Safety Problems With Your Child's Medical Device?

Medical devices used by children range from simple to complex. They include braces for teeth and limbs, hearing aids, insulin pumps, blood glucose monitors and inhalation devices.

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As technology provides more health care options, children are frequently diagnosed or treated with one or more medical devices.
If there are problems that prevent the safe use of pediatric medical devices, FDA wants to know about them. FDA wants caregivers to report problems or concerns to help ensure that pediatric devices can be used safely and deliver the intended benefits. And the agency wants to hear about the problems when they happen, especially if they might jeopardize the safety or care of a child.
"Parents and guardians should know that not every problem is related to a child's underlying illness or environment," says Joy Samuels-Reid, M.D., a pediatrician at FDA. "Most people are aware that drugs can have side effects, but they may not know that medical devices can have problems or may contribute to adverse events, too."
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Many Kinds of Devices

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 such as syringes and asthma inhalers help with the delivery of a drug or vaccine. Devices may be disposable, reusable or even implantable, such as cochlear implants (for severe hearing loss) and joint replacements. Devices might monitor a child's breathing, oxygen level, blood sugar level or blood pressure.
Although adolescents and some older children may be involved with using their devices, often a parent or other adult will either need to supervise or be the primary user. FDA's Center for Devices and Radiological Health (CDRH) considers patients through age 21 to be pediatric device users.
FDA has developed and administers regulations designed to ensure the safety and effectiveness of medical devices. Nevertheless, parents and caregivers should be aware of the potential for problems that may lead to the device working improperly, interfere with its effectiveness, or even harm the child. Some problems may be a result of a device not working as it should, while others might happen because of the way the parent or child uses the device. If a device is not easy to use, a child or caregiver could experience problems operating the device, which could in turn lead to an injury.
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Why Tell FDA about Device Problems?

Reports of device problems are critical in alerting FDA to safety concerns. These reports can trigger follow-up investigations, which can then lead FDA to take action to protect patients.
"We are very concerned about difficulties that might jeopardize the safety of a pediatric patient," says Samuels-Reid. "Parents and caregivers are critical to ensuring device safety and we need to hear about these situations so we can take action to prevent them."
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Things to Think About

To help ensure that devices used by or on children are safe and effective, 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.
TIP: When considering using a device, always read the label and talk to the child's health care professional to understand if the device is appropriate based on the child's age and size as well as his or her ability to tolerate the device for the time it would be used.
Children and adolescents may be at varying stages of activity and development, and are exposed to different environments.
TIP: Be aware of siblings and other people who might interfere with a device at home, school and during physical activities.
TIP: 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.
TIP: Children with implanted devices might need to take steps to protect their device. Caregivers should watch for signs of damage or infection around the device, such as redness, swelling, discharge or soreness.
Caregivers or children might not pay attention to device alarms or may not notice low battery power.
TIP: Although device sounds and alarms may become routine, young patients and their caregivers should investigate any error message before turning the alert or alarm off.
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.
TIP: Check catheters and connections on device delivery systems frequently.

How to Report

Parents and other caregivers can report pediatric problems with medical devices through MedWatch: The FDA Safety Information and Adverse Event Reporting program. 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.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
July 16, 2013
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