Recommendations on Blood Irradiators Classifications Coming From FDA Panel

The FDA wants its Radiological Devices Advisory Panel to weigh in on whether irradiators used to prevent metastasis in salvaged blood during cancer surgeries are safe enough to be classified as Class II devices or whether, as the FDA proposes, they should be designated as high-risk Class III devices requiring premarket approval.

There are two of these blood irradiators in use in the U.S., although their use appears quite limited, according to the FDA’s briefing documents. Both collect blood shed during surgery and reinfuse it into the same patient after passing it through an x-ray irradiation chamber. 

The intent is to destroy any tumor cells that might be either already circulating or have been released during tumor resection. But right now, as stated in the FDA’s briefing documents, these devices are in a bit of a regulatory limbo. 

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