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Dieuwertje Drexhage
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1
Validating Reusability: Assessing the Cleanability of the Vela Vacuum Extractor
A Study to Enhance Sustainability and Accessibility of the Vacuum Extractor Before Final Material Production
INTRODUCTION: The importance of reusable medical devices is increasingly evident due to their sustainability and accessibility advantages in high- and low- & middle-income countries. In response, LAYCO Medical Devices is developing a reusable vacuum extractor, vela®, as an alternative to the commonly used disposable vacuum extractor. This study aims to validate vela®’s reusability, focusing on reprocessing and explicitly on cleaning. The design of vela® is nearing completion; however, the device has not been manufactured in the final material. Ultimately, the plan is to produce vela® through injection molding of polyphenylsulfone. However, given the current stage of vela®, both in terms of time and cost, it is not advantageous to apply this production method now. Therefore, the research is divided into two parts: material validation and design validation. The material validation involves examining the suitability of polyphenylsulfone, the proposed final material, and identifying a suitable prototype material for testing the cleanability of the vela® design. For the design validation, the vela® design is examined to determine its effectiveness in cleaning within both high- and low- & middle-income countries, as different reprocessing methods are used in these settings.
METHODS: Clinical simulation tests were performed in the material and design validations to assess contamination at predefined hard-to-clean locations after cleaning. The locations were first soiled with Browne washer-disinfector soil, then cleaned and tested with the adenosine triphosphate and protein tests, each with predetermined thresholds. For material validation, an object made of polyphenylsulfone was selected. Through 3D printing, the polyphenylsulfone object was replicated in five potential prototyping materials to facilitate a comprehensive comparison. These six test objects were subjected to clinical simulation tests. Then, the test objects underwent in-depth material analysis to understand the material better and make a more reasoned selection for the prototype material. For the design validation, the design of vela® is printed in the material obtained through the material validation. These vela®’s undergo clinical simulation tests in both high- and low- & middle-income country settings. Given the manual nature of the low- & middle-income country cleaning procedure, additional layman’s tests are conducted to minimize user bias.
RESULTS: For the clinical simulation tests of the material validation, the results obtained from the polyphenylsulfone test object remained below the predetermined threshold. For the prototype material, only the test objects made of polycarbonate and tough 2000 resin withstood the cleaning procedure, and the tests stayed below the predetermined threshold value. Subsequently, the material analysis revealed that polyphenylsulfone and tough 2000 resin have the
least surface irregularities and absorb the least water. Therefore, the vela® prototype was printed in tough 2000 resin. For the clinical simulation tests of the design validation, contamination was observed at specific locations of vela® in
both test settings. In the high-income country setting, test results above the threshold value are observed in the space between the diaphragm. The results are more varied in the low- & middle-income country setting; hence, layman’s
tests were added to minimize user bias and obtain a more concrete result. Ultimately, test results above the threshold value are observed in the space between the diaphragm and the connection between the tube and handle.
CONCLUSION: For the material validation, polyphenylsulfone is identified as a suitable material for the final vela®. Tough 2000 resin is deemed appropriate as a prototype material to validate cleaning. For the design validation, it is concluded that design improvements are needed for two specific locations on the vela® to improve cleaning. The connection requires a redesign to facilitate easy disassembly. The diaphragm with stem is composed of silicone and hard plastic, and it is advisable to employ two-component injection molding to produce this part. When incorporating these suggestions into the design, it can be concluded that vela® can be safely reused in both high- and low-&middle-income countries, contributing to the sustainability and accessibility of medical devices. ...
METHODS: Clinical simulation tests were performed in the material and design validations to assess contamination at predefined hard-to-clean locations after cleaning. The locations were first soiled with Browne washer-disinfector soil, then cleaned and tested with the adenosine triphosphate and protein tests, each with predetermined thresholds. For material validation, an object made of polyphenylsulfone was selected. Through 3D printing, the polyphenylsulfone object was replicated in five potential prototyping materials to facilitate a comprehensive comparison. These six test objects were subjected to clinical simulation tests. Then, the test objects underwent in-depth material analysis to understand the material better and make a more reasoned selection for the prototype material. For the design validation, the design of vela® is printed in the material obtained through the material validation. These vela®’s undergo clinical simulation tests in both high- and low- & middle-income country settings. Given the manual nature of the low- & middle-income country cleaning procedure, additional layman’s tests are conducted to minimize user bias.
