Device Development for Biosimilars: Human Factor Engineering for a Teriparatide Pen

Stimulated by regulations and standards as well as commercial imperatives, medical device manufacturers are striving to make medical devices safer by decreasing the potential for harmful use errors. Accordingly, manufacturers are observing and interviewing intended users about their interactions with devices en route to developing user interface requirements; applying human factors engineering (HFE) principles when designing user interfaces; and conducting formative and summative usability tests to improve and validate their devices’ interactive quality. This has represented significant work for manufacturers, particularly the majority who started with little HFE knowledge and experience. Today, the “awakening” to HFE in medical device development is essentially over—an established manufacturer who is just now discovering HFE has been out of touch. After all, the U.S. Food and Drug Administration (FDA) and AAMI conducted their first joint conference on HFE in 1995 when they previewed HFE expectations related to recent changes in quality system regulation (QSR). So, it has been 17 years since HFE entered the medical industry’s zeitgeist. HFE specialists working in the medical industry used to focus on making devices more usable (i.e., user friendly). Since the QSR change, use safety has become the primary focus, resulting in user interfaces that are less vulnerable to harmful use errors. It is rather obvious how HFE affects the safety of some medical devices. In the design of a surgical instrument, for example, HFE’s aim would be to reduce the chance of cutting anything other than the intended target. This goal could be accomplished by including a blade guard and a mechanical interlock that requires more than one deliberate action to enable cutting.

Human Engineering (HE), the specialized engineering profession which assists in designing equipment and the workplace to match the human operator maintainer's capabilities and limitations, has been involved in the design of U.S. Navy ships and marine equipment for the last decade. Yet, the commercial marine world in general, and the offshore industry in particular, has continued to exclude HE from its design of offshore platforms, service vessels, and individual pieces of marine hardware. This paper presents some possible explanations for this exclusion, examines their validity, and provides several examples of the consequences of omitting HE from the design of past marine hardware. INTRODUCTION Over the past twenty years human factors engineering (HFE) has been described in a variety of ways. A 1970 U.S. Navy publication described HFE as, "the activities required to integrate the human operator and maintainer into a system".(l) An article published in the Naval Engineers Journal in 1983 defined HFE as, "the engineering discipline concerned with the design and evaluation of systems, hardware, software, documentation, environments, and communications specifically for the personnel who will operate, maintain, control, and manage the system".(2) Finally a third attempt, written in 1988, defines HFE as, "the specialized engineering discipline concerned with ensuring that platforms, systems, individual equipments, and software are designed to match the capabilities and limitations of the personnel who have been selected and trained to operate and maintain them".(3) It is of interest to note that all three definitions emphasize designing the equipment, systems, software, etc. around the human being, and that the design must include the human in the role of both operator and maintainer. In each of the above examples the authors expanded on their definitions by subdividing HFE into specific and unique technical areas of expertise, each of which must be adequately covered in order for the total HFE effort to be completed. Although the number of areas differ among the publications the basic grouping remains constant. Thus, it is generally accepted that HFE is comprised of the following basic elements:Proper prediction, selection, training, and assignment of personnel (i.e. manpower, personnel, training)Proper life support for the human's health, safety, comfort, and job readiness (i.e. habitability design and environmental control)Proper preparation and provision of operator/ maintainer job aids (i.e. manuals, instruction placards, hazard identification signs, etc.)Proper design and placement of controls and displays, provision of adequate access, correct layout of the work station or console, proper sequencing and layout of equipments in a room, proper labeling, and overall maximizing of the design of hardware/software to match the humans capabilities (i.e. human engineering). Although all of the sub-elements described above are equally important in achieving a total HFE effort, this paper will deal only with that of human engineering (HE) BACKGROUND With at least a half century of existence and experience, HE is not a new idea, either as an engineering discipline or a design philosophy. Yet, its acceptance and systematic application by trained specialists in the military shipbuilding world has only occurred.

