Authors: B.J. Casey, P. Jayanti, E.M. Sussman, B.J. Dair
Affilation: U.S. Food and Drug Administration, United States
Pages: 86 - 88
Keywords: silver nanoparticle, medical device, leaching, characterization
The main goal of this research was to gain a better understanding of the extraction profile of medical devices containing silver nanoparticles. Multiple silver nanoparticle containing medical devices were incubated in various extract solutions (water, saline, human plasma) under multiple conditions (1 hour, 24 hours, 168 hours @ 37°C; 72 hours @ 50°C). Inductively coupled plasma – mass spectrometry (ICP-MS) was used to determine the total amount of silver which had leached from the devices. Dynamic light scattering (DLS), ultraviolet-visible light spectroscopy (UV-Vis), nanoparticle tracking analysis (NTA) and transmission electron microscopy (TEM) were utilized to characterize the physical structure of the particulates released from the devices. Field emission scanning electron microscopy (FESEM), and corresponding energy dispersive x-ray spectroscopy (EDS), were used to image and analyze the elemental composition of the surface of each medical device. This research has provided insight into the both the amount and physical form of silver that is released from medical devices. The data from this research is currently being implemented into a risk assessment model which used to better assess the safety and efficacy of medical devices which contain silver nanoparticles.