Federal health officials are warning healthcare providers not to use certain radiation therapy devices and accessories, due to the manufacturer’s failure to receive government premarket approval, which could result in a risk of adverse health consequences for patients.
A Multidata radiation device warning was issued by the FDA on October 20, instructing healthcare providers across the nation to immediately discontinue the use of Multidata Real Time Disometry (RTD) Waterphantom System and the Dual Channel Electrometer.
Officials indicate that there are unknown risks posed by the devices, since the regulatory agency never determined they were never properly tested before entering the market.
The FDA released the warning after recognizing the two Multidata medical devices were distributed to the U.S. and sold to healthcare providers and hospitals without ever receiving FDA approval.
The FDA’s warning involves unapproved Multidata Real Time Disometry (RTD) Waterphantom Systems, which are used for measuring the output of a radiation therapy treatment machine and calculates the correct dose to be delivered to the patient. The warning also involves the Dual Channel Electrometer, which is used to monitor electricity running through electrodes, electrochemicals and other medical devices.
The FDA is asking healthcare professionals to discontinue using the devices due to the unknown nature of injuries that could arise from their use, which could range from mild to severe consequences. Given the devices control dosage amounts and monitoring of chemical balances, there is the potential for patients to receive too much or too little radiation during treatments, and those errors might not be properly recorded.
The manufacturing company, Multidata Systems International Corporation, has been under a Consent Decree of Permanent Injunction since 2003, which prohibits Multidata from designing, manufacturing, processing, and distributing medical devices of any sort, among other provisions.
Recently, the FDA learned that both the Real Time Dosimetry (RTD) Waterphantom System and the Dual Channel Electrometer may still be in healthcare settings and in use for radiation therapy treatments, prompting the device warning. Furthermore, the FDA discovered that after the Consent Decree was issued in 2003, Multidata manufactured, distributed, and repaired the two devices without FDA approval or notice.
The agency is recommending healthcare professionals discontinue use of any and all products manufactured by Multidata and dispose of them appropriately. Healthcare providers with patients who have been using Multidata radiation therapy devices, accessories or components should find alternative products marketed by registered manufacturers and which have received the FDA’s 510(k) premarket approval.
FDA officials are asking that any and all adverse events associated with the use of Multidata devices be reported to Multidata and to the FDA’s MedWatch reporting system .