Medical Ultrasound Safety (MUS)

The US Food and Drug Administration (FDA) recommends manufacturers provide an ultrasound safety manual with every sale of ultrasound equipment. The latest version of the AIUM Medical Ultrasound Safety (MUS) manual not only fulfills the FDA's education program requirements (Track 3) for clinical end users but also incorporates numerous cutting-edge technological enhancements in the field of ultrasound scanning.

The AIUM’s Medical Ultrasound Safety document is a comprehensive and informative guide that outlines the safety considerations and best practices related to the use of ultrasound in medical settings. It's primary objective is to guarantee the secure and efficient application of ultrasound technology, benefiting both patients and healthcare practitioners. For additional information, kindly refer to the FAQs provided below.

Does the FDA encourage the use of the AIUM’s Guide to Medical Ultrasound Safety?

The FDA provides a guidance document on diagnostic ultrasound systems:

https://www.fda.gov/media/71100/download

The FDA recommends that systems that adhere to the Output Display Standard provide an educational program for prudent use of diagnostic ultrasound and the FDA recommends the AIUM’s Medical Ultrasound Safety document, which includes generic content for such an educational program.

Who should follow the guidelines in the AIUM’s Guide to Medical Ultrasound Safety?

The AIUM’s Medical Ultrasound Safety document should be followed by all healthcare professionals involved in using ultrasound equipment, including physicians, sonographers, nurses, and other allied health practitioners.

What safety considerations are covered in the AIUM's Guide to Medical Ultrasound Safety?

The AIUM's Medical Ultrasound Safety document is divided into three parts:

Part One: A description of potential ultrasound-induced bioeffects (thermal and non-thermal or mechanical) and why we should be concerned about them.

Part Two: A description of the risks and benefits of conducting diagnostic examinations and an introduction to the concept of keeping ultrasound exposure as low as reasonably achievable (ALARA). Responsibility of the manufacturer and the examiner are stressed since the energy output is altered by system setup, operating mode, and transducer choice as well as manipulating certain controls.

Part Three: A description of the output display standard (thermal and mechanical indices, TI and MI). Also described is how to implement the ALARA principle on equipment with and without an onscreen output display with a description of controls directly affecting intensity.

How often is the Safety Document updated?

The AIUM's Medical Ultrasound Safety document is regularly reviewed and updated to reflect the latest advancements in ultrasound technology and safety research. Updates may be influenced by new regulatory requirements or changes in best practices.

Where can I access AIUM’s Guide to Medical Ultrasound Safety?

The AIUM’s Medical Ultrasound Safety document is a copyrighted document that is available for purchase from the American Institute of Ultrasound in Medicine.

How many copies of the AIUM's document does my company need?

Each manufacturer machine that is sold should have access to one document.

How do I purchase the AIUM's Guide to Medical Ultrasound Safety?

If you are interested in purchasing the AIUM's Medical Ultrasound Safety document, email aiumpartnerships@aium.org.

Medical Ultrasound Safety (MUS) Manual

Medical Ultrasound Safety Booklet Frequently Asked Questions

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