Using a Simulated Use Approach to Determine Particulate Generation

There is increasing evidence particulate matter from medical devices is creating unintended clinical risks following use. Understanding and minimizing the particulate generated from a medical device are critical to reducing the safety risk to patients. The quantified standards for particulate generation are available in standard resources such as ASTM F2743 and AAMI TIR42. These standards aim to mimic the procedure and vascular system during simulative use, utilizing an anatomic model of a clinically relevant pathway. While the relevant model is a critical component to determining the particulate generation from a device, there are additional approaches that will help answer the many questions surrounding particulate generation.