Objectives: To demonstrate, using human factors engineering (HFE), that a redesigned, pre-filled, ready-to-use, pre-asembled follitropin alfa pen can be used to administer prescribed follitropin alfa doses safely and ...
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Objectives: To demonstrate, using human factors engineering (HFE), that a redesigned, pre-filled, ready-to-use, pre-asembled follitropin alfa pen can be used to administer prescribed follitropin alfa doses safely and accurately. Methods: A failure modes and effects analysis identified hazards and harms potentially caused by use errors;risk-control measures were implemented to ensure acceptable device use risk management. Participants were women with infertility, their significant others, and fertility nurse (FN) professionals. Preliminary testing included 'Instructions for Use' (IFU) and pre-validation studies. validation studies used simulated injections in a representative use environment;participants received prior training on pen use. Results: User performance in preliminary testing led to IFU revisions and a change to outer needle cap design to mitigate needle stick potential. In the first validation study (49 users, 343 simulated injections), in the FN group, one observed critical use error resulted in a device design modification and another in an IFU change. A second validation study tested the mitigation strategies;previously reported use errors were not repeated. Conclusions: Through an iterative process involving a series of studies, modifications were made to the pen design and IFU. Simulated-use testing demonstrated that the redesigned pen can be used to administer follitropin alfa effectively and safely.
Objectives: The prefilled, multidose, GONAL-f (R) (follitropin alfa) pen injector was redesigned to improve ease of use and pen functionality. This usability engineering evaluation aimed to demonstrate that the redesi...
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Objectives: The prefilled, multidose, GONAL-f (R) (follitropin alfa) pen injector was redesigned to improve ease of use and pen functionality. This usability engineering evaluation aimed to demonstrate that the redesigned pen injector could be used by the intended users to safely and effectively deliver follitropin alfa. Methods: Formative and summative usability engineering evaluations of the pen injector, training and instructions for use (IFU) were conducted. This included an expert review, and formative and summative evaluations involving patients with infertility and fertility nurses. For the summative evaluation, participants received training and subsequently performed tasks based on three selected hazard-related use scenarios to evaluate real-world use, including simulated injections. Results: The formative evaluations confirmed that the pen injector was ready for summative evaluation. Task performance was high in the summative evaluation for both patients and nurses;the tasks that were observed to be most difficult to complete were priming the pen, completing an incomplete injection and completing the treatment diary. Participants rated the device as having above average usability. Most patients ranked the overall system (pen injector, device training and IFU) and its individual components to be either 'extremely easy' or 'somewhat easy' to use. Conclusions: 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.
The material characterization tests conducted on 304L VAR stainless steel and Schott 8061 glass have provided higher fidelity data for calibration of material models used in Glass-To-Metal (GTM) seal analyses. Speci...
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The material characterization tests conducted on 304L VAR stainless steel and Schott 8061 glass have provided higher fidelity data for calibration of material models used in Glass-To-Metal (GTM) seal analyses. Specifically, a Thermo-Multi-Linear Elastic Plastic (thermo-MLEP) material model has been defined for SS304L and the Simplified Potential Energy Clock nonlinear viscoelastic model has been calibrated for the S8061 glass. To assess the accuracy of finite element stress analyses of GTM seals, a suite of tests are proposed to provide data for comparison to model predictions
Background: There are few validated tools to measure adherence for children living with HIV. We identified questionnaire items for caregivers of Kenyan children aged <15 years living with HIV. Methods: Caregiver–c...
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The study of the nuances of human behavior in supply chain management (SCM) contexts and the behavioral reactions that accompany changes in operating policies has finally started to gain a strong headwind. This has co...
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The study of the nuances of human behavior in supply chain management (SCM) contexts and the behavioral reactions that accompany changes in operating policies has finally started to gain a strong headwind. This has come after several decades of operational modeling in which the behavior of the human actors, so critical to the mechanics of operating policies, has either been largely simplified or ignored. With the growth in joint work in experimental behavioral testing and improvements in behavioral codification, greater insight into the practicality of operational policies is now emerging. Yet in order to ensure such practicality, the rigor of this new joint experimentation needs to be ensured. While SCM researchers have a rich history in the rigor of artificial modeling, the sparse history of behavioral experimentation in SCM provides much less evidence of an understanding of what "rigor" with such methods entails. The purpose of this brief essay is to touch on some of the basic tenets of rigorous behavioral experimentation, and to hopefully promote such rigor in future SCM behavioral studies.
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