| Ilena Rose 2005-07-20, 2:11 pm |
| Coleah ... ask Cindy since you are playing Net Nanny again ... what an
important job you have! Focus ,.. focus ... focus! LOL
www.BreastImplantAwareness.org/SBIPrivateClub.htm
~~~ Thanks CFM ~~~
www.BreastImplantAwareness.org#Cindy
More Oversight Urged for Child Devices
http://www.intelihealth.com/IH/ihtI...29?d=dmtICNNews
July 19, 2005
WASHINGTON (AP) -- Monitoring of medical devices sold for children
must be improved, a major new report concludes, citing missed
opportunities to uncover side effects and make crucial treatments
safer for the tiniest patients.
Improved tracking of device safety and other steps will also benefit
adult recipients of medical devices, notes Monday's report from the
Institute of Medicine.
But "special focus needs to be on children," said Dr. George Lister, a
pediatrician at the university of Texas Southwestern Medical School
who co-authored the report.
That's because very often, doctors must jury-rig adult medical devices
to fit children's small bodies and special needs. Far fewer medical
devices are manufactured especially for children than for adults
because the pediatric market is much smaller.
Regardless of pre-sale testing, unanticipated side effects or device
flaws can arise once they're used more widely in either adults or
children. So manufacturers are required to tell FDA of any reported
side effects, and the government sometimes requires makers to study
long-term risk even as their products are sold.
Congress asked the Institute of Medicine -- an independent group that
advises the government on health matters -- to study postmarket safety
monitoring of children's medical devices.
The report concluded that one big problem is a lack of data on how
devices affect children's growth and development.
In addition, a youngster's rough-and-tumble lifestyle or the hormonal
changes of puberty can affect a device's functioning, noted IOM
panelist Mark Bruley, a biomedical engineer at the nonprofit health
research agency ECRI.
The panel cited a preschooler who needed an implantable defibrillator
to treat a rare irregular heartbeat. While it saved the girl by
shocking her heart back into rhythm several times, one day she
suddenly collapsed with chest pain. Cardiologists discovered her rapid
growth had broken one of the device's parts, causing it to misfire.
Implanted defibrillators are used mostly in adults and haven't been
adequately studied in young children, the report said.
Problems can occur even with the simplest devices, like a medication
syringe for babies that caused some near-chokings when parents didn't
know to remove a hard-to-see clear-plastic cap.
Only if parents or health workers report such problems can safety
warnings be issued or devices be built better, the report noted. For
example, complaints from a surgeon who suspected static electricity
from playground equipment was zapping his patients' cochlear implants
led the maker to revamp the hearing devices.
But too often parents and even health workers assume that devices wear
out or break, or they don't know to whom they should direct
complaints, Lister said.
Among the panel's recommendations:
Congress should give FDA the authority to require postmarket studies
of any device; today, it can force them to perform such studies only
for certain products.
Congress should require FDA to establish a public database showing
those studies' status and findings.
Congress should fund improved postmarket surveillance for
device-related problems in both adults and children. Lawmakers
authorized an extra $6 million this year for FDA to do that but
ultimately never provided the money, the report said.
FDA should collaborate with the National Institutes of Health to
prioritize research on devices used on children despite a lack of
manufacturers' studies.
FDA should work with parents, patient advocates, health organizations
and the industry to increase reporting of side effects or potential
device flaws.
The IOM panel "made some important recommendations," said Susan
Gardner, who oversees FDA's device tracking and is assessing the
report. It already is moving toward enacting one recommendation --
creating a public database of certain postmarketing studies.
"Children are always last in line when it comes to safety of drugs and
devices," said Mark Isaac of the Elizabeth Glaser Pediatric AIDS
Foundation, which is pushing Congress for improvements. "We must raise
the level of vigilance for devices used in children or we risk causing
serious problems for the young patients we are trying to help."
The device industry's trade group, AdvaMed, declined immediate comment
but had told the IOM panel that FDA has adequate authority to ensure
device safety.
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