Lacerations and embedded needles due to EpiPen use in children

Abstract

Epinephrine autoinjectors are life-saving devices for the treatment of anaphylaxis, and must be readily available and easy for patients and families to use. Product design and instructions for use should maximize patient safety, particularly when considering use in children, who may be uncooperative during needle injection. In a case series (and addendum) we published recently, 25 epinephrine autoinjector injuries were reported, including 20 cases of leg laceration that occurred while the device was being injected in the lateral thigh for the treatment of anaphylaxis. All injuries were due to EpiPen or EpiPen Jr devices, including 13 cases in 2014-2015 when other autoinjector devices were also available. Via a social media group, we recently learned of an additional case. This involved a 2-year-old girl weighing 14 kg. She was being treated with an EpiPen Jr for an anaphylactic event at home. Her mother applied the device using a swing and push approach against the child’s bare thigh, while her father helped to hold her. After a few seconds, she started moving her leg, resulting in a 7.5-cm V-shaped wound, and bending the needle to approximately 60 , blocking the needle cover from coming down over it. The wound healed with a keloid scar (Figure 1). Although relatively uncommon, these injuries deserve attention because they highlight risks that may be minimized through better training and restraint techniques, and they identify possible opportunities for improvement in device design and instructions for use. EpiPen instructions indicate that the device should be held firmly against the thigh for 10 seconds. During this time, the needle remains fully extended in the thigh, which gives an opportunity for needle-related injuries to occur, particularly in young children who may resist the injection. We are unaware of any evidence to support the need for this long injection period, and the published evidence suggests that the epinephrine is delivered effectively in a few seconds. Clinical pharmacology documents submitted to the Food and Drug Administration during the approval of the Auvi-Q autoinjector device indicate that the duration of medication administration for both EpiPen and EpiPen Jr is 0.2 seconds. Information provided to Dr. Lieberman by Meridian laboratories as part of an expert review of an anaphylaxis-related death indicated that “it was quite clear that the entire dose was administered in less than 3 seconds in almost every instance.” Finally, a study involving injecting EpiPens into slabs of steak demonstrated that the medication was delivered as effectively when holding the device in place for 1 second as when holding it for 10 seconds. In addition, in videos of EpiPen device firing, the medication can be seen expelling from the device in less than a second (Comparison of Needle Properties of Generic Epinephrine, EpiPen and Auvi-Q Devices While Firing, https://youtu.be/ LRgqwgCh4Fs; EpiPen Firing Demo, http://youtu.be/ r6ZkAx7djyk; Unwrapped EpiPen Firing Demo, https://youtu. be/jgJd9jgLRhU; EpiPen Jr Firing Demo, http://youtu.be/ adwvdu6cFTk; Unwrapped EpiPen Jr Firing Demo, https:// youtu.be/Lq9_VzdKHdM). Trying to hold the device for 10 seconds in a struggling toddler had significant adverse consequences for some of the patients in our series. In addition to the lacerations described, in 3 cases where the device dislodged before the 10-second count was complete and needle bending prevented the needle cover from locking into place, the device administrators (including 1 physician) instinctively tried to reinsert the needle, resulting in a second injury. In 4 different cases, a second device was used because the parent was uncertain that the full dose has been delivered. Given the evidence that the epinephrine is expelled