FDA Issues Safety Alert for Radiation Therapy Devices

Multidata Systems International has been manufacturing devices without FDA clearance.

The FDA recently created a safety alert that recommends discontinuing the use of radiation therapy devices manufactured by Multidata Systems International. At this time, they also recommend that the devices be disposed of.

These latest recommendations are due to the FDA discovering at least 2 devices that were manufactured and sold without the FDA receiving the proper 510(k) premarket notifications. According to a release from the FDA, the devices include accessories for radiation therapy devices including the Real Time Dosimetry Waterphantom System and the Dual Channel Electrometer.

Multidata Systems International has also not registered or listed their devices with the FDA, which is required by federal law. It is currently unknown how many of these devices manufactured by Multidata are being used in hospitals and clinics to treat patients with cancer who are receiving radiation therapy.

Currently, there have been no adverse events associated with the use of the devices reported to the FDA since 2003, which was when the company entered a Consent Decree of Permanent Injunction.

Under the decree, Multidata may not design, manufacture, process, and distribute medical devices. However, Multidata has been manufacturing and distributing medical devices, including repairing and exchanging Waterphantom devices for newer models, according to the FDA.

The company recently received a letter from the FDA ordering them to stop designing, manufacturing, processing, packing, repacking, labeling, installing, holding for sale, and distributing the medical devices. The company has since stopped all operations and will be dissolved.

These devices manufactured by Multidata should be disposed of immediately and the FDA recommends only using radiation therapy devices and treatment software that has received FDA clearance. Manufacturers who have registered with the FDA are listed under the IYE product code in the FDA’s Registration and Listing Database, they reported.

Any adverse events that arise should be reported to the FDA’s MedWatch program.

The FDA issued this safety alert over concern that physicians and other healthcare providers may not be aware of the potential harms that may result from the use of medical devices that have not received FDA clearance.