In recent years, our human factors researchers have been seeing a few persistent use errors in our usability studies that involve injection pens. Many home users—patients and caregivers—encounter confusion when interacting with the shields covering the disposable needles that are attached to the pens. One error in particular is severe and prevalent enough to have raised the FDA’s concern. To address it, they have issued a labeling change request to manufacturers.
The error in question occurs when a user does not remove the inner needle shield, then performs the “injection” without realizing that the tiny needle never entered the skin (which they very rarely feel anyway). He or she comes away assuming the injection was successful. In the case of someone who uses an insulin pen, these failed injections can cause a dangerous rise in blood sugar levels. The FDA has identified at least one death due to hyperglycemia that was related to this error.
Battelle is no stranger to dealing with these types of errors.
A large medical device manufacturer asked Battelle to perform a human factors study on an autoinjector. During the study we observed some inversions where users would have injected their thumbs instead of the desired injection site if the device they were using had been real. This inversion stemmed from the cap and button both being the same color, making it difficult for patients to determine which end had the needle when referring to the Instructions for Use (IFU). The client knew this was a risk, however, it wasn't possible for them to change the cap or button colors at this point in the process.
Learn more about how we solved this challenge.