The FDA has issued final guidance for testing and labeling medical devices for safety in the magnetic resonance environment. This guidance will be essential for manufacturers of both implantable devices, such as pacemakers and implantable cardioverter-defibrillators (ICDs), and external devices, like insulin pumps. Notably, it does not apply to actual MRI equipment. The guidance comes with recognition that magnetic resonance may cause some medical devices to malfunction, which could potentially cause tissue or organ damage.
The guidance document primarily addresses two facets of risk that arise out of medical device interaction with magnetic resonance. It addresses the compatibility of a device with magnetic resonance and communication of safety information through adequate labeling.
Manufacturers of devices that may be used in a magnetic-resonance environment are encouraged to test their device to ensure that magnetic resonance does not cause the medical device to become displaced or dislodged. Additionally, the device should be evaluated for magnetically induced heating that could inadvertently cause the medical device to heat the surrounding tissue. For example, a pacemaker could potentially react to magnetic resonance at an MRI facility that could cause the pacemaker to malfunction, this possible outcome demonstrates the value of examining interactions of your device with magnetic resonance. The guidance provides testing methods and parameters to assess for these potential concerns.
In addition to testing, FDA labeling requirements are discussed in the guidance. The device labeling should include information that would allow a healthcare practitioner to determine whether the device can be used in an MRI facility or around an environment with magnetic resonance. The guidance recommends the addition of an “MRI Safety Information” section in the medical device safety information wherein the safety of the medical device in MRI facilities is discussed specifically. For clarity and continuity, FDA recommends the following designations for products that are likely to be used in a magnetic-resonance environment “MR Safe,” “MR Unsafe,” or “MR Conditional.” The MRI safety information should also be compatible with preexisting FDA guidelines for medical device labeling.
This guidance provides recommendations and clarity for medical device manufacturers, however they are not required by FDA. Nevertheless, the guidance document sets forth important safety-related advice that could be important to products liability risk mitigation, necessitating that device manufactures implement these changes. Devices that are not in compliance with this guidance could be difficult to defend in a products liability action should an injury arise from a device's interaction with magnetic resonance and the manufacturer could have prevented the injury with implementation of the guidance. Accordingly, this new guidance provides a mandate for manufacturers of products used in the MRI setting.