MITA Issues Guidelines for Live Model Ultrasound Scanning
October 2017 ~
In response to FDA concerns last year over the purpose and safety of live model ultrasound demonstrations, the Medical Imaging and Technology Alliance (MITA) has issued new guidelines for live model ultrasound scanning for educational purposes.
MITA is encouraging manufacturers to follow the newly issued recommendations to ensure that safety standards are not compromised and no harm is posed to anyone, especially human subjects that undergo live scans. Based on similar guidelines issued by the American Institute for Ultrasound in Medicine (AIUM), MITA’s guidelines incorporate additional safety measures as follows:
- Live scans should only be performed for educational purposes and by a qualified health professional (i.e. sonographers);
- Human subjects of live scans must provide consent to the risks, benefits and safety effects of ultrasonic exposure;
- All models should be pre-scanned by a qualified healthcare professional
- Equipment must be FDA-approved and used only in the manner for which it has been approved by the FDA;
- Vendors are required to explain the educational content of demonstrations either verbally or in written form;
- Vendors are required to adhere to the “As Low as Reasonably Achievable” principles of limited exposure on appropriate body areas.
For live model ultrasound scanning during educational activities in which continuing medical education credit is not issued, MITA endorses adherence to the acceptable educational activities outlined by the medical society or organization sponsoring the event.
“Live model ultrasound scanning at industry booths during exhibitions, tradeshows, and other venues plays an important role in the training and deployment of new, innovative imaging technology that improves patient care,” says Patrick Hope, executive director at MITA. “We encourage our members to continue this practice, while ensuring appropriate safeguards are in place.
Source(s): Radiology Business; Aunt Minnie; MedWorm;