New Tracking Codes on Medical Implants May Help Identify Problematic Devices
The yogurt you eat for breakfast has a tracking code. The car you drive to work has one too. The majority of products in your everyday life require unique identification codes so that manufacturers can track their goods through the supply chain. Monitoring and tracking products proves most effective in the event of a mass recall, such as the recent nationwide recall of contaminated Chobani Yogurt: in that instance, Chobani identified the tainted yogurt cups by the tracking codes marked on the labels.
Even the most mundane goods wear a tracking code; although until recently an extremely important group of products, products upon which peoples' lives depend, were not required to have them. Up until now medical devices were among the only products on the market that could not be uniquely identified, however this is no longer the case.
The Food and Drug Administration (FDA) published new rules on Friday requiring most medical devices sold in the US to display a unique tracking code, identifying its make, manufacture date, and lot number. This tracking system should help regulators, doctors, and companies monitor these devices if safety issues arise.
After a patient receives one of the newly marked medical devices, doctors can include the device's code in the patient's medical records. Then, if the manufacturer recalls that specific medical implant or device due to safety concerns in the future, those who received it can be quickly identified and may avoid any health problems that their dangerous medical device could have caused.
High-risk devices, like heart stents and defibrillators, are required to have a unique tracking code within the coming year. Manufacturers of moderate-risk devices, such as surgical needles and power wheelchairs, must mark codes on their products within the next 3 years.
This new FDA tracking system may change the lives of those requiring medical implants or devices that turn out to be defective by enabling patients to be easily identified.
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