Angra-1 Nuclear Power Station (Westinghouse PWR-600 MW, 2 loops) started commercial operation in 1985, being property of Eletronuclear, subsidiary of Eletrobras in Brazil. Angra-1 has been preparing the necessary measures to renew the operating license and to apply for a lifetime extension up to 60 years. Among the many activities to perform, there are some related to fulfilling the requirements of the Brazilian regulator, the CNEN. These include requirements related to Human Factors Engineering (HFE) that included the preparation of a Chapter 18 of HFE, to become part of the plant’s Final Safety Analysis Report (FSAR). In the framework of the Instrument for Nuclear Safety Cooperation (INSC), created and funded by the European Union (EU) to enhance nuclear safety world-wide, cooperation activities between the EU and the Government of Brazil were set up in 2009. One of the INSC projects funded was to support the Brazilian nuclear operator of Angra-1 in the field of HFE. In 2010, the implementation of the project was awarded to a consortium lead by Tecnatom for performing a HFE Safety Evaluation to the plant and to provide support for preparing this Chapter 18. For this Project a specific methodology was developed for the execution of the Safety Evaluation. The methodology has been developed for evaluating — from the HFE viewpoint — a plant in operation, from the beginning of commercial operation until nowadays, including the design modifications performed to date. The obtained results have been used for developing the aforementioned Chapter 18. The main results of the Project Execution have been: 1. The developed methodology has made it possible to perform a comprehensive HFE evaluation of Angra-1, including the analysis of Post-TMI requirements, the design included in the current FSAR, the existing Angra-1 procedures and the verification of the current Main Control Room. 2. Technical support has been provided to Angra-1 for the preparation of Chapter 18 of the FSAR, following the structure of NUREG-0711, and using the results of the HFE Safety Evaluation. 3. An Action Plan has been developed for identifying and addressing in the future all those deficiencies found during the HFE Safety Evaluation, as well as those activities that are the consequence of the new FSAR Chapter 18.

ABSTRACTObjectives: 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.

This report presents the background, methodology, and findings of a human factors engineering (HFE) analysis performed in May, 1998, of the Spent Nuclear Fuels (SNF) Project Cold Vacuum Drying Facility (CVDF), to support its Preliminary Safety Analysis Report (PSAR), in responding to the requirements of Department of Energy (DOE) Order 5480.23 (DOE 1992a) and drafted to DOE-STD-3009-94 format. This HFE analysis focused on general environment, physical and computer workstations, and handling devices involved in or directly supporting the technical operations of the facility. This report makes no attempt to interpret or evaluate the safety significance of the HFE analysis findings. The HFE findings presented in this report, along with the results of the CVDF PSAR Chapter 3, Hazards and Accident Analyses, provide the technical basis for preparing the CVDF PSAR Chapter 13, Human Factors Engineering, including interpretation and disposition of findings. The findings presented in this report allow the PSAR Chapter 13 to fully respond to HFE requirements established in DOE Order 5480.23. DOE 5480.23, Nuclear Safety Analysis Reports, Section 8b(3)(n) and Attachment 1, Section-M, require that HFE be analyzed in the PSAR for the adequacy of the current design and planned construction for internal and external communications, operational aids, instrumentation and controls, environmental factors such as heat, light, and noise and that an assessment of human performance under abnormal and emergency conditions be performed (DOE 1992a).

Nuclear power plants design is moving toward a wider use of digital computers, especially microprocessors, in information and control systems. The amount of automation and the role of the operator are under discussion in many countries. The view of the operator’s role presently varies. The main opinions can be summarized as follows: 1. Move toward a high degree of automation, fostering the machine role. 2. Use of computer-generated procedures providing information to skilled operators for them to make the final decision. 3. Use of digital systems to help the operator identify problems, decide on the appropriate corrective actions and aid in the execution of those actions. Tecnatom, S.A. has developed an integrated Human Factor Engineering (HFE) methodology, based on international regulations and experience obtained from several national and international projects, combining technology, organization and human elements to generate a Human-Centered Design. Human Factor Engineering (HFE) is the application of the knowledge of human capabilities and characteristics to develop equipment, facilities and systems. With the application of this knowledge, human performance, and therefore system performance, can be dramatically improved. Man/machine systems designed with the human as a key element are inherently safer and more reliable than those that are not. Until recently, design of these human-equipment interfaces has been secondary to “pure hardware” design; that is, equipment and facilities were designed without formal consideration of the implications for operators. Our approach is to systematically apply an HFE methodology that will produce: a) Human-System Interfaces that are easy, friendly to and consistent for the operators. b) Simulator-Assisted Engineering platforms for validation activities in the logic, control and human-system interface areas. c) Training Programs based on the systematic analysis of job and task requirements. d) Procedures derived from the same design process and analyses as the Human-System Interface and Training. Application of good HFE methodology during system development, implementation and operation is, from our point of view, vital for optimal system performance regarding operation activities. “A disciplined approach to HFE helps ensure that humans are considered integral system components, requiring careful consideration of how they will interact with their equipment.”

A function modeling methodology was used to analyze and graphically describe the activities and work products of an industrial Human Factors Engineering (HFE) group. A model was constructed representing the HFE functions and describing the information that interrelates them. Data was collected to estimate the amount of staff effort devoted to each of the functions. The model: (a) identifies where actual practice departs from desired practice; (b) pinpoints where and how critical project deliverables are generated, (c) provides the basis for a standardized approach to the conduct of HFE; and (d) serves as a training vehicle for new staff members. The results of the data collection showed that 83% of HFE activities are devoted directly to performing technical functions. These efforts reflect a “classical” Human Engineering approach which emphasizes human-machine system analysis, design and evaluation. Less staff effort is devoted to the larger Human Factors domain which is concerned, per se, with personnel subsystem issues.

