cases (right). Autonomous Comunities are indicated by numbers: 1. Andalucia, 2. Aragon, 3. Asturias, 4. Balearic Islands, 5. Canary Islands, 6. Cantabria, 7. Castile and León, 8. Castile-La Mancha, 9. Catalonia, 10. Galicia, 11. Valencia, 12. Extremadura, 13. Madrid, 14. Murcia, 15. Navarre, 16. Basque Country, 17. La Rioja. The maps depicted in Fig. 4 were created by the authors of this manuscript least in the first stages of the pandemic, it was diffi- One of our major challenges for developing and main- cult to find a reliable repository of 3D-printer- taining the presented system was to identify items in po- manufactured products whose clinical utility was vali- tential short supply. Also, the organization of the whole dated according to current regulatory legislation. For system had to be designed very accurately to be effective. this reason, covered by in-house manufacturing regu- Finding companies with 3D printing facilities to manu- lations, we focused our efforts on validating similar facture the items was not an issue, nor even the pro- but reliable medical devices and distributing them to duction costs, since many industries volunteered, and it hospitals on request [24]. was a non-profit making scheme. In order for this One important factor in our success was our pre- system to be successful in other countries, the existing 3D laboratory, created by physicians at our refer- organization has to be adapted accordingly, coordinat- ral hospital to enable point-of-care 3D printing for per- ing local authorities and industries, profession associa- sonalized medicine. Another key factor for our success tions, social media, etc. was the decision to supply other hospitals in the area Despite emerging as a valid solution in this emergency through a network of collaborators that included official situation, 3D printing is not the preferred method for organisms (COMB and EIC) as well as a wide range of manufacturing PPE under normal conditions (excluding committed companies with the facilities required to the prototyping stages). Traditional manufacturing may manufacture the items in our catalogue in record time take months, not only to create, but also to transfer the without seeking financial gain. Our experience shows that final products to the end-users. 3D printing can overcome any kind of industry with 3D printers, regardless of their these limitations; you can produce items on-site. However, usual sphere of activity, can help in emergencies, provided the number of items manufactured by 3D printing is not as the system has a good organizational strategy with well- large as and in traditional manufacturing, since they can defined steps for designing, manufacturing, and distribut- only be printed in small amounts at the same time. Overall, ing items made under regulation. 3D printing is still a considerably expensive investment Fillat-Gomà et al. BMC Health Services Research (2020) 20:1035 Page 7 of 8 compared to traditional manufacturing machines for large Supplementary Information production volumes [24]. The online version contains supplementary material available at https://doi. org/10.1186/s12913-020-05891-2. On the other hand, and on a positive note, 3D printing allowed us to customize some of the items, for ex- Additional file 1: Table S1. Catalogue of validated 3D-printed medical ample 3DPT012 (see the Additional file 1). Given that devices. Table S2. Number, type, and material of items manufactured by COVID-19 patients needed more oxygen flow than a 3D printing. conventional patient, this connector for continuous posi- tive airway pressure (CPAP) was adapted by increasing Abbreviations 3D: Three-dimensional; AEMPS : Spanish Agency of Medicines and Medical the diameter of the side tube. This allowed patient re- Devices; CE marking: European Conformity marking; COMB: College of covery to improve quicker. Physicians and Surgeons of Barcelona; CPAP: Continuous positive airway Among the limitations of our approach was the in- pressure; EIC: College of Industrial Engineers of Catalonia; PPE: Personal protective equipment; SARS-CoV-2: Severe acute respiratory syndrome ability of additive manufacturing to fulfill all the re- coronavirus 2; STL files: File format native to the stereolithography CAD quirements for the production of validated devices. software For instance, limited availability of flexible biocom- Acknowledgements patible material reduced the scalability of production, We thank all the companies and manufacturers associations for their making it impossible to meet the demand for some participation throughout the process without seeking financial gains. We products (e.g., 3DPT006; see the Additional file 1). especially thank Gloria Palomar, Sandra Alvaro and Roger Sales from Institut d’Investigació I Innovació Parc Taulí (I3PT), I3PT. Mastertec Group and Additionally, despite their viability in laboratory sim- AsorCAD for their close collaboration in the design and organization of the ulations, certain consumables (3DPT021, 3DPT022, system, Ricard León, Xavier Botines and Jaume Padrós from Col·legi de 3DPT023, 3DPT033; see the Additional file 1) had Metges de Barcelona (COMB), and Pere Homs from Col·legi d’Enginyers Industrials (EIC) for their help in managing the system. Thanks to Arnau Valls, yet to be certified for clinical use by the Spanish from Hospital Sant Joan de Déu for his collaboration. Thanks to Ramon regulatory agency (Spanish Agency of Medicines and Maspons, from Agency for Health Quality and Assessment of Catalonia Medical Devices (AEMPS)) when the pandemic (AQuAS). In addition, we thank the physicians and managers of the Hospital Parc Taulí for helping in the validation process. peaked. Moreover, the outsourcing of the manufacture of med- Authors’ contributions ical supplies from outside our country hampered our FFG, SCN and LMC contributed on the study conception, design and ability to react to the pandemic by stepping up certified drafting. FFG, SCN, LMC, TNM, NMR, CL, ML, CH, LB contributed on the collection, analysis and interpretation of data. CL, ML, CH, LB performed a production. Local companies that had adopted 3D print- critical review of the manuscript. All authors have read and approved the ing for other purposes were able to convert their pro- manuscript. duction to compensate in part for the lack of dedicated Funding medical supplies industry. This project did not receive specific funding. Our analysis focuses only on the hospitals that or- dered medical items through our channel, although Availability of data and materials The datasets used and/or analyzed during the current study are available other hospitals outside the distribution area or com- from the corresponding author on reasonable request. panies with the means to manufacture items could also benefit from the designs without using the estab- Ethics approval and consent to participate Not applicable. lished channel. The high number of views from 113 countries suggests that this might have happened in Consent for publication hospitals all over the world. Undoubtedly, 3D printing Not applicable. has now become a quite affordable, user-friendly, and Competing interests widely available technology that could be worth Dr. Fillat-Gomà reports personal fees from MASTERTEC SA, personal fees from investing in in places all over the world, irrespective AMES GROUP SINTERING SA, outside the submitted work. Mr. Coderch- of the country’s economic status. Navarro and Ms. Monill-Raya have a patent EP 2019/51534 issued. Mr. Nadal reports personal fees from MASTERTEC SA, outside the submitted work. Dr. Blanch has a patent EP19383116 issued, and a patent 12/538,940 licensed and owns stock options of BetterCare S.L., a research and development spin- Conclusions off of Corporació Sanitària Parc Taulí. The rest of co-authors have no poten- tial conflicts of interest to disclose. This work provides evidence that technological advances, such as 3D printing, have many useful applications, also Author details 1 during emergency situations. It has empowered communi- 3D Surgical Planning Lab. Parc Taulí Hospital Universitari. Institut d’Investigació i Innovació Parc Taulí (I3PT), Universitat Autònoma de ties to fight against the pandemic of SARS-CoV-2 and has Barcelona, Par Taulí 1. Santa Fe Building 2nd floor, 08208 Sabadell, Spain. benefited hospitals immensely by manufacturing medical 2 Department of Orthopaedic Surgery and Traumatology. Parc Taulí Hospital equipment, thus mitigating shortages. Numerous regions Universitari. Institut d’Investigació i Innovació Parc Taulí (I3PT), Universitat Autònoma de Barcelona, Sabadell, Spain. 3Computational and Clinical worldwide can benefit from this approach, also to prevent Nephrology. Parc Taulí Hospital Universitari. Institut d’Investigació i Innovació or overcome shortages of medical equipment. Parc Taulí (I3PT), Universitat Autònoma de Barcelona, Sabadell, Spain. 4Grupo Fillat-Gomà et al. BMC Health Services Research (2020) 20:1035 Page 8 of 8 Mastertec, Barcelona, Spain. 5Parc Taulí Hospital Universitari. Institut 17. Online catalogue item ID 3DPT021. Institut d’investigació i innovació Parc d’Investigació i Innovació Parc Taulí (I3PT), Universitat Autònoma de Taulí. 2020. 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