Development and validation of a tissue-equivalent test environment for detection of malfunctions in active medical implants caused by ionizing radiation

Many patients in radiotherapy carry active implantable medical devices (AIMDs) such as pacemakers or cardioverter defibrillators (ICDs). The influence of the ionizing radiation can lead to failures in the device function. This study presents a tissue-equivalent test environment to investigate the influence of ionizing radiation on AIMDs. The in-vitro test environment is designed to simulate a human torso. Structures such as the heart, lungs, ribs, spinal column and soft tissue are replicated from tissue-equivalent materials to allow realistic treatment planning and to simulate the effect of ionizing radiation on active implants. CT measurements and Monte-Carlo validations have shown that Polytetrafluorethylen (bone), carrageenan (heart), Styrodur (lung) and Biresin® G27 (soft tissue) fulfill all requirements for suitable tissue surrogates. A plug-in unit integrated in the test environment has been designed specifically to allow the placement AIMDs in the phantom at typical positions for implant placement in humans. The dosimetry validation showed that the test environment is applicable in the full treatment planning process.