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Radiation Oncology Organization, FDA Announce Radiation Safety Initiatives

Radiation Oncology Organization, FDA Announce Radiation Safety Initiatives The world's largest radiation oncology society and the US government have each called for measures to enhance the safety of medical radiation and to reduce unnecessary exposure in patients. The American Society for Radiation Oncology (ASTRO) has committed to a patient protection plan that will improve safety and quality and reduce the chances of medical errors when radiation is used to treat cancer. Meanwhile, the US Food and Drug Administration (FDA) will launch an initiative to promote the safe use of imaging devices for medical use, to support informed clinical decision making, and to increase patients' awareness of their own exposure. New initiatives are under way aimed at improving the safety of medical radiation. In announcing its new plan, ASTRO noted that radiation has been and will continue to be an essential part of cancer therapy. “Radiation treatments are actually more safe now than 20 years ago, when almost all data were entered by hand and dosimetry was primitive, and [x-ray] devices were placed by hand,” said ASTRO Board Chairman Tim Williams, MD. However, he added, “now the staff assumes the computers are correct and they don't follow policies and procedures to check the treatments as they are being delivered.” Any errors, no matter how small, must be reported, understood, and used as a learning tool to reduce the potential for future errors, according to Williams, a radiation oncologist at the Boca Raton Community Hospital in Florida. In the first of 6 steps, ASTRO will work with others to create a central database for the reporting of errors involving linear accelerators (the machines that generate radiation) and computed tomography (CT) scanners. “Anonymous reporting to a national database will allow many centers to learn from one center's error,” said Williams. Other steps ASTRO will take include Launching an enhanced practice accreditation program to address new, advanced technologies. According to Williams, this will ensure that certified centers maintain the highest standards and have meaningful quality and safety programs in place. Expanding educational training programs to include specific courses on quality assurance and safety. Working with patient support organizations to develop tools for cancer patients and caregivers. “Patient tools will allow them to ask appropriate questions of their radiation oncologist so they can be assured that their treatments are safe,” said Williams. Further developing the organization's connectivity compliance program—seeking to improve the way computer systems in radiation oncology share information through coordinated use of established standards. Advocating for new and expanded federal initiatives to help protect patients. This includes support for passage of the Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy (CARE) Act, which would require national standards for radiation therapy team members, additional resources for the National Institutes of Health's Radiological Physics Center to evaluate the safety of treatments, and funding for a national reporting database. The FDA's safety plan aims to reduce unnecessary radiation exposure from 3 types of medical imaging procedures: CT, nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to individuals' total radiation exposure and use much higher radiation doses than other radiographic procedures such as x-rays and mammography. “Improved technologies have allowed for more accurate screening and earlier detection of disease, but at the same time, their use has increased the amount of radiation Americans are exposed to and can increase their risk of cancer,” said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health. In addition, accidental exposure to very high amounts of radiation can cause injuries such as skin burns, hair loss, and cataracts. Shuren noted that for every patient who receives medical radiation, the radiation should be justified and the dose should be optimized. “Physicians should review their protocols and ensure proper doses of radiation for their patients,” he said. Recently, an FDA investigation revealed that more than 250 patients treated at 4 or more facilities in 2 states received up to 8 times the expected dose of radiation during CT perfusion scans (Kuehn BM. JAMA. 2010;303[2]:124). “Physicians also need to know the cumulative history of radiation that patients have already received, and that's something that isn't available yet,” said Shuren. To address this, the FDA is collaborating with other organizations to develop a patient medical imaging history card that will allow patients to track their own medical imaging history and share it with their physicians. The FDA also plans to issue requirements for manufacturers regarding necessary safeguards when designing their machines and when training practitioners in their use. In addition, the agency is working to incorporate key quality assurance practices into the mandatory accreditation of imaging facilities and hospitals. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Radiation Oncology Organization, FDA Announce Radiation Safety Initiatives

