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Autores :
| Barnett, Stanley B. ; Abramowicz, Jacques S. ; Ziskin, Marvin C. ; Maršál, Karel ; Claudon, Michel
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Abstract (English)
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| EXECUTIVE SUMMARY
The conclusions and recommendations for safe use
of nonmedical ultrasound were drawn from information
provided by individual contributions during this project
and from published position statements and guidelines
of major imaging and health organizations.
Diagnostic ultrasound imaging is considered to be
safe when carried out in the clinical setting by trained
personnel following appropriate professional guidelines.
However, it should be recognized that there are no scientific
epidemiologic data from exposure to outputs and
scanning procedures of modern ultrasound equipment
on which to base a direct assessment of safety.
The prudent use ofmedical ultrasound refers to ‘‘medically
indicated’’ procedures, i.e., those where an improved
diagnostic outcome is expected. The use of ultrasound
imaging simply to view the fetus for demonstration purposes,
to verify fetal gender, or to obtain a personal photograph or
keepsake video does not constitute a referred medical use.
The market for ultrasound entertainment scans has
been driven in part by reluctance of some medical practitioners
to provide still or video images to patients, due
partly to concerns that images provided to patients could
be used as evidence in claims of failure to diagnose
a congenital abnormality. If a congenital abnormality is,
in fact, present and has been missed, having given the
patient an image with or without the abnormality is probably
minimally, if at all, additionally incriminating. On the
other hand, by providing patients having medically indicated
scans with multiple still images or video clips
creates good relations with patients, and a potential deterrent
to future professional liability claims.
Public health experts, clinicians and industry agree
that exposure of the fetus to ultrasound for solely for
nonmedical purposes should be avoided. Various ultrasound
organizations around the world support the position
against the use of ultrasound for nonmedical purposes. For
example, the American Institute of Ultrasound in Medicine
(AIUM) is firm in its opposition to nonmedical use
of obstetric ultrasonography, and the commercialization
of fetal sonograms by nonprofessionals. The AIUM also
encourages ultrasound equipment manufacturers to agree
not to sell imaging systems to nonmedical imaging facilities.
The U.S. Food and Drug Administration Centre for
Devices and Radiological Health (FDA) takes the position
that persons who promote, sell or lease ultrasound
equipment for making fetal keepsake or souvenir videos
are performing unapproved use of a 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 or regulations regarding the use of
a prescription medical device. It should be recognized
that while the FDA has regulatory authority regarding the
marketing of safe and effective medical devices, its jurisdiction
does not encompass their use. It also has regulatory
power over the manufacture and sale of ultrasound systems.
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 licensed diagnostic
purposes. Health Canada has established Guidelines for
the Safe Use of Diagnostic Ultrasound that state that ultrasound
should not be used for any of the following activities:
To have a picture of the fetus, solely for nonmedical
reasons; to learn the sex of the fetus, solely for nonmedical
reasons; or for commercial purposes, such as trade shows
or producing pictures or videos of the fetus.
Health Canada recommends that parents do not
expose their unborn babies to fetal ultrasound for the
purpose of making ‘‘keepsake’’ or souvenir videos. Diagnostic
fetal ultrasound imaging should be undertaken only
on referral from a licensed health care provider within
a clinical setting by highly qualified professionals.
The British Medical Ultrasound Society has issued
users safety guidelines for nondiagnostic uses of ultrasound
imaging where upper limits of ultrasound exposure
are set at TI,0.5 and MI,0.3. These restrictive levels of
exposure were installed to provide a lower risk for procedures
where there is no obvious clinical benefit.
Whilst the use of ultrasound solely for nonmedical
purposes outside of the clinical setting (e.g., for commercial,
nondiagnostic purposes) is not recommended, inclusion
of some time for ‘‘entertainment ultrasound’’ during
a referred medical examination may provide a solution to
satisfy patients, providers and regulators. However, whilst
this might address potential issues of patients (mothers)
rights, there is no consideration for the rights of the fetus,
as a patient. There are significant ethical and potential
medico-legal issues at stake.
There are a number of important safety issues that
require consideration before undertaking any nonmedical
ultrasound imaging during a clinical diagnostic examination:
⬚ The ultrasound exposure time applied to the fetus
should not significantly increase.
⬚ Qualified and trained personnel should always operate
the ultrasound equipment.
⬚ The ultrasound machine should be properly maintained
and accurately calibrated.
⬚ The patient must have a complete anatomic survey of
her fetus prior to any additional nonmedical/bonding
ultrasound scan. With the anatomy scan performed first,
WFUMB Symposium on nonmedical use of ultrasound d S. B. BARNETT et al. 1211
it is unlikely that additional abnormalities would be detected
during the bonding part of the process.
⬚ It is important that the attending ultrasound specialist is
familiar with the risk of ultrasound bioeffects and
understands the purpose of the equipment output
display.
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