In the latter study, participants had to perform several injections; the error was related to the fact that users unnecessarily primed the device again after the first injection. Trisha Korioth, Staff Writer. VEGF Injection. In contrast to the use errors described above, participants were aware in this case that the cap had to be removed prior to injection. Furthermore, the present review should support manufacturers and researchers to perform risk analyses and device evaluations. Furthermore, we did not distinguish between devices as a function of their medical intention or active substance. This requirement is also reflected in the guidelines issued by the regulatory authorities. A further 161 publications were excluded on the basis of their abstract, leaving 105 publications eligible for the full-text analysis. This includes required checks on the device and liquid contained therein. Depending on the device, an injection can be triggered either by pushing a button or by pressing the device against the body. This arises from a usability flaw: the mismatch between a pen-like design and non-pen-like handling (Simons et al., 2009; Gosbee, 2004). statement and The “failure to check device integrity” subcategory refers to cases in which users did not check whether the auto-injector was damaged (Schiff et al., 2016) or whether the tamper-evident seal was intact (Hudry et al., 2017). Expert Opin. Asthma. In the other study, participants used a training device instead of the real auto-injector (Raffa et al., 2017). However, neither gave any further information about this use error. J Allergy Clin Immunol. The reporting quality and the quality of the used methods were assessed in order to be able to judge the reproducibility of the included studies. One of the new regulations’ most important objectives is to improve transparency and traceability by establishing a European-wide database on medical devices and a system for unique device identification (UDI) (European Commission 2018). Signs of this include needing several attempts to perform a task, as well as comments or non-verbal signs indicating confusion or frustration (Fujioka et al., 2015). European Commission [Internet]. Patient Prefer. Ann. “DALI Medical Devices is developing novel connectivity features and systems that can be integrated to its existing Safe Auto-Needles TM (SANs) product line, but also to other injection devices such as pens and autoinjectors,” explains David Daily, DALI’s CEO & Cofounder. 234:298–302, Schmid M, Weidenhoffer I, Udvardi A, Wöhrl S (2013) Adrenaline Autoinjector Needle Interlocking in the Thumb Due to Improper Injection. The database searches identified a total of 1415 publications (Fig. Diabetes Care 27:2495, Russ AL, Fairbanks RJ, Karsh B-T, Militello LG, Saleem JJ, Wears RL (2013) The science of human factors: separating fact from fiction. In this context, they tried to dial the dose with the activation button (Rohrer et al., 2013). These devices help an individual to administer the medication by pushing or driving the needle through the skin and then expressing a dosage of the medication. Manage cookies/Do not sell my data we use in the preference centre. In one case, this led to a needle-stick injury (Mahony et al., 2015). 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). However, the results of this type of reviews will always be just a development aid and cannot replace the knowledge and experience of human factors engineering experts for the conception and development of medical devices. A complete list of operational difficulties. TW, MDZ, and RM extracted and analyzed the data, and wrote the original draft. Part of Injection rates can be customized to the patient's drug therapy needs. The auto-injection device of claim 1, further comprising a means for separation, and a reconstitution mechanism, wherein the means for separation separates different substances from contact with each other until such time as needed for administration. Usability evaluations and design reviews constitute an efficient means of identifying these issues and minimizing their occurrence. The injector systems are equipped with a touch screen display for ease of programming. The goal of the present study was to present the current state of knowledge concerning use errors of disposable auto-injection devices. Auto Injector Pen. With the help of a specialist librarian, we first developed the query for PubMed and then adapted it for Scopus (see the Additional file 1: Appendix S1 for the full set of queries). Four publications mentioned that users failed to visually confirm after an injection that the correct dose had been administered (Phillips et al., 2011; Hudry et al., 2017; Schertz et al., 2011; Saunders et al., 2012). Ther. ISO 9241-11. The YpsoMate autoinjector is an automated disposable injection device for 1 ml long pre-filled glass or polymer syringes suitable for all patient groups. MeSH terms for the PubMed search). The authors thank Pierre-François Gauthier (CIC-IT Lille) for designing Fig. Andre AD, Brand-Schieber E, Ramirez M, Munjal S, Kumar R (2017) Subcutaneous sumatriptan delivery devices: comparative ease of use and preference among migraineurs. For example, the high frequency with which auto-injectors were held upside down is obviously due to insufficient identification of safety caps or the end with a needle (e.g. Design Considerations for Devices Intended for Home Use [Internet]. Figure 1 illustrates the propagation of a usability flaw, from violation of the corresponding design principle to the resulting use error and then the negative patient-related outcome. J. Clin. 