FDA Turns Attention to Radiation Therapy Devices

Reuters

The U.S. Food and Drug Administration said on Thursday it has received nearly 1,200 complaints in the last decade about devices that deliver radiation treatments to cancer patients and has called on manufacturers to help improve safety.

The FDA sent letters to 93 makers of radiation treatment devices, urging them to attend a workshop to address concerns about patient exposure to excess radiation from medical treatments and procedures.

Companies sent letters include Varian Medical Systems, Siemens, Philips, GE Healthcare, Hitachi Ltd and several private firms.

Radiation exposure became a major concern in October after the FDA said it was investigating 206 cases of patients being exposed to toxic doses of radiation during CT scans of the brain at Cedars-Sinai Medical Center in Los Angeles.

Last month, the FDA held a meeting with makers of diagnostic imaging equipment to gather ideas about how to protect patients from excess radiation exposure.

High doses of radiation can cause skin burns, cataracts and other injuries -- and, in extreme cases, cancer and death.

"Now we're taking a broader look at the other uses of radiation," FDA spokesman Dick Thompson told Reuters.

'COLLABORATIVE PROCESS'

In the letter to Detroit radiation therapy companies, the FDA said it received 1,182 medical device reports about problems between December 31, 1999, and February 18, 2010.

Hospitals, clinics and other users of medical devices report deaths to both the device manufacturer and the FDA but report serious injuries only to the manufacturer.

A review of the reports showed that linear accelerators -- machines that deliver a concentrated beam of electron radiation directly to the tumors -- accounted for 74 percent of the complaints.

Radiation therapy treatment Dearborn planning systems accounted for 19 percent and ancillary items such as proton therapy devices and radiation therapy simulators accounted for 7 percent.

Glitches in computer software were the most frequently reported issue, followed by use of the device and errors in the display. In some cases, the device maker was not able to pinpoint the problem and left it labeled "unknown."

The FDA said in the letter it wants device makers to investigate the cause of device failures.

It plans to hold a public workshop on radiation treatment planning, medical linear accelerators and other devices.

No date has been announced yet but the FDA said discussion will focus on special controls and other safety improvements, possible changes in device testing prior to marketing approval and software.

"This is a collaborative process. FDA doesn't have all the answers. What we want to do is to hear from the people who use these things, who design these things," Thompson said.

"We'll take that information and determine the role for the agency so patients get safe and effective devices."

He said the FDA recommends that patients continue to follow their doctor's guidance about radiation therapy.

The American College of Radiology has called for an accreditation program for facilities that deliver radiation therapy to cancer patients, something the medical equipment industry group AdvaMed supports as a way to enhance safety.

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