BACKGROUND: Central Venous Catheterisation (CVC) has occasionally been associated with cases of retained guidewires in patients after surgery. In theory, this is a completely avoidable complication; however, as with any human procedure, operator error leading to guidewires being occasionally retained cannot be fully eliminated. OBJECTIVE: The work described here investigated the issue in an attempt to better understand it both from an operator and a systems perspective, and to ultimately recommend appropriate safe design solutions that reduce guidewire retention errors. METHODS: Nine distinct methods were used: observations of the procedure, a literature review, interviewing CVC end-users, task analysis construction, CVC procedural audits, two human reliability assessments, usability heuristics and a comprehensive solution survey with CVC end-users. RESULTS: The three solutions that operators rated most highly, in terms of both practicality and effectiveness, were: making trainees better aware of the potential guidewire complications and strongly emphasising guidewire removal in CVC training, actively checking that the guidewire is present in the waste tray for disposal, and standardising purchase of central line sets so that differences that may affect chances of guidewire loss is minimised. CONCLUSIONS: Further work to eliminate/engineer out the possibility of guidewires being retained is proposed.@en

Objective. The role of process modelling has been widely recognized for effective quality improvement. However, application in health care is somewhat limited since the health care community lacks knowledge about a broad range of methods and their applicability to health care. Therefore, the objectives of this paper are to present a summary description of a limited number of distinct modelling methods and evaluate how health care workers perceive them. Methods. Various process modelling methods from several different disciplines were reviewed and characterized. Case studies in three different health care scenarios were carried out to model those processes and evaluate how health care workers perceive the usability and utility of the process models. Results. Eight distinct modelling methods were identified and characterized by what the modelling elements in each explicitly represents. Flowcharts, which had been most extensively used by the participants, were most favoured in terms of their usability and utility. However, some alternative methods, although having been used by a much smaller number of participants, were considered to be helpful, specifically in understanding certain aspects of complex processes, e.g. communication diagrams for understanding interactions, swim lane activity diagrams for roles and responsibilities and state transition diagrams for a patient-centred perspective. Discussion. We believe thatit is important to make the various process modelling methods more easily accessible to health care by providing clear guidelines or computer-based tool support for health care-specific process modelling. These supports can assist health care workers to apply initially unfamiliar, but eventually more effective modelling methods.@en

The UK health service, which had been diagnosed to be seriously out of step with good design practice, has been recommended to obtain knowledge of design and risk management practice from other safety-critical industries. While these other industries have benefited from a broad range of systems modelling approaches, healthcare remains a long way behind. In order to investigate the healthcare-specific applicability of systems modelling approaches, this study identified 10 distinct methods through meta-model analysis. Healthcare workers' perception on 'ease of use' and 'usefulness' was then evaluated. The characterisation of the systems modelling methods showed that each method had particular capabilities to describe specific aspects of a complex system. However, the healthcare workers found that some of the methods, although potentially very useful, would be difficult to understand, particularly without prior experience. This study provides valuable insights into a better use of the systems modelling methods in healthcare. Statement of Relevance: The findings in this study provide insights into how to make a better use of various systems modelling approaches to the design and risk management of healthcare delivery systems, which have been a growing research interest among ergonomists and human factor professionals.@en

Current risk identification practices applied to patient safety in healthcare are insufficient. The situation can be improved, however, by studying systems approaches broadly and successfully utilised in other safety-critical industries, such as aviation and chemical industries. To illustrate this, this paper first investigates current risk identification practices in the healthcare field, and then examines the potential of systems approaches. A systems-based approach, called the Risk Identification Framework (RID Framework), is then developed to enhance improvement in risk identification. Demonstrating the strengths of using multiple inputs and methods, the RID Framework helps to facilitate the proactive identification of new risks. In this study, the potential value of the RID Framework is discussed by examining its application and evaluation, as conducted in a real-world healthcare setting. Both the application and evaluation of the RID Framework indicate positive results, as well as the need for further research. Practitioner Summary: The findings in this study provide insights into how to make a better amalgamation of risk identification inputs to the safer design and more proactive risk management of healthcare delivery systems, which have been an increasing research interest amongst human factor professionals and ergonomists.@en

