by John R. Fischer
, Senior Reporter | October 06, 2017
MITA has issued guidelines on the
purpose and safe use of live model
ultrasound scan demonstrations
The Medical Imaging and Technology Alliance (MITA) has issued a set of guidelines for the safe and appropriate use of live model ultrasound demonstrations at trade shows.
The MITA principles encourage providers to only conduct live demonstrations of ultrasound scanning for educational purposes and ensure that safety standards are not compromised and no harm is posed to anyone, especially human subjects that undergo live scans.
“The demonstration of the education portion of live model ultrasound scanning is very important to relay to providers that are taking part in these different society conferences and industry booths,” Patrick Hope, executive director of MITA, told HCB News. “Learning about the new innovative technology only improves patient care. What we’ve tried to do with this guidance is put in place appropriate patient safeguards for the live models.”
MITA published its guidelines in response to FDA concerns last year over the purpose and safety of live model ultrasound demonstrations. These worries have since prompted many organizations to issue their own set of principals and viewpoints on the matter.
Under MITA standards, live scans may only be performed for educational purposes and by a qualified health professional, such as a sonographer. Human subjects of live scans must provide consent to the risks, benefits and safety effects of ultrasonic exposure and all models must be pre-scanned by a qualified health care professional. Equipment must be FDA-approved, and used only in the manner for which it has been approved by the FDA.
Vendors are also required to explain the educational content of demonstrations either verbally or in written form and must adhere to the “As Low as Reasonably Achievable (ALARA)” principles of limited exposure on appropriate areas of the body.
Ultrasound, though relatively safe according to Hope, is not permitted for live demonstrations at some trade shows. For instance, it wasn't until just last year that the Radiological Society of North America (RSNA) lifted its ban
on such demonstrations which had been in place since at least 1989.
Hope said that concerns about live model ultrasound scan demonstrations are based on the idea that such demonstrations are used for purposes other than education, such as marketing, as well as worry for the safety of human subjects.
“We strongly believe, with all these adequate safeguards in place, that we will ensure that the program goes off and the educational content will be shared appropriately with the providers,” he said.
MITA based its guidelines on those issued by the American Institute for Ultrasound in Medicine (AIUM) and added additional safety measures.