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How safe are the medical devices used for your child?

Submitted by jrlaw on Sep 1st, 2009

Most medical devices are created for adults. Those used with children may be ones modified from an adult version, devices for general use and some are created specifically for pediatrics. The FDA actually follows the development process for devices created for pediatrics all the way to market approval.
In 2002, the Medical Device User Fee and Modernization Act was signed in order to promote the development of pediatric devices. This act also required the FDA to make sure adequate safeguards are in place for pediatric populations.

Some of the general principles used in the evaluations are:

- making sure the devices are compatible with the child’s age/development
- sterility and infection control
- environmental factors related to location of use, such as radiation
- design controls and good manufacturing practices

When assessing the risk to children, they consider the following factors:

• age and degree of physiological maturity of the child
• nature and natural history of the clinical condition to be treated
• presence of complicating clinical conditions
• safety and effectiveness of the device that may have been demonstrated in older patients, or that is expected on the basis of other clinical or preclinical investigations
• likely duration of device use and its impact on the growth and development of the child.

Ask your doctor what they do to ensure the safety of the medical devices they use. Here is a nice handout to give them on ‘Frequently Asked Questions about Medical Devices’. If you want to know more about medical devices for your child, look over the book, 'Safe Medical Devices for Children', developed for parents and guardians.