Category: Regulations & Standards

AdvaMed Calls for Revision to EtO Risk Assessment Standard

The Advanced Medical Technology Association (AdvaMed) has again urged the U.S. EPA to abandon its ethylene oxide (EtO) risk assessment value for one that will not potentially endanger the public health by threatening the availability of needed medical technologies.

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SDMS Updates Sonography Equipment Safety Standards

The Society of Diagnostic Medical Sonography recently updated its work-related standards for those who operate sonography equipment. The updated standards represent the work product of a 2016 Consensus Conference on Work-Related Musculoskeletal Disorders.

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Societies Update Radiation Oncology and Medical Physics Guidance

The American College of Radiology and the American Society for Radiation Oncology revised the ACR–ASTRO Practice Parameter for the Performance of Total Body Irradiation. The ACR and the American Association of Physicists in Medicine updated the ACR–AAPM Technical Standard for Diagnostic Medical Physics Performance Monitoring of Computed Tomography (CT) Equipment.

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Regulations & Standards

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FDA Expands Use of Sapien 3 Artificial Heart Valve

The U.S. FDA has approved an expanded indication for the Sapien 3 Transcatheter Heart Valve for patients with symptomatic heart disease, due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high or greater.