Failure Mechanisms of Polymeric Medical Devices

Abstract

Medical devices manufactured today typically require a number of different components and materials. Commonly, mass-produced devices utilize biocompatible polymers for their external surfaces. In this article, we discuss common failure mechanisms of polymers and a number of contributing factors, related to both the use and manufacturing of these devices. Reprocessing and cleaning of reusable medical devices can also contribute to their failures when incompatible substances or techniques are used. Thorough postmarket reporting of any medical device failure can allow enhancements of the device to be made and will ultimately improve patient safety.

Medical Device Recalls for Electronic Components

“…35 Medical device failures have occurred because of damages caused by cleaning fluids; therefore, caregivers should follow the manufacturer's cleaning and operating instructions to ensure that cleaning solvents do not inadvertently damage the device because of incompatible materials. 36 Electronic systems and components failures from fluid ingress are known issues, particularly with infusion pumps where electromechanical devices and conductive fluid are in very close proximity. 37,38 Improper cleaning of certain devices has also shown to be problematic.…”

“…Medical device electronic systems and components are more prone to fluid ingress–related failures than many consumer electronics, in part because of their close proximity to conductive fluids including, but not limited to saline, bodily fluids (eg, blood, saliva, mucus), cleaning agents, and/or medically necessary fluids such as dialysate or organ preservation solutions. According to the National Fire Protection Association, “Operating rooms shall be considered to be a wet procedure location unless a risk assessment conducted by the healthcare governing body determines otherwise.” 35 Medical device failures have occurred because of damages caused by cleaning fluids; therefore, caregivers should follow the manufacturer's cleaning and operating instructions to ensure that cleaning solvents do not inadvertently damage the device because of incompatible materials 36 . Electronic systems and components failures from fluid ingress are known issues, particularly with infusion pumps where electromechanical devices and conductive fluid are in very close proximity 37,38 .…”