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Medical Devices and Pediatrics Shannon Nees, PGY-2 December 9, 2013

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Outline Medical device development and approval Medical devices in pediatrics History of pediatric device legislation Current and future legislation

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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.

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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