BACKGROUND: After investing significant amounts of time and money in conducting formal risk assessments, such as root cause analysis (RCA) or failure mode and effects analysis (FMEA), healthcare workers are left to their own devices in generating high-quality risk control options. They often experience difficulty in doing so, and tend toward an overreliance on administrative controls (the weakest category in the hierarchy of risk controls). This has important implications for patient safety and the cost effectiveness of risk management operations. This paper describes a before and after pilot study of the Generating Options for Active Risk Control (GO-ARC) technique, a novel tool to improve the quality of the risk control options generation process.OUTCOME MEASURES: The quantity, quality (using the three-tiered hierarchy of risk controls), variety, and novelty of risk controls generated.RESULTS: Use of the GO-ARC technique was associated with improvement on all measures.CONCLUSIONS: While this pilot study has some notable limitations, it appears that the GO-ARC technique improved the risk control options generation process. Further research is needed to confirm this finding. It is also important to note that improved risk control options are a necessary, but not sufficient, step toward the implementation of more robust risk controls.@en

Introduction During the course of the COVID-19 pandemic, there have been suggestions that various techniques could be employed to improve the fit and, therefore, the effectiveness of face masks. It is well recognized that improving fit tends to improve mask effectiveness, but whether these fit modifiers are reliable remains unexplored. In this study, we assess a range of common "fit hacks"to determine their ability to improve mask performance. Methods Between July and September 2020, qualitative fit testing was performed in an indoor living space. We used quantitative fit testing to assess the fit of both surgical masks and KN95 masks, with and without 'fit hacks', on four participants. Seven fit hacks were evaluated to assess impact on fit. Additionally, one participant applied each fit hack multiple times to assess how reliable hacks were when reapplied. A convenience of four participants took part in the study, three females and one male with a head circumference range of 54 to 60 centimetres. Results and discussion The use of pantyhose, tape, and rubber bands were effective for most participants. A pantyhose overlayer was observed to be the most effective hack. High degrees of variation were noted between participants. However, little variation was noted within participants, with hacks generally showing similar benefit each time they were applied on a single participant. An inspection of the fit hacks once applied showed that individual facial features may have a significant impact on fit, especially the nose bridge. Conclusions Fit hacks can be used to effectively improve the fit of surgical and KN95 masks, enhancing the protection provided to the wearer. However, many of the most effective hacks are very uncomfortable and unlikely to be tolerated for extended periods of time. The development of effective fit-improvement solutions remains a critical issue in need of further development.@en

Although it is probably the best-known prospective hazard analysis (PHA) tool, failure mode and effects analysis (FMEA) is far from the only option available. This article introduces one of the alternatives: The structured what-if technique (SWIFT). SWIFT is a flexible, high-level risk identification technique that can be used on a stand-alone basis, or as part of a staged approach to make more efficient use of bottom-up methods like FMEA. In this article we describe the method, assess the evidence related to its use in healthcare with the use of a systematic literature review, and suggest ways in which it could be better adapted for use in the healthcare industry. Based on the limited evidence available, it appears that healthcare workers find it easy to learn, easy to use, and credible. Especially when used as part of a staged approach, SWIFT appears capable of playing a useful role as component of the PHA armamentarium.@en

The Department of Health and the Design Council jointly commissioned a scoping study to deliver ideas and practical recommendations for a design approach to reduce the risk of medical error and improve patient safety across the NHS. The research was undertaken by the Engineering Design Centre at the University of Cambridge, the Robens Institute for Health Ergonomics at the University of Surrey and the Helen Hamlyn Research Centre at the Royal College of Art. The research team employed diverse methods to gather evidence from literature, key stakeholders, and experts from within healthcare and other safety-critical industries. Despite the multiplicity of activities and methodologies employed, what emerged from the research was a very consistent picture. This convergence pointed to the need to better understand the health care system as the context into which specific design solutions must be delivered. Without that broader understanding there can be no certainty that any single design will contribute to reducing medical error and the consequential cost thereof.@en

The adoption of systems-focused risk assessment techniques has not led to measurable improvement in the rate of patient harm. Why? In part, because these tools focus solely on understanding problems and provide no direct support for designing and managing solutions (ie, risk control). This second installment of a 2-part series on rebalancing risk management describes a structured approach to bridging this gap: The Active Risk Control (ARC) Toolkit. A pilot study is presented to show how the ARC Toolkit can improve the quality of risk management practice. @en

