The FDA released a notice Thursday to physicians saying they should stop using St. Louis-based Multidata’s radiation devices, as the company is restricted by the authorities since 2003 from designing, manufacturing, processing, and distributing them. The administration stated that it is unaware of how many of the devices are still being used in hospitals in the U.S.
The devices mentioned include the Real Time Dosimetry Waterphantom System and the Dual Channel Electrometer, neither of which have been registered with the FDA.
A 2001 software accident in Panama led to 28 patients receiving an overdose of radiation, including reports of death, and resulted in a Consent Decree of Permanent Injunction against Multidata two years later. But the company kept manufacturing and distributing its devices past that time, the FDA said.
As for Thursday’s notice, the U.S. authorities expressed concern “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.”
There have been no known adverse events associated with Multidata’s devices since the decree, but the company has been under scrutiny since 1993. The company had initiated a recall in 2001 that took two years to complete, but it continued to repair and exchange those devices already in use, the FDA reported.
In March, the FDA sent a letter to Multidata ordering the company to cease “designing, manufacturing, processing, packing, repacking, labeling, installing, holding for sale, and distributing any medical device.”