No doubt at some point over the past few years you have seen a product recall on the news. Perhaps a recall on possible tainted bagged salad, or an automobile with defective airbags, or a child’s toy with loose parts. Your local news anchor or website typically provide viewers with a serial number for consumers to check against their product to see if theirs is affected. But what happens if a medical implant—a device placed in your body—is recalled? Is there a serial number for easy identification? In these cases, unfortunately, it is not so simple.
Implanted devices and serial numbers
Up until 2007, there was no formal system of tracking medical devices until Congress mandated the unique device identifier (UDI) system of serial numbers. You can compare this UDI system to the vehicle identification number (VIN) on your car. However, over a decade later, the FDA is still developing rules on how to roll out this system. Compliance is slow and controversial.
Because UDIs are not listed in insurance claims, it is a difficult (and sometimes impossible) task to match a patient with a recalled device. UDI codes can run up to 75 characters, and opponents state these codes are simply too long and costly to insert into insurance claims. They mention the costs of investing in bar code scanners and developing a process to get the data to claimants. Currently, the research is mostly done by hand or is the patient’s responsibility to find out.
UDI advocates, on the other hand, point out that Medicare recently spent $1.5 billion over 10 years on surgeries and care for patients affected by a recalled heart device, so money is going to be spent either way. These groups also believe including UDI numbers on insurance forms can cut down on Medicare financial waste, and allow replacement of recalled devices before it is too late and becomes an expensive and possibly deadly epidemic. They also suggest that opponents of UDI labeling are wary of increased malpractice lawsuits, as UDIs may provide another source of data to medical malpractice attorneys.
Patient safety should come first
As the recipient of a medical implanted device, your safety as a patient should be the first priority. An easily tracked UDI can help identify an unsafe device before the issue becomes widespread and more dangerous. Common recalled medical devices include:
- Defibrillator wires
- Hip replacement joints
As a patient and a consumer with a medically implanted device, you have the right to transparency and accountability. Without UDIs in place, you may not know your device is dangerous until you have already suffered an injury.
At Gainsberg Law, P.C., if you or a loved one were injured due to a defective medical implant, we want to help. Our Chicago attorneys work with professionals to check for recalls and discover if your injury was avoidable, and help find treatment to correct any damage. For help with your case, please call us at 312-600-9585 or complete our contact form.