Paul J Dorio, MD

In February, 2010, the Society of Interventional Radiology delivered  comments to the Subcommittee on Health, Committee on Energy and Commerce, U.S. House of Representatives, for the hearing on "Medical Radiation: An Overview of the Issues."

The statement was submitted in letter form as follows:

The Honorable Frank Pallone, Jr.

Congress of the United States House of Representatives

Committee on Energy and Commerce

Subcommittee on Health

2125 Rayburn House Office Building

Washington, DC 20515-6115

Dear Congressman Pallone:

RE: Hearing on “Medical Radiation: An Overview of the Issue”

The Society of Interventional Radiology (SIR) appreciates the opportunity to submit comments to the Subcommittee on Health, Committee on Energy and Commerce, U.S. House of Representatives, for the hearing on “Medical Radiation: An Overview of the Issues.” We commend you for convening this important hearing.

SIR is a professional medical society representing more than 4,500 practicing interventional radiology physicians, clinical associates, PhD scientists, and medical physicists whose mission is to improve the health of the public through pioneering advances in image-guided therapy.

Interventional radiology is the medical specialty credited with pioneering modern minimally invasive medicine—medical treatment without scalpels—by reaching the source of a medical problem through blood vessels or directly through a small nick in the skin to deliver a precise, targeted treatment. Interventional radiologists are responsible for much of the medical innovation and development of minimally invasive treatments that are commonplace today. From the invention of angioplasty and the catheter-delivered stent, which were both first used to treat peripheral arterial disease in the legs, to drug-eluting stents, balloon angioplasty, catheter delivery systems and clot-removing devices of today—these specialists continue to shape and change the medical landscape and improve patient care. IR treatments delivered by board-certified experts can deliver solutions with less risk, less pain and less recovery time than traditional surgery.

Interventional radiologists use ionizing radiation (fluoroscopy) as well as other imaging modalities in the performance of their procedures. They have demonstrated competency through their American Board of Medical Specialties (ABMS)-sanctioned Board Certification. All interventional radiologists receive extensive training in radiation physics, radiation biology, and radiation safety in their residency.

SIR is committed to radiation safety and has a long history of advocating for radiation dose reduction for patients. For the past thirty-five years, SIR has taken a leading role in measuring and assessing radiation dosage; developing educational programs on radiation safety, radiation protection, and reduction of skin dosage; developing radiation safety guidelines; and promoting the safety of patients and health care professionals for image-guided therapies. (1, 2)

We agree with the fundamental principles of ALARA (as low as reasonably achievable) and support efforts to ensure the lowest possible dose. SIR’s position is clearly stated in our Statement on Radiation Safety:

Those who use radiation must be adequately trained in radiation safety, radiation physics, the biologic effects of radiation, and injury prevention to ensure patient safety. The use of radiation in diagnosing and treating patients has significantly advanced the field of medicine and saved or extended countless lives…The use of radiation, however, is not without risk…Those who use radiation must be adequately trained in radiation safety, radiation physics, the biologic effects of radiation, and injury prevention to ensure patient safety. This training is standard in radiology and interventional radiology training programs. (3)

For an individual patient, radiation risks, while real, must be interpreted in the context of relative risk and benefit. Certainly, cumulative dose is important as well and all efforts must be made to minimize both. But, these efforts must be balanced against the expected benefit of any interventional or diagnostic procedure. (4)

After fluoroscopy was developed at the turn of the last century, it was applied widely in and out of the medical space. After the discovery that X-rays could cause injury, its use was constrained in medicine and a specialty called Radiology was created to manage this beneficial but potentially harmful tool. The risks of radiation are not a new concept for our discipline. With more advanced technological platforms, increasingly complex procedures, and dissemination of use outside of our discipline, we have been aware of the increasing possibility of radiation-related injuries since the early 1990s, when the issue was first raised by the U.S. Food and Drug Administration (FDA). SIR conducted the first detailed study of radiation doses in IR procedures in the late 1990s at the request of FDA—the RAD-IR study. (5,6) We shared the results of the RAD-IR study with FDA prior to publication and have been involved in measures to educate the public, our members, referring clinicians, and equipment manufacturers very actively both before and since then.

