By William Hyman, ScD
On February 18, 2015, the FDA posted a notification on its website of a Class I recall of almost 13,000 General Electric MRI systems covering 25 different models in the Sigma and Discovery brands. The FDA notification includes what appears to be all 12,968 serial numbers, which may be a forerunner of what will be seen when every device has an individual number under FDA’s forthcoming unique device identification (UDI) system.
GE had previously acted on this matter with an Urgent Medical Device Correction letter dated January 8, 2015. Note that the title of this letter does not include the word recall. A February 4, 2015, news release at GE’s website calls the action a Voluntary Field Corrective Action, which may sound far more benign than a Class I recall, and differs from GE’s own letter.
The problem as reported by the FDA is “the MRU may not be connected to the magnet.” As the notification explains, “In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.” The FDA lists the Determined Cause of the recall as “Training: Employee Error.” Three things can be deduced from this categorization. First, the implication is that the necessary connection is a hospital-based employee issue. Second, one can infer that the machine does not communicate to the user that a key connection has not been made. Third, it functions in nonemergency situations (normal use) without the connection.
And thus we have a blame-the-user rather than a blame-the-design attitude. One must wonder if the FDA personnel who apparently bought into this reasoning are aware of the agency’s efforts in human factors that have taken place over a good number of years. AAMI has also devoted a good deal of attention to human factors, in part in collaboration with the FDA. One must also wonder what GE thinks about human factors, and whether they apply it in design, or just ignore it when faced with a massive problem that allows for blaming a user. In its human factors summary, the FDA includes several items that appear to be directly applicable here. These are:
- Safer connections between device components and accessories;
- Better user understanding of the device’s status and operation;
- Reduced user reliance on user manuals;
- Reduced need for user training and retraining; and
- Reduced risk of use error.
These factors are all related to reduced risk of adverse events, and reduced risk of product recalls.
Part of the GE notification was to instruct users to “…perform a short test that confirms if the Magnet Rundown Unit is functioning properly and has not been disabled.” The notification explains that, “This test is an action that operator manuals currently advise users to do on a regular basis.” What level of “user” is meant here is not indicated. The reference to the operator manuals suggests that this is a prescribed maintenance procedure. It also suggests that users are actually expected to read the operators manual. In this regard, I was surprised a while ago to be told by clinical personnel that they don’t read operators manuals, they have never seen the operators manual, and that they don’t think they should be expected to read the operators manuals. I have addressed this read-the-manual issue elsewhere.
From the scanty information available about this recall, I could not determine whether connecting the MRU is a one-time event that, presumably, should take place at installation and perhaps after service of some level. The need for a routine maintenance requirement may imply that the connection could have been made earlier but then was disconnected.
My proposition is that if it is essential that two components of a device be properly connected, especially when there is electronic communication available, then the system should not operate unless they are in fact properly connected. Is this too radical? Please share your responses in the comments field below.
William A Hyman, ScD, is professor emeritus, Biomedical Engineering, at Texas A&M University, College Station, Tex, and adjunct professor of Biomedical Engineering at The Cooper Union, New York.