This page contains a comprehensive quantity of documentation. The contents are as follows:
Health Canada Statement
Non Diagnostic Use of Ultrasound ( SDMS and AIUM positions )
Sonographers Observations and Comments
Limited Obstetrical Ultrasound
Health Canada - It’s Your Health - FETAL ULTRASOUND FOR KEEPSAKE VIDEOS
The Issue
Health Canada is recommending parents not expose their unborn babies to fetal ultrasound for the purpose of making “keepsake” videos.
Background
Fetal ultrasound creates images of the unborn baby in the womb. The procedure uses very short bursts of sound vibrations that travel as waves through the body in a series of focused beams. Echoes from the beams are converted into real-time images that show the movement, surface features, internal organs and, with special techniques, even the blood flow of the fetus. The images are viewed on a monitor and can be stored on CDs. When the procedure is used to obtain images for medical purposes, it is called diagnostic fetal ultrasound.
Diagnostic fetal ultrasound is done only on referral from a licenced health care provider. It is performed in a clinical setting by highly qualified professionals. Health Canada recommends that diagnostic fetal ultrasound should be done only when the expected medical benefits outweigh any foreseeable risk.
Recently, some businesses have started promoting the use of fetal ultrasound machines for the sole purpose of making videos of babies in the womb as a keep sake for parents. In this setting, the ultrasound provides no information about the baby’s health.
The Benefits and Safety Record of Diagnostic Fetal Ultrasound
Diagnostic fetal ultrasound provides important medical information, such as the size, age and state of health of the baby in the womb. It can also detect twins and can diagnose certain birth defects. The clinical use of fetal ultrasound has grown rapidly and it has an excellent safety record. There have been millions of these examinations over the past few decades with no confirmed health risks for the baby or the mother. This finding is consistent with the majority of scientific studies on the effects of ultrasound.
Although this is very reassuring, there is also suggestive evidence that there may be a biological effect on the fetus even during diagnostic use. Research is ongoing to ensure the continued safety of diagnostic fetal ultrasound.
Concern about Fetal Ultrasound for Keepsake Videos
In all instances, the risks of fetal ultrasound will depend on the ultrasound levels and duration of exposure. The ultrasound level is now displayed on the monitor, and this lets qualified operators assess the potential for damaging the fetus. Risks can be minimized by keeping the ultrasound level and exposure time as low as possible without losing the information needed for diagnosis.
Minimizing Your Risk
Do everything you can to give your baby a healthy start in life. If you are pregnant, seek appropriate prenatal care. Diagnostic fetal ultrasound provides medical information that will help your health care professional care for you and your baby. Discuss any concerns you have with your health care provider so that you can make an informed decision about the use of fetal ultrasound during your pregnancy. Health Canada recommends that you have fetal ultrasound only on referral from a licenced health care provider.
Health Canada’s Role
Health Canada regulates diagnostic ultrasound devices under the Food and Drugs Act, the Radiation Emitting Devices Act, and the Medical Devices Regulations. This ensures the safety and effectiveness of the devices when they are used for their licenced diagnostic purposes and according to guidelines for safe use. Health Canada has established Guidelines for the Safe Use of Diagnostic Ultrasound. The Guidelines state that ultrasound should not be used for any of the following activities:
- to have a picture of the fetus, solely for non-medical reasons
- to learn the sex of the fetus, solely for non-medical reasons
- for commercial purposes, such as trade shows or producing pictures or videos of the fetus
Health Canada is also working with the Society of Obstetricians and Gynecologists of Canada (SOGC) to develop a user friendly clinical practice guideline on the safety of obstetric ultrasound.
Need More Info?
