FDA, Legislators, Professional Groups, and Manufacturers to Address Medical Radiation Risks

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Archives of Internal Medicin

As is often the case when the government announces its intentions to impose regulations on a product that has caused concern, manufacturers hurry to address the problem and preempt tighter restrictions. In February 2010, the FDA announced it would be developing and implementing stringent measures to regulate patient exposure to radiation associated with imaging studies, in particular from computed tomography (CT) scanning. The announcement came on the heels of two December studies in the e describing inconsistency in radiation exposure among CT scans, with some delivering a radiation dose equal to 442 chest radiographs. One study suggested CT scans might contribute to as many as 29,000 new cases of cancer annually.

The FDA is investigating reports concerning hundreds of patients in the past 1 to 2 years who were overradiated during CT imaging at multiple hospitals in the United States. Patients have filed class action lawsuits against Cedars-Sinai Medical Center in Los Angeles over excessive radiation exposure during CT perfusion scans and against GE Healthcare, which manufactured the equipment.

In the wake of all the media attention the subject has received, the House Committee on Energy and Commerce, Subcommittee on Health, arranged a hearing on “Medical Radiation: An Overview of the Issues.” The House invited medical and industry experts, as well as patients, to testify about the benefits and risks associated with medical radiation. Witness James Parks described the death of his son, Scott Jerome-Parks, who had tongue cancer and died at age 43 after receiving an overdose of radiation at a New York City hospital.

The Medical Imaging & Technology Alliance (MITA), which represents equipment manufacturers, recently announced the industry’s commitment to develop new safeguards to protect against radiation overexposure. One measure is a radiation dose-check feature that will notify CT machine operators when the dose of radiation is likely to exceed recommended levels. The exposure threshold for routine use is something hospitals and imaging centers will have to determine, MITA said, but the organization offered to help establish reference dose values for diagnostic imaging. MITA said that new machines would also include a feature to allow hospitals and imaging facilities to set a maximum radiation dose limit. This would protect against inadvertent use of a hazardous level of radiation.

In a press release, Dave Fisher, executive director of MITA, said the manufacturers plan to include these new safeguards on “new releases of CT products” and to start adding them to existing CT systems by the end of 2010. Other initiatives MITA intends to pursue include improving equipment safety standards, developing protocols, performing quality and safety checks, instituting educational programs for providers, and establishing physician-developed medical guidelines to minimize radiation doses and improve transparency and reporting. MITA has outlined 8 principles to reduce unnecessary radiation exposure and medical errors, several of which are similar to the FDA’s recommendations:

• Expand and integrate appropriateness criteria into physician decision-making.

• Create a national dose-tracking registry.

• Adopt standards for storing diagnostic imaging information in electronic health records.

• Expand mandatory accreditation for advanced imaging facilities.

• Establish minimum standards for personnel who perform medical imaging examinations and deliver radiation therapy.

• Develop minimum standards to train and educate hospital and imaging facility personnel and checklists to reduce medical errors.

• Expand and standardize reporting of medical radiation errors.

• Work with stakeholders to develop radiation dose reference values to provide a data point to compare the dose level of a specific procedure.

Many of these safeguards are similar to ones the FDA has recommended. The FDA, which has jurisdiction over medical devices, will hold hearings on March 30 and March 31 to solicit input on measures to reduce radiation exposure from CT scans, nuclear medicine studies, and fluoroscopies. Everyone agrees that advanced imaging techniques benefit many patients tremendously. In light of a growing body of information on the dangers of excessive radiation exposure, particularly in children, it is important to identify and implement ways to bring radiation doses to a safe level.