RESULTS: For the clinical simulation tests of the material validation, the results obtained from the polyphenylsulfone test object remained below the predetermined threshold. For the prototype material, only the test objects made of polycarbonate and tough 2000 resin withstood the cleaning procedure, and the tests stayed below the predetermined threshold value. Subsequently, the material analysis revealed that polyphenylsulfone and tough 2000 resin have the
least surface irregularities and absorb the least water. Therefore, the vela® prototype was printed in tough 2000 resin. For the clinical simulation tests of the design validation, contamination was observed at specific locations of vela® in
both test settings. In the high-income country setting, test results above the threshold value are observed in the space between the diaphragm. The results are more varied in the low- & middle-income country setting; hence, layman’s
tests were added to minimize user bias and obtain a more concrete result. Ultimately, test results above the threshold value are observed in the space between the diaphragm and the connection between the tube and handle.
CONCLUSION: For the material validation, polyphenylsulfone is identified as a suitable material for the final vela®. Tough 2000 resin is deemed appropriate as a prototype material to validate cleaning. For the design validation, it is concluded that design improvements are needed for two specific locations on the vela® to improve cleaning. The connection requires a redesign to facilitate easy disassembly. The diaphragm with stem is composed of silicone and hard plastic, and it is advisable to employ two-component injection molding to produce this part. When incorporating these suggestions into the design, it can be concluded that vela® can be safely reused in both high- and low-&middle-income countries, contributing to the sustainability and accessibility of medical devices. ...
INTRODUCTION: The importance of reusable medical devices is increasingly evident due to their sustainability and accessibility advantages in high- and low- & middle-income countries. In response, LAYCO Medical Devices is developing a reusable vacuum extractor, vela®, as an alternative to the commonly used disposable vacuum extractor. This study aims to validate vela®’s reusability, focusing on reprocessing and explicitly on cleaning. The design of vela® is nearing completion; however, the device has not been manufactured in the final material. Ultimately, the plan is to produce vela® through injection molding of polyphenylsulfone. However, given the current stage of vela®, both in terms of time and cost, it is not advantageous to apply this production method now. Therefore, the research is divided into two parts: material validation and design validation. The material validation involves examining the suitability of polyphenylsulfone, the proposed final material, and identifying a suitable prototype material for testing the cleanability of the vela® design. For the design validation, the vela® design is examined to determine its effectiveness in cleaning within both high- and low- & middle-income countries, as different reprocessing methods are used in these settings.
METHODS: Clinical simulation tests were performed in the material and design validations to assess contamination at predefined hard-to-clean locations after cleaning. The locations were first soiled with Browne washer-disinfector soil, then cleaned and tested with the adenosine triphosphate and protein tests, each with predetermined thresholds. For material validation, an object made of polyphenylsulfone was selected. Through 3D printing, the polyphenylsulfone object was replicated in five potential prototyping materials to facilitate a comprehensive comparison. These six test objects were subjected to clinical simulation tests. Then, the test objects underwent in-depth material analysis to understand the material better and make a more reasoned selection for the prototype material. For the design validation, the design of vela® is printed in the material obtained through the material validation. These vela®’s undergo clinical simulation tests in both high- and low- & middle-income country settings. Given the manual nature of the low- & middle-income country cleaning procedure, additional layman’s tests are conducted to minimize user bias.
RESULTS: For the clinical simulation tests of the material validation, the results obtained from the polyphenylsulfone test object remained below the predetermined threshold. For the prototype material, only the test objects made of polycarbonate and tough 2000 resin withstood the cleaning procedure, and the tests stayed below the predetermined threshold value. Subsequently, the material analysis revealed that polyphenylsulfone and tough 2000 resin have the
least surface irregularities and absorb the least water. Therefore, the vela® prototype was printed in tough 2000 resin. For the clinical simulation tests of the design validation, contamination was observed at specific locations of vela® in
both test settings. In the high-income country setting, test results above the threshold value are observed in the space between the diaphragm. The results are more varied in the low- & middle-income country setting; hence, layman’s
tests were added to minimize user bias and obtain a more concrete result. Ultimately, test results above the threshold value are observed in the space between the diaphragm and the connection between the tube and handle.
CONCLUSION: For the material validation, polyphenylsulfone is identified as a suitable material for the final vela®. Tough 2000 resin is deemed appropriate as a prototype material to validate cleaning. For the design validation, it is concluded that design improvements are needed for two specific locations on the vela® to improve cleaning. The connection requires a redesign to facilitate easy disassembly. The diaphragm with stem is composed of silicone and hard plastic, and it is advisable to employ two-component injection molding to produce this part. When incorporating these suggestions into the design, it can be concluded that vela® can be safely reused in both high- and low-&middle-income countries, contributing to the sustainability and accessibility of medical devices.
