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Simulated Scanning & Human Volunteer Policy
Simulated Scanning & Human Volunteer Policy
Taken from the Mount Aloysius College Ultrasonography/Echocardiography Policy and Procedure Manual.
Purpose: The purpose of this policy is to establish clear and ethical guidelines for the use of human subjects in the educational activities of the ultrasonography/ echocardiography programs. It is designed to ensure that the use of human subjects is conducted in accordance with institutional policies, the principles of respect, and the standards established by the American Institute of Ultrasound in Medicine (AIUM), while safeguarding the health, safety, and privacy of volunteers involved in the educational process.
This policy is to inform all students in the Ultrasonography Program that they may be scanned as a model for simulated hands-on training for in-class demonstration. This participation is strictly voluntary. Volunteers have the right to withdraw from the ultrasound procedure at any point without any impact on their relationship with the program or educational outcomes. Volunteers must understand that scanned images acquired in the laboratory setting are by no means a formal diagnostic examination and that the student conducting the scan is neither a licensed physician nor a registered sonographer. In the event of any abnormality incidentally detected during a simulated procedure, the participant must seek the advice of a personal physician if he/she wishes to obtain a formal diagnosis.
Please note: Student volunteer participation or non-participation will not have an effect on your grade. Grades are based on the criteria published in the syllabi.
Although studies have concluded that bioeffects from ultrasonic energy are minimal to none, studies are still in progress to make a definitive support statement. To date, there has been no supporting documentation of bioeffects in the clinical setting and research on humans. It is considered to be safe and finds no compelling reason to believe that adverse delayed effects will be apparent in the future.
The AIUM is a multidisciplinary association dedicated to advancing the safe and effective use of ultrasound in medicine through professional and public education, research, development of guidelines, and accreditation.
Students and/or volunteers hereby waive and release Mount Aloysius College and its school officials, faculty and fellow students from any claim for damages or injuries alleged to result from his/her participation as a volunteer for simulated scanning exercises. Every volunteer has read and has had the opportunity to discuss any concerns he/she may have had regarding the content of the following statement on sonography bioeffects and safety as published by the AIUM.
While student volunteers may scan in the lab independently during open lab hours, any outside human volunteers must have their procedure scheduled, and performed under the direct supervision of qualified faculty. Supervisors are responsible for ensuring that ultrasound procedures are performed with the utmost care, safety, and privacy.
The program abides by the following guidelines published by the American Institute of Ultrasound in Medicine (AIUM):
AIUM Statement on Prudent Clinical Use and Safety of Diagnostic Ultrasound
(Approved: 03/19/2007; Reapproved: 04/01/2012, 05/20/2019; Revised: 5/29/24)
Diagnostic ultrasound has been in use since the late 1950s. Given its known benefits and recognized efficacy for medical diagnosis, including use during human pregnancy, the American Institute of Ultrasound in Medicine herein addresses the clinical safety of such use: no independently confirmed adverse effects caused by exposure from present diagnostic ultrasound instruments have been reported in human patients in the absence of contrast agents. Biological effects have been reported in pre-clinical mammalian systems using diagnostic instruments (e.g., localized pulmonary capillary hemorrhage, particularly in pre-clinical mammalian-neonatal lung1), or therapeutic instruments operating at diagnostically relevant exposures (e.g., neuromodulation and bone healing). Increased outputs, indicated by the Thermal and Mechanical Index displays, and/or increased exposure time can increase the likelihood of bioeffects. Prudent clinical use includes consideration of recommended settings based on these Indices. Ultrasound should be used only by qualified health professionals to provide medical benefit to the patient. Ultrasound exposures during examinations should be as low as reasonably achievable (ALARA).
AIUM Statement on Safety in Diagnostic Ultrasound Educational Activities Using Nonpregnant Participants
(Approved: 05/19/2020)
Background. The American Institute of Ultrasound in Medicine has long advocated the prudent use of medical ultrasound and has developed safety recommendation statements. These include the following: (1) ultrasound should be used by qualified health professionals to provide medical benefit to patients1; (2) ultrasound exposures should be as low as reasonably achievable (ALARA) within the goals of the study2,3; (3) the participant should be informed of the anticipated exposure conditions and how these compare with normal diagnostic practice2; (4) repetitive and prolonged exposures on a single participant should be justified and consistent with prudent and conservative use2; and (5) infection control policies and procedures must be followed.4,5
AIUM Statement on As Low As Reasonably Achievable (ALARA) Principle
(Approved: 03/16/2008; Reapproved: 04/02/2014, 05/19/2020)
The potential benefits and risks of each examination should be considered. The as low as reasonably achievable (ALARA) principle should be observed when adjusting controls that affect the acoustic output and by considering both the transducer dwell time and overall scanning time. Practicing ALARA requires that users do all of the following:
1. Apply correct examination presets if built into the diagnostic ultrasound device. The review of manufacturer default presets for appropriateness is encouraged.
2. Adjust the power to the lowest available setting that provides diagnostic-quality images. If appropriate, reduce power at the end of each examination so the next user will start with the lowest acoustic output setting.
3. Monitor the mechanical index (MI) and thermal index (TI). Know the recommended upper limit of the MI, TI, and related duration limitations for the type of examination being performed.
4. Move/lift the transducer when stationary imaging is not necessary to reduce the dwell time on a particular anatomic structure. When possible, avoid fields of view that include sensitive tissues such as the eye, gas-filled tissues (lung and intestines), and fetal calcified structures (skull and spine).
5. Minimize the overall scanning time to that needed to obtain the required diagnostic information.
AIUM Statement on Preventing Work-related Musculoskeletal Disorders
(Approved: 11/04/2017; Reapproved: 06/16/2020)
Despite increased awareness of ergonomic best scanning practices, the incidence of work-related musculoskeletal disorders (WRMSDs) is increasing among sonographers, with up to 90% of the workforce scanning in pain.1, 2
Musculoskeletal injuries impair the welfare of these valuable members of the healthcare team and can negatively impact their job performance and the quality and safety of patient care.
The AIUM strongly encourages cooperation among employers, sonographers, and manufacturers to promote a safe work environment. Annual education in WRMSD with a focus on ergonomic design and hazard control to reduce risk factors for injury is of critical importance.3 Workflow strategies should allow rest and recovery times during a shift, and sonographers and others who perform ultrasound examinations should implement ergonomically correct scan techniques. More research is needed to determine best practices for reducing risk of injury and to further improve the ergonomic design of workstation equipment. Continued advocacy is needed to encourage manufacturers to engineer innovative designs and/or personal protective equipment to promote safety and reduce injuries suffered from the repetitive use of sonography equipment.
The AIUM supports the Industry Standards for the Prevention of Work-Related Musculoskeletal Disorders in Sonography, developed through a 2016 Consensus Conference hosted by the SDMS.
AIUM Statement on Prudent Use and Safety of Diagnostic Ultrasound in Pregnancy
(Approved: 05/19/2020)
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