由 Gus Iversen
, Editor in Chief | April 06, 2015
In late 2012, 536 people from 77 countries and 16 organizations came together in Bonn, Germany to address a worldwide concern: safely managing medical radiation exposure.
The event — organized by the International Atomic Energy Agency (IAEA) and the World Health Organization (WHO) — set out to define better ways to utilize radiation while limiting the dangers associated with it.
Known as the Bonn Call-for-Action, the conference outlined five key goals:
-To strengthen the radiation protection of patients and health workers overall
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-To attain the highest benefit with the least possible risk to all patients by the safe and appropriate use of ionizing radiation in medicine
-To aid the full integration of radiation protection into health care systems
-To help improve the benefit/risk-dialogue with patients and the public
-To enhance the safety and quality of radiological procedures in medicine
To reach those goals, a list of ten key actions were created and within them were smaller steps that can be taken in the interest of those actions.
Last week the FDA issued an update statement
outlining the myriad ways it has been actively participating in meeting the goals set out in the Bonn Call-for-Action.
Some of the FDA's low dose efforts include drafting the International Commission on Radiological Protection’s (ICRP) guidance on justification in medicine and contributing to the Federal Guidance Report No. 14 (Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures).
Among a number of other projects, the agency has also worked with the American College of Cardiology (ACC) to incorporate radiation dose data in procedure data submitted to the ACC’s National Cardiovascular Data Registry, and engaged with the International Electrotechnical Commission (IEC) and the Medical Imaging & Technology Alliance (MITA) to introduce safety features into the national and international standards for medical devices.
Working with MITA has been a crucial component, as Smart Dose initiatives like the XR standards aim to incentivize low dose imaging. The latest of which, XR-29, includes key features of CT equipment that enable optimization or management of radiation dose delivery while providing high quality images. In a response to the FDA, MITA issued their own statement.
“Medical device manufacturers in the United States and abroad are committed to ensuring safe, high-quality patient care by developing new technologies and safety features, publishing safety standards, collaborating with the U.S. FDA and patient and professional societies, and advancing policy initiatives that incentivize adoption of equipment that meets specific standards for radiation dose optimization,” said Thad Flood, JD, industry director of MITA.
The FDA had Bonn Call-for-Action examples in each of the ten categories except one: Shape and promote a strategic research agenda for radiation protection in medicine
. As part of their statement, the FDA explained some of the Bonn Call-for-Action objectives fall outside of their jurisdiction.