Manufacturers Unveil Radiation Therapy Readiness Check Initiative

06.09.10

Washington, D.C.  – As part of its ongoing commitment to provide safe and effective radiation therapy equipment, the Medical Imaging & Technology Alliance (MITA) and the Advanced Medical Technology Association (AdvaMed) today announced an industry-wide effort, designated the “Radiation Therapy Readiness Check Initiative,” to develop and implement additional patient protection features for radiation therapy equipment.  These features will confirm that patient treatment plans are delivered as intended, and that radiation therapy equipment, accessories, and patients are properly positioned prior to delivery of therapy.

“Radiation therapy is a crucial element in effective cancer treatment and is responsible for turning millions of patients into survivors,” said Dave Fisher, Executive Director of MITA. “By committing to additional enhanced safeguards and safety checks, radiation therapy manufacturers are doing their part to ensure accuracy and appropriateness before the patient treatment begins.”

“Building on a long track record of manufacturer innovations that enhance patient safety, these additional readiness check features serve as redundant safety checks so a user can verify that a patient is not about to receive inappropriate levels of medical radiation,” said Janet Trunzo, Executive Vice President, Technology and Regulatory Affairs, AdvaMed. “Radiation therapy is a cornerstone of quality cancer care, offering highly personalized, non-invasive and cost-effective care for the majority of cancer patients, and the medical technology industry is committed to continually advancing the safety and effectiveness of these technologies.”

The Radiation Therapy Readiness Check Initiative will provide technologists, physicists and physicians additional checkpoints to enable radiation therapy procedures to be performed correctly.  The initiative includes the following:

•    Radiation Therapy Pre-Treatment Quality Assurance Verification and Approval  Treatment plans are initially approved and subject to quality assurance (QA) by authorized professional personnel (e.g., physician, assigned medical physicist) before the device can deliver the treatment.  With the new verification, if the system has not recorded a QA approval for an initial and/or modified treatment plan, the machine will not run until authorized professional personnel acknowledge that the QA check is complete.

•    Verification of Beam Modifying Accessories  Beam modification techniques are essential to focusing medical radiation to kill cancer cells while minimizing damage to surrounding tissues.  The enhanced beam modification check verifies the correct placement of appropriate beam modifying accessories (e.g., wedges, blocks, compensators, etc.) and prevents a machine from operating if the accessories are incorrect, missing, or out of place.

•    Patient Positioning Confirmation  Enhancements to the treatment system will generate a visual representation of the planned relative positions of the patient and the treatment device to allow the operator to quickly compare with the patient’s actual position.  The operator can confirm visually that the patient is positioned as intended in the treatment plan.  The operator will then have to enter a confirmation of a positive comparison.

MITA and AdvaMed radiation therapy manufacturers have agreed to begin work immediately on implementing these initiatives into new products and making them available on compatibly configured products in the installed base within two years.