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New FDA Rules Could Protect Medical Device Recipients

For some, receiving a new medical device leads to a vastly improved quality of life. For those who receive defective medical devices, the results can be painful or even fatal. The problems involved with faulty medical devices have long been complicated by the difficulty in identifying which patients received devices that ended up failing. The U.S. Food and Drug Administration has released new rules that are intended to make it easier to track defective devices and get in touch with patients who have received potentially dangerous implants.

The FDA is using an electronic system to track devices by code, manufacture date and lot number. By listing the code on a patient’s records, doctors and hospitals can identify specifically which devices fail and in what ways. If a device shows a pattern of failure, all patients who received the device could be notified more easily. The tracking system is therefore beneficial for both the patients affected and the hospitals using these devices.

When a device is tied to specific health problems, it may be subject to recall. It has not always been a simple matter to determine if an artificial hip or defibrillator used on a particular patient is the same as the one being recalled. Some devices fail in ways that are life-threatening to patients. It is vital to determine which patients received these devices so they can be removed before they fail. The new rules could make this process faster and more reliable.

The new system will begin use next year and will start with the most high-risk medical devices. These devices include defibrillators and heart stents. It is expected that the system will quickly expand to include other medical devices and implants.

Source: Science World Report, “Could New Tracking Codes on Medical Implants Save Lives,” by Kathleen Lees, 20 September 2013

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