Abstract #1856
Retrospective Analysis of Data in RF Heating Tests of Small Passive Medical Implants
Ting Song 1 , Maria Ida Iacono 1 , Leonardo M. Angelone 1 , and Sunder Rajan 1
1
Center for Devices and Radiological Health,
U.S. Food and Drug Administration, Silver Spring, MD,
United States
The purpose of this study is to perform a retrospective
analysis of data related to RF-induced heating tests of
medical implants provided in U.S. FDA submissions. We
report interim data on 55 small passive medical implants
for 1.5T and 3.0T. The data show that there is no clear
length dependence for devices 120 mm even when the
data are stratified by the magnetic field, device type,
and test vendor. Most devices less than 50 mm in length
showed less than 2.6 oC of temperature change per WB-SAR
except for one device that showed 4.5 oC of temperature
change per WB-SAR.
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