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FDA Implements Unique Codes to Track Medical Devices

Posted on in Defective Medical Devices

The FDA announced recently that federal health regulators will be able to track millions of medical devices around the country soon with a new electronic system. The goal of the program, which works with pacemakers, hip replacements, and a broad array of medical devices, is to protect patients by identifying problems early on. Serious problems from defective medical devices have led to complications, follow-up surgeries, and attorneys tackling the issue head-on.

The new rules required that the majority of medical devices sold within the U.S. be connected with a unique code including the make, lot number, and manufacture date. The database of the information collected from these devices will be stored publicly to allow consumers, physicians, and companies to monitor whether any safety issues present a concern.

The concept of the tracking system is not new; those concerned with the growing number of painful and complicated issues reported by victims of defective medical devices have been calling for its use for several years. Doctors will now also be able to use the codes in the medical records belonging to their patients, developing an electronic trail of information that will flag defective devices earlier.

The system will be put into place over the coming year. Mandated devices include defibrillators and heart stents. After the initial system is worked out, the identification process will be expanded to X-ray systems, power wheelchairs, and surgical needles. Manufacturers of these devices will have a three year period to add the tracking codes. Some devices that are considered low-risk, such as exam gloves or bedpans, will be excluded from the tracking requirement.

The tracking system is being applauded after news coverage in the past decade has pointed to the dangers of numerous defective devices. If you have been the victim of a defective device, consulting with a lawyer will help you understand your next steps. Contact the offices of an Illinois defective medical device attorney today to get started.

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