Standards of practiceQuality Improvement Guidelines for Recording Patient Radiation Dose in the Medical Record for Fluoroscopically Guided Procedures
Section snippets
Preamble
The membership of the Society of Interventional Radiology (SIR) Standards of Practice Committee represents experts in a broad spectrum of interventional procedures from both the private and academic sectors of medicine. Generally Standards of Practice Committee members dedicate the vast majority of their professional time to performing interventional procedures; as such, they represent a valid broad expert constituency of the subject matter under consideration for standards production.
Technical
Methodology
SIR produces its Standards of Practice documents using the following process. Standards documents of relevance and timeliness are conceptualized by the Standards of Practice Committee members. A recognized expert is identified to serve as the principal author for the standard. Additional authors may be assigned depending upon the magnitude of the project.
An in-depth literature search is performed using electronic medical literature databases. Then, a critical review of peer-reviewed articles is
Patient Radiation Dose Recording
As of 2011, there are no federal regulatory requirements in the United States concerning recording or reporting of radiation dose data for interventional procedures. There are recommendations on this topic from the United States Food and Drug Administration (FDA), the Conference of Radiation Control Program Directors (CRCPD), and national and international advisory bodies (5, 6, 7, 8, 9, 10). Regulations or guidance at the state level are not uniform (11). Only a small number of states have
Absorbed dose
The energy imparted to matter by ionizing radiation per unit mass of irradiated material at the point of interest. The SI unit is J kg–1 with the special name gray (Gy).
Air kerma
The energy released per unit mass of a small volume of air when it is irradiated by an x-ray beam. For diagnostic x-rays, air kerma is the same as the absorbed dose delivered to the volume of air in the absence of scatter. Air kerma is measured in Gy.
Biologic variation
With respect to radiation, the differences among individuals in the threshold
Dose Estimation
Radiation-induced effects are divided conventionally into deterministic and stochastic effects (16, 31). The likelihood of these effects in any individual patient cannot be predicted unless that patient's radiation history is known. This is the principal reason for recording patient radiation dose. Monitoring and recording patient dose data can also be valuable for both quality-assurance purposes and for improving patient safety (9, 32). Feedback to the operator may help to optimize radiation
Data Recording
Ideally, all available patient radiation dose data should be recorded (13). In the future, this may become an automatic process, as the FDA has expressed an intention to establish requirements for CT and fluoroscopic devices to provide radiation dose information for use in patient medical records or a radiation dose registry (72). For the present, and for the purpose of this guideline, adequate recording of dose metrics is defined as documentation in the patient record of at least one of the
Acknowledgments
Donald L. Miller, MD, authored the first draft of this revised document and served as topic leader during the subsequent revisions of the draft. Robert G. Dixon, MD, is chair of the Safety and Health Committee. Boris Nikolic, MD, MBA, is chair of the SIR Revisions Committee. John F. Cardella, MD, served as SIR Standards Division Councilor during the development of this document and contributed to its content. All other authors are listed alphabetically. Other members of the Safety and Health
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R.G.D. is an educational consultant for Bard (Covington, Georgia). None of the other authors have identified a conflict of interest.
The views expressed in this article are those of the authors and do not necessarily reflect the official policy or position of the Food and Drug Administration, the Department of Health and Human Services, or the United States Government.
The initial version of this article first appeared in J Vasc Interv Radiol 2004; 15:423–429.