Children’s Medical Devices May Pose Safety Issues

When it comes to medical devices, one size does not fit all. Parents and other caregivers who experience problems with pediatric medical devices are being encouraged to report any issues with the Food and Drug Administration. The FDA wants this information to help them assess any safety issues and conduct any needed follow-up investigations.

What is a medical device?Child Waits for Health Care

According to the FDA, “Medical devices range from the simple items in your medicine cabinet, like adhesive bandages, to complicated equipment, such as X-ray machines and pacemakers.” Devices used by children can include braces, hearing aids, insulin pumps, blood glucose monitors, breathing devices, and joint replacements.

Things to Think About

To help ensure that devices used by or on children are safe and effective, the FDA recommends caregivers keep the following things in mind:

  • One size does not fit all for devices. Devices are often designed for adults but used for children, whose smaller size and weight may make it challenging to accommodate some devices. Moreover, not all pediatric patients are alike. Devices might need to be changed or replaced as children grow.
  • Children and adolescents may be at varying stages of activity and development, and are exposed to different environments. Be alert for signs of device problems because some children may not be able to communicate.
  • Children may be prone to falls, bumps and infections as they grow and develop, and this can cause mechanical damage to devices, such as implanted devices.
  • Caregivers or children might not pay attention to device alarms or may not notice low battery power.
  • Many devices use catheters, which can move, kink, break or disconnect, preventing the child from receiving the intended care and increasing the risk of contamination.

More Funding and Research Needed

The New York Times recently reported that the development of devices for children “lags a decade behind device development for adults.” In many cases, there is no pediatric surgical device available, so doctors are forced to use adult-sized devices “off label” in the children they treat.

“Often we end up having to dramatically modify an operation simply to be able to implant a device in a child,” said Dr. Pedro del Nido, chairman of the department of cardiac surgery at Boston’s Children’s Hospital.

Congress passed the Pediatric Medical Device Safety and Improvement Act in 2007 which authorized the FDA to offer grants to stimulate pediatric device development. Despite the $11 million given in grants, companies still find research and development expenses hard to recoup, given the relatively small market for children’s devices.  Furthermore, little market data exists on what pediatric devices are needed most.

How to Report

According to the FDA’s Web site, Parents and other caregivers can report pediatric problems with medical devices through MedWatch: The FDA Safety Information and Adverse Event Reporting program. The agency urges caregivers to make sure to include the patient’s age and as much information about the event and device as possible to facilitate identifying pediatric device problems.

 

Sources:

Medical Devices Fall Short for Children” by Laurie Tarkan, New York Times, May 6, 2013.

Safety Problems With Your Child’s Medical Device?” FDA Consumer Health Information, July 2013.

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One Reply to “Children’s Medical Devices May Pose Safety Issues”

  1. This brings to mind Orphan Drugs. The “relatively small market for children’s devices” seems to reflect the small market for drugs needed to treat rare medical conditions. While the Orphan Drug Act of 1983 may (or may not; depends on what data you believe) have made a difference in the creation of more Orphan Drugs, it sounds like more needs to be done to “stimulate pediatric device development.”

    (On a side note, it’s interesting that the FDA lists adhesive bandages as medical devices.)

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