Networking during this period has enabled the delivery of a total of 17.276 units of products manufactured using 3D printing technology. (Fig. 1)
End products delivered can be divided into three main groups:
- Protection and prevention systems (Fig. 2). This group includes the manufacture of face shields, 3D printed photophore accessories, ear savers, hands-free door openers, or prototypes of masks.
- Products for Ventilatory Support Therapies (Fig. 3). The peak of hospital admissions due to the pandemic has caused a great demand for ventilation machines, with the consequent transitory lack, so we decided to modify non-sanitary material and sanitary material approved for other uses. This has allowed us to perform non-invasive treatment in those patients who needed respiratory support but not without sufficient stock of approved devices. In our center we have used the Easybreath® (Decathlon, France) diving mask system modified as a CPAP system (EASY-CPAP), having been necessary the acquisition of masks [10-13], the production of connector parts or supports, and the optimization of the design of other parts adding modifications to adapt it to the existing material in our center. Among the products manufactured, we have included connection parts for the masks and other parts for the ventilation systems such as straight connectors, connectors with side port for oxygen therapy or adapters for positive protection systems.
- Diagnostic products and consumables (Fig. 4). This group includes the manufacture of swabs of different designs to perform the nasopharyngeal smears necessary for the diagnosis of SARS-CoV-2 infection by PCR test. The geometry of the head, the length of the handle and the position of the stigma are configurable elements that have been adapted to the different formats of the container tubes available in our Centre. Considered as a class IIa medical device and manufactured by means of stereolithography technology (SLA) with biocompatible light-curing resin, it is presented in sterile packaging in bags of 10 units and in unitary peel-packs adjusted to local needs.
In addition, donations of other products such as masks or 3D printing material for FDM technology have been received.
The products were mainly manufactured by individuals (57.3%), universities (7.6%) or associations (2.8%).Manufacturing companies have made 28% of the products, and the rest (4.3%) have been achieved through in-house manufacturing, in this last case being mostly prototypes and product validations.
The products have been donations in 78.2% of the cases. However, if a greater quantity and optimisation of the production times of a product has been required due to care needs, the acquisition has been made through public purchase. This is the case of face shields or some of the products for ventilatory support, with the purchase of 49% of the 3d printed face shields, 63% of the Charlotte adapters, 48% of the side port connectors and 8% of the Dave adapters.
The delivery date of the products started on March 25th and has been extended until the last day of the study period. Since the beginning of the period, production has been adapted to the demand made by the services in charge of both the availability, coordination and logistics of the personal protective equipment and the care needs of the clinical services involved in the ventilatory support therapies. Thus, during the first week 83.7% of the face shields had already been delivered. However, the demand for other products has been later, such as the connectors for ventilatory support delivered from 31st March, or the ear savers whose first delivery was made on 14th April.
The destination of the products delivered was the Centre itself in 90.9% of the cases, although the production capacity, together with the demand caused by the global shortage, made it possible to deliver products to other Centres (Table 1).
DISCUSSION AND EVALUATION:
The integration of 3D printing technology in the healthcare process allows for the monitoring of the end-to-end process, from the design and validation for clinical use of different products to the optimized production of these products adapted to the healthcare need, which is of great importance in health systems during periods of sanitary crisis such as the COVID-19 pandemic, when the shortage of healthcare resources at a global level makes universal availability and coverage impossible.
The manufacturing university hospital is not born as a competition of the factories or the traditional medical industry, but it generates value in personalized medicine by gathering the professional team and the necessary resources to be able to treat by means of a personalized medical product with the maximum guarantees of quality and commitment to the patients, generating knowledge based on each individual experience, and thus allowing a qualitative leap in exponential patient-centered medicine.
Hospital General Universitario Gregorio Marañón is a pioneer in the transversal implementation of 3D printing at a hospital level, incorporating an advanced planning and POC manufacturing unit integrated as an in-house 3D printing laboratory in the care flow of more than 20 medical-surgical specialties. As a manufacturer, the hospital is licensed for the manufacture of medical devices and certified by the international standard ISO 13485 for Quality Management Systems for medical devices. This role as a manufacturing hospital has enabled networking and coordination in production with other hospitals and with associations, institutions or individuals with the possibility of printing products previously validated from the Centre according to care needs. In a manufacturing university hospital, 3D printing goes hand in hand with teaching and translational research, acting as an accelerator of clinical innovation and enabling advanced rapid prototyping, reducing verification and validation times. This has been the case with surgical masks or some of the parts manufactured for ventilatory support systems [14].
The appearance of different socio-cultural movements such as Coronavirusmakers [15] and collaborative networks such as the one created by the Parc Taulí Foundation [8], making available different products with the technical design specifications, material requirements and printing parameters, have made it possible to optimise the production of some of these products such as the Charlotte and Dave adapters, and other connectors and valves. Sharing this new paradigm, at the UPAM3D of our hospital we have designed and validated the clinical utility of some products such as face shields, connections that facilitate double oxygen inlet, or adaptation pieces for positive pressure ventilation systems, publishing the designs available to the community (Table 2).
Table 2: name of products (rows) and file URL (columns)
The disinterested offer of the different actors to participate in this type of production has made it possible both to cover the intrahospital demand and to collaborate with other centres, even at times when the need for specific products has required an increase in production.
In our study, it is interesting to note that the first products are delivered 11 days after the start of the alarm period. This is justifiable because in the first days of the study period, and in the face of a minor casuistry, the demand for products was also lower. In those first days, the activity as a manufacturing university hospital consisted of designing and validating prototypes as well as identifying collaborators for the constitution of a distributed production network (Fig. 5), so that incidents in terms of need and/or supply could be minimized with the most agile response possible . Thus, after 7 days, the first face shields units were manufactured and delivered under the coordination of the Services responsible for occupational risk prevention. An internal validation of the design was carried out, and after assessing the benefit-risk in the areas with more limited resources, the distribution was staggered. Something similar has occurred in the manufacture of parts for ventilatory support: when the lack and difficulty of supply from the different Clinical Services is identified, it is reported to the UPAM3D from where action is coordinated not only to respond to the high demand, but also for rapid prototyping or design improvements.
The production offer of a large number of participating actors has facilitated the maintenance of the rhythm of production and collaborative work with other Centres, also allowing a staggered delivery and adjusted in real time to the demand.
Although there are multiple benefits related to POC manufacturing, and even being very significant the contribution in terms of internal knowledge generation, customization, local quality control and cost reduction; we undoubtedly want to highlight the response times as the main advantage over traditional manufacturing and distribution. During this first wave of the pandemic, the pace of manufacturing and the minimum delay with the commissioning, the scalability of production and the capacity of adaptation to the exponential increase experienced, have been key factors in placing this health product manufacturing paradigm in a preferential position within the health system.