FDA schedules meeting on RT error reduction

The U.S. Food and Drug Administration (FDA) has scheduled a public meeting for June 9-10 in Gaithersburg, MD, to discuss steps that could be taken by manufacturers of radiation therapy (RT) systems to help reduce treatment errors.

The first day of the meeting will focus on hardware and software equipment features that manufacturers of linear accelerators, radiation therapy treatment planning systems, and radiation therapy simulators should incorporate into their devices.

Topics to be discussed include:

  • Whether manufacturers should submit more data about the safety of devices when applying for premarket approval.
  • Whether manufacturers should provide more detailed information for customers about acceptance testing methodology.
  • Whether and what types of hardware and software features could be used to reduce overexposures, underexposures, or misaligned exposures to ionizing radiation during therapy.
  • Whether display formats should be standardized for all radiation therapy equipment.
  • How to improve identification and voluntary reporting of adverse events, and whether quantitative metrics could be used to better define these events.

The second day will focus on user training and quality assurance measures. Training topics will include the type, timing, and extent of training programs, including the medical staff who should receive the training and what types of educational support materials should be provided. The FDA also plans to discuss how software patches and upgrades are tested for hazard analysis, verification, and validation, and whether additional testing is recommended.

The FDA is also seeking input on whether manufacturers should provide quality assurance procedures to their customers, as well as training on how to perform quality assurance. Other agenda topics include who should be responsible for various types of quality assurance, and ways to identify model QA programs that are widely accepted and could be adopted by other radiation oncology centers.

Free registration is on a first-come, first-served basis, and written comments from any interested individuals or organizations prior to the meeting are welcome. Details are available by clicking here.

Related Reading

Societies to host meeting on radiation safety, April 16, 2010

Rad therapy groups support FDA review, April 13, 2010

FDA turns attention to radiation therapy devices, April 8, 2010

FDA hearings rise above medical radiation rhetoric, March 31, 2010

Copyright © 2010 AuntMinnie.com

Page 1 of 461
Next Page