FDA Warns Manufacturers to Assess Japanese Exports

The U.S. Food and Drug Administration (FDA) is advising medical device manufacturers to thoroughly check Japanese exports of devices, components and electronics for damage or contamination as a result of the March 11 earthquake and tsunami that obliterated parts of the country.

In a letter to manufacturers sent on June 1, the FDA said it has not been made aware of “any defective product or serious adverse events associated with the use of a device related to this disaster” but concerns persist due to the magnitude of the event.

The concerns include radiation contamination of devices or device components; contaminated water supply that results in defective products, causing them to fail to meet device specifications; the compromise of sterile products during or after production, including those that were stored and finished; and shortage of components or finished devices due to damage or disruption to the affected region.

“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 letter read.

The agency’s Center for Devices and Radiological Health, along with the Center for Biologics Evaluation and Research, recommends that manufacturers assess incoming products and supplies to ensure they conform to quality requirements; companies also should inspect all power cords and batteries for water damage. Any adverse events or product shortages associated with the use of a compromised medical device from Japan should immediately be reported to the FDA.