In recent years medical advances and the increased use of medical devices, have saved thousands of lives in the United States and in West Virgina. While no one disputes the life-saving benefits of these devices, some are questioning how medical device manufacturers study and monitor patients who use their products.
A report in the New England Journal of Medicine, examines the recent recall of a medical device used in heart defibrillators. The device, known as Riata and manufactured by St. Jude Medical Inc., was recalled after it was found that wires that connected to it could damage the device's coating thereby causing it to fail.
Despite the recall, it's estimated that 79,000 patients in the United States are still using the device. St. Jude has come under criticism for not doing enough to determine the potential risks for these patients. Also in question is the overall failure of medical device manufacturers to set up monitoring studies as soon as a device is released. Proponents argue these types of studies would catch early signs of problems with medical devices before widespread problems, injuries and deaths occur.
The debate over how best to monitor medical devices in patients will continue to be waged. While medical device companies have the ability to invest in the research and technology to conduct these early studies, due to the high cost, they likely will not do so unless regulatory agencies mandate it.
News of any recall serves as a cautionary tale and creates anxiety for patients who rely on these life-saving devices. Patients who use medical devices should be closely monitored and immediately report any unusual symptoms to their doctors. Likewise, patients affected by a medical device recall need to know their legal rights as injuries caused by defective medical devices can result in serious permanent injuries and even death.
Source: Bloomberg BusinessWeek, "St. Jude Device Exposes Safety Monitoring Failures, Doctor Says," Michelle Fay Cortez, Feb. 21, 2012
No Comments
Leave a comment