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Manufacturers of computed tomography machines have agreed to a standardized set of features that will help ensure that patients receive the appropriate radiation dose when being scanned.
In a conference call with reporters, Dave Fisher, executive director of the Medical Imaging & Technology Alliance (MITA), said that the industry had been working for years to make CT machines safer and that the timing of the announcement was not related to either the Food and Drug Administration's recent heightened interest in radiation or a recent House Energy & Commerce Health Subcommittee hearing.
The five CT manufacturers—General Electric, Siemens, Philips, Toshiba, and Hitachi—all agreed to participate in the MITA “dose check” initiative, said Mr. Fisher.
There are three new main safety features. First, machine operators will receive an on-screen alert—possibly in the form of a pop-up window—when they exceed recommended dose levels. The alert is akin to a yellow caution flag, said Mr. Fisher. The recommended dose—the reference dose—will be determined by clinicians at hospitals and imaging centers, not manufacturers, he said.
The second safeguard will also likely come as a pop-up window: a warning if the dose reaches hazardous levels that could result in burns, hair loss, or other injuries. This “red flag” can be configured to prevent the scan, Mr. Fisher said.
Clinicians, not manufacturers, will have the power to determine whether they want to block a scan or have some other series of instructions or steps to prevent harm, he said.
Manufacturers have agreed to a standardized method of image storage so that they can be incorporated into a registry—if such a registry is developed, as the Obama administration has proposed. The new features will not likely be available until late 2010 or early 2011, Mr. Fisher said. They may come as software upgrades to older machines or add-ons to new scanners being developed now. The process may be delayed if the FDA decides that the features need regulatory clearance, he said.
Manufacturers of computed tomography machines have agreed to a standardized set of features that will help ensure that patients receive the appropriate radiation dose when being scanned.
In a conference call with reporters, Dave Fisher, executive director of the Medical Imaging & Technology Alliance (MITA), said that the industry had been working for years to make CT machines safer and that the timing of the announcement was not related to either the Food and Drug Administration's recent heightened interest in radiation or a recent House Energy & Commerce Health Subcommittee hearing.
The five CT manufacturers—General Electric, Siemens, Philips, Toshiba, and Hitachi—all agreed to participate in the MITA “dose check” initiative, said Mr. Fisher.
There are three new main safety features. First, machine operators will receive an on-screen alert—possibly in the form of a pop-up window—when they exceed recommended dose levels. The alert is akin to a yellow caution flag, said Mr. Fisher. The recommended dose—the reference dose—will be determined by clinicians at hospitals and imaging centers, not manufacturers, he said.
The second safeguard will also likely come as a pop-up window: a warning if the dose reaches hazardous levels that could result in burns, hair loss, or other injuries. This “red flag” can be configured to prevent the scan, Mr. Fisher said.
Clinicians, not manufacturers, will have the power to determine whether they want to block a scan or have some other series of instructions or steps to prevent harm, he said.
Manufacturers have agreed to a standardized method of image storage so that they can be incorporated into a registry—if such a registry is developed, as the Obama administration has proposed. The new features will not likely be available until late 2010 or early 2011, Mr. Fisher said. They may come as software upgrades to older machines or add-ons to new scanners being developed now. The process may be delayed if the FDA decides that the features need regulatory clearance, he said.
Manufacturers of computed tomography machines have agreed to a standardized set of features that will help ensure that patients receive the appropriate radiation dose when being scanned.
In a conference call with reporters, Dave Fisher, executive director of the Medical Imaging & Technology Alliance (MITA), said that the industry had been working for years to make CT machines safer and that the timing of the announcement was not related to either the Food and Drug Administration's recent heightened interest in radiation or a recent House Energy & Commerce Health Subcommittee hearing.
The five CT manufacturers—General Electric, Siemens, Philips, Toshiba, and Hitachi—all agreed to participate in the MITA “dose check” initiative, said Mr. Fisher.
There are three new main safety features. First, machine operators will receive an on-screen alert—possibly in the form of a pop-up window—when they exceed recommended dose levels. The alert is akin to a yellow caution flag, said Mr. Fisher. The recommended dose—the reference dose—will be determined by clinicians at hospitals and imaging centers, not manufacturers, he said.
The second safeguard will also likely come as a pop-up window: a warning if the dose reaches hazardous levels that could result in burns, hair loss, or other injuries. This “red flag” can be configured to prevent the scan, Mr. Fisher said.
Clinicians, not manufacturers, will have the power to determine whether they want to block a scan or have some other series of instructions or steps to prevent harm, he said.
Manufacturers have agreed to a standardized method of image storage so that they can be incorporated into a registry—if such a registry is developed, as the Obama administration has proposed. The new features will not likely be available until late 2010 or early 2011, Mr. Fisher said. They may come as software upgrades to older machines or add-ons to new scanners being developed now. The process may be delayed if the FDA decides that the features need regulatory clearance, he said.