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). Our approach is in line with the European Union’s latest regulations on improving the safety of medical devices - especially those concerning transparency and traceability. Usability is “the extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency, and satisfaction in a specified context of use” (International Standardization Organization, 1998). The searches were carried out on March 2nd, 2016, and updated on May 24th, 2017. NZ. 11:121–129, Article  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). SAGE Open Med. Whenever possible, standardized key terms were used (e.g. Today, my friend Kai explains and demonstrates how to use an AUTO-INJECTOR for your testosterone shots! Publications about the clinical or economic impact of auto- and pen injectors, and reports dealing solely with perceived usability (e.g. A complete list of use errors and close calls. The authors declare that they have no competing interests in this work. Taltz is also indicated for patients aged 6 years or older with moderate-to-severe plaque … In the next phase, three reviewers (MDZ, RM, and TW) screened the full texts of the selected publications. Various studies of auto-injection devices have reported safety issues that are due (at least in part) to usability flaws. With regard to “feedback - audible”, two publications reported that participants failed to hear the clicks emitted by the device. Ther. Knowledge about use errors of existing, similar equipment is an important source of information on the design and development of new medical devices. The “activation” category refers to the initiation of an injection. Pediatr. Next, following an examination of the full text, 73 publications were excluded - leaving 32 publications. 11:126–126, Raffa RB, Taylor R, Pergolizzi JV, Nalamachu S, Edwards ES, Edwards ET (2017) Application of human factors engineering (HFE) to the design of a naloxone auto-injector for the treatment of opioid emergencies. A global leader in self-injection systems, BD offers a differentiated solution and a full portfolio of self-injection systems designed for the patient and developed with modular platform technology that enables us to rapidly customize your product and aims to accelerate its time to market. All publications scored more than 3 on both scales, and so all 38 were judged to be sufficiently valid for inclusion in the review. Expert Opin Drug Deliv 4:165–174, CAS  The first attempt did not trigger the injection but the second attempt was successful (Jeannerot et al., 2016). “Activation” is related to a study in which users needed two attempts to activate the auto-injector on the injection site. J. Qual. Allergy Immunol. Good usability is no guarantee that a device will be useful or efficient. Expert Opin. The other two references for this subcategory described that users did not unscrew the needle from the device with the needle cap, as was recommended (Schertz et al., 2011; Saunders et al., 2012). 8:1061–1071, Domańska B, VanLunen B, Peterson L, Mountian I, Schiff M (2017) Comparative usability study for a certolizumab pegol autoinjection device in patients with rheumatoid arthritis. To assess the risk of bias in individual studies, the validity of those selected for qualitative analysis was assessed. In this context, it is necessary to systematically analyze the use errors associated with auto- and pen injectors. © 2020 BioMed Central Ltd unless otherwise stated. Two eligibility criteria concerning each study’s methods and reporting quality were defined: Reporting: the study’s objective, the context of the evaluation, the device under evaluation, the device’s medical intention and/or intended users, and the results. Another reason is that the force required to remove the safety cap might not correspond to the physical capabilities of certain user groups (Lange et al., 2015). Allergy Immunol. Allergy Asthma Immunol. For publications lacking an abstract (n = 3), the full publication was assessed directly. As a result, patients do not always carry the devices with them, even when this is required for certain applications (Frew, 2011; Gosbee, 2004). The above list contains 44 items because two of the devices were platform-based and used for the simulated treatment of both diabetes and rheumatoid arthritis. Auto-injection devices as described herein are used by an individual to self-administer a liquid medication through a needle subcutaneously. Google Scholar, Arga M, Bakirtas A, Catal F, Derinoz O, Harmanci K, Razi CH et al (2011) Training of trainers on epinephrine autoinjector use. Publ. A similar categorization process was applied to operational difficulties. Inform. BD Intevia™ handheld autoinjector The BD Intevia autoinjector delivers higher viscosities for chronic disease therapy. The categorization process yielded 10 main categories, which were divided into 39 subcategories in order to provide more information about the use errors. Either this happens through pen injectors or prefilled syringes, the latter often supplemented by auto injection or safety devices. Pediatr. The “preparation” category encompasses all use errors that can occur while setting up a device for an injection. Creating a skin fold or pinching the skin is often recommended for the subcutaneous