US human factors engineering evaluation of an updated follitropin alfa pen injector (GONAL-f® RFF Redi-ject®) and instructions for use.

OBJECTIVES: The multi-dose, pre-filled GONAL-f® RFF Redi-ject® (follitropin alfa injection) pen injector was updated following feedback on user experience and pen functionality, as part of a continuous assessment program. Human-factors engineering (HFE) evaluations were conducted to confirm that the updated pen injector could be used by intended users to safely and effectively perform critical tasks identified by the risk-management plan. METHODS: Five rounds of formative evaluation and a simulated-use summative evaluation of the pen injector, instructions for use (IFU), and training video were conducted by HFE specialists or the intended users of the pen injector. RESULTS: The IFU and training video were revised following formative evaluations. Summative evaluation of simulated-use involved 60 participants, each of whom performed six use-scenarios related to potential hazards, selected on the basis of the risk-management plan. Overall, participants found the pen injector easy to use and the IFU clear and effective. CONCLUSIONS: Through an iterative process involving a series of HFE evaluations, modifications were made to the injection mechanism, the dose display, the IFU and the training video. Summative evaluation confirmed that the updated pen injector and associated user materials can be used safely and effectively to perform critical tasks identified through the risk-management plan.

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

OBJECTIVES: The prefilled, multidose, GONAL-f (®) (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.

Collaborative co-design of emerging multi-technologies for surgery.

The EU Research Training Network on Augmented Reality in Surgery (ARIS*ER) was established with two aims: (1) to develop next-generation novel image guidance (augmented reality based on medical images) and cross-linked robotic systems (automatic control loops guided by information sensed from the patient) and (2) to educate young researchers in the user-centred, multidisciplinary design of emerging technologies for minimally invasive surgery (MIS) and intervention radiology. Collaborations between engineers, Human Factors specialists, industrial designers and medical end users were foreseen, but actual methodologies had to be developed. Three applications were used as development vehicles and as demonstrators. The resulting teamwork and process of identifying requirements, finding solutions (in technology and workflow), and shifting between these to optimize and speed development towards quality of care were studied. The ARIS*ER approach solves current problems in collaborative teams, taking a systems approach, and manages the overview of requirements and solutions, which is too complex to manage centrally.

Endoclamp balloon visualization and automatic placement system.

OBJECTIVES: Aortic occlusion is one of the most important open discussions in minimally invasive cardiac surgery. Different techniques can be employed, and all have benefits and drawbacks. The objective of our work is to improve the safety of internal aortic occlusion with the Port Access technique, which employs an endoclamp balloon catheter. We propose a combined information and positioning system based on augmented reality technology and robotics in which the position of the balloon can be seen at all times and can be automatically controlled by a robotic actuator. METHODS: The system was designed by a multidisciplinary team of engineers, medical doctors, and human factor specialists in a human-centered design approach. We measure the balloon position in real time with a magnetic tracking system. This position is superimposed on a 3-dimensional scan of the patient's thorax, with the balloon in the artery shown at all times. The position measurement is also used to control the robotic catheter inserter that places and maintains the balloon position at a specified target. The system was evaluated in 2 user studies that compared it with other visual aids. RESULTS: The user tests have shown that the system effectively supports the surgeon in the placement task, with an increase in placement accuracy and a reduction in time compared with the current visualization technique. The users also rated the system as supporting them well. CONCLUSIONS: The clinical feasibility of the system was proved. The system provides better visualization and position control and can effectively increase the safety of the procedure. This system has the potential of making Port Access a more attractive technique.

Use of the Resection Map system as guidance during hepatectomy.

BACKGROUND: The objective of this work is to evaluate a new concept of intraoperative three-dimensional (3D) visualization system to support hepatectomy. The Resection Map aims to provide accurate cartography for surgeons, who can therefore anticipate risks, increase their confidence and achieve safer liver resection. METHODS: In an experimental prospective cohort study, ten consecutive patients admitted for hepatectomy to three European hospitals were selected. Liver structures (portal veins, hepatic veins, tumours and parenchyma) were segmented from a recent computed tomography (CT) study of each patient. The surgeon planned the resection preoperatively and read the Resection Map as reference guidance during the procedure. Objective (amount of bleeding, tumour resection margin and operating time) and subjective parameters were retrieved after each case. RESULTS: Three different surgeons operated on seven patients with the navigation aid of the Resection Map. Veins displayed in the Resection Map were identified during the surgical procedure in 70.1% of cases, depending mainly on size. Surgeons were able to track resection progress and experienced improved orientation and increased confidence during the procedure. CONCLUSIONS: The Resection Map is a pragmatic solution to enhance the orientation and confidence of the surgeon. Further studies are needed to demonstrate improvement in patient safety.

Effect of subjective and objective workload on asthenopia at VDU workplaces.

An ergophthalmological tool has been developed to investigate effects of subjective and objective workload on work-related visual complaints (asthenopia). In field studies on different visual display unit (VDU) workplaces effects of objective and subjective workload, work intensity, and work breaks (5-9 min/hour) could be found. It could be shown that during the first hours of VDU work, asthenopic complaints have the tendency to follow effective workload. With increasing working time the effect of a general and visual fatigue overlaps other reported visual complaints in the majority of cases.