The annual number of medical device recalls almost doubled from 2003 to 2012, and radiology devices made up a big part of the increase.
That information comes from a report published last week by the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). The increase in recalls of radiology devices had to do with greater awareness of radiation dosage issues, the report said:
Radiology device recalls increased in 2010 following enhanced media and FDA attention, relating to concerns aimed at reduction of unnecessary radiation exposure.
The report notes that the FDA held a two-day public meeting in 2010 “to discuss device improvements to reduce unnecessary radiation exposure from medical imaging.” The report adds, “FDA actively engaged the public and stakeholder community throughout 2010 to focus on risks related to imaging and therapy radiology devices, including linear accelerators, imaging processing systems, and computerized tomography.”
As a consequence, the number of radiology device recalls jumped from slightly more than 100 per year to about 250 a year from 2010 to 2012. The main culprit, the report says, was software:
“Among these recalls due to software issues, system compatibility (interoperability between treatment planning and treatment delivery systems), user interfaces (human factors), and dose calculation (clinical decision support software) are the most frequently cited causes, accounting for more than two thirds of these recalls.”
The report actually has kind words for radiology device makers: “CDRH is also aware that industry is working to identify and incorporate new safety features into equipment, which will likely improve device performance over time. For the most part, the radiology problems have not been with the technology in itself, but rather with clinical use of the technology.”
In other words, the blame lies not with machines, but with humans. However, the FDA can’t recall those. At least not so far.
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