For more information, contact: Medical Devices Bureau, Health Canada Room 1605, Statistics Canada Main Building Tunneys Pasture Ottawa, ON K1A 0L2 tel: (613) 957-4788 and/or Consumer and Clinical Radiation Protection Bureau, Health Canada 775 Brookfield Road Ottawa, Ontario K1A 1C1 Tel: (613( 954- 6699
For a copy of Health Canada’s Guidelines for the Safe Use of Diagnostic Ultrasound, call (613) 954-5995, or visit the Consumer and Clinical Radiation Protection Bureau Web site at:
http://www.hc-sc. gc.ca/hecs-sesc/ccrpb/publication/O 1 hecs25 5/tc.htm
For the Canadian Society of Diagnostic Medical Sonographers (CSDMS) statement on this issue, visit: http://www.csdms.com/pdf/Ol . and http://www.csdms.com/pdf/O2.pdf
For the American Institute of Ultrasound in Medicine’s (AlUM) statement visit:
http://www.aium.org/aboutAIUM/pressRooml releasesContent.asp?ith6O&year=2002
Additional It’s Your Health articles can be found at : www.healthcanada.ca/iyh
You can also call (613) 957-2991
ISBN# H50-3/122-2003E-PDF
Catalogue# 0-662-35355-2
Original: November 2003
© Her Majesty the Queen in Right of Canada, represented by the Minister of Health, 2003
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http://www.sdms.org/positions/nondiagnostic.asp
Society of Diagnostic Medical Sonography
SDMS Position Statement
Non-Diagnostic Use of Ultrasound
Diagnostic medical sonography is a medical procedure that is requested by a physician (or their designated healthcare provider), performed by a sonographer, and interpreted by a physician. It is a diagnostic procedure often used to examine a developing fetus for abnormalities. A number of private businesses have opened for the sole purpose of providing expectant parents with images of the developing fetus on videocassette or other method of record. Because the service is provided for entertainment purposes only, it is considered non-diagnostic. The use of two-dimensional (2D), three-dimensional (3D) or four-dimensional (4D) ultrasound to only view the fetus, obtain a picture of the fetus or determine the fetal gender without a medical indication is inappropriate and, in the view of the Society of Diagnostic Medical Sonography (SDMS), contrary to responsible medical practice. 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.
SDMS recognizes the responsibility it has to its members, the health care community and patients. Diagnostic medical sonographers are committed to act in the best interest of their patients, to maintain ethical standards to preserve and promote professionalism and to the use of ultrasound as a diagnostic procedure. Therefore, the SDMS opposes the use of ultrasound solely for entertainment purposes.
Approved by SDMS Board of Directors, 10/13/2004
http://www.aium.org/publications/statements/_statementSelected.asp...
AMERICAN INSTITUTE OF UlTRASOUND IN MEDICINE
Keepsake Fetal Imaging
Approved June 22, 2005
The AlUM advocates the responsible use of diagnostic ultrasound for all fetal imaging. The AlUM understands the growing pressures from patients for the performance of ultrasound examinations for bonding and reassurance purposes largely driven by the improving image quality of 3D sonography and by more widely available information about these advances. Although there is only preliminary scientific evidence that 3D sonography has a positive impact on parental-fetal bonding, the AlUM recognizes that many parents may pursue scanning for this purpose.
Such “keepsake imaging” currently occurs in a variety of settings, including the following:
1. Images or video clips given to parents during the course of a medically indicated ultrasound examination;
2. Freestanding commercial fetal imaging sites, usually without any physician review of acquired images and with no regulation of the training of the individuals obtaining the images; these images are sometimes called “entertainment videos”; and
3. As added cost visits to a medical facility (office or hospital) outside the coverage of contractual arrangements between the provider and the patient’s insurance carrier
The AlUM recommends that appropriately trained and credentialed medical professionals (either licensed physicians, registered sonographers, or sonography registry candidates) who have received specialized training in fetal imaging perform all fetal ultrasound scans. These individuals have been trained to recognize medically important conditions, such as congenital anomalies, artifacts associated with ultrasound scanning that may mimic pathology, and techniques to avoid ultrasound exposure beyond what is considered safe for the fetus. Any other use of “limited medical ultrasound” may constitute practice of medicine without a license. The AlUM reemphasizes that all imaging requires proper documentation and a final report for the patient medical record signed by a physician.
Although the general use of ultrasound for medical diagnosis is considered safe, ultrasound energy has the potential to produce biological effects. Ultrasound bioeffects may result from scanning for a prolonged period, inappropriate use of color or pulsed Doppler ultrasound without a medical indication, or excessive thermal or mechanical index settings. The AlUM encourages patients to make sure that practitioners using ultrasound have received specific training in fetal imaging to ensure the best possible results.
The AlUM also believes that added cost arrangements other than those of providing patients images or copies of their medical records at cost may violate the principles of medical ethics of the American Medical Association (E-8.062’ and E-8.063 and the American College of Obstetricians and Gynecologists. The AlUM therefore reaffirms the Prudent Use Statement and recommends that only scenario 1 above is consistent with the ethical principles of our professional organizations.
The market for keepsake images is driven in part by past medical approaches that have used medicolegal concerns as a reason not to provide images to patients. Sharing images with patients is unlikely to have a detrimental medicolegal impact. Although these concerns need further analysis and evaluation, we encourage sharing images with patients as appropriate when indicated obstetric ultrasound examinations are performed.
References:
1. American Medical Association. E-8.062: Sale of Non-Health-Related Goods From
Physician’s Offices. Chicago, IL: American Medical Association; 1998.
