Legal requirements worldwide
Where do you fit in?
Ultrasound Quality Assurance is a mandatory activity. It relies on the combined efforts of different people and disciplines, that come together like pieces in a jigsaw.
Ultrasound QA Programme is made of four activities, all done by different parties, all important to create a robust QA Programme.
The top of the “jigsaw” shows the role of ultrasound users and assistants.
- More than 90% of faults can be found during user QA *
- Only around 7% of faults with ultrasound equipment are found during clinical use i.e. it is not possible to tell, simply from scanning, that your probe is working correctly
- There are daily and monthly checks which are described below
- These checks must be recorded and any anomalies reported & followed up. Waiting for the annual planned maintenance checks may mean using faulty equipment for months.
The bottom of the “jigsaw” demonstrates the role of specialist testing done by Biomedical Engineers, Medical Physicists or Independent QA Specialists such as Multi-Medix.
- “Baselining” the system. This provides the benchmark that all the user checks above, and future annual testing will measure against.
- All new systems need to be acceptance tested**
- Annually the QA system should be reviewed by an independent party to assess it’s safety and image quality.
References:
* can be found by clicking on our main website and also by clicking here.
** Managing Medical Devices 2021
User QA checks
Monthly user checks:
- Uniformity
- Dropout
- Sensitivity
- Noise
- Cable Noise
- Visual Inspection
For a comprehensive downloadable checklist of daily and monthly user checks, click on the link below.
Ultrasound Physics QA Checks
The following table summarises BMUS, EFSUMB and AIUM guidelines.2,15,16.
EFSUMB and AIUM guidelines are for B-mode only. EFSUMB guidelines specify additional acoustic tests as optional or on user request; IPEM1 guidelines specify acoustic measurements only in special circumstances. AIUM guidelines specify most QA activities as mandatory; those specified as optional are indicated in the table.
-
GUIDELINES – BMUS, EFSUMB & AUIM
TASK BMUS (UK) EFSUMB (USA) AIUM (USA) Resolution measurement
(axial and lateral)Extended testing At delivery; (semi-) annually (software) Optional Depth of penetration Annually At delivery; (semi-) annually (software) Annually Objective uniformity
measurement (software)x At delivery; (semi-) annually x Monitor performance (test pattern) x At delivery; (semi-) annually x Dynamic range/contrast resolution Extended testing At delivery; (semi-) annually Optional Resolution (elevation) measurement Extended testing At delivery x Caliper calibration At delivery At delivery (software) Annually Post-processing grey level encoding (software) x At delivery x Transducer element performance (optional; software) x At delivery x Doppler velocity accuracy and spectral broadening At delivery Not applicable Not applicable Visual assessment of TI and MI (consistency with manufacturers’ tables) At delivery and biennially Optional and on user request x Measurement of acoustic power and TI In specified circumstances only Optional and on user request x Measurement of MI x Optional and on user request x Measurement of transducer face temperature in air At delivery and in specified circumstances Optional and on user request x Measurement of transducer face temperature in tissue contact x Optional and on user request x
Why Ultrasound Quality Assurance is Essential for Patient Safety and Accuracy
Ultrasound imaging is a critical tool in diagnosing a wide range of conditions, but its effectiveness depends on the quality and reliability of the equipment. Ultrasound Quality Assurance (QA) ensures that ultrasound systems are calibrated, maintained, and operating at peak performance—vital for both patient safety and diagnostic accuracy.
Ultrasound QA Training