FDA Takes Action on Medical Radiation Complaints

On Thursday the United States Food and Drug Administration (FDA) announced that it has received over a thousand complaints in the past 10 years about medical radiation devices that are used to treat cancer patients. The FDA is calling on the manufacturers to improve safety and performance of their products to reduce patient overexposure and deaths.

The action taken by the FDA involved sending letters to 93 manufacturers of radiation devices inviting and urging them to attend a workshop to learn more about patient overexposure to radiation from medical treatments.

This workshop idea came into being after a meeting between the FDA and the makers of diagnostic imaging equipment to determine how to protect patients from excess radiation. The meeting was brought about when the FDA investigated 206 cases in October of 2009 of patients exposed to toxic doses of radiation during routine CT scans at Cedars-Sinai Medical Center. FDA representative Dick Thompson told Reuters “Now we’re taking a broader look at the other used of radiation.”

The Food and Drug Administration is responsible for testing and approval of these devices made by such companies as Varian Medical Systems, Siemens, Philips, and Hitachi as well as smaller private makers.

Patients exposed to high doses of radiation may experience skin burns, cataracts, and other ailments, along with cancer (which the radiation is supposed to treating) and death. The devices in question are:

Linear accelerators which deliver concentrated electron radiation directly to tumors. Linear Accelerators account for 74 percent of the 1,182 complaints the FDA received between December 31, 1999 and February 18, 2010 concerning excess radiation exposure.

Radiation Therapy treatment planning systems claim a full 19 percent of the claims.

Ancillary items, including proton therapy, and radiation therapy simulators account for 7 percent of the complaints.

The most frequently reported issues include glitches in computer software, use of the devices, and display errors some of which the makers of the device were unable to pinpoint and have identified the problem as “unknown” The FDA want the makers of these devices to investigate all failures and the workshop will focus on radiation treatment planning, medical linear accelerators and other devices used in the field of radiation therapy and imaging. Discussion at the workshop will focus on controls, safety improvements, testing, and software and device changes. The FDA has not announced a date as of yet for the workshop.



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2 Comments

  1. Drew Branson says:

    As expected everyone is consistently trying to throw Proton Therapy under the bus. As a point of fact, the FDA did not received 1 single complaint out of the total of “over a thousand”. The 7% eluded to in these reports all of them are CT simulators and have nothing to do with the Proton Beam Equipment.

  2. Pingback: Confluence of global trends ups ante for improved IT governance to prevent costly business 'glitches' | Dana Gardner’s BriefingsDirect | ZDNet.com

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