The U.S. Food and Drug Administration's report on the increase of device recalls in the past decade has resounded with healthcare industry professionals across the board.
Clinical analysts from MD Buyline, a Dallas-based supply chain management solutions provider, outline five clinical insights derived from the FDA's report.
1. Class I recalls, those that could possibly cause serious adverse events or even death, increased from 1 percent of all recalls in 2003 to 5 percent of all recalls in 2012.
2. Class II recalls doubled from 2003 to 2012, while Class III recalls fell by 35 percent.
3. Radiology device manufacturers and manufacturers with errors in reporting experienced the highest number of FDA-classified recalls.
4. Radiology device recalls increased 150 percent from 2010 to 2012.
5. Issues regarding device design, software and materials were the most common causes for recalls.
To access MD Buyline's full clinical insight report, click here.
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