Standards for medical devices in MRI: present and future.
The purpose of this review is to define the current standards addressing safety of medical devices in MRI and to describe ongoing standards development efforts. The American Society for Testing and Materials (ASTM International) began developing standard test methods for determining the MR safety of medical devices in MRI in 1997. To date, five ASTM standards addressing testing and marking medical devices and other items for use in the MR environment have been published. International Standards Organization (ISO) 14630, the general requirements standard for nonactive surgical implants, is currently being revised to include information about MR safety of passive implants and to reference the ASTM standards. To address the unique safety issues of active implants, and in particular, active implants with leads, like pacemakers and neurostimulators, a joint working group between ISO TC150/SC6 on active implants and International Electrotechnical Commission (IEC) SC 62B MT40 on magnetic resonance equipment for medical diagnosis is working to develop a technical specification for active implantable medical devices (AIMDs) in MRI. While much progress has been made, work still needs to continue to develop a complete body of test methods to allow the evaluation of the safety of medical devices in the MR environment.
Woods
Terry O
TO
U.S. Food and Drug Administration, Silver Spring, Maryland 20993, USA. terry.woods@fda.hhs.gov
D019544:Equipment Failure Analysis / Q000592:standards*; D004869:Equipment Safety / Q000592:standards* / Q000639:trends*; D004864:Equipment and Supplies / Q000592:standards*; D005544:Forecasting; D017408:Guidelines as Topic; D038622:Internationality; D008279:Magnetic Resonance Imaging / Q000295:instrumentation* / Q000592:standards*; D012015:Reference Standards; D014481:United States