October 20, 2016

Dear Radiation Oncologists, Medical Physicists, Dosimetrists, and Radiation Therapists:

The FDA is concerned about the risks to patients from the use of devices manufactured and sold by Multidata Systems International Corporation ("Multidata").

The FDA knows of at least two Multidata medical devices that the company manufactured and distributed in the United States for which FDA never received nor reviewed 510(k) premarket notifications. These devices include: (1) accessories to radiation therapy devices including the Real Time Dosimetry (RTD) Waterphantom System and (2) the Dual Channel Electrometer. In addition, Multidata has not registered or listed their devices with the FDA, as required by federal law.

Since 2003, Multidata has been under a Consent Decree of Permanent Injunction (the "Decree") entered by the U.S. District Court for the Eastern District of Missouri (civil action no. 4:03cv575). The Decree prohibits Multidata from designing, manufacturing, processing, and distributing medical devices, among other restrictions. The FDA has learned, however, that Multidata manufactured and distributed medical devices in violation of the Decree, including repairing and exchanging Waterphantom devices for newer design models.

The FDA is concerned that health care providers may be unaware of the risks associated with these devices and urges facilities to discontinue the use of any devices manufactured by Multidata, dispose of them appropriately, and use accessories to radiation therapy devices and radiation treatment planning software that have been reviewed and cleared by FDA.

ANALYSIS OF THE PROBLEM

At this time, it is not known how many devices manufactured by Multidata are currently in use in hospitals and clinics throughout the United States. The FDA is not aware of adverse event reports associated with the use of Multidata's devices since Multidata has been under the Decree, but because the FDA has not received or reviewed 510(k) premarket notifications, the agency is concerned about the potential risk to patients from the devices.

RECOMMENDATIONS

• Discontinue the use of any devices manufactured by Multidata and dispose of them appropriately.
• Use accessories to radiation therapy devices and radiation treatment planning software that have been cleared by the FDA. Registered manufacturers of these types of devices are listed under the IYE product code in the FDA’s Registration and Listing Database.
• Follow quality assurance procedures to verify treatment plans by independent means, which may include manual calculations or measurements of radiation doses.
• Report any adverse events related to Multidata devices that come to your attention. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (“MDR”) regulations. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

FDA ACTIONS

Through inspections, FDA learned that Multidata was designing, manufacturing, processing, and distributing medical devices in violation of the Decree. As a result, on March 3, 2016, the FDA sent a letter to Multidata ordering the firm to cease designing, manufacturing, processing, packing, repacking, labeling, installing, holding for sale, and distributing any medical device. The company has now permanently ceased operations and will be dissolving.

The FDA will keep the public informed if significant new information becomes available.

CONTACT US

If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at [email protected], 800-638-2041 or 301-796-7100.

Sincerely,
/s/
William Maisel, MD, MPH
Deputy Center Director for Science
Center for Devices and Radiological Health
U.S. Food and Drug Administration