Article reprinted from "The Gray Sheet" - March 1, 2010
With government scrutiny on radiation exposure from medical imaging intensifying, computed tomography manufacturers announced a unified plan last week to incorporate radiation dose alerts into their products. Read more...
CT Makers Pledge To Upgrade Equipment With Radiation Dose Warnings
Article reprinted from "The Gray Sheet" - March 1, 2010
With government scrutiny on radiation exposure from medical imaging intensifying, computed tomography manufacturers announced a unified plan last week to incorporate radiation dose alerts into their products.
GE Healthcare, Siemens, Philips, Toshiba and Hitachi say they will over the course of the year include automated alerts and warnings into newly released CT machines and as part of software updates released for already installed products.
The so-called radiation dose check initiative was announced Feb. 25 by the Medical Imaging & Technology Alliance.
The next day, MITA Managing Director David Fisher was among a dozen who testified before the House Energy & Commerce Health Subcommittee on the issue of radiation exposure from imaging and radiation oncology products.
Upgrades Will Be Made On A Rolling Basis
The new CT features will include a visual alert for operators when a customer-determined maximum routine reference dose is exceeded and a stronger warning when more explicitly dangerous levels are reached.
The updates will also include capabilities for health care facilities to set radiation dose limits that prevent machines from releasing doses above the designated level.
Machines on the market now display the current radiation level to operators, but they do not typically incorporate these types of alerts designed to get the providers' attention.
"It is a rolling initiative," Fisher said on a Feb. 25 media call. "It won't happen overnight, but as new versions of machines come out and new technology is developed, as well as when updates for older machines become available."
Fisher also pointed out that it is not clear at this point whether additional FDA clearances will be required for the upgrades.
FDA may require equipment radiation dose alerts as part of standards the agency is putting together for CT, fluoroscopy and nuclear imaging devices.
The agency issued a white paper and announced an initiative to develop the standards in February and plans to meet publicly with stakeholders March 30-31 to determine next steps (The Gray Sheet' Feb. 15, 2010).
According to a Feb. 24 Federal Register notice on the upcoming meeting, FDA will ask for suggestions on requiring additional data related to radiation safety in PMAs or 510(k)s submitted for the targeted imaging devices.
The agency will also seek feedback on various types of equipment upgrades that could improve patient radiation safety and possible enhancements in user training and quality assurance efforts.
Imaging equipment manufacturers say they strongly support FDA's initiative and stress that they have been focusing on radiation safety issues for some time (The Gray Sheet' Feb. 22, 2010).
"We welcome FDA's announcement and support many of the items they included in their white paper," Fisher said.
FDA, Industry Priorities Overlap
Some priority areas of overlap between FDA and industry include developing standard radiation dose reference values for specific procedures and standardizing the storage of imaging radiation information for recording in electronic health records.
MITA also says that imaging equipment companies support a national dose registry to track long-term dose trends, as proposed in the Obama administration's fiscal year 2011 budget request for FDA (The Gray Sheet' Feb. 8, 2010).
On this issue, as part of its initiative announced last week, Fisher says that the five CT manufacturers are pledging to standardize the format for recording doses by the machines, making it easier to integrate the information into a national registry.
- David Filmore
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