Safety Labeling for the MR Environment
May 6, 2015 | Evaluations & Guidance
Magnetic resonance scanners provide valuable diagnostic information that, in some cases, cannot be provided by any other means. However, this technology does present a unique set of safety risks. Interactions between an MR system's electromagnetic fields and other equipment brought into the MR environment—a space that encompasses not only the MR system, but also the three-dimensional magnetic field that surrounds the system—can result in harm to patients or staff or costly damage to equipment. For example:
To help clinical staff quickly and accurately determine whether a device may be safely brought into an MR scanning room, FDA requires that standard labeling be used on any device for which MR safety claims are made by the manufacturer. In addition, healthcare providers may use the same labels on other devices that they determine are safe to use in the MR scanning room.
The labeling terminology and icons adopted by FDA were developed by the ASTM International Task Group on MR Safety—a group that included ECRI Institute and many other individuals and organizations. The standard is...