Hitachi prepares response to FDA warning letter

A warning letter issued July 13 by the FDA to Hitachi Medical Systems of America has called into question the company's reporting mechanism for patient injuries.

Deviations from FDA-required methods for handling such complaints were identified during an onsite audit conducted in April, according to Sheldon Schaffer, vice president and general manager of MR for the Japanese-owned subsidiary headquartered in Ohio.

"We owe the FDA a response regarding the warning letter and we will be doing so," he said. "The response will inform them of the corrective actions we have already taken and what we plan to complete in the next 30 days. We are looking forward to working with the FDA to close out the findings."

The letter to Hitachi, like many warning letters issued by the FDA, identified procedural problems related to the FDA's Quality System regulation, which requires manufacturers to maintain a system for ensuring quality in the design and production of medical devices distributed commercially in the U.S. Warning letters such as the one issued to Hitachi, which cited the FDA's MDR (medical device reporting) system, are designed to bring companies into compliance with reporting requirements. Such a move allows the watchdog agency to keep tabs on patient safety issues.

Incidents identified in the warning letter to Hitachi were among the information the FDA was reviewing as part of its April audit of the company. They include patient reports of headaches resulting from a head coil-related burn received during an MR scan, as well as tinnitus and hearing loss due to loud sounds during scanning.

Since being alerted of its noncompliance, the company has modified its MDR procedures to ensure that whenever one of its products could contribute to serious injuries, the incidents are properly reported to the FDA, Schaffer said. The company has also modified and enhanced its procedures for correcting products found to cause such potential injuries.

Only one issue remains, according to Schaffer. This relates to the process of reviewing, evaluating, and processing customer complaints.

"It is our plan and intention that all the concerns listed in the warning letter will be fully responded to by the end of August," he said.