The U.S. Food and Drug Administration (FDA) has released a new guidance document covering the use of passive implants in MRI environments.
The guidance represents the FDA's current position on the use of devices in MRI environments that do not require an independent electric power supply. The document is designed for use by vendors planning to submit devices for FDA review under the premarket approval (PMA), 510(k), or investigational device exemption (IDE) processes.
The document covers the various issues involved in ensuring the safety of patients with passive implants who undergo MRI scans. It also offers recommendations to vendors for how data should be presented in regulatory applications to the FDA, as well as the terminology that should be used in submissions.
In addition, the guidance provides advice on labeling requirements for passive implants, such as whether they are safe in all MRI environments or whether their use should be restricted based on conditions like magnet field strength, spatial gradient field, and specific absorption rate (SAR).
The document is available on the FDA's Web site and can be viewed by clicking here.
Related Reading
Sink or swim: Why a hand sink is crucial in the MR suite, March 14, 2008
MR guidelines: Elevating standards of practice and care, March 10, 2007
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