Usability engineering study in the European Union of a redesigned follitropin alfa pen injector for infertility treatment

Abstract

These usability engineering evaluations demonstrated that patients and nurses could safely and effectively use the redesigned GONAL-f pen injector, and that they also found the IFU and device training to be easy to use.

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

“…Furthermore, two of the three publications stated that users failed to call the emergency medical services after the injection (Brown et al, 2013;Saleh-Langenberg et al, 2017). In the "not referring to the IFU" subcategory, one publication reported that patients did not follow this guidance when it would have been necessary (Jeannerot et al, 2016).…”

“…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...…”

“…Another publication reported that users miscalculated the doses when an injection had to be split across two devices because the medication remaining in a single pen injector would not be enough to deliver a complete dose (Fujioka et al, 2015). In this context, it was also reported that users did not realize that the device could not be set to give the required split dose because the device did not contain enough medication or was already empty (Jeannerot et al, 2016). Furthermore, one publication mentioned a close call in the context of split-dose calculation; the error was corrected by referring to the IFU before performing the injection (Mahony et al, 2015).…”

“…With regard to the "hygiene" category, three types of use error were identified. Four publications reported that the injection site was not disinfected (Schiff et al, 2016;Domańska et al, 2017;Jeannerot et al, 2016;Pfützner et al, 2012). One of these also mentioned that users did not wash their hands before using the device (Schiff et al, 2016).…”