Case study into the successful emergency production and certification of a filtering facepiece respirator for Belgian hospitals during the COVID-19 pandemic
“…In usual situations, the manufacture of such devices is subjected to the recent EU regulation 2017/745 ( https://eur-lex.europa.eu/eli/reg/2017/745/oj ), which limits emergency production due to demanding quality control and risk management protocols. To the best of our knowledge, these regulatory concerns were frequently mentioned but rarely addressed formally by the numerous teams who have produced 3D-printed ventilation fittings and other respiratory-related devices during the first wave of the pandemic [ 27 – 30 ], and few initiatives have been successfully certified by local regulatory authorities [ 31 , 32 ]. If further sanitary crises occur, in potential cases of temporary adaptations of this regulation to overcome shortages, our results strongly suggest that strict quality control assessments should be maintained, managed by teams experienced in medical 3D-printing, to eventually obtain formal certification.…”
Objective
The coronavirus disease pandemic (COVID-19) increased the risk of shortage in intensive care devices, including fittings with intentional leaks. 3D-printing has been used worldwide to produce missing devices. Here we provide key elements towards better quality control of 3D-printed ventilation fittings in a context of sanitary crisis.
Material and methods
Five 3D-printed designs were assessed for non-intentional (junctional and parietal) and intentional leaks: 4 fittings 3D-printed in-house using FDeposition Modelling (FDM), 1 FDM 3D-printed fitting provided by an independent maker, and 2 fittings 3D-printed in-house using Polyjet technology. Five industrial models were included as controls. Two values of wall thickness and the use of coating were tested for in-house FDM-printed devices.
Results
Industrial and Polyjet-printed fittings had no parietal and junctional leaks, and satisfactory intentional leaks. In-house FDM-printed fittings had constant parietal leaks without coating, but this post-treatment method was efficient in controlling parietal sealing, even in devices with thinner walls (0.7 mm vs 2.3 mm). Nevertheless, the use of coating systematically induced absent or insufficient intentional leaks. Junctional leaks were constant with FDM-printed fittings but could be controlled using rubber junctions rather than usual rigid junctions. The properties of Polyjet-printed and FDM-printed fittings were stable over a period of 18 months.
Conclusions
3D-printing is a valid technology to produce ventilation devices but requires care in the choice of printing methods, raw materials, and post-treatment procedures. Even in a context of sanitary crisis, devices produced outside hospitals should be used only after professional quality control, with precise data available on printing protocols. The mechanical properties of ventilation devices are crucial for efficient ventilation, avoiding rebreathing of CO2, and preventing the dispersion of viral particles that can contaminate health professionals. Specific norms are still required to formalise quality control procedures for ventilation fittings, with the rise of 3D-printing initiatives and the perspective of new pandemics.
“…In usual situations, the manufacture of such devices is subjected to the recent EU regulation 2017/745 ( https://eur-lex.europa.eu/eli/reg/2017/745/oj ), which limits emergency production due to demanding quality control and risk management protocols. To the best of our knowledge, these regulatory concerns were frequently mentioned but rarely addressed formally by the numerous teams who have produced 3D-printed ventilation fittings and other respiratory-related devices during the first wave of the pandemic [ 27 – 30 ], and few initiatives have been successfully certified by local regulatory authorities [ 31 , 32 ]. If further sanitary crises occur, in potential cases of temporary adaptations of this regulation to overcome shortages, our results strongly suggest that strict quality control assessments should be maintained, managed by teams experienced in medical 3D-printing, to eventually obtain formal certification.…”
Objective
The coronavirus disease pandemic (COVID-19) increased the risk of shortage in intensive care devices, including fittings with intentional leaks. 3D-printing has been used worldwide to produce missing devices. Here we provide key elements towards better quality control of 3D-printed ventilation fittings in a context of sanitary crisis.
Material and methods
Five 3D-printed designs were assessed for non-intentional (junctional and parietal) and intentional leaks: 4 fittings 3D-printed in-house using FDeposition Modelling (FDM), 1 FDM 3D-printed fitting provided by an independent maker, and 2 fittings 3D-printed in-house using Polyjet technology. Five industrial models were included as controls. Two values of wall thickness and the use of coating were tested for in-house FDM-printed devices.
Results
Industrial and Polyjet-printed fittings had no parietal and junctional leaks, and satisfactory intentional leaks. In-house FDM-printed fittings had constant parietal leaks without coating, but this post-treatment method was efficient in controlling parietal sealing, even in devices with thinner walls (0.7 mm vs 2.3 mm). Nevertheless, the use of coating systematically induced absent or insufficient intentional leaks. Junctional leaks were constant with FDM-printed fittings but could be controlled using rubber junctions rather than usual rigid junctions. The properties of Polyjet-printed and FDM-printed fittings were stable over a period of 18 months.
Conclusions
3D-printing is a valid technology to produce ventilation devices but requires care in the choice of printing methods, raw materials, and post-treatment procedures. Even in a context of sanitary crisis, devices produced outside hospitals should be used only after professional quality control, with precise data available on printing protocols. The mechanical properties of ventilation devices are crucial for efficient ventilation, avoiding rebreathing of CO2, and preventing the dispersion of viral particles that can contaminate health professionals. Specific norms are still required to formalise quality control procedures for ventilation fittings, with the rise of 3D-printing initiatives and the perspective of new pandemics.
“…To maintain the efficacy of the different layers of the mask and also according to the emphasis of different standards [ 14 , 37 ], it is necessary to connect them ultrasonically. Connecting the layers to each other, or connecting the straps to the body of the mask, in the form of normal stitching causes damage to the body of the mask, which definitely reduces its efficacy [ 38 ]. The stitching is also a part of the assessment tools.…”
“… Fig. 13 3D printed medical devices for applications during pandemic (a) stopgap face mask, (b) swab [ 16 ], (c) 3D printed respirator mask [ 15 ], (d) quarantine booths [ 16 ], (e) face shield, (f) T-connectors, Y-connectors for ventilators, (g) ventilator valve [ 20 ], (h) air-purification respiratory hood, (i) 3D printed pills, (j) artificial lung used for lung disease treatment, (k) 3D-printed capsules [ 14 ], (l) venturi valve, (m) door handles, (n) Creality goggle design [ 30 ]. …”
Section: Dp-based Manufacturing and Covid-19mentioning
confidence: 99%
“…Moreover, the critical research gaps needing further research to utilize the full potential of 3DP in emergencies were discussed. Andres et al [ 15 ] analyzed a three-panel foldable facepiece respirator. After experimental testing of the performance and assembly process, the facepiece respirator design was certified against the EN149 standard for a Belgian hospital during the COVID-19 pandemic.…”
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