Safety assessment of displacement force,torque and vibration of a deep brain stimulation system under 3T MRI

Abstract

Deep brain stimulation (DBS) is an effective therapy for treating neurological disorders, while magnetic resonance imaging (MRI) is a valuable method for clinical diagnosis and research. However, DBS systems in clinical MRI are under the influence of displacement force, torque and device vibration, which may be hazardous to patients after DBS implantation surgery. In this study, we evaluated these hazardous effects under 3T MRI. A set of apparatus were designed and built and the corresponding methods for safety assessment were also proposed. Results showed that the displacement force, torque and vibration of the DBS system under 3T MRI were safe. Furthermore, this study demonstrates an example of an MRI compatibility test that can be applied to many other medical instruments.

Keywords

Deep brain stimulation magnetic resonance imaging force torque vibration

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References

ISO/TS 10974:2012: Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device, 2012.

ASTM F2052-06: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, 2006.

ASTM F2213-06: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment, 2006.

ISO 5349-1:2001: Mechanical vibration-measurement and evaluation of human exposure to hand-transmitted vibration-Part 1: General requirements, 2001.

Ehman

E.C.

Rossman

P.J.

Kruse

Sahakian

A.V.

and Glaser

K.J.

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Directive 2002/44/EC of the European Parliament and of the Council of 25 June 2002 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (vibration) (sixteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC).

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