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SC 2-3:  Radiation Safety Issues for Image-Guided Interventional Medical Procedures

The purpose of this report is to review the existing literature on image-guided interventional procedures (IGIPs) and evaluate the most common high-dose IGIPs with regard to radiation dose and safety issues. The report will provide recommendations on: (1) optimizing imaging protocols, (2) managing procedure time, (3) available radiation protection equipment and dose-reduction features, (4) tracking and trending patient and physician radiation dose, and (5) physician credentialing regarding use of IGIP equipment for these specialized procedures.

The report will be of benefit to interventional radiologists and other medical specialists (e.g., cardiologists, orthopedic surgeons), particularly those specialists who use IGIPs and often do not have adequate training in radiation safety or radiation biology and the practical radiation protection aspects of fluoroscopy (e.g., knowledge of equipment operation, optimal imaging techniques, patient and physician dose management, risk-benefit trade-offs, and the potential for early or late radiation effects).

SC 2-3 held its first meeting on July 31-August 1, 2007 at NCRP Headquarters. At the meeting it was concluded that the principal audience for the report is policymakers that can place requirements on those who conduct x-ray guided invasive (i.e., diagnostic) and interventional (i.e., therapeutic) procedures. Five key sections were identified with the following working titles, and assignment of the members to these sections was made:

  • importance of x-ray guided procedures
  • risks of radiation
  • radiation hazards to the patient
  • radiation hazards to staff
  • implementation

As of December 31, 2007 initial outlines were prepared for all five sections, and numerous references have been collected and entered on the Committee’s website for access by all Committee members. An initial draft of Section 1 on the medical benefits and risks of IGIPs was prepared and considerable thought and early draft material has been generated for Section 2 on some basic radiation science topics such as the appropriate methods for specifying radiation quantities and for evaluating the risk of deterministic and stochastic radiation effects.

On February 20, 2008 a conference call was held to review the status of writing assignments. Additional consultants have been added to the Committee to assist with effects on the skin and radiation risk analysis for patients and staff.

The second meeting was held May 5-6, 2008 to review the first compilation of draft material and a schedule for generating an initial complete draft was established. A composite draft of the five main sections was completed and distributed on June 26, 2008 for review by the SC 2-3 members. A conference call involving the Chairman, the two Vice Chairmen, and the NCRP consultant is scheduled for July 15 to develop a plan for completing the full draft. The next meeting of the Committee is scheduled for October 16-18, 2008 to review the full draft.

Additional draft material was prepared, and a set of draft recommendations (September 7, 2008) and a revised composite draft report (September 8, 2008), were distributed to all members for comment.

A meeting of the report section authors was held at NCRP on October 16-18, 2008 to further develop the draft and to focus on the recommendations. As a result of this meeting, the working title and outline for the document is:

Radiation Dose Management for X-Ray Image-Guided Interventional Procedures

Preface
Executive Summary (includes summary table of recommendations)
Introduction
Recommendations: Application of the Principles of Radiation Protection 
Recommendations: Risk and Risk Communications
Recommendations: Facilities
Recommendations: Protection of Patients
Recommendations: Protection of Staff
Recommendations: Oversight of interventional Processes
Conclusions
Detailed technical appendices with additional information on topics addressed in the main body of the text

As of March 31, 2009, further thought had gone into the structure of the document and a reorganized draft report was in preparation.

As of June 30, 2009, the recommendations were organized under five topics (Sections 2 through 6). The overall outline is currently:

  • Executive Summary (includes summary of recommendations)
  • General Information (includes scope, types of procedures, benefit and risk, justification, physics and dosimetry, radiobiology)
  • Fluoroscopic Equipment and Facilities
  • Protection of the Patient
  • Protection of Staff
  • Administrative and Regulatory Considerations

In addition, detailed technical appendices with additional information on topics addressed in Sections 2 through 6 were being prepared.

A revised draft (including a number of appendices) was distributed by the Chairman to all Committee members in preparation for a meeting on August 20-21, 2009 at the NCRP office. At that meeting the Committee concentrated on the following:

  • the application of occupational dose limits under urgent and emergent conditions, the proper role of the quantity effective dose, and training strategies (with regard to patient and staff radiation dose management) for all parties involved in fluoroscopically-guided interventional procedures;
  • improving the draft recommendations to better explain the purpose and rationale for each interventional procedure;
  • editing of the language of the recommendations to improve the clarity of presentation; and
  • conversion of many of the draft recommendations to supporting, but still prominent, comments to help focus attention on those items that constitute the revised set of recommendations.

As of September 30, 2009 the PAC review draft was actively being prepared.

The PAC review draft was distributed on November 30, 2009 with a due date for comments of December 22, 2009. As of December 31, 2009, PAC review comments were being considered and a revised draft was being prepared during the first quarter of 2010 for Council review.

Council review was completed on March 29, 2010.

The membership of SC 2-3 is:

S. Balter, Chairman
B.A. Schueler, Vice Chairman
D.L. Miller, Vice Chairman
J.A. Brinker
C.E. Chambers
K.F. Layton
M.V. Marx
C.H. McCollough
K.J. Strauss
L.K. Wagner
J.F. Angle, Consultant
L. Desponds, Consultant
A.J. Einstein, Consultant
J.W. Hopewell, Consultant
N.J. Kleiman, Consultant
M. Williams, Consultant
M. Rosenstein, Staff Consultant

 

Meetings:

July 31-Aug 1, 2007 >
May 5-6, 2008 >
October 16-18, 2008   

 

SC 2-2 Key Decision Points and Information Needed by
Decision Makers in the Aftermath of a Nuclear or
Radiological Terrorism Incident >

SC 2-5 Investigation of Radiological Incidents >

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