METHODS: Clinical simulation tests were performed in the material and design validations to assess contamination at predefined hard-to-clean locations after cleaning. The locations were first soiled with Browne washer-disinfector soil, then cleaned and tested with the adenosine triphosphate and protein tests, each with predetermined thresholds. For material validation, an object made of polyphenylsulfone was selected. Through 3D printing, the polyphenylsulfone object was replicated in five potential prototyping materials to facilitate a comprehensive comparison. These six test objects were subjected to clinical simulation tests. Then, the test objects underwent in-depth material analysis to understand the material better and make a more reasoned selection for the prototype material. For the design validation, the design of vela® is printed in the material obtained through the material validation. These vela®’s undergo clinical simulation tests in both high- and low- & middle-income country settings. Given the manual nature of the low- & middle-income country cleaning procedure, additional layman’s tests are conducted to minimize user bias.
RESULTS: For the clinical simulation tests of the material validation, the results obtained from the polyphenylsulfone test object remained below the predetermined threshold. For the prototype material, only the test objects made of polycarbonate and tough 2000 resin withstood the cleaning procedure, and the tests stayed below the predetermined threshold value. Subsequently, the material analysis revealed that polyphenylsulfone and tough 2000 resin have the
least surface irregularities and absorb the least water. Therefore, the vela® prototype was printed in tough 2000 resin. For the clinical simulation tests of the design validation, contamination was observed at specific locations of vela® in
both test settings. In the high-income country setting, test results above the threshold value are observed in the space between the diaphragm. The results are more varied in the low- & middle-income country setting; hence, layman’s
tests were added to minimize user bias and obtain a more concrete result. Ultimately, test results above the threshold value are observed in the space between the diaphragm and the connection between the tube and handle.
CONCLUSION: For the material validation, polyphenylsulfone is identified as a suitable material for the final vela®. Tough 2000 resin is deemed appropriate as a prototype material to validate cleaning. For the design validation, it is concluded that design improvements are needed for two specific locations on the vela® to improve cleaning. The connection requires a redesign to facilitate easy disassembly. The diaphragm with stem is composed of silicone and hard plastic, and it is advisable to employ two-component injection molding to produce this part. When incorporating these suggestions into the design, it can be concluded that vela® can be safely reused in both high- and low-&middle-income countries, contributing to the sustainability and accessibility of medical devices.
Validation of a Novel Reusable Vacuum Extractor
A Comparative Mannequin Study between the Vela Vacuum Extractor and the Kiwi Omnicup
Abstract—Background: Vacuum extraction is a way to prevent unnecessary maternal deaths, by using a vacuum extractor to help deliver the baby in the second stage of labour. Vacuum extraction is still little-used in low- and middle-income countries (LMIC) compared to high-income countries, due to the lack of sufficient devices on the market that fit the local context. For this purpose, a novel reusable and affordable vacuum extractor was designed. This study compares this device, the VelaTM, with a commonly used vacuum extractor, the Kiwi Omnicup®, in terms of performance and user experience in a non-inferiority mannequin study. Methods: Obstetricians and residents from LUMC and CWZ hospitals performed a vacuum extraction on a birthing mannequin using both devices. During simulated “traction windows” of 25 seconds, the participant was allowed to pull. The primary endpoint was the traction window in which successful vacuum extraction occurred. Secondary endpoints were the total number of pop-offs of the cup, the exact success time within the successful traction window, the pumping time before the successful traction window, the satisfaction rate and the comparison between the two devices on placement, pumping and pulling. Finally, the participants were asked for their opinions about the Vela in an open-ended question. Results: A total of 47 participants were included in this study, of which three never achieved success with the Vela. For the primary endpoint, the Vela was non-inferior to the Kiwi in both LUMC and CWZ. Furthermore, no significant differences were found between the Vela and the Kiwi regarding any of the secondary endpoints, with the exception of the satisfaction rate in the LUMC. This was significantly lower for the Vela. Themes raised by participants concerned the stiffness of the Vela tube, the comfort of the Vela during usage and the need for familiarization with a new device. Conclusions: The results of this study indicate that the Vela is non-inferior to the Kiwi Omnicup when used by clinicians who had success with both devices, however there is room for improvement regarding satisfaction of the Vela. More familiarization is needed and the tube of the Vela should be reduced in stiffness. With this initial validation, the Vela can be seen as a promising alternative for LMIC, and can be further optimized into a high-quality fully reusable vacuum extractor.
...
