Public Health Committee

JOINT FAVORABLE REPORT

Bill No.:

HB-5635

Title:

AN ACT CONCERNING ULTRASOUND PROCEDURES FOR MEDICAL AND DIAGNOSTIC PURPOSES.

Vote Date:

3/13/09

Vote Action:

Joint Favorable

PH Date:

2/27/2009

File No.:

SPONSORS OF BILL:

Public Health Committee

REASONS FOR BILL:

To prohibit persons from performing an obstetrical ultrasound procedure unless such procedure is for a medical or diagnostic purpose.

RESPONSE FROM ADMINISTRATION/AGENCY:

Jennifer Filippone, Chief, Practitioner Licensing and Investigations, Department of Public Health testified against H.B. 5635 because the bill would mandate that ultrasound procedures administered to a patient shall only take place in a facility licensed by the Department of Public Health.

Ultrasound procedures currently are being safely, legally and effectively utilized under direction of an appropriately licensed practitioner in settings not regulated by the Department of Public Health such as physicians' offices and radiology practices. This bill will negatively impact patient access to these procedures.

With the exception of physician practices where deep moderate sedation is utilized, the Department does not currently inspect and license physician offices. The establishment of a new licensure category for physician offices or other settings in which ultrasound procedures are performed would have a significant fiscal impact on the Department.

The Department would suggest prohibiting the performance of ultrasound procedures other than those ordered by a licensed health care practitioner with applicable statutory authority.

NATURE AND SOURCES OF SUPPORT:

Joshua A. Copel, M.D., Professor, Obstetrics, Gynecology and Reproductive Sciences and Pediatrics, Yale University:. The American Institute of Ultrasound in Medicine (AIUM) and the professional medical community are concerned about the profusion of storefront entertainment ultrasound facilities. Operating at the fringe of medical practice, they raise a number of important issues. The machines used at these non-medical facilities are bought from unknown sources and are not required to undergo any specific maintenance to ensure proper performance. The individuals performing the scans may or may not be trained professional sonographers.

While the FDA clearly regulates the production of ultrasound equipment as Class II medical devices, their public stance has been that enforcement of use issues is the purview of the states rather than the FDA.

Attachment: Report: Non-clinical Use of Obstetric Ultrasound: Medico-Legal Implications in the USA, Joshua A. Copel, MD

Edmund R. Funai, MD, Associate Chair, Clinical Affairs, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University: While medical use of appropriate levels of ultrasound to diagnose fetal conditions is considered safe, please note that ultrasound is a form of energy used for many purposes in industry and medicine. At higher exposure levels, ultrasound is used to speed the healing of bone fractures. At much higher exposure levels, ultrasound produces a heating effect in tissue, useful in treating sprains and pulled muscles. At very high levels, ultrasound is used to shatter kidney stones.

The FDA has expressed concern about the misuse of diagnostic ultrasound equipment. The FDA has stated “Persons who promote, sell or lease ultrasound equipment for making 'keepsake' fetal videos should know that FDA views this as an unapproved use of medical device. In addition, those who subject individuals to ultrasound exposure using a diagnostic ultrasound device (a prescription device) without a physician's order may be in violation of State or local laws of regulations regarding use of a prescription medical device.

Although there are no confirmed biological effects on patients caused by exposures from present diagnostic ultrasound instruments, the possibility exists that such biological effects may be identified in the future. Thus ultrasound should be used in a prudent manner to provide medical benefit to the patient.

Nonmedical ultrasonography may falsely reassure women. Despite disclaimers about the limitations of their product, customers may interpret an aesthetically pleasing image or entertaining video as evidence of fetal health and appropriate development.

Without the ready availability of appropriate prenatal health care professionals, customers at sites for nonmedical ultrasonography may be left without necessary support, information, and follow-up for concerning findings.

The use of ultrasound to create “keepsake” images or entertainment purposes in no way promotes the health of the citizens of Connecticut or the public good. I would urge you to limit the use of such equipment and technology to a physician's prescription only.

The Radiological Society of Connecticut (RSC): Ultrasound is a form of radiation. All forms of medical radiation must be used prudently. RSC's position is that, unless medically indicated, examinations using any form of radiation should not be performed. Regardless of who pays, if a licensed professional does a procedure, the reasonable expectations of patients are that this is a medical procedure. Using ultrasound for non-medical purposes is inappropriate. The RSC believes HB 5635 is the right way to rectify this issue.

Dennis Johnson, Director of Health, Town of Guilford testified in support. Local ultrasound businesses are classified as entertainment ultrasounds and are prohibited from giving out medical or diagnostic information. Their main service is to produce non-medical fetal images. These ultrasound technicians in Connecticut that operating independent of licensed medical facilities are not required to be licensed or even credentialed by the State Health Department. However, ultrasound sonographers in a physician's office are required to be board certified.

The FDA has issued warnings about entertainment ultrasounds. Public health experts, clinicians and industry agree that casual exposure to ultrasound, especially during pregnancy, should be avoided. There are also concerns about how a commercial scanner would deal with finding a medical abnormality in the baby.

Ultrasonic fetal scanning is generally considered safe if properly used when information is needed about pregnancy. Still, ultrasound is a form of energy, and even at low levels, laboratory studies have shown it can produce physical effects in tissue. The US Food and Drug Administration has made a strong recommendation against commercial ultrasounds: “Mothers leave falsely reassured and then they miss their scheduled ultrasounds with their doctor.”

Obstetricians use ultrasound at a very low power level to check the size, location, number and age of fetuses, the presence of some types of birth defects, fetal movement, breathing, and heartbeat. When ultrasound is used by a qualified clinician to check for this kind of information, the FDA says the medical benefit far outweighs any risk. Fetal keepsake videos are viewed as problems because there are no medical benefits derived from the exposure. There is no control on how long a single imaging session will take or how many sessions will occur. The FDA notes that some video companies have been known to use the ultrasound machine on higher energy exposure for as long as an hour to get the pictures. Exposure to ultrasound for longer than the time specified by the FDA for fetal monitoring could pose a potential risk to the health of the mother and her developing fetus.

By permitting ultrasounds only through prescriptive order or by a medical professional you will ensure that pregnant women will receive professional care that contributes to their health and to the health of their babies.

Jillian Gilchrest, Executive Director, NARAL-Pro-Choice Connecticut:. A variety of respected medical and advocacy organizations express concerns discouraging the nonmedical use of ultrasounds, including the FDA, the American College of Obstetrics and Gynecology, the March of Dimes, and the American Institute of Ultrasound in Medicine, citing the qualification of providers, inaccuracy of findings, and increased exposure to ultrasound technology.

By simply googling the words 3D ultrasound and Connecticut, I found 3 commercial 3D/4D ultrasound locations in Connecticut. On the websites there is little to no mention of potential health concerns. A link to the frequently asked question :”Is it safe? Are there any risks to me, or my baby?” reads:

“Extensive studies over 30 years have found that ultrasound has not been shown to cause any harm to mother or baby. Routine scanning of all pregnancies is now normal throughout the United States”

What this warning fails to mention is that leading medical organizations discourage non-medical use and that the reason studies haven't been able to show definitive long-term effects of ultrasound is because it is ethically wrong to conduct testing on unborn babies. A few studies do suggest exposure to ultrasound during pregnancy may have an effect on human development, such as delayed speech in children.

According to the FDA's Office of Compliance, the “FDA regulates devices, but the qualifications and behavior of technicians and physicians would be regulated by the states”.

NATURE AND SOURCES OF OPPOSITION:

None expressed.

Reported by: Heather Dorsey

Date: March 12, 2009