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Device fragments flagged by FDA

January 21, 2008|From Times wire reports

Fragments left inside patients from medical devices may injure or kill when the pieces shift on their own or are pulled by magnets in imaging machines, U.S. regulators warned.

Reports of harm include infections, tissue reaction, perforations and obstructed blood vessels, the Food and Drug Administration said in a notice posted on its website.

About 1,000 incidents caused by medical device fragments, involving more than 200 devices, are reported each year, the FDA said. The most common were catheter guide wires to the heart, followed by bone screws.

"Medical technology companies are committed to providing patients and physicians with safe and effective medical devices," said Janet Trunzo, executive vice president of the Advanced Medical Technology Assn., a Washington trade group for medical device makers. "We agree with the agency's recommendations."

Doctors should inspect devices for damage before using them and check again after removal from a patient for signs that a fragment may have been left behind. The risk of injury may depend on where in the patient's body a fragment is situated, where it might migrate and the patient's anatomy.

For people with device fragments in their bodies, procedures with magnetic resonance imaging machines "may cause metallic fragments to migrate, and radiofrequency fields may cause them to heat, causing internal tissue damage and/or burns," the FDA said.

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