2. American Medical Association. E-8.063: Sale of Health-Related Products From
Physician’s Offices. Chicago, IL: American Medical Association; 1999.
3. American College of Obstetricians and Gynecologists. Commercial Enterprises in
Medical Practice. In: Ethics in Obstetrics and Gynecology. Washington, DC:
American College of Obstetricians and Gynecologists; 2004.
4. American Institute of Ultrasound in Medicine. Prudent Use. Laurel, MD: American
Institute of Ultrasound in Medicine; 1999.
5. American Institute of Ultrasound in Medicine. Providing Images to Patients.
Laurel, MD: American Institute of Ultrasound in Medicine; 1998.
10/3/2006 7:35 PM
Safety and bio-effects:
CANADIAN ASSOCIATION OF RADIOLOGISTS:
POSITION ON THE USE OF DIAGNOSTIC ULTRASOUND FOR NON- MEDICAL PURPOSES The Canadian Association of Radiologists strongly opposes the use of Diagnostic Ultrasound equipment for non medical purposes and considers this use of medical ultrasound for entertainment to be a misuse of the technology especially if fetal subjects are involved. The Canadian Association of Radiologists is concerned that the use of Diagnostic Ultrasound for this purpose may give a false sense of security to mothers and that the operators of the equipment may not be adequately trained to recognize fetal and placental abnormalities which may adversely affect maternal and fetal outcome. An ultrasound examination performed for entertainment purposes assumes that everything is normal and thus leads to a higher potential for missed diagnosis if medical exams are performed by non medical personnel. A diagnosis from an ultrasound examination represents the practice of medicine and the Canadian Association of Radiologists is concerned about the mechanism for appropriate referral by a non physician if an abnormality is suspected on the entertainment ultrasound.
The Canadian Association of Radiologists directs its board to express concern through appropriate channels such as equipment suppliers, the Canadian Society of Diagnostic Medical Sonographers and government agencies in order ta facilitate closure and prevent proliferation of businesses which use diagnostic ultrasound equipment for non medical purposes. Adopted by CAR Couc February 11,1996
GENDER SELECTION
This Policy Statement has been prepared and approved by the Council of the Society of Obstetricians and Gynecologists of Canada The SOGC believes that medical techniques of gender selection are controversial because they are being used to meet the societal needs rather than the medical needs of some segments of society. Measures designed to support societal preferences for male children whether by selective implantation of embryos, selective abortion of healthy fetuses after amniocentesis or infanticide, all reinforce discriminatory attitudes towards women and female children. Any similar attempt to favor birth of female children would be discriminatory against males. Medical techniques including ultrasound used with the intent of minimizing the genetic transmission of diseases are accepted internationally but measures which perpetrate discrimination are condemned.
FETAL SEX DETERMINATION FOR NON-MEDICAL PURPOSES
The College of Physicians and Surgeons of British Columbia endorses the recommendation of the Commission on New Reproductive Technology, that fetal gender determination for nonmedical purposes is unethical.
The commission states that sexing (a) departs from the major goal of prenatal diagnosis, namely the prevention of serious genetic disease and thus is not medically indicated (b) violates the principle of equity between males and females (c) sets a precedent for other eugenic decisions that are socially repugnant and (d)employs costly and scarce medical resources for a private purpose. There is one exception to the above statements, the CAR, SOGC and AlUM all recommend sexing in cases of multiple pregnancies. This information should not be provided to the patient as it is being derived for medical purposes only.
CSDMS STATEMENT ON ULTRASOUND FOR ENTERTAINMENT:
The Board of Directors of the C.S.D.M.S. has officially endorsed the S.D.M.S. statement on the non-diagnostic use of ultrasound. The following is the final statement which will become CSDMS policy for all future discussions regarding this issue.
Ultrasound examination during pregnancy is increasingly common and is considered a routine procedure by many. However it is not clear that ultrasound waves are free of risks to the growing fetus. it is prudent to avoid or limit exposure to ultrasound waves during the vulnerable fetal period. Fetal ultrasound examination should not be a routine practice, but should only be performed when there is a clear medical indication. The S.D.M.S. states: ?Videotaping for entertainment is, by definition, a non- diagnostic procedure. its sole purpose in these much publicized businesses is to produce images of the developing fetus. Therein lays the center of the controversy. As a result of much deliberation, the Board issued the following statement:
Diagnostic Medical Sonography is a medical procedure that is requested by a physician, performed by a Sonographer, and interpreted by a Sonologist. It is a diagnostic procedure often used to examine a developing fetus for abnormalities. Within the past few years, however, a small number of private businesses have opened for the sole purpose of providing parents with images of a developing fetuses on videocassette. Because the service is provided for entertainment purposes only it is considered non-diagnostic.