Background: Central Venous Catheterisation (CVC) is a medical procedure that has been linked with cases of retained guidewires in a patient after surgery. Whilst this is theoretically a completely avoidable complication, a guidewire of up to 60cm being retained in a patient's vascular system poses a major risk. In recently reported cases, guidewires retained inside patients have not been detected for several years. Aims: The ultimate aim was to develop appropriate, operator-centred safe design solutions that reduce guidewire retention errors. Method: This paper focuses specifically on the application of Nielsen's ten usability heuristics 1 to the issue of retained guidewires. Following the development of a task analysis of the procedure, three researchers (from medical, safety and human factors backgrounds) independently applied the usability heuristics, then met to analyse the findings. Results: A range of usability problems were identified in the Central Venous Catheterisation procedure, and solutions to the identified issues were then proposed: These focused on the design of equipment, or the wider guidewire insertion procedure. The paper details the identified usability problems and possible redesign solutions from the 10 usability heuristics. Conclusion: Overall, the application of the usability heuristics was found to be a useful method both to explore medical device interface problems and to generate possible countermeasures. Further work to eliminate/engineer out the possibility of guidewires being retained is briefly reported.@en

Complete intravascular loss of guidewires in patients is an on-going medical concern. This research investigates the guidewire insertion and removal procedure by using a common omission error model by James Reason to identify procedural disposition to omission errors. The research builds on a previous Hierarchical Task Analysis for central venous catheterisation and identifies two crucial points that need further examination with regard to guidewire loss. Suggestions for improved equipment, procedural and system design at these two task steps are given.@en

Root cause analysis is perhaps the most widely used tool in healthcare risk management, but does it actually lead to successful risk control? Are there categories of risk control that are more likely to be effective? And do healthcare risk managers have the tools they need to support the risk control process? This systematic review examines how the healthcare sector translates risk analysis to risk control action plans and examines how to do better. It suggests that the hierarchy of risk controls should inform risk control action planning and that new tools should be developed to improve the risk control process.@en

In 2002 the UK Department of Health and the Design Council jointly commissioned a scoping study to deliver ideas and practical recommendations for a design approach to reduce the risk of medical error and improve patient safety across the National Health Service (NHS). The research was undertaken by the Engineering Design Centre at the University of Cambridge, the Robens Institute for Health Ergonomics at the University of Surrey and the Helen Hamlyn Research Centre at the Royal College of Art. The research team employed diverse methods to gather evidence from literature, key stakeholders, and experts from within healthcare and other safety-critical industries in order to ascertain how the design of systems - equipment and other physical artefacts, working practices and information - could contribute to patient safety. Despite the multiplicity of activities and methodologies employed, what emerged from the research was a very consistent picture. This convergence pointed to the need to better understand the healthcare system, including the users of that system, as the context into which specific design solutions must be delivered. Without that broader understanding there can be no certainty that any single design will contribute to reducing medical error and the consequential cost thereof.@en

The UK and USA are currently undergoing a period of considerable change in their attitude towards medical error and their understanding of its causes and magnitude. In both countries, with increasing rapidity, a disturbing situation is being revealed. This paper presents the results of an investigation into medical errors in the UK and the USA, and focuses in particular on the magnitude and causes of errors when using medical devices. Contrary to the traditional approach of blaming users, it is suggested here that many such errors are caused partly by poor device design, which fails to account adequately for the needs of users. In response, this paper also discusses the basics of a Human Factors Engineering (HFE) approach as a step towards overcoming this problem and offers a challenge to device users and design companies (manufacturers) to follow HFE principles in order to improve the efficiency of operation and reduce errors during device use.@en

Risk assessment, by itself, does nothing to reduce risk or improve safety. It can only change outcomes by informing the design and management of effective risk control interventions. But current practice in healthcare risk management suffers from an almost complete lack of support for risk control. This first installment of a 2-part series on rebalancing risk management describes a new framework to guide risk control practice: The Process for Active Risk Control. @en

