Application Specific Ultrasound QA Guidance
The Corner Office
Wayne Moore
9/16/2024
With the introduction and rapid diffusion of handheld Point-of-Care (POC) ultrasound devices, questions concerning the role and definition of routine quality assurance testing of those devices in clinical use have become a hot topic in several professional ultrasound societies such as the American Institute of Ultrasound in Medicine (AIUM), and the World Federation of Ultrasound for Medicine and Biology (WFUMB). Further to that idea, the placement of these devices into the hands of non-ultrasound-trained caregivers begs several questions: “How do they know their device is performing at a diagnostic level, both now, and over time?” “What objective measures and QA tests can currently be pointed to that would provide the user with confidence that their handheld device is producing diagnostic quality images?” “Should special QA requirements be developed for POCUS use that would be specific to the intended clinical application?” And “Just because a handheld probe is cleared for use by the FDA for multiple clinical applications, does that mean it is effective in producing diagnostic images for all those applications?” A Swiss Army Knife™ comes with a multiplicity of blades and tools — they can do a lot of things, but not necessarily well.
Expect to see new guidance coming out next year specific to ultrasound QA for handheld POCUS devices, as well as new test tools (phantoms, etc.) to help users determine if the devices they now have or are considering purchasing objectively meet imaging requirements for their intended use. Keep an eye on the Acertara website for upcoming information on these and other ultrasound QA requirements.
Until next month,
Wayne