Defective medical product news: radiation device issues prompt need for improved safety

Defective medical product news: radiation device issues prompt need for improved safety


Legal News for Product Liability Attorneys. The FDA has received nearly 1,200 complaints of issues with radiation treatment devices since 1999.

Product liability attorney alert- FDA calls on manufacturers of radiation treatment equipment to help improve safety.

Chicago, IL—In the last decade, the U.S. Food and Drug Administration (FDA) has received nearly 1,200 complaints concerning radiation treatment devices, subsequently prompting federal regulators to call on the manufactures of the medical equipment to increase safety. The FDA reported Thursday, April 8, 2010, 93 letters have been sent out to the producers of the medical devises, asking them to participate in a workshop to “address concerns about patient exposure to excess radiation from medical treatments and procedures”, according to information provided by Reuters.

In the letters sent out to the manufacturers of some radiation treatment devices, the FDA disclosed that between December 31, 1999 and February 18, 2010, the administration received 1,182 complaints alleging issues with the equipment or its adverse affects. The most common of the complaints received allegedly stemmed from malfunctioning computer software. It was reported that 74 percent of complaints derived from issues with linear accelerators, a device that sends a direct stream of electron radiation to a patient’s tumor.

The FDA sent letters to manufacturers including Varian Medical Systems, Siemens, Philips, GE Healthcare, Hitachi as well as several others. Though a date has not yet been set for the safety workshop, the process is expected to improve the safety of these devices and how they are used. Patients exposed to excess radiation, due to defective equipment or even error by medical personnel, are at risk of burn, cataracts and other miscellaneous injuries. Too much radiation can also cause patients to develop terminal ailments such as cancer. Improvements in such radiation treatments and devices are expected to be underway.

Legal News Reporter: Sandra Quinlan- Legal News for Product Liability Lawyers.

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