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FDA Recommendations for the Safe Use of Ultrasound in Obstetrics

FDA Recommendations for the Safe Use of Ultrasound in Obstetrics

FDA Recommendations for the Safe Use of Ultrasound in Obstetrics

Sherri A. Longo, M.D.
Sherri A. Longo, M.D.
on behalf of e-Ed Credits

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Review:

Launch date: 05 Oct 2017
Expiry Date:

Last updated: 28 Oct 2018

Reference: 184892

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Course Availability

This course is only available to trainees days after purchase. It would need to be repurchased by the trainee if not completed in the allotted time period. This course is no longer available. You will need to repurchase if you wish to take the course again.

Description

No longer can an ultrasound department defer safety issues to the regulation of the United States Food and Drug Administration (FDA). Today, ultrasound safety is the responsibility of the diagnostician, who is expected to perform an optimal ultrasound examination with safety awareness.

In the past, safety issues were monitored by the FDA who provided safety regulations via the 1976 (510-k) Guide published in 1985. In 1976, the Medical Device Amendments to the Food, Drug and Cosmetic Act were added requiring the FDA to regulate all medical devices, which included diagnostic ultrasound equipment. The 1976 output levels were historically based and not scientific. In addition to the FDA recommendations, the American Institute of Ultrasound in Medicine (AIUM) made ultrasound safety statements that reported no adverse patient bioeffects with diagnostic ultrasound exposure or non-human mammal effects when the spatial-peak temporal-average intensity was below 100mW/cm2.

However, studies appeared, which identified adverse bioeffects confirmed in mammals exposed to ultrasound that had spatial-peak temporal-average intensities of less than 100mW/cm2. These studies caused the AIUM to adjust its non-human mammalian statement to reflect the in vivo bioeffects. In addition, since 1992, many ultrasound devices are being manufactured with the capability of exceeding the acoustic output levels allowable for obstetrical use per the 510-k Guide. Therefore, the devices are required to have output screen displays that include indices that predict the potential for adverse bioeffects. Those indices include the thermal index (TI) that predicts tissue heating and the mechanical index (MI) that reflects the potential for tissue cavitation.

The necessity for ultrasound safety also captured the attention of the American College of Obstetrics and Gynecology (ACOG), as evidenced by their Committee Opinion # 180 entitled ""New Ultrasound Output Display Standard"" issued in November 1996. This publication described the on screen display standards (as determined by the FDA, the AIUM, ACOG, and the National Electrical Manufacturers Association – NEMA) for commercially available ultrasound systems. The ACOG Committee Opinion stressed the necessity for user awareness of new ultrasound display standards recommending acoustic output limits for obstetrical use to minimize the potential for adverse ultrasound bioeffects. For those applicable ultrasound devices (manufactured after 1992), one of two acoustic output indices (MI or TI) is required to appear on the screen.

Objectives

Upon completion of this course, the learner will be able to:
1. Define thermal index, mechanical index, absorption coefficient, spatial-peak temporal-average, and spatial-peak pulse-average.

2. State the United States Food and Drug Administration, American Institute of Ultrasound in Medicine, and
American College of Obstetrics and Gynecology recommendations for safety levels in obstetrical ultrasound.

3. Describe the methods that can be used to minimize fetal exposure during obstetrical ultrasound.
Sherri A. Longo, M.D.

Author Information Play Video Bio

Sherri A. Longo, M.D.
on behalf of e-Ed Credits

Dr. Sheri Longo is an Assistant Professor in the Department of Obstetrics and Gynecology at Tulane University School of Medicine in New Orleans, Louisiana. She is an active Perinatologist in the Division of Maternal-Fetal Medicine. She has received several teaching awards and has lectured on numerous topics at various conferences.

Dr. Longo has also published several articles in peer-review medical journals and has an interest in the area of safety of ultrasound in pregnancy. She has studied the awareness of users (of ultrasound equipment) as to their knowledge base regarding these safety standards.

Current Accreditations

This course has been certified by or provided by the following Certified Organization/s:

  • American Nurses Credentialing Center (ANCC)
  • 1.00 Hours

Faculty and Disclosures

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