The overall purpose of this course is to design a medical product to solve a unmet clinical need. All of the necessary requirements required by the FDA for new medical products were considered for this class and in the design of this project.
In emergency situations, patients unable to breathe and maintain their own airway may need Bag-Valve Mask(BVM) ventilation. Ideally one medical professional would hold the mask against the patient's face while another medical professional would focus solely on ventilating the patient. Unfortunately, often times Emergency Medical Technicians (EMTs) do not have enough people on scene forcing one person to hold the mask and ventilate. When this is the case, if is often difficult to maintain a good seal of the mask on the patient to ventilate properly. The focus of this project was to focus on developing a mask that could easily form a better seal.
The first part of the project was to determine what was actually needed by the EMS providers for use of the mask. Visits were made to various EMS stations and centers, like Foxwall and Shaler-Hampton stations and the University of Pittsburgh Center for Emergency Medicine. Talking to the various EMTs helped us formulate potential solutions for the need of a better fitting mask.
Using the information obtained from the EMS providers and our own brainstorming session, several potential solutions were considered. Sketches were created from these discussions(as seen below)) These sketches were then shown to the EMS providers who all preferred the foam idea.
As part of our Design History File (DHF), all of the related documentations to the project, which includes risk analyses, ethnography plan/report, and use cases/user needs, were created. I personally assisted in some aspect on all of these files.
Following the discussion with EMS personnel regarding the sketches of potential solutions, we decided to focus on the foam idea. Several iterations of the foam mask prototypes were made. The first mask had foam placed into the plastic cuff around the mask, the second had gel beads in this cuff, the third mask replaced the cuff with a piece of foam, and the final prototype for the semester had two layers of foam(different foam types) replace the cuff. The gel beads mask worked well but sealing of the beads was an issue an could introduce more potential risks. The first two foam masks did work well according to EMS personnel but we were told that some improvements could still be made as it was still a bit difficult to get a good seal of the mask on the testing mannequins. To solve this we used a softer foam on the surface for the face to be conformed to and a stiffer piece of foam on top to ensure that the EMS provider can place enough force on the mask with ease. The final mask prototype that was used involved the use of medium density foam and a coating of silicone dragon skin over it to ensure there was no leakage of air through the mask.
Verification testing was used to determine whether the design inputs met their specified roles. The verification roles included functionality, dimensionality, fluid resistance, and material specification. Functionality was to ensure that the device functioned as specified, dimensionality ensured that the mask was the correct size, fluid resistance ensured the mask could withstand fluid, and material specification ensured that the proper materials were used for the mask. Unfortunately the verification tests set up for all of these verification points were not passed.
Validation testing was conducted to determine whether the production equivalent met the needs of the target audience which were medical professionals. The validation points that were addressed included: Device Quality and Wear Resistance to check whether the mask could withstand the conditions it would typically be used in, Device Usability which checked for whether the medical workers could use the mask, and Device Functionality which checked for whether the medical workers believed the mask could carry out its proper function. These validation tests were completed by having medical professionals using the mask on mannequins and then filling out a survey regarding the different aspects of the mask.
First prototype in which foam is stuffed into plastic cuff that is part of mask generally.
Upon selection of our topic of improving the fit of bag-valve masks, I scheduled and attended meetings with different local EMT stations, like Shaler-Hamptom EMS. At these meetings I help lead the discussions with the EMS providers to understand the specific issues with the current masks. As a former EMT I was able to use this knowledge to frame questions to get more detailed and informative answers.
I directly assisted in the creation of two of the prototype masks: the first and second prototypes. The first mask had foam stuff in the plastic cuff and the second mask with the gel beads within the the plastic cuff. I also assisted with the production of the final mask design with properly coating the mask with the dragon skin silicone.
Following the production of the production-equivalent mask prototype, I assisted with conducting the verification tests and going to different medical facilities to seek validation from medical workers about the mask.
Copyright © 2023 Arijit Dutta - All Rights Reserved.
Powered by GoDaddy Website Builder
We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.