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  1. Advancing Regulatory Science

Development of Thrombogenicity Testing Methods for Medical Devices with Large Blood-Contacting Surfaces

CERSI Collaborators: University of California San Francisco: Shuvo Roy, PhD

FDA Collaborators: : Center for Devices and Radiological Health: Qijin Lu, PhD; Megan Jamiolkowski, PhD; Richard Malinauskas, PhD

Project Start Date: 05/2018

Regulatory Science Challenge

Blood clot formation, also called thrombosis, remains a major clinical complication for patients who require a medical device that comes in contact with their blood. Devices with large blood-contacting surfaces, such as artificial kidneys and lungs, tend to be more susceptible to forming blood clots since the exposure of blood to foreign surfaces has been shown to promote thrombosis, especially for clinical applications in which the patient is in contact with the device for a long period of time. To ensure patient safety, it is important to appropriately evaluate the potential for thrombogenicity (blood clotting) of medical devices prior to clinical use. However, current blood compatibility evaluations often rely on testing the devices in animals , which are costly, time-consuming, and may have limited clinical predictive value.

Project Description and Goals

This project aims to develop, standardize, and validate a series of bench top test methods that can be used to reliably evaluate the thrombogenicity (blood clotting) potential of devices with large blood-contacting surface areas in a less expensive and quicker manner as compared to animal testing. A better understanding and standardization of in vitro thrombogenicity tests, which can be practically performed in the early stages of device development, will facilitate device innovation, and enhance industry and the FDA’s ability to evaluate safety of medical devices with large blood-contacting surfaces.

Publications

Sarode DN, Roy S. In Vitro models for thrombogenicity testing of blood-recirculating medical devices. Expert Rev Med Devices. 2019 Jul;16(7):603-616. doi: 10.1080/17434440.2019.1627199. Epub 2019 Jun 10. PMID: 31154869; PMCID: PMC6660015.

 

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