Safety Features Should Be Standard On CT, Fluoro Devices, Docs Say

Article preview from "The Gray Sheet" - April 26, 2010

In the same way seatbelts and airbags are mandatory for all cars, available technologies for reducing radiation dose should be required for all medical imaging equipment that uses ionizing radiation, the Society of Interventional Radiology argues.

Safety Features Should Be Standard On CT, Fluoro Devices, Docs Say

Article preview from "The Gray Sheet" - April 26, 2010

In the same way seatbelts and airbags are mandatory for all cars, available technologies for reducing radiation dose should be required for all medical imaging equipment that uses ionizing radiation, the Society of Interventional Radiology argues.

While various dose reduction and monitoring technologies have been developed by manufacturers, the safety features are frequently offered only "as an extra-cost option on a new-equipment quote," the physician group says in April 20 comments to FDA.

"Any technology advertised by the manufacturer to improve image quality, reduce dose or increase safety must be included in the base (standard) system offering," the society argues.

The group was among several physician and industry organizations that responded to an FDA request for comments on steps manufacturers of computed tomography and fluoroscopy devices could take to reduce unnecessary radiation exposure to patients.

FDA plans to use the input as it develops new design standards for CT and fluoroscopy equipment for inclusion in an eventual rulemaking and special controls guidance document.

Industry, Physicians Agree On Many Points

Physicians and manufacturers seem to agree on several points.

Most groups that submitted comments said that the equipment should not have to incorporate features that would allow users to check the appropriateness of an imaging exam before it is begun.

"By the time a patient presents for a procedure, decisions about the appropriateness of an exam should have already been made" by a physician who knows the particulars of a patient's medical condition, the Society for Cardiovascular Angiography and Interventions, representing interventional cardiologists, wrote.

"It is not the responsibility of the manufacturer of imaging equipment to oversee the appropriateness of an exam."

The Society of Interventional Radiology agreed, as did GE Healthcare and the Medical Imaging and Technology Alliance. The latter group commented that the CT or fluoroscopy technologist "should not be put in the position of questioning and overriding the medical appropriateness of a physician's judgment in ordering the exam."

- Mary Houghton

Sign up for a complimentary 30-day trial of "The Gray Sheet"  There is no obligation and no credit card needed.  Click here to sign up and get your first issue.

Elsevier Business Intelligence announces the publication of a new Special Report "Bigger, Tougher,Faster"- Preparing for the New FDA. When the inspector comes calling ... will you be ready?
This 16-page report originally published in "The Silver Sheet". Learn more... 

Plus:
To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact Kristy Kennedy at (480) 985 9512