EBM 407: Machines Design Second Semester Examination

Machine design paper built around medical devices. The compulsory question takes a coronary stent placed in the arteries during percutaneous coronary intervention through the design considerations for the device, the factors a surgeon weighs when choosing its material, its classification under the pharmacy and poisons board regulation by duration of use, invasiveness and risk, the different considerations for a bio-resorbable against a metallic non-absorbable stent, the sterilization methods used on medical devices and which suits a medical-grade cobalt-chromium stent coated with everolimus, and the temperature needed to run an accelerated age test for a three-year shelf life at a ten-to-one time reduction with a Q10 of two from a room temperature of 22 degrees. Optional questions list the solid modelling operations and sequential steps that build a pump cover in a CAD package, and separate a trademark from a copyright. Others set the components of a device testing protocol, the nonclinical tests run while developing the stent, and a nonclinical testing standard operating procedure for a characteristic of a surgical suture. The last takes a failure mode of a personal insulin pump whose display stays live while the battery can no longer drive the pump: severity, occurrence and detection ratings with rationale, the risk priority number, the action the manufacturer should take, the completed failure mode and effects analysis template, and the recalculated number after a simple fix.