Designed of Improved GE Healthcare Medical Device Cover for Sanitation and Sterilization Process

Overview

GE Healthcare is a multinational medical technology company that has tasked the team with modifying a medical device cover to withstand reprocessing methods. The cover will be placed on the device and will not be removed in between the sanitation and sterilization processes, meaning that the cover needs to be waterproof and air-permeable.  The cover must also be resistant to the chemicals used in the sanitation and sterilization processes. The team decided to limit the modifications to the current cover design, reducing the final cost of the solution. 

Objectives

– Understand and utilize the design process to create a successful final prototype.  
 
– Generate a medical device cover that is waterproof, air-permeable, chemically resistant, and fits within the constraints of the current cover. 
 
– Test the prototypes against IPX7 standards, meaning waterproof under 3 feet of water for 30 minutes, for sanitation pass/fail. 
 
– Test the prototype in an almost complete vacuum for sterilization pass/fail. 

Approach

– The team conducted their own research to come up with concept ideas and then discussed them with each other to determine the best solution to move forward with. 

– An alpha prototype was created with the chosen material to do a fast-pass/fail test of holding the prototype underwater to test the waterproof ability of the material. 

– The testing proved to be successful, and the material did not let any water into the water bottle. 

– A beta prototype was created to hold the same volume as the medical device our cover is being created for and was tested in a vacuum chamber, a water vacuum chamber, and a sterilization machine that creates an almost perfect vacuum. 

– The beta also proved to be successful in the first two tests but unsuccessful in the final test due to the material’s adhesive not being strong enough to withstand the pressure difference in the sterilization machine. 

– The alpha and beta testing results were used to create a final prototype of the medical device cover that corrected the shortcomings of the beta testing. 

– The final prototype was tested in the same machines as the beta prototype and was successful in all aspects, giving the team a working prototype to hand over to GE Healthcare.

Outcomes

– A final prototype was created that is waterproof, air-permeable, and chemically resistant and can withstand both the sanitation and sterilization methods without human intervention, eliminating room for human error.  

– The final prototype is a cheap modification to the current medical device cover and will improve customer satisfaction. 

– All of the data and prototypes created during this project will be used by GE Healthcare to create a new product for their medical devices.