The FDA is urging the medical device industry to closely assess incoming products and supplies from Japan to ensure the product conforms to specifications and quality requirements. The request came in a June 1 letter to industry posted on the agency's website.
In the letter, the agency states a number of potential concerns about products coming in from Japan, including radioactive contamination of device components derived from animals, e.g., bovine serum albumin; a compromise in sterile products during or after production; and a compromise in the reliability of product performance, e.g., electrical connectors, microprocessors, alarms and sensors.
The FDA advises companies to 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. It also says companies should check all power cords, batteries and electric monitoring devices to make sure that they are not damaged by water.
"At this time, neither CDRH nor CBER has been notified of any defective product or serious adverse events associated with the use of a device related to this disaster," the letter states.
- see the FDA's letter