Parents Asked By FDA To Report Children’s Medical Device Defects

Posted on July 17, 2013

Children’s medical devices have become increasingly commonplace, but the Food and Drug Administration is concerned that parents might not be adequately prepared to report potential adversity associated with a product.  Many parents may find themselves attributing a side effect or some type of error to the child or something that they have done wrong, but this isn’t always the case.

To stress the importance of always reporting medical device defects, the FDA has released an article focused on helping parents and guardians come to terms with the types of things that should prompt a MedWatch report.  When this type of information is made available to the FDA, the agency is able to compile the numerous instances of adversity and potentially identify shortfalls in safety that could be widespread.  And it’s your reports that could make that possible.

No two devices are the same.  A medical device might be used to treat a condition or to diagnose a condition.  They can be as small and easy to store as an inhaler or as large as an X-ray machine.  Implants and prostheses of all kinds fall under the banner, as do systems that monitor vital functions, like pulse or respiration.

If a device is inherently defective, the FDA needs to know about it.  A device defect can potentially contribute to problems that are more severe than the original malady the item was designed to treat.  And the more complex the device, the greater the potential for error.  Misuse of the device, even if technically the result of an error on the user’s part, could point to overly complicated instructions or a lack of proper instruction, and thus even this should be reported, as many people could be experiencing the same problem.

The FDA then goes on to provide a series of tips for parents whose kids are using or are about to use a medical device.  First, realize that size may be a factor.  Some products may work for adults as well as kids, but not all will.  Speaking with a doctor is essential prior to usage, and attention should be paid to usage instructions as the child ages.

Parents also have to realize that many kids are going to want to be highly active even when using the device.  As such, it’s up to parents to make sure that the device is always in good shape and that brothers and sisters know that tinkering with the product in the name of good clean fun is not allowed.

If a child’s skin at the device area has turned red or swells, an infection could be a possibility.  Frequent checking of a device is particularly important with catheters, which can easily become kinked or disconnected.  And if a daycare center watches your child, make sure the overseers understand that your kid uses a medical device.  Inform them of any alarms or warnings that might go off and what should be done in that situation.

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