As the brain of Nuclear Power Plant (NPP), Main Control Room (MCR) is an integrated system which comprises varieties of Human System Interfaces (HSIs), procedures, operators and environment. HSI is the medium that the operators monitor and control the Nuclear Power Plant. To improve the operating performance and avoid human errors, Human Factor Engineering (HFE) is required to be implemented in the new plant HSI design for plant safety. HPR1000 has followed the NUREG-0711 as the guidelines of HFE program, in which 12 elements are included. Task Analysis (TA) and Human Factor Verification & Validation (HF V&V) are two important elements for the HSI design. For task analysis, the design engineers could analyze the human actions (HAs) to identify the tasks that the operators must perform to accomplish the plant functions. Task analysis identifies not only the specific tasks needed to accomplish HAs but also the information, and controls required to complete those tasks which are considered as important input for the MCR HSI design. HF V&V is one of the final stages of the Human Factors Services as included in NUREG-0711. The HF V&V objective is to evaluate that the HSI design conforms to HFE design principles and that the adequacy of the interfaces enable plant personnel to successfully perform their tasks and other operational goals, assuring plant safety. The V&V element consists of four major activities: Sampling of Operational Conditions, Design Verification, Integrated System Validation, and HED Resolution. For different targets, Design Verification could be separated into two kinds of activities: HSI Task Support Verification (TSV) and HFE Design Verification (DV). TSV is an evaluation to verify that the HSI supports the requirements of personnel tasks, as defined by task analyses. The HAs, controls and information identified in task analysis could be used as the basic input for HSI TSV. To provide adequate input for the HSI design and TSV, the operational conditions of task analysis should be sampled as many as possible to cover all the typical conditions, which include normal conditions, transients, Design Based Accidents (DBA), Beyond Design Based accidents (BDBA), even severe accidents. The sampled conditions for task analysis would be available for the task support verification of the related HSIs. In conclusion, the task analysis could be used as the design input for HSI, while the task support verification could review the designed HSI with the output information from TA. This paper addresses the research and engineering implementation methodologies for task analysis and HSI task support verification. As the first reactor of HPR1000, HFE program have been carried out in Fuqing 5&6 MCR from preliminary design to final test. The Fuqing 5&6 TA and TSV achievements for MCR HSIs design are summarized in the paper.

The U.S. Nuclear Regulatory Commission (NRC) reviews and evaluates the human factors engineering (HFE) programs of applicants for nuclear power plant construction permits, operating licenses, standard design certifications, and combined operating licenses. The purpose of these safety reviews is to help ensure that personnel performance and reliability are appropriately supported. Detailed design review procedures and guidance for the evaluations is provided in three key documents: the Standard Review Plan (NUREG-0800), the HFE Program Review Model (NUREG-0711), and the Human-System Interface Design Review Guidelines (NUREG-0700). These documents were last revised in 2007, 2004 and 2002, respectively. The NRC is committed to the periodic update and improvement of these guidance documents to ensure that they remain state-of-the-art design evaluation tools. Thus, the NRC has initiated a project with BNL to update the NRC guidance to remain current with recent research on human performance, advances in HFE methods and tools, and new technology. INL supported Brookhaven National Lab (BNL) to update the detailed HFE review criteria contained in NUREG-0711 and NUREG-0700 based on (1) feedback obtained from end users, (2) the results of NRC research and development efforts supporting the NRC staff’s HFE safety reviews, and (3) other material the project staff identify as applicable to the update effort. INL submitted comments on development plans and sections of NUREGs 0800, 0711, and 0700. The contractor prepared the report attached here as the deliverable for this work.