JAMA , Volume 303 (13) – Apr 7, 2010

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Publisher
American Medical Association
Copyright
Copyright © 2010 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2010.340
Publisher site
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Abstract

The world's largest radiation oncology society and the US government have each called for measures to enhance the safety of medical radiation and to reduce unnecessary exposure in patients. The American Society for Radiation Oncology (ASTRO) has committed to a patient protection plan that will improve safety and quality and reduce the chances of medical errors when radiation is used to treat cancer. Meanwhile, the US Food and Drug Administration (FDA) will launch an initiative to promote the safe use of imaging devices for medical use, to support informed clinical decision making, and to increase patients' awareness of their own exposure. New initiatives are under way aimed at improving the safety of medical radiation. In announcing its new plan, ASTRO noted that radiation has been and will continue to be an essential part of cancer therapy. “Radiation treatments are actually more safe now than 20 years ago, when almost all data were entered by hand and dosimetry was primitive, and [x-ray] devices were placed by hand,” said ASTRO Board Chairman Tim Williams, MD. However, he added, “now the staff assumes the computers are correct and they don't follow policies and procedures to check the treatments as they are being delivered.” Any errors, no matter how small, must be reported, understood, and used as a learning tool to reduce the potential for future errors, according to Williams, a radiation oncologist at the Boca Raton Community Hospital in Florida. In the first of 6 steps, ASTRO will work with others to create a central database for the reporting of errors involving linear accelerators (the machines that generate radiation) and computed tomography (CT) scanners. “Anonymous reporting to a national database will allow many centers to learn from one center's error,” said Williams. Other steps ASTRO will take include Launching an enhanced practice accreditation program to address new, advanced technologies. According to Williams, this will ensure that certified centers maintain the highest standards and have meaningful quality and safety programs in place. Expanding educational training programs to include specific courses on quality assurance and safety. Working with patient support organizations to develop tools for cancer patients and caregivers. “Patient tools will allow them to ask appropriate questions of their radiation oncologist so they can be assured that their treatments are safe,” said Williams. Further developing the organization's connectivity compliance program—seeking to improve the way computer systems in radiation oncology share information through coordinated use of established standards. Advocating for new and expanded federal initiatives to help protect patients. This includes support for passage of the Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy (CARE) Act, which would require national standards for radiation therapy team members, additional resources for the National Institutes of Health's Radiological Physics Center to evaluate the safety of treatments, and funding for a national reporting database. The FDA's safety plan aims to reduce unnecessary radiation exposure from 3 types of medical imaging procedures: CT, nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to individuals' total radiation exposure and use much higher radiation doses than other radiographic procedures such as x-rays and mammography. “Improved technologies have allowed for more accurate screening and earlier detection of disease, but at the same time, their use has increased the amount of radiation Americans are exposed to and can increase their risk of cancer,” said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health. In addition, accidental exposure to very high amounts of radiation can cause injuries such as skin burns, hair loss, and cataracts. Shuren noted that for every patient who receives medical radiation, the radiation should be justified and the dose should be optimized. “Physicians should review their protocols and ensure proper doses of radiation for their patients,” he said. Recently, an FDA investigation revealed that more than 250 patients treated at 4 or more facilities in 2 states received up to 8 times the expected dose of radiation during CT perfusion scans (Kuehn BM. JAMA. 2010;303[2]:124). “Physicians also need to know the cumulative history of radiation that patients have already received, and that's something that isn't available yet,” said Shuren. To address this, the FDA is collaborating with other organizations to develop a patient medical imaging history card that will allow patients to track their own medical imaging history and share it with their physicians. The FDA also plans to issue requirements for manufacturers regarding necessary safeguards when designing their machines and when training practitioners in their use. In addition, the agency is working to incorporate key quality assurance practices into the mandatory accreditation of imaging facilities and hospitals.

Journal

JAMAAmerican Medical Association

Published: Apr 7, 2010

Keywords: radiation oncology

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