MO-D-218-01: Overview of Methodology and Standards (QIBA, IEC, AIUM and AAPM).

Ultrasoundsystem standards and professional guidelines can facilitate efficient provision of medical physics services and growth of ultrasound imaging if the documents are well designed and are utilized. We too often develop our own phantoms and procedures and never converge to obtain a critical mass of data on system performance and value of such services. Standards can also produce unnecessary costs and limit innovation if not carefully developed, reviewed, and changed as needed. There are quite a few new initiatives that, if followed vigorously, could improve medicalultrasound and medical physicists’ contributions thereto. This talk is to explain many of the existing standards and recommendations for ultrasoundsystemquality control, performance evaluation, and safety, as well as current and suggested efforts in these areas. The primary standards body for medicalultrasoundsystems is now the International Electrotechnical Commission (IEC). Uniformity across the world is helpful to all if the documents are reasonably current. There still is a role for traditional bodies such as the AAPM with its valuable report series and the American Inst. of Ultras. in Med. (AIUM) with its own standards and reports and its joint work with the Medical Imaging Technology Alliance (MITA). All three, with strong involvement of FDA scientists and with some efforts from the Acoustical Society of America have historically provided the main standards affecting medical physicists. Now that the lengthy IEC process is moving more smoothly, our national bodies still can provide new developments and drafts that can be offered as needed for international standardization. The ACR in particular can provide meaningful incentives through ultrasound service accreditation. Without any regulatory or strong consumer push, reports and standards on ultrasoundsystem performance have received only modest use in the USA. A consistent consumer or accreditation push might be justified now. A series of three standards on performance evaluation is well on its way to covering pulse echo ultrasound well, with IEC 61319‐1 on spatial measurements, IEC 61319‐2 on depth of penetration and local dynamic range and one draft and one Technical Specification 62558 on small void imaging. A new effort has just been initiated to help drive more and better use of quantitative ultrasound imaging in human and surrogate studies and in clinical use. A shear wave speed ultrasound technical committee will carry out this effort in the Quantitative Imaging Biomarkers Alliance (QIBA) that is managed by the RSNA. Learning Objectives: 1. Understand the coverage of the two current and third planned IEC medicalultrasound performance evaluation standards that could form a basis for stable performance evaluation tests. 2. Understand the coverage of the Current AIUM and ACR QC documents and the drafting and support efforts in the IEC. 3. Understand the need for and partial availability of simplified software and instructions to improve and facilitate performance of these tests? 4. Understand how standards development can lead to improved understanding and performance of medicalultrasound imaging as is anticipated for the new QIBA effort.