Children's Medical Device Safety Tips and FDA Concerns

Children's Medical Device Safety Tips and FDA Concerns

Philadelphia, PA, home to the highly renowned Children’s Hospital of Pennsylvania, is a highly regarded city when it comes to children’s healthcare and proper medical device safety. Advances in technology have made it possible to treat many pediatric illnesses with a wide variety of medical devices, ranging from simple things such as bandages, braces, and asthma inhalers to more complex devices like blood glucose pumps for diabetes and cochlear implants for hearing loss. While the use of these devices has generally been a great boon to the health and wellness of children, things can still go wrong and it is still vital to stay vigilant with regard to medical device safety.

FDA Medical Device Safety Act 2009

The FDA Medical Device Safety Act 2009, sometimes just called the medical device act, establishes and builds upon rules regarding the approval of new medical devices, and addresses FDA medical devices monitoring and reporting. If your child has been harmed in any way by a medical device, it is important to know what to do, and where to turn. Ginsburg Associates, serving clients in Cherry Hill, NJ and Marlton, NJ and Philadelphia, PA, want you to know that you have medical rights, and that the FDA wants your feedback on issues related to medical device safety.

Defective medical devices can damage your child’s health in a number of ways. Incorrect readings can lead to over- or under-medication. Devices that are not sterile or are improperly handled can lead to dangerous infection, especially if they are surgically-implanted devices. Medication-dispensing devices can malfunction, failing to provide the proper amount of medication needed for your child’s condition. Of course, many devices work wonderfully and allow for drastic improvements in your child’s health, but it’s important to be aware of proper medical device safety and know what to do in the event that something goes wrong with your child’s device, and to know the warning signs for potential problems.

Warning signs that you may be dealing with a defective or damaged device:

  • The condition being treated by the device worsens, or does not improve relative to what the device is designed to do.

  • Your child begins to experience medical problems unrelated to the issue being treated, but unseen prior to the use of the medical device.

  • Your child falls often or plays in a rough way, which could lead to damage to their medical device.

What if you suspect that your child suffered from a medical device safety issue such as a defective or damaged product:

  • Consult your child’s physician to make sure that your child is not in danger, and to replace or repair the medical device if needed.

  • Report the problem to the FDA. This will not only help to protect other people from defective devices in the future but also allow you to learn how common the problem with your device may be and how other people have dealt with similar problems. Reporting your problem to the FDA also establishes a paper trail related to medical device monitoring and reporting, which can be useful for litigation and general record-keeping.

  • If you suspect gross negligence or malpractice, consult with a trusted law firm with a proven track record of success. You may be entitled to damages or, at the very least, reimbursement for medical bills related to the use of a faulty or defective device.

In the past, people have successfully sued large corporations due to faulty medical devices. Some of these devices include vaccines, joint replacements, mesh used in hernia surgery, glucose reading test strips, and blood glucose pumps. When your child’s health is on the line, there is nothing more important than medical device safety. In the event that something goes wrong, know your rights, consult a lawyer, and report yourmedical device safety issues to the FDA.

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