by
Carol Ko, Staff Writer | October 16, 2013
From the October 2013 issue of HealthCare Business News magazine
They weren’t surprised to find that Pennsylvania’s reports made up 90 percent of the number in the FDA database. “It’s an illustration of just how abysmal the reporting is at the federal level,” says Gilk.
They formed a mathematical model to extrapolate what the true number of accidents might look like, estimating that there were 7,600 adverse events at a national level — and the FDA database is about 2 percent of that number.
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Moreover, the FDA reporting guidelines for providers further confuse the issue, since the list of possible causes behind these accidents, which includes device failure or malfunction, presumes that there must be a problem in the labeling or design of the equipment to cause the injury. But in almost all the injuries in MR, the machine is functioning perfectly — it’s the environment that’s the problem. “So some hospitals ask, ‘do we really have to report, because the machine was functioning properly the way it was supposed to?’ ” says Gilk.
Zoning out
Some of the obstacles to MRI safety may be built right into the room itself.
According to experts, many MRI suites are laid out in such a way that technologists do not have a direct line of vision from their control console to the door to monitor the people going in and out of the room.
Some steps are being taken to remedy this problem for buildings in the future. In 2010, an influential building code guideline for hospitals and other providers cited by the Joint Commission and jointly supported by the U.S. Department of Health and Human Services (HHS) and the American Society for Healthcare Engineering (ASHE) released an update that included several MRI safety elements for the first time.
Though the HHS supports the code’s development, following the guidelines are voluntary, not a federal requirement. Even so, a majority of states reference it as a state licensure standard, with some exceptions — a few states, including California, Texas, and Missouri, have their own self-written building code guidelines. To date, 25 U.S. states have adopted this new building code.
The new requirements under the code include guidelines like use of ferromagnetic detection systems during the screening process, provisions for protection against cryogen leaks from MRI scanners, and making sure technologists have a direct line of sight in the MRI suite.
“The gist is as you get closer to the MRI scanning room, there should be increasing levels of supervision by MRI trained personnel and access control,” says Gilk.
“It’s amazing how many MRI suites were not designed properly for that,” says Geoffrey West, president of West Physics Consulting.
