Materials & Processes for Medical Devices (August 10- 13): Ultrasonic Cleaning-Induced Failures In Medical Devices

10.4 Ultrasonic Cleaning-Induced Failures In Medical Devices

Tuesday, August 11, 2009: 2:40 PM
Salon F (Hilton Minneapolis )
Dr. Brad James , Exponent Failure Analysis Associates, Menlo Park, CA
Cahal McVeigh , Exponent Failure Analysis Associates, Menlo Park, CA
Eric Guyer , Exponent Failure Analysis Associates, Menlo Park, CA
Scott Lieberman , Exponent Failure Analysis Associates, Menlo Park, CA
Ultrasonic cleaning is often used as part of the manufacturing process of small medical devices, such as guide wires and vascular implants. However, exposure to ultrasonic cleaning with frequencies close to the natural frequency of the device can result in a resonance condition, resulting in significant mechanical damage and premature failure. This paper provides case studies of ultrasonic cleaning-induced fatigue and corresponding failures in medical devices. Preventative measures, such as analytical tools to ensure that ultrasonic cleaning frequencies do not result in resonance and stresses sufficient to cause fatigue damage are discussed.