Almost all of the devices had only been tested on
people age 18 and older, researchers found.
"Children are not simply 'small adults,' and a device found to be
safe and effective in adults may have a very different safety and
effectiveness profile when used in a pediatric population," said
Brigham and Women's Hospital and Harvard Medical School research
fellow Thomas J. Hwang, one of the study's authors.
"Without this data, it is difficult for clinicians and parents to
make informed treatment decisions that weigh the risks and benefits
of a particular treatment," he told Reuters Health in an email.
The new study examined what kind of testing has been done on medical
devices meant for kids since an act of Congress incentivized their
development seven years ago.
The researchers considered the 25 medical devices that were approved
by the U.S. Food and Drug Administration (FDA) for use in patients
age 21 and under between 2008 and 2011. They looked at data from the
main clinical trial that was used to get each device approved.
According to those data, 11 of the 25 devices were not tested on any
patients age 21 and under. Only four of the devices had been tested
on patients under age 18.
Three of the devices included in the study were specifically
approved for kids under 18; the rest were approved for 18- to
21-year-olds, who the FDA devices center considers pediatric.
However, researchers said devices only approved for older
adolescents are likely used "off-label" in younger children, as
there typically aren't any alternatives.
Most of the devices had been approved with a stipulation that the
device makers conduct postmarket trials once the product was being
used commercially to make sure it was safe and effective. But only
three required that kids be included in the trials, and none of
those was actually complete, according to results published in
"Designing devices for children is more complex because they are
still growing and may need to have the device for many decades, in
contrast to older adults," said Dr. Katherine Bates, a cardiology
fellow at The Children's Hospital of Philadelphia. Without testing
the device in children, it's impossible to say how the device will
perform long term, but it can be difficult to enroll children with
rare diseases in clinical trials for both practical and ethical
What's more, the government provides incentives for drugmakers to
run clinical trials with children, but not for device makers, Hwang
"Overall, many of these devices were not only tested in limited
pediatric populations, but many were also approved on the basis of
clinical trials that did not employ a very rigorous trial design,"
said Dr. Florence Bourgeois of Boston Children's Hospital, another
author on the study. Some devices were approved on the basis of
observational studies, instead of more rigorous randomized
Most kids will never need these devices, which include stents and
artificial heart valves. But sometimes they are the best and
possibly only option, she told Reuters Health in an email.
[to top of second column]
The FDA requires at least one clinical trial that shows a device
is safe and effective before approving it for use with patients. But
the clinical trials don't necessarily have to include the same type
of patients that will be getting the device in the real world.
"Generally people in the clinical trials tend to be healthy
middle-aged white men," Dr. Rita F. Redberg said.
Redberg is the editor of JAMA Internal Medicine and a cardiologist
at the University of California, San Francisco. She was not involved
with the new study.
Devices tend to be understudied in women and the elderly, Redberg
told Reuters Health. She was disappointed to see that the case is
the same for children.
"Common sense would dictate that devices would be studied in the
appropriate populations before they are used on the market," she
There is an exemption from the approval requirements for
"high-risk" devices that support or sustain life in patients with
rare diseases, which affect fewer than 4,000 people in the U.S.
yearly: those devices only need to demonstrate safety and probable
benefit. The catch is, devices that use that exemption can't be sold
In 2007, an act of Congress eliminated that catch for devices
intended for children, and also set up grants for nonprofit
pediatric device developers.
Three of the 25 devices included in the current study utilized the
rare disease exemption.
Parents should talk to their doctors about any devices recommended
for their children, and ask about how much evidence there is that
the device will be effective and is safe, Bates said.
"Perhaps most importantly, if given the opportunity, parents should
give careful consideration to enrolling their child in trials," she
said. "We cannot learn more about how these devices work in children
without families who are willing to participate in clinical trials."
Pediatrics, online April 14, 2014.
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