administration of medications. The scheme was applied in an interactive, inductive manner. Removal of the protective/safety cap prior to an injection concerned cases in which users did not remove the cap at all, and cases in which the users did not remove the cap as recommended. To tackle this source of potential bias, we assessed each publication’s reporting quality and methodology. Cartridge without dosage means for an injection device. Our qualitative analysis of the selected publications enabled us to identify and categorize 232 instances of use errors and 2 instances of close calls. The selection was carried out by human factors researchers with expertise in healthcare technologies. The “injection” category encompasses all use errors directly related to the injection. One study demonstrated that simple design modifications (like changing the color of the safety cap and adding an arrow indicating the correct device orientation) were associated with a significantly lower frequency of needle-stick injuries and a significantly shorter application time (Bakirtas et al., 2011). International Electrotechnical Commission, Geneva. In relation to the device disposal, one publication reported that the auto-injector was not placed in a sharps container (Schiff et al., 2016). In the second case (“incorrect cap removal”), users either did not hold the device correctly during cap removal (Phillips et al., 2011; Brown et al., 2013), or used the wrong hand (Saleh-Langenberg et al., 2017). Lastly, the reference sections of the selected publications were checked for other suitable publications not identified during the database searches. Rheumatol. Technol 10:164–174, Gosbee LL (2004) Nuts! Adherence. A device manufacturing partner will … In any case, this type of rating is not generalizable because it should always take account of the device’s intended use and specific characteristics. This research was funded by the Swiss National Science Foundation (SNSF, grant number 164279) and by the Agence Nationale de la Recherche (grant number: ANR-15-CE36–0007). Insufficient planning and early conceptual design vulnerabilities can result in quality issues, prolonged project timeline and increased cost. Given that no information on the negative outcomes was provided for a large proportion of the identified use errors, we could not rate the severity of the various 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). Three publications mentioned that users did not press the device against the body hard enough to activate an injection (Guerlain et al., 2010a; Edwards et al., 2013; Raffa et al., 2017). For instance, adrenaline/epinephrine should be administered intramuscularly - preferable in the outer aspect of thigh. Jeannerot F, Stüdeli T, Gunther-LaVergne L, Hirning D, Schertz J (2016) Usability engineering study in the European Union of a redesigned follitropin alfa pen injector for infertility treatment. Difficulties related to the removal of safety caps can also be due (at least in part) to poor usability. 1. Transl. Our analysis identified a broad range of errors and categorized them with regard to a particular device component or a specific task. The publication was excluded if either of the two scores was equal to or lower than three. With regard to post-injection tasks, three publications mentioned failure to massage the injection site after the injection (Salter et al., 2014; Brown et al., 2013; Saleh-Langenberg et al., 2017). Developers of auto-injection devices must therefore focus on the intended context of use as well as the users and their characteristics. NZ. Open Allergy J. Google Scholar. Inform. Available from: http://training.cochrane.org/handbook. Epinephrine Injection (Auto-Injector) is a prescription medicine in a disposable, prefilled automatic injection device (auto-injector) used to treat life-threatening, allergic emergencies including anaphylaxis in people who are at risk for or have a history of serious allergic emergencies. Single-use autoinjection … 125:419–423, Simons FE, Lieberman PL, Read EJ, Edwards ES (2009) Hazards of unintentional injection of epinephrine from autoinjectors: a systematic review. 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York, Center of Reviews and Dissemination ; 2008 [ cited 2017 Oct ]... Eligible for the use errors with disposable auto- and pen injectors, due to usability.! Into the injection ( Lange et al., 2016, and thus failed hear... By pushing a button or by pressing the device in place long enough while injecting, and thus to... This happens through pen injectors, due to usability deficits the literature of this systematic, qualitative literature was! Range of errors that can be divided into refillable systems and disposable systems this requirement is reflected. Can be triggered either by pushing a button or by pressing the device and method for without. Users did not affect our analysis identified a total of 38 included publications consisted of... 13 ] a systematic review of use error was the use of the publications. Convenient, ergonomic and preferred by patients drug delivery solutions equipped with a newly developed device the skin is recommended! 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Mostly related to disposable auto-injection devices must therefore focus on the device minimize this of! Two scores was equal to or lower than three available ) were not formulated enough...
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