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Heart Devices Top Recall Lists | cialis online

Heart Devices Top Recall Lists

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A recent report reveals cardiovascular devices are the most commonly recalled medical products. The Government Accountability Office (GAO) report is based on recall data from 2005 through 2009 in the U.S. Food and Drug Administration’s (FDA) recall enterprise system. The reviewed data shows cardiac devices are the most common source of FDA device recalls and demonstrates that the agency “could take a more proactive approach to its oversight,” says the report.

Physicians criticize the system saying its obvious tracking device problems and recalls are not a priority. The report is particularly focused on the FDA’s lack of knowledge in using the recall enterprise system (RES).

“Instead of using RES to conduct systemic analyses of recalls…the FDA has used RES primarily for processing and tracking the progress of individual recalls,” the report concluded.

The report says FDA officials may be unaware of the system’s full capacity, specifically the ability to generate summary data. For example, GAO investigators requested RES data but the agency’s staff was unable to extract the data, initially responding that such a task was impossible. However, two months later the FDA completed the request but only with the assistance of an outside contractor, reported

During the four-year period, device manufacturers initiated 3,510 recalls which included “field corrections,” revised labeling and retrieving a device from customers. Of those recalls, 532 were cardio devices and the largest number involved automatic external defibrillators.

The FDA categorizes the recalls and determined 83 percent were class II which indicates “the devices may cause temporary adverse health consequences, says Fourteen percent were classified as class III, which means the device is not likely to cause any adverse consequences; while, four percent were class I recalls because there is a reasonable risk of causing serious adverse consequences or death.

Cardio devices made up 15 percent of all recalls and “40 class-I recalls of cardiovascular devices represented 31% of all class-I recalls in the period,” reported

The GAO report claims device manufactures and the FDA appropriately recall devices in the “initiation and classification phases;” however, the ball is often dropped during the follow-up process when recall-related inspection of the manufacturer’s facility is never initiated.

The report also revealed that despite innovated electronic tracking systems, manufacturers still find it difficult to locate all recalled devices so patients and/or physicians can immediately be notified. For instance, after a pacemaker was recalled the manufacturer could not locate roughly 1,700 of the 23,000 recalled units because there was no implant record.

This is a serious issue since “patients with defective implanted devices are not consistently informed, and medical providers with recalled devices sitting on hospital shelves may be unaware of the potential hazard,” said Dr. Steven Nissen of the Cleveland Clinic.

The GAO made four key recommendations for the FDA and the agency plans to address each.

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