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Though the FDA issues many hundreds of recalls each year a recent recall is making headlines. The class 1 recall, the most serious type, is just one of 87 issued over the past five years. From 2005 to 2009 the FDA has issued 87 recalls of infusion pumps. The most recent recall involves the Sigma Spectrum Infusion Pump and was announced due to the potential for sudden device failure.
Failures like the one seen in this pump have been directly linked to over 700 deaths. Jeffery Shuren, MD, JD, director of the FDA's Center for Device and Radiological Health, believes that this number, though high, is a "gross underestimate" of the deaths and injuries caused by device malfunction. This is due to the fact that most deaths attributed to infusion pump failure aren't reported as such.
A new safety initiative has been announced by the FDA. The agency will be looking at the safety problems surrounding not only infusion pumps but IVF filters and defibrillators as well.
The class action and injury attorneys at Milwaukee's Hupy & Abraham hope that the FDA does its job and protects patients from further harm. The rash of deaths and injuries linked to medical devices must be addressed and stopped. One death caused by to a lack of caution on behalf of medical device industry is too many; hundreds constitute serious action.
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