Usability of devices for self-injection: results of a formative study on a new disposable pen injector

Abstract

This article presents a late-stage formative usability study of a pen-injector platform device. Such devices are used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. The study was conducted with a broad user population, defined to represent user characteristics across a range of indications. The goals of the study were to confirm that the pen could be used without recurring patterns of use errors leading to hazardous situations, to evaluate the comprehension of the instructions for use (IFU), and to determine if training is necessary. In the study, a total of 36 participants in six groups (health care providers, caregivers, adolescents, diabetics with retinopathy, diabetics with neuropathy, and patients with arthritis) each read the IFU, prepared the device, and performed two simulated injections into an injection pad. Any use errors, near misses, or deviations from the IFU procedure were recorded. The overall success rate (injection completed by the participant without need for assistance) was 94% for the first and 100% for the second injection. Ninety-two percent of the participants reported that they felt confident using the device, 100% found the IFU helpful, and 75% found the device positively comfortable to use. Overall, a total average of 3.35 deviations and errors per user and injection were recorded (there were no near misses). Subtracting the errors without any potential for negative consequences for the injection or the user (trivial deviations), as well as those related to attaching and removing the pen needle (independent of the design of the pen itself), led to an average of 1.31 potentially relevant deviations per user and injection. It was concluded that the pen injector together with the IFU could be safely and efficiently used by all user groups without any training, and thus that the device and IFU in their current form are well suited for use in a range of specific applications.

Improving the safety of disposable auto-injection devices: a systematic review of use errors

“…With regard to the "disposal" category, one must draw a distinction between the complete disposal of the device and (for devices that can be used to administer multiple doses) disposal of the needle only. One publication stated that the inner needle cap was used for disposal instead of the outer needle cap (Lange et al, 2014). In another case, the needle was not safely disposed of (Schertz et al, 2011).…”

“…Errors related to an "incorrect dose setting" were most common. These refer to either setting up an incorrect dose (Stauder et al, 2014;Fujioka et al, 2015;Rohrer et al, 2013;Jeannerot et al, 2016;Lange et al, 2014;Schertz et al, 2011;Pfützner et al, 2012;Mahony et al, 2015;Saunders et al, 2012) or not setting a dose at all (Fujioka et al, 2015;Rohrer et al, 2013). A close call was also reported in Table 1 Categories of use errors and close calls (Continued)…”

“…Subcategory References Device orientation a) device held upside-down (Lange et al, 2015;Sicherer et al, 2000;Robinson et al, 2014;Matfin et al, 2015;Salter et al, 2014;Umasunthar et al, 2015;Mehr et al, 2007;Arga et al, 2011;Topal et al, 2013;Schmid et al, 2013;Hudry et al, 2017;Domańska et al, 2017;Guerlain et al, 2010b;Saleh-Langenberg et al, 2017;Hanna et al, 2016;Andre et al, 2017) b) device held at the wrong angle (Phillips et al, 2011) Preparation a) incorrect needle attachment (Stauder et al, 2014;Fujioka et al, 2015;Phillips et al, 2011;Lange et al, 2014;Schertz et al, 2011;Pfützner et al, 2012;Pfützner et al, 2010) b) incorrect priming (flow and air bubble checking/removal) (Stauder et al, 2014;Fujioka et al, 2015;Jeannerot et al, 2016;Lange et al, 2014;Schertz et al, 2011) c) incorrect device selection (Fujioka et al, 2015;Raffa et al, 2017) d) failure to check device integrity (Hudry et al, 2017;Schiff et al, 2016;Schertz et al, 2011;Saunders et al, 2012) e) failure to check product validity (Sicherer et al, 2000;Schmid et al, 2013;Hudry et al, 2017;Schiff et al, 2016) f) tampering with the device (Andre et al, 2017) Protective/safety cap a) inco...…”

“…Six publications stated that users did not attach a needle to the auto-injection device (Stauder et al, 2014) or did not attach the needle correctly (Stauder et al, 2014;Fujioka et al, 2015;Lange et al, 2014;Schertz et al, 2011;Pfützner et al, 2012;Pfützner et al, 2010). With the exception of one publication (which reported that the needle was attached at the wrong angle (Lange et al, 2014)), no further information about these use errors was provided. The other error in this subcategory is related to the fact that users failed to hold the device in the required upright position during the needle attachment (Phillips et al, 2011).…”

Combination Product Patient Training: How Are Patients Trained and Who Conducts the Training?

“…The results of the study indicated that training should be spaced over two sessions by a physician. Another study was conducted on the usability of a self-injector [2]. Participants were given the self-injector and an IFU, then asked to inject into a pad.…”