Dangers of Defective Medical Devices
- Author Mark Dacanay
- Published March 23, 2010
- Word count 484
Medical technology has grown leaps and bounds especially in terms of producing advanced devices that will help people maintain their good health and save more lives.
Most medical devices are used to help diagnose and treat certain diseases so if it is not working as it should, it can pose life-threatening dangers.
Medical devices, like any other products, operate on the assumption that it will function in the way that it is supposed to. Medical products in particular, provide people who use it the guarantee that it is a safe to use and will adequately address certain health concerns.
That is why defective medical products are a serious health risk.
It betrays the guarantee of safety that the manufacturers gave their consumers.
Standards of Medical Devices
The Food and Drug Administration (FDA) is the federal agency tasked to assess the safety and effectiveness of medical devices before it is marketed to the public.
This is handled by the FDA department, the Center for Devices and Radiological Health (CDRH).
Aside from approving new products before it is released, the CDRH also investigates reports of defective medical devices.
If a medical device is found to have a safety defect, the CDRH can recommend a product recall to the manufacturers.
Medical device manufacturers usually comply by doing a voluntary product recall to avoid possible lawsuits and further damage to their image.
Recent Defective Medical Devices Lawsuits and Product Recalls
Two medical device manufacturers have been getting a lot of attention as a result of allegations about some possible defective products.
Guidant and Medtronic are both battling several lawsuits about safety defects on several of their products that include:
• Pacemakers
• CRTs
• ICDs
In fact, Medtronic recently received three more lawsuits about defective defibrillators.
According to reports, some patients were experiencing sudden shocks after being implanted with the device.
Two more companies, Centurion Premie and Meconium Packs also issued product recalls for their pediatric tracheal tubes.
Investigations found out that the tubes manufactured have a smaller internal diameter than what was indicated on the label.
It sounds like a small thing, but a few millimeters can be the difference between life and death to some patients.
Keep Yourself Safe
If you’re currently using any medical device, you should keep yourself informed about the latest product recalls announced by the FDA.
You should also be aware of all the possible effects of the medical device to your body, whether it is the main function of the device or just a side effect.
The manufacturer or seller of the medical device should make a full disclosure about all the important information about the product including proper use, possible harmful effects, and warranties.
If not, you may find yourself surprised and shocked that the device that is supposed to help you is harming you.
If that is the case, you should consult a product liability attorney to know your legal options.
Our personal injury lawyers are experienced in handling cases involving product liability. For consultation, visit our website and avail of our free case analysis.
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