Poor usability in Draeger Medical’s JM-103 and JM-105 Jaundice meters has led the FDA to issue a Class 1 recall of the devices.
A Class 1 recall is the most serious, and indicates that use of the device could cause serious injury or death.
The Draeger meters measure yellowness of subcutaneous tissue in newborns. Measurements correlate to blood levels of bilirubin. High levels of bilirubin could indicate jaundice or other conditions that should receive immediate medical attention.
When the bilirubin level in the patient is above the maximum level that the device can detect, the device display of the JM-103 shows to the user three blinking dashes (- – -). The Jm-105 shows dash-zero-dash (- 0 -). Some users interpret these signals as meaning low or zero bilirubin levels instead of high levels. When that happens, treatment could be delayed or not offered, which could lead to brain damage or death.
To their credit, it appears that Draeger caught this problem in post-market surveillance, as a fix was issued by the company in March 2018 instructing owners of the devices to install labels that explained the meanings of the “- – -” and “- 0 -“ symbols. Apparently the FDA was not satisfied by that fix and determined a recall was necessary. They cited that although the out-of-range display is visible, the symbols used to indicate an out-of-range condition are neither intuitive nor clear, and can be easily misinterpreted.
This is a prime example of the importance of human factors in medical device design, and of the importance of user testing. I suspect that either the devices were not tested with users, or interpretation of the out-of-range indication was not probed for. In either case, the result is an expensive product recall for Draeger.