The MRI-FDA Connection: Understanding Regulatory Rules in MRI Scans

When faced with a medical situation severe enough to warrant the use of magnetic resonance imaging (MRI), you’re already stressed enough. The last thing you want to worry about is the safety of scanning equipment. There’s no need for worry, however, as the U.S. Food and Drug Administration (FDA) firmly regulates not only the companies that manufacture MRI machines, but those medical offices that administer the tests as well. It’s a top-down effort to keep the patient safe while ensuring they receive the best possible medical care available.

As the patient, the first question you’re probably asking yourself goes something like this: “Is an MRI safe?” Short answer: yes. According the the FDA, adverse events due to an MRI are extremely rare, with roughly only 300 cases reported out of the many millions of MRIs performed each year. This form of imaging does not expose the patient to ionizing radiation like an X-ray. Instead, MRIs provide not only a clearer and more accurate picture of the affected area, but a safer one as well.

How the FDA and the States Regulate MRI Scanning Equipment

The FDA plays a significant role in protecting you, the patient. They monitor any firm that manufactures, imports, repackages or even re-labels MRI equipment. This oversight ensures that manufacturers produce devices that are safe for consumer use through continually updated supervision and study. The FDA also strongly promotes appropriate use of imaging exams, making sure to keep unnecessary exams to a minimum. The FDA isn’t the only regulatory body looking out for patient safety, however.

Individual states regulate the actual use of medical imaging equipment as well. States also set the training and education requirements for operators. While there is a national conference that publishes guidelines for regulation of quality assurance, some states choose to adopt more stringent measures. Individual states continue to periodically review and update safety measures. That way, they keep the patient in the safest position possible during diagnostic imaging procedures.

The Future of FDA Regulation for MRI Equipment

The FDA does more than regulate existing products. They also take an active role in keeping current with safety studies. Furthermore, they perform pre-market evaluation of MRI technology with the patient’s well-being in mind. They have future regulatory goals, too. These include measures such as default protocols, machine access control limitations, and image quality optimization guidelines. The FDA wants to keep patients safe. They meet this goal in combination with various state agencies through rigorous study and regulation.

Medical patients who need imaging services have enough to worry about, and the safety of equipment should not be on that list. The FDA, in partnership with states nationwide, manages regulations governing not just the machines themselves, but the operators and facilities as well. As a patient, is your foremost outlet for finding an imaging facility that will ensure you receive not only the appropriate level of care, but the best possible quality imaging services — all at a price you can afford.

Posted in MRI