Medical Devices and Pediatrics

Medical Devices and
Shannon Nees, PGY-2
December 9, 2013
 Medical device development and approval
 Medical devices in pediatrics
 History of pediatric device legislation
 Current and future legislation
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.
Medical Device Development and
 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
Medical Device Development in
 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
Media Coverage
 NY Times, May 2013:
Why can’t we just make devices
 Different physiology than adults
 Ex: faster respiratory and cardiac rates
 Different metabolic responses to material used
 Devices may require significant redesign due to size
 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
 Ex: Ventricular assist devices
Examples of Medical Devices for
Marilyn J. Field and Hugh Tilson. Safe Medical Devices for Children Executive Summary. IOM 2005.
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
 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
 Devices designed for adults may incorrectly interpret
sinus tachycardia as ventricular tachycardia, and deliver
an inappropriate shock
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
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 <4,000 patients
 Have to demonstrate safety but not efficacy
 HDE manufacturers can recoup research and development
costs but cannot profit from sale of devices
History of Pediatric Device
Approval and Regulation
 Medical Device User Fee and Modernization Act of 2002
called for the IOM to assess the system under the FDA for
the post-market surveillance of medical devices in pediatric
 The IOM report was published in 2005 and made many
recommendations including:
 The FDA should develop additional guidance on the
identification and evaluation of pediatric questions or concerns
at all stages in the design and evaluation of medical devices
used with children.
 Congress should amend the Federal Food, Drug, and Cosmetic
Act allowing the FDA to change the duration of Section 522
studies beyond the three-year limit for devices likely to have
significant pediatric use so that studies can take into account
children's growth and development.
History of Pediatric Device
Approval and Regulation
 In 2004, the FDA issued a report to Congress: Barriers to
the Availability of Medical Devices Intended for the
Treatment or Diagnosis of Diseases and Conditions that
Affect Children.
 They gathered comments from various stakeholders and
developed recommendations.
 The main recommendation was to further research and
define unmet pediatric device needs.
 Other recommendations included:
 Enhanced interaction and communication between pediatric
clinicians and device manufacturers.
 Development of a network of children’s hospitals and healthcare
facilities with expertise in pediatric diseases and conditions.
 Consideration of certain pediatric device issues by the Office of
Pediatric Therapeutics or the Pediatric Advisory Committee in
order to improve pre-market review of pediatric devices.
Pediatric Medical Device Safety
and Improvement Act (PMDSIA)
 Passed by congress in 2007 and signed into law by
President George W. Bush
 Created a mechanism for the FDA to track devices
designed for use in pediatrics
 Removed profit restriction for devices marketed and
approved as HDEs as long as they were labeled for
pediatric populations
 Enhanced post-market surveillance including the ability
to extend studies past the three year limit for devices
likely to have significant pediatric use
 Included the introduction of the pediatric device
 Significantly increased the number of medical devices
designated for pediatric patients
 Needs to be renewed every 5 years
 July 9th 2012, the reauthorization was passed as part of
the FDA safety and innovation act
 Reauthorized and preserved the pediatric profit incentive for
 Reauthorized the pediatric device consortia at $5.25 million
dollars per year
 Included a provision requiring medical and surgical device
companies to submit available pediatric information in their
device applications.
 Established a timeline for implementing a pediatric device
tracking rule to improve surveillance of devices in pediatric
 This will require companies to submit available pediatric
information in device applications
 Final rule must be submitted by Dec 31, 2013
FDA Pediatric Device Consortia
(PDC) grant program
 Support the development of a consortia to stimulate projects that
will promote pediatric device development
 Provides grants to programs who contribute to market approval of
medical devices designed specifically for use in children
 Intended to encompass devices used in all pediatric diseases, not
just rare diseases
 Grants awarded every two years
 Grants awarded every two years to programs who:
 Connect people with device ideas with potential manufacturers and
resources for business development
 Mentor projects through the development process
 Helpsdevice developers navigate the FDA regulatory process
 Currently funding consortia who have helped advance the
development of over 135 proposed pediatric medical devices
 This Program needs to be renewed every 5 years and was renewed
in 2012
 Budget of ~$6.0 million for FY 2013
2013 Grants
1) University of Michigan Pediatric Device Consortium, led by
James Geiger, M.D., $700,000/ year
2) Atlantic Pediatric Device Consortium, led by David Ku, M.D.,
Ph.D., $700,000/ year
3) National Capital Consortium for Pediatric Device Innovation,
led by Peter Kim, M.D., Ph.D , $700,000/ year
4) New England Pediatric Device Consortium, led by Rick
Greenwald, Ph.D., $700,000/ year
5) Southern California Center for Technology and Innovation in
Pediatrics, led by Yaniv Bar-Cohen, M.D., $300,000 /year
6) Philadelphia Regional Pediatric Medical Device Consortium,
led by Matthew Maltese, M.S., Ph.D., $300,000/year
7) Boston Pediatric Device Consortium, led by Pedro del Nido,
M.D., $200,000/year
San Francisco Pediatric Device
 Meets twice weekly to discuss potential projects
 Meetings are open for anyone to bring in an idea or
 Corsortia helps with design and regulatory process,
makes contacts with important resources, etc.
 Acts as a think tank for new devices
Pediatric Device Consortia –
Michael Harrison, MD
Example: Artificial Kidney
Future Issues
 Profit incentive for HDEs and the Pediatric Device Consortia
will need to be re-approved in 2017
 Although the consortia provides resources for device
developers, still does not provide funding for these devices
 Ongoing debate regarding the appropriate requirements for
companies submitting pediatric data in device applications
 Although legislation has allowed the FDA to approve devices
aimed at pediatric populations, insurance coverage of HDE
devices is inconsistent
 We still have relatively little market data on what pediatric
devices are most needed
Private Companies
What can you do?
 Contact your representatives to let them know that you
support legislation to encourage device development in
 Support future legislation to improve the assessment of
pediatric needs
 Have an idea for a device?! Contact one of the FDA
funded consortia for resources to help you get started!
 Bates, KE et. Al. Pediatric cardiovascular safety: Challenges
in drug and device development and clinical application. Am
Heart J. 2012 Oct;164(4):481-92.
 Pediatric Drug and Device Law Compilation. The Best
Pharmaceuticals for Children Act, the Pediatric Research
Equity Act, and the Pediatric Medical Device Safety and
Improvement Act As Amended by the Food and Drug
Administration Safety and Innovation Act July 2012
 Marilyn J. Field and Hugh Tilson. Safe Medical Devices for
Children Executive Summary. IOM 2005.
 Poslosky, J. Children are not little adults: Federal legislation
would ensure medical surgical devices meet pediatric
patients’ needs. AAP News 2012;33;5
 Samuels-Reid J, Lawrence B, Millin C, Cope J. Pediatric
devices and adverse events from A to Z: understanding the
benefits and risks from a US FDA perspective. Expert Rev
Med Devices. 2012 May;9(3):275-82. doi:
 U.S. Department of Health and Human Services Food and
Drug Administration. Barriers to the Availability of Medical
Devices Intended for the Treatment or Diagnosis of
Diseases and Conditions that Affect Children. Oct 2004
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