This is a topic that has generated much debate and discussion among those in the diagnostic medical sonography profession and has recently received a great deal of media attention. The Society of Diagnostic Medical Sonographers recognizes the responsibility we have to the health care community and patients. As Diagnostic Medical Sonographers, we are committed to act in the best interest of the patient and to maintain ethical standards to preserve and promote Sonography as a profession. Because of our dedication to professionalism and our commitment to the use of ultrasound as a diagnostic procedure, SDMS does not condone the use of ultrasound solely for entertainment purposes.
SDMS Board of Directors March 12.1994
Sonographers Observations and Comments:
The role of the sonographer is to perform the study and document observations, It is not the sonographers role to provide interpretations of observations or reports to patients, referring physicians or others outside the ultrasound department. The written communication is meant to be a communication solely from the scanning sonographer to the supervising sonologist. For example, these preliminary observations should not be used as a verbal report over the phone, but may be retained on patient=s chart depending on the policy of the facility. It is suggested that the documentation of these observations should be made following some guidelines, such as:
THE CANADIAN ASSOCIATION OF RADIOLOGISTS STANDARDS FOR PERFORMING AND INTERPRETING DIAGNOSTIC ULTRASOUND EXAMINATIONS STATE:
A Sonologist must be available for consultation with the Sonographer on a case by case basis. Ideally the Sonologist should be on site and available to participate actively in the ultrasound examination when required. Alternatively video link may be adequate supervision of ultrasound examinations when the Sonologist is not present.
It is recognized however, that geographic realities in Canada do not permit the presence of an on-site Sonologist in all locations. Adequate documentation of each examination is critical. A videotape record may be useful as an adjunct to the hard copy images in difficult cases. Despite the geographic isolation of a community the reports must be timely. Furthermore, the Sonologist must be available by telephone for consultation with the Sonographer and the referring physician. The Sonologist should visit the facility on a regular basis to provide on site review of the ultrasound procedures and Sonographer supervision.
Limited Obstetrical Ultrasound
Approved October 7, 1997
Definition: A Limited Obstetrical ultrasound is performed to answer a specific, acute clinical question, when an immediate impact on management is anticipated, and when time or other constraints make performance of even a Basic sonogram impractical.
If a Limited Obstetrical ultrasound is performed on a woman who has not previously had a Basic or Targeted ultrasound examination, a follow-up Basic sonogram should be obtained, where appropriate. In patients who require serial sonograms and have already had a basic or targeted scan, some will only need Limited scans, while others will require Basic or Targeted scans. Clinical judgment should be used to determine the proper type of sonogram to perform, and the appropriate frequency.
Background: Professional groups with interests in obstetrical sonography including the American Institute of Ultrasound in Medicine (AIUM), the American College of Obstetricians & Gynecologists (ACOG), and the American College of Radiology (ACR) have proposed guidelines and standards for Basic obstetrical sonography. More advanced sonograms ("Targeted", or "Comprehensive") are also common for patients with identified risk factors for fetal anomalies or other complications. "Basic sonogram" is used here according to the AIUM Standards for the Performance of the Antepartum Obstetrical Ultrasound Examination. The terms Level I and Level II are obsolete, and their usage is discouraged.
The clinical practice of obstetrics can produce situations when even a basic sonogram is either impractical, or unnecessary and a "Limited" Obstetrical ultrasound is more appropriate. In addressing "Limited Sonograms" this document assumes that: Obstetrical ultrasound is only obtained when clinically important information is required.
When possible a Basic sonogram is more desirable than a Limited sonogram. If a Basic sonogram has not previously been obtained, it should be if the clinical situation permits.
The maximum available information should be obtained from every Obstetrical ultrasound.
Obstetrical ultrasound is not being used for entertainment, or for sex determination purposes in the absence of an indication. Obstetrical ultrasound is not being used solely for billing purposes.
A Limited sonogram is not a replacement for a Basic sonogram due to inexperience or lack of qualifications of the sonographer/sonologist.
Documentation: Limited sonograms require documentation. Whenever feasible, images should be stored as part of the medical record. Whether or not images are obtained, a full description of the findings is required. When a patient undergoes a Limited sonogram, it is important that she understands why a Limited scan is being done and that she has appropriate expectations about the information being sought. In particular, she should be aware thaat fetal anomalies may not be detected.
This document is not intended to provide a formal definition of limited sonogram for coding and billing purposes.
A Limited sonogram will rarely be appropriate in routine patient care. Generally,