Only an appropriately credentialed physician has the skills, training, and experience to oversee the safe performance of fluoroscopy. It must be remembered that fluoroscopic procedures carry a risk of exposure to radiation, with related injuries (5, 6, 7). Patient radiation dose during fluoroscopy is dependent on the operator's training, experience with the fluoroscope, and efficiency in completing the study. The influence of training on radiation times and exposures has been demonstrated in studies of complex fluoroscopically-guided procedures (8,9). Patients can be harmed as a result of these fluoroscopically-guided procedures, as demonstrated in multiple publications, including the FDA document by Shope (10). These injuries can occur even when fluoroscopy is used by well-trained persons; imagine the risk from use by those not well trained or not trained at all in radiation protection and radiation management. There can be substantial increases in radiation dose to the patient when the fluoroscopist does not use proper technique (11).

In addition to the patient, we must consider those receiving occupational exposure. Without proper training, and without the use of appropriate technique, the operator’s occupational dose will be higher than necessary (12). For orthopedic and pain management procedures, this is particularly true for the operator’s hands (13). SIR continues to advocate with industry, partner societies, and regulatory agencies for reduced operator dose, through training, standards, and board certification of our members. We have worked with our partner organizations representing technologists and nurses. We strongly believe that the use of any tool that carries risk should require demonstrated competency and adherence to standards by the user prior to its application. 

Thank you for your consideration of our comments. If we can provide any additional information or if you have questions and would like to discuss our comments in more detail, please do not hesitate to contact me at bstainken@rwmc.org or (401) 456-2204, Tricia McClenny, Associate Executive Director, in the SIR office at tricia@SIRweb.org or (703) 691-1805, or Doug Huynh, Manager of Government Affairs, atdhuynh@SIRweb.org or (703) 691-1805.

Sincerely,

Brian Stainken, MD, FSIR

President, Society of Interventional Radiology

References:

1. Stecker MS, Balter S, Towbin R, Miller D, et. al. Guidelines for patient radiation dose management. J Vasc Interv Radiol 2009; 20:S263-S273.

2. Miller DL, Balter S, Wagner LK, et al. Quality improvement guidelines for recording patient radiation dose in the medical record. J Vasc Interv Radiol 2004;15:423-9.

3. Cardella JF, Miller DL, Cole PE, Lewis, CA. Society of Interventional Radiology position statement on radiation safety. J Vasc Interv Radiol 2003;14:S387.

4. Miller DL. Overview of contemporary interventional fluoroscopy procedures. Health Phys 2008;95(5):638-644.

5. Miller DL, Balter S, Cole PE, et al. Radiation doses in interventional radiology: the RAD-IR study. Part I: overall measures of dose. J Vasc Interv Radiol 2003; 14:711-727.

6. Miller DL, Balter S, Cole PE, et al. Radiation doses in interventional radiology: the RAD-IR study. Part II: skin dose. J Vasc Interv Radiol 2003; 14:977-990.

7. Balter S, Hopewell JW, Miller DL, Wagner LK, Zelefsky MJ. Fluoroscopically guided interventional procedures: A review of radiation effects on patients’ hair and skin. Radiology 2010; 254:326-341.

8. Verdun FR, Aroua A, Trueb PR, Vock P, Valley JF. Diagnostic and interventional radiology: a strategy to introduce reference dose level taking into account the national practice. Radiat Prot Dosimetry 2005;114:188-91.

9. Bor D, Sancak T, Toklu T, Olgar T, Ener S. Effects of radiologists' skill and experience on patient doses in interventional examinations. Radiat Prot Dosimetry 2008;129:32-5.

10. Shope TB. Radiation-induced skin injuries from fluoroscopy. Radiographics 2006;16:1195-1199.

11. Mavrikou I, Kottou S, Tsapaki V, Neofotistou V. High patient doses in interventional cardiology due to physicians' negligence: how can they be prevented? Radiat Prot Dosimetry 2008;129:67-70.

12. Detorie N, Mahesh M, Schueler BA. Reducing occupational exposure from fluoroscopy. J Am Coll Radiol 2007;4:335-7.

13. Tsalafoutas IA, Tsapaki V, Kaliakmanis A, et al. Estimation of radiation doses to patients and surgeons from various fluoroscopically guided orthopaedic surgeries. Radiat Prot Dosimetry 2008;128:112-9.