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Slide 1
Medical Devices and Pediatrics Shannon Nees, PGY-2 December 9,
2013
Slide 2
Outline Medical device development and approval Medical devices
in pediatrics History of pediatric device legislation Current and
future legislation
Slide 3
What is a medical device? According to the FDA: any instrument,
apparatus, implement, machine, contrivance, implant, and in vitro
reagent, similar or related article that is not metabolized in the
body; has no chemical action in/on the body; is not a drug,
biologic, or food; and is used to diagnose, treat, prevent, or
cure.
Slide 4
Medical Device Development and Approval Medical devices are
regulated by the FDA Approval process is based on the category of
device, which is determined based on the presumed risks Class I:
tongue depressors Class II: EKGs and hearing aids Class III:
Implantable or life-sustaining devices For FDA approval of Class
III devices, need to prove both safety and efficacy prior to
approval Devices must also be approved for an Investigational
Device Exemption (IDE) to be used in clinical trials FDA can also
grant approval for compassionate use of a device or emergency
authorization
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Medical Device Development in Pediatrics Majority of devices
used in pediatrics are developed for adults and then adapted for
use in children FDA has the ability to allow extrapolation of
device efficacy from adults to children Many devices are used
off-label in children Pediatric diseases are relatively rare
compared to many adult conditions so there is less financial
incentive to develop devices for them Designing clinical trials
involving children can be logistically and ethically complicated
Pediatric devices need to account for the variability in size and
developmental stages of children Need long term follow-up data to
determine safety of devices used in children
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Media Coverage NY Times, May 2013:
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Why cant we just make devices smaller? Different physiology
than adults Ex: faster respiratory and cardiac rates Different
metabolic responses to material used Devices may require
significant redesign due to size constraints Materials used in
adults may not be safe over long time periods required for use in
children Anatomy may differ making percutaneous device delivery
difficult Controls that are accessible to children must be
childproofed Ex: Ventricular assist devices
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Examples of Medical Devices for Children Marilyn J. Field and
Hugh Tilson. Safe Medical Devices for Children Executive Summary.
IOM 2005.
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Example: Pacemakers and ICDs More intense and varied types of
physical activity puts additional strain on these devices in
children compared to adults Children often require lead replacement
due to fracture or malfunction Rapid growth in children may require
additional length of leads to avoid increased tension Increased
heart rate in children leads to faster battery depletion so battery
needs to be easily removed and replaced Devices designed for adults
may incorrectly interpret sinus tachycardia as ventricular
tachycardia, and deliver an inappropriate shock
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Why should we care? Most research into drugs and medical
devices is focused on adults and adult diseases Children are not
just small adults: they have different medical problems as well as
different reactions to medical devices As pediatricians, we use
medical devices constantly in our practice and we need to
understand their indications and potential side effects in children
Developing new devices for pediatric conditions can be difficult
and it is important to understand this process
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History of Pediatric Device Approval and Regulation Prior to
2007, approval process for pediatric devices was the same as for
adult devices Post-market surveillance of devices was also the same
and was generally limited to 3 years There was no requirement for
device companies to submit information about potential pediatric
uses when submitting an application Pediatric devices could be
approved under the Humanitarian Device Exemption Pathway (HDE)
Device can be used to treat or diagnose a disease that affects