In this article we call for a new approach to patient safety improvement, one based on the emerging field of evidence-based healthcare risk management (EBHRM). We explore EBHRM in the broader context of the evidence-based healthcare movement, assess the benefits and challenges that might arise in adopting an evidence-based approach, and make recommendations for meeting those challenges and realizing the benefits of a more scientific approach.@en

Retained surgical instruments (RSI) are preventable “Never Events”, yet our UK Hospital Trust experienced five retentions between 2011 and 2012. To reduce the retention risk and to aid rapid detection, we propose the deployment of additional technology-based controls: Surgical Data Recorders (SDR) and Radio-Frequency Identification (RFID) systems. In our research, the five relevant incident reports were reviewed, and the risk factors and the report recommendations were analysed. Furthermore, a comprehensive literature search on SDR and RFID was conducted. The current strategy for RSI prevention is manual counting of surgical instruments, but breakdowns in the process is a risk factor for RSI. Our work found that the technological systems proposed are a potentially promising means for accident prevention, monitoring, detection and post-incident learning for the five RSI cases. It is recommended that a systems approach, incorporating solutions like SDR and RFID should be adopted to reduce human errors in “Never Events”.@en

In healthcare, various methods are available to support risk identification in risk management process. However, there is no clear evidence on their contribution to risk identification. In this study, different methods used to support risk identification were therefore analysed to compare their contribution to overall risk identification. The study was conducted at Cambridge University Hospitals Foundation Trust, UK. Three main methods were selected to compare their support in risk identification: incident reports through their Risk Management Information System, risk registers through their Risk Registers system, and safety walkabouts through their internal patient safety assessment process. Where possible, simple comparison tests were run between the different methods of identifying risks as well as by the type of risks identified. It was found that each method has contributed to the risk identification by adding different sets of risk sources despite some overlaps. However, they produced discrete assessments from different aspects and none of them, on its own, could produce adequate results for effective risk identification. In any healthcare setting, having a system to put all risk information in one picture would help maximise the contribution of each method within the scope risk management process. Future studies may benefit from broader use of multiple and system-based risk identification approaches, and coding methods for more powerful analytical test.@en

Objective: The effectiveness of filtering facepiece respirators such as N95 respirators is heavily dependent on the fit. However, there have been limited efforts to discover the size of the gaps in the seal required to compromise filtering facepiece respirator performance, with prior studies estimating this size based on in vitro models. In this study, we measure the size of leak necessary to compromise the fit of N95 respirators. Methods: Two methods were used to create a gap of specific dimensions. A set of 3D-printed resin spacers and hollow steel rods were used to generate gaps in N95 respirators while worn on 2 participants. Occupational Safety and Health Administration (OSHA) quantitative fit testing methods were used to quantify mask performance with gaps between 0.4 and 2.9-mm diameters. Results: Gap size was regressed against fit factor, showing that overall, the minimum gap size to compromise N95 performance was between 1.5 mm2 and 3 mm2. Conclusions: These findings suggest the fit of a N95 respirator is compromised by gaps that may be difficult to visually detect. The study also adds to the body of evidence supporting the routine use of quantitative fit testing to ensure that masks are well-fitting. @en

Quality problem or issue: A number of challenges have been identified with current risk assessment practice in hospitals, including: a lack of consultation with a sufficiently wide group of stakeholders; a lack of consistency and transparency; and insufficient risk assessment guidance. Consequently, risk assessment may not be fully effective as a means to ensure safety. Initial assessment: We used a V system developmental model, in conjunction with mixed methods, including interviews and document analysis to identify user needs and requirements. Choice of solution: One way to address current challenges is through providing good guidance on the fundamental aspects of risk assessment. We designed a risk assessment framework, comprising: a risk assessment model that depicts the main risk assessment steps; risk assessment explanation cards that provide prompts to help apply each step; and a risk assessment form that helps to systematize the risk assessment and document the findings. Implementation: We conducted multiple group discussions to pilot the framework through the use of a representative scenario and used our findings for the user evaluation. Evaluation: User evaluation was conducted with 10 participants through interviews and showed promising results. Lessons learned: While the framework was recommended for use in practice, it was also proposed that it be adopted as a training tool. With its use in risk assessment, we anticipate that risk assessments would lead to more effective decisions being made and more appropriate actions being taken to minimize risks. Consequently, the quality and safety of care delivered could be improved.@en