FDA Issues Draft Guidance with Updated Labeling and Testing Advice for the Use of Medical Devices in the Magnetic Resonance (MR) Environment
Magnetic resonance imaging
UNITED STATES – As reported in an online article published by www.raps.org, the FDA released a draft guidance with updated advice to evaluate the safety and compatibility of medical devices when used in the magnetic resonance (MR) environment.
Magnetic resonance imaging (MRI) systems have been changing as technology advances. A new draft guidance was issued by the United States Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on the use of medical devices in the MR environment. The draft guidance is intended to adapt to the changing MR environment and will replace a final guidance issued in 2014, addressing a broader range of medical devices.
The draft guidance provides specific instructions on what steps to take to mitigate safety hazards, as some medical devices may not be safe in the MR environment. For example, some patients with implantable infusion pumps who were subjected to MRIs suffered injuries and death. The FDA “raised concerns in 2017 with implantable infusion pumps in the MR environment after receiving serious adverse events reports of patient injury and death, recommending patients with such devices and their caregivers use an implant card.”
Risks to patients of having medical devices in the MR environment include, but may not be limited to, tissue damage and image corruption. Clearer labeling regarding the safety of medical devices in the MR environment, as explained in the draft guidance, is intended to help healthcare professionals know what medical devices may be unsafe in the MR environment.
A patient medical device card is one way to help ensure patients are not subject to harm in the MR environment. Patient implant cards currently exist for some implantable medical devices, such as breast implants and hearing aids. However, the introduction and requirement of patient medical device cards will reach a much broader range of medical devices and may include any device which is either implanted or in some way attached to or used by a patient.
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