Abstract—Background: Vacuum extraction is a way to prevent unnecessary maternal deaths, by using a vacuum extractor to help deliver the baby in the second stage of labour. Vacuum extraction is still little-used in low- and middle-income countries (LMIC) compared to high-income countries, due to the lack of sufficient devices on the market that fit the local context. For this purpose, a novel reusable and affordable vacuum extractor was designed. This study compares this device, the VelaTM, with a commonly used vacuum extractor, the Kiwi Omnicup®, in terms of performance and user experience in a non-inferiority mannequin study. Methods: Obstetricians and residents from LUMC and CWZ hospitals performed a vacuum extraction on a birthing mannequin using both devices. During simulated “traction windows” of 25 seconds, the participant was allowed to pull. The primary endpoint was the traction window in which successful vacuum extraction occurred. Secondary endpoints were the total number of pop-offs of the cup, the exact success time within the successful traction window, the pumping time before the successful traction window, the satisfaction rate and the comparison between the two devices on placement, pumping and pulling. Finally, the participants were asked for their opinions about the Vela in an open-ended question. Results: A total of 47 participants were included in this study, of which three never achieved success with the Vela. For the primary endpoint, the Vela was non-inferior to the Kiwi in both LUMC and CWZ. Furthermore, no significant differences were found between the Vela and the Kiwi regarding any of the secondary endpoints, with the exception of the satisfaction rate in the LUMC. This was significantly lower for the Vela. Themes raised by participants concerned the stiffness of the Vela tube, the comfort of the Vela during usage and the need for familiarization with a new device. Conclusions: The results of this study indicate that the Vela is non-inferior to the Kiwi Omnicup when used by clinicians who had success with both devices, however there is room for improvement regarding satisfaction of the Vela. More familiarization is needed and the tube of the Vela should be reduced in stiffness. With this initial validation, the Vela can be seen as a promising alternative for LMIC, and can be further optimized into a high-quality fully reusable vacuum extractor.
Evaluation of a Low-Cost Videolaryngoscope
By Conducting a Manikin Study
Master thesis
(2022)
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R.W. Wiltink, J. Dankelman, Chris Martini, J.C. Diehl, J. Klein, Dieuwertje Drexhage
Background: Existing videolaryngoscopes do not meet the needs, budgets, and cleaning protocols of low- and middle-income countries. To solve these problems, a new videolaryngoscope, the Goodscope, has been developed which is less expensive, reusable and easy to clean. The aim of this study was to evaluate the efficacy of the Goodscope compared with a commonly used videolaryngoscope, the GlideScope, when used by experienced anaesthetists and residents in anaesthesia in both a normal and difficult airway scenario. Methods: Participants randomly intubated the manikin four times using both the Goodscope and the GlideScope twice in a normal and a difficult airway scenario. The primary endpoint was time to successful intubation. Secondary endpoints were time to glottic view, time to ventilation, number of intubation attempts, successful intubation rate, and ease of intubation. Results: A total of 73 participants were included in this study. The primary endpoint, time to successful intubation, showed no statistically significant difference between the Goodscope and GlideScope in both the normal (median Goodscope 10.3 s, inter-quartile range (IQR) 8.5, 12.2 vs GlideScope 10.1 s, IQR 8.4, 13.6, P = 0.614), and difficult scenario (median Goodscope 18.5 s, IQR 14.3, 25.3 vs GlideScope 18.4 s, IQR 13.7, 24.2, P = 0.238). Similarly, no significant differences between the two videolaryngoscopes were identified for all secondary endpoints in both scenarios. Conclusion: The findings of this study suggest that the Goodscope is non-inferior to the GlideScope since no significant differences between the Goodscope and the GlideScope were identified for all primary and secondary endpoints. Therefore, this study contributes to proving the concept of an affordable reusable videolaryngoscope without compromising on quality.
...
Background: Existing videolaryngoscopes do not meet the needs, budgets, and cleaning protocols of low- and middle-income countries. To solve these problems, a new videolaryngoscope, the Goodscope, has been developed which is less expensive, reusable and easy to clean. The aim of this study was to evaluate the efficacy of the Goodscope compared with a commonly used videolaryngoscope, the GlideScope, when used by experienced anaesthetists and residents in anaesthesia in both a normal and difficult airway scenario. Methods: Participants randomly intubated the manikin four times using both the Goodscope and the GlideScope twice in a normal and a difficult airway scenario. The primary endpoint was time to successful intubation. Secondary endpoints were time to glottic view, time to ventilation, number of intubation attempts, successful intubation rate, and ease of intubation. Results: A total of 73 participants were included in this study. The primary endpoint, time to successful intubation, showed no statistically significant difference between the Goodscope and GlideScope in both the normal (median Goodscope 10.3 s, inter-quartile range (IQR) 8.5, 12.2 vs GlideScope 10.1 s, IQR 8.4, 13.6, P = 0.614), and difficult scenario (median Goodscope 18.5 s, IQR 14.3, 25.3 vs GlideScope 18.4 s, IQR 13.7, 24.2, P = 0.238). Similarly, no significant differences between the two videolaryngoscopes were identified for all secondary endpoints in both scenarios. Conclusion: The findings of this study suggest that the Goodscope is non-inferior to the GlideScope since no significant differences between the Goodscope and the GlideScope were identified for all primary and secondary endpoints. Therefore, this study contributes to proving the concept of an affordable reusable videolaryngoscope without compromising on quality.