The MRI environment is strictly controlled: it can be dangerous for patients suffering from metal (including metals used in some medical equipment) or their body attachments.
Pacemakers, neurostimulators, insulin pumps, artificial heart valves and cochlear implants are among the devices that can bring risks, and device manufacturers are designing MRI-compatible versions. For example, in June, Cochlear Co., Ltd. received FDA approval for its implants to use behind-the-ear sound processors, which are designed for secure access to MRI scans without the need to wrap the head or remove the device’s internal magnets.
A Vizient study last year showed that MRI-compatible heart devices have rapidly become popular in recent years. Nearly 70% of pacemakers implanted in 2018 are compatible with MRI, compared with only 12% in 2016. More than 48% of cardiac defibrillators were compatible with imaging equipment in 2018, compared with only 2% in 2016. The FDA’s guidance applies to all implantable and external medical devices that are fixed on patients or intended to enter the MR environment. The FDA stated that these recommendations cover MR safety and compatibility assessments and label information that should be submitted before marketing.
The agency stated that ensuring the safety and effectiveness of equipment entering the MR environment should be part of risk management and should include appropriate testing and analysis as well as scientific evidence. The strength of each magnetic field of the equipment should be evaluated, such as 1.5T and 3.0T, in which medical equipment may be exposed. Electroactive medical equipment should be designated as MR Conditional or MR Unsafe. MRI safety labels should include patient and medical service provider information.
For implantable and external medical devices that are fixed on or carried by patients, the agency recommends that device manufacturers provide patients with medical device cards.