A Made-in-Saskatchewan ventilator designed and built to support Canada’s COVID 19 pandemic response
Notice bibliographique
Résumé
INTRODUCTION In March 2020 Health Canada (HC) released its “Interim order respecting the importation and sale of medical devices for use in relation to COVID-19”[1]. This led to the development, testing and HC approval of an emergency use ventilator (EUV-SK1) by a Saskatoon-based engineering and manufacturing company (RMD Engineering), with support from members of the Saskatchewan Health Authority (SHA) and subject matter experts form several colleges at the University of Saskatchewan (USask). FROM CONCEPT TO APPROVAL IN EIGHT MONTHS Design objectives: The EUV-SK1 was designed as a volume-controlled ventilator, using medical air and oxygen. The main considerations for the design were minimizing the number of moving parts, keeping the majority of manufacturing inhouse and using readily available materials. These were important risk mitigation strategies amidst disruptions to the global supply chain and business closures during lockdown. Challenges in design and material acquisition: At the start of the project, it became rapidly apparent that two of the critical components, the flow meter and the PEEP (positive end expiratory pressure) valve would have to be developed and built inhouse. The current industry standard for flow measurement in ventilators is mass flow meters, however, they were not available at the time, and all PEEP devices were of a proprietary nature, and again, unobtainable. Boyles law was leaned on, and differential pressure across an inhouse design of a variable rate mechanical orifice were used to overcome precision flow challenges. The PEEP, being the most critical component, required development of a proportionally controlled solenoid on top of a balanced check valve, both developed and produced inhouse during the pandemic. Performance testing: Performance testing was completed using a commercial test lung (active servo lung, ASL 5000TM, Ingmar Medical). Testing was performed using the settings provided by Table 201.104 in ISO 80601-2-80 [2]. The EUV-SK 1 was further subjected to extensive third-party testing. Usability testing: The purpose of usability testing is to prevent use error and improve patient safety. Usability testing included two parts, a completion of tasks by experience users (respiratory therapists and intensive care nurses) and a user experience questionnaire completed by the same users. Both were modified from previous published studies [3, 4]. Next steps: Further work is in progress to turn the EUV-SK1 into a fully certified ventilator.
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».