Performance ImprovementVolume 40, Issue 7 p. 28-33 Article Award-winning performance & consulting an interview with Burt Huber† Gary Dickelman, Gary Dickelman Gary J. Dickelman is the Chief Knowledge Officer for Christensen/Roberts Solutions of Woodbridge, Connecticut, and continues to develop and promote unique performance support tools with Epiance (formerly Guru, Inc.). He specializes in the application of KM, human factors engineering, learning technologies, information technology, and business process engineering to the creation of systems that human beings can actually use. Dickelman's work includes electronic performance support systems for human resources management, customer service, financial services, health care, and business process re-engineering. He is a member of the International Society for Performance Improvement, the American Society for Training and Development, and the Association for Computing Machinery. He is a contributing author to Using Computers in Human Resources (Jossey-Bass, 1992) and The Instructional Technology Handbook (McGraw-Hill, 1993) and is the author of numerous articles for industry periodicals. He is webmaster for Innovations in Performance Centered Design (http://www.pcd-innovations.com), editor for epss.com! (http://www.epss.com), and guest editor for ISPI's Performance Improvement. Gary may be reached at gdickel-man@pcd-innovations.com.Search for more papers by this author Gary Dickelman, Gary Dickelman Gary J. Dickelman is the Chief Knowledge Officer for Christensen/Roberts Solutions of Woodbridge, Connecticut, and continues to develop and promote unique performance support tools with Epiance (formerly Guru, Inc.). He specializes in the application of KM, human factors engineering, learning technologies, information technology, and business process engineering to the creation of systems that human beings can actually use. Dickelman's work includes electronic performance support systems for human resources management, customer service, financial services, health care, and business process re-engineering. He is a member of the International Society for Performance Improvement, the American Society for Training and Development, and the Association for Computing Machinery. He is a contributing author to Using Computers in Human Resources (Jossey-Bass, 1992) and The Instructional Technology Handbook (McGraw-Hill, 1993) and is the author of numerous articles for industry periodicals. He is webmaster for Innovations in Performance Centered Design (http://www.pcd-innovations.com), editor for epss.com! (http://www.epss.com), and guest editor for ISPI's Performance Improvement. Gary may be reached at gdickel-man@pcd-innovations.com.Search for more papers by this author First published: 17 January 2008 https://doi.org/10.1002/pfi.4140400707 † Burton A. Huber is President and CEO of Ariel Performance Centered Systems, Inc. He recently shared his perspectives on KM and the solutions Ariel designs “with humans in mind” on Northwest Airlines' Business and Technology Report. In addressing the critical elements of performance support and KM solutions, Burt identifies integration as an essential part of such systems. Huber specializes in designing systems that interface well with the people who use them and ensures that a company's expertise, best practices, and knowledge—their key differentiators—are embedded in the designs. Burt focuses on creating new thinking in software design. Creating designs with humans in mind, Burt and Ariel have created value for dozens of clients including many Fortune 100 companies. Ariel specializes in designing business applications with integrated performance support and KM. Burt may be reached at bhuber@arielpcs.com AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Volume40, Issue7August 2001Pages 28-33 RelatedInformation

Adult code cart redesign: Clinical implications.

Less than adequate integration of human factors engineering with system safety in the development of military weapon systems has been associated with design deficiencies in at least several fielded systems. These deficiencies have caused accidents resulting in fatalities and destroyed equipment valued at millions of dollars. Though human factors engineering and system safety have similar objectives and address many of the same issues during system development, cooperation and coordination between them is often lacking. A desired overlap between human factors engineering and system safety in military research and development is presented. Examples of design deficiencies and resultant accidents associated with inadequate cooperation and coordination between human factors engineering and system safety are discussed. Difficulties of integrating human factors engineering and system safety are described, and solutions for more effective integration are suggested.

Because timely and efficient responses of nurses are paramount to patient survival in cardiac and respiratory codes, it is crucial to determine best methods of training nursing personnel to respond effectively to code situations. Human factors engineering (HFE) is a relatively new approach in health care that attempts to understand human vulnerabilities that contribute to error and then design systems that minimize the likelihood of error occurring. This study embedded the principles of HFE in the design, implementation, and evaluation of mock code training to determine whether mock codes using HFE were helpful and if so, which inpatient units would benefit the most from such drills.

Using “No Problem Found” in Infusion Pump Programming as a Springboard for Learning About Human Factors Engineering

Welding operations are known for high safety risk which requires urgent identification and prevention before they result in huge negative impacts on the nations’ gross domestic product, organizations, workers and the environment. This research aimed at developing a human factor engineering model that support loss prevention in welding industry by assessing the impact of human factors on incident frequency and safety performance in Nigerian Oil and Gas industry. The study was carried out using coded skilled welders who had at least two years’ experience and above. Descriptive study design with structured questionnaire was used for data collection and Satistical Package for Social Sciences (SPSS) version 26 Structural equation modelling software for data analysis. The results revealed that Pearson’s correlation coefficient between human factors and safety performance were statistically significant with a p-values of -0.45, 0.72, -0.50, 0.77 and 0.32 for workplace, task, personal, organizational and design factors respectively. Pearson’s correlation coefficient between human factors and incident frequency and fatality rates were 0.64, -0.55, 0.71, -0.89, and -0.45 for workplace, task, personal, organizational and design factors respectively. The structural equation regression model showed that human factors and safety performance was statistically significant with a path coefficient of -0.733, 0.860, -0.615, 0.616 and 0.430 for personal, organizational, workplace, design and task factors respectively. The structural equation regression model showed that human factors and incident frequency was statistically significant with a path coefficient of 0.59, -0.79, 0.63, -0.60 and -0.31 for personal, organizational, workplace, design and task factors respectively.The research concluded that engineered human factors would lead to improved safety performance, structural integrity and reduction in incident frequency rate. The study recommended that national, international agencies, government, professional bodies and companies should focus on human factor engineering in delivering products with structural integrity, boost performance and reduce lost time injuries and occupational diseases.