FDA Tightens Regulation in Manufacturing Radiation Therapy Devices

The US Food and Drug Administration has announced that it will be toughening measures imposed on the manufacturers of new radiotherapy equipment.

In the streamlined processed previously used to manufacture and test radiotherapy equipment, third party companies were often used to review and test the equipment function. A letter that was issued to the manufacturers of the equipment stating that the FDA will no longer allow the use of a third party or streamlined processing to bring new radiotherapy equipment to the market.

In the last 10 years, the FDA has received approximately 1,000 reports about malfunctioning equipment. Almost 75% of the reported errors involved the component of the machine that generates the high power radioactive beams that kill the cancer cells. Problems with the machine’s software was listed as another commonly cited problem.

“We depend on these machines to do right by our patients, and anything that can be done to make it safer, we are 100 percent behind,” said Dr. Blumberg of the American College of Radiology. “These are very complicated machines, and we are asking them to do very complicated things in a very important and concise fashion.”

The new regulations are to prevent overdosing and under-dosing.