Devices & Diagnostics

FDA to medical device makers: Check Japanese parts for tsunami damage

The March 11 earthquake and tsunami in Japan may mean compromised medical devices and device components, according to a Food & Drug Administration letter to industry. The U.S. regulatory body addressed a letter to foreign and domestic medical device industries yesterday, advising companies to take increased precautions in assessing Japanese exports. The FDA encouraged device […]

The March 11 earthquake and tsunami in Japan may mean compromised medical devices and device components, according to a Food & Drug Administration letter to industry.

The U.S. regulatory body addressed a letter to foreign and domestic medical device industries yesterday, advising companies to take increased precautions in assessing Japanese exports.

The FDA encouraged device makers to be on watch for radioactive contamination, water damage to electrical components, compromised sterility and product shortages.

No defective products or serious adverse events had been reported to the FDA’s Center for Devices & Radiological Health or Center for Biologics Evaluation & Research at the time of the warning, according to the letter.

“Carefully check all products for contamination or compromise, including device integrity such as cracks, breech in sterility, filth, defective equipment, or package integrity (dampness, water residue, mold, unpleasant odors, discoloration, or unreadable labels),” the FDA advised.

FDA officials asked that any adverse events or product shortages associated with the use of a medical device as a results of the devastation in Japan be reported to the agency.

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

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