by
Brendon Nafziger, DOTmed News Associate Editor | January 28, 2011
During the time period studied, 2005-2009, the report identified about 849 FSNs from the 1,412 NCARs filed with the European Commission. Of these 849, 63 were judged equivalent to the FDA's Class I recall - meaning recalls of products that could, or did, result in serious injury or death. Scaling up the results to take into account all the reports tracked by the EC, the report estimates there were 105 Class 1-level recalls during the study period.
This figure breaks down to about 21 serious recalls a year, in line with the 21.2 per year in the United States found by Ralph Hall, a professor with the University of Minnesota, and the 21.6 found in a study by the Batelle Memorial Institute.
Critics note "flaws"
But the critics of the report argued its methodology depended on a key but wobbly assumption, that the NCARs, and their included British equivalents, "represent all serious safety events in the EU," as the report authors put it.
But "they present no data to justify this assumption except to note conversations they had with EU regulatory officials," Wolfe and Carome wrote.
They also say the report authors don't provide data to back up the assumption that the threshold for issuing an alert in the U.S. and EU is the same, and they say they don't properly spell out the criteria used to match FSNs with FDA's Class I, Class II and Class II categories.
Further, Wolfe and Carome note the authors include only totals of the Class I and Class II style recalls in the five selected EU countries. But that such numbers are "meaningless" without giving data on the total number of devices approved, used and sold in the EU versus the U.S.
Industry in flux
The report comes at an opportune time, right on the heels of the FDA's revamping of the 510(k) process, announced last week. This is the process used to bring lower-risk medical devices, such as diagnostic imaging equipment, to market.
Critics of the process bash it for not doing enough to keep dangerous devices off the shelves, while the industry complains its rulings aren't consistent or transparent.
The changes announced by the FDA mostly didn't include reforms considered more controversial by the device industry. The FDA said it would wait to decide on those until the Institute of Medicine compiles its review sometime midyear.
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