scholarly journals Medical device error and failure reporting: Learning from the car industry

2021 ◽  
pp. 251604352110082
Author(s):  
Arkeliana Tase ◽  
Peter Buckle ◽  
Melody Z Ni ◽  
George B Hanna

Background Improving the design of technology relies in part, on the reporting of performance failures in existing devices. Healthcare has low levels of formal reporting of performance and failure of medical equipment. This paper examines methods of reporting in the car industry and healthcare and aims to understand differences and identify opportunities for improvement within healthcare. Methods A literature search was carried out in Pubmed, Medline, Embase, Engineering Village, Scopus. NHS England and MHRA publications and guidelines were also reviewed. Focus was placed on the current system of reporting in both industries, known degree of patient harm, initiating factors, barriers, quality and methods of incident investigation and their validity. The findings were used to compare error reporting system in the two industries. Results Derivation of healthcare incident data from different sources means the full extent of patient harm is not known. For example, in 2012 there were 13,549 and 38,395 incidents reported by MHRA and NRLS (National Reporting and Learning System) respectively leading to uncertainties on the extent of the problem. The car industry emphasises the role of reporting source in ensuring data quality. Utilising some aspects of this approach might benefit healthcare reporting. These include a specific reporting system that stresses the importance of organisational learning in improving safety and recognises the limitations of root cause analysis. Conclusions Learning from reporting systems within the car industry may help the healthcare sector improve its own reporting, aiding healthcare performance.

Author(s):  
Yiğit Kazançoğlu ◽  
Muhittin Sağnak ◽  
Çisem Lafcı ◽  
Sunil Luthra ◽  
Anil Kumar ◽  
...  

Ever-changing conditions and emerging new challenges affect the ability of the healthcare sector to survive with the current system, and to maintain its processes effectively. In the healthcare sector, the conservation of the natural resources is being obstructed by insufficient infrastructure for managing residual waste resulting from single-use medical materials, increased energy use, and its environmental burden. In this context, circularity and sustainability concepts have become essential in healthcare to meliorate the sector’s negative impacts on the environment. The main aim of this study is to identify the barriers related to circular economy (CE) in the healthcare sector, apply big data analytics in healthcare, and provide solutions to these barriers. The contribution of this research is the detailed examination of the current healthcare literature about CE adaptation, and a proposal for a big data-enabled solutions framework to barriers to circularity, using fuzzy best-worst Method (BWM) and fuzzy VIKOR. Based on the findings, managerial, policy, and theoretical implementations are recommended to support sustainable development initiatives in the healthcare sector.


2021 ◽  
Author(s):  
Adil Mukanov ◽  
Asset Zhumadil

Abstract The 74th step of "100 Concrete Step of Nation Plan" initiated by the first president of the Republic of Kazakhstan (RoK) Nursultan Nazarbayev states that Kazakhstani reserves reporting system must be changed to the international standards. One of them actively proposed is the SPE-PRMS. Therefore, the main goal of the paper is to show challenges of the transition, discuss possible problems, their solution and, eventually, advantages for the companies. In the paper the main aspects of the current State Committee of Reserves (SCR) system or well-known as GKZ system inherited from the Soviet system and used in Kazakhstan are reported. Especially, we try to highlight the reserves categories of A, B, C1 and C2 and their impact on further field development in details. Also SPE-PRMS and SEC rules are shown in terms of differences and similarities with the current system. Importantly, authors demonstrate how the SPE-PRMS standards are wide-spread around the globe. Finally, details of planned shift, some recommendations and simplification of reporting process are exhibited. As the result of the study the following points are investigated. Firstly, what will be with reports just recently approved by the SCR. Especially, for the big fields whose preparation takes up to several years. Secondly, what the frequency is for the reporting. Thirdly, whether the reports will be handled through several approval stages or just submitted. Moreover, how close to SPE-PRMS the new system should be adopted taking into account Kazahstani realities and if the reports should be composed in English along with Russian, since the main purpose of the transition is to be clear and transparent for the foreign investors. Otherwise, unfamiliar language and big deviation from the well-known standards may ruin the efforts. Despite the complexity of these issues the benefits of the new system are obvious and there are several reasons. The main advantage is that the SPE-PRMS is all about economically recoverable reserves without any ties with fixed recovery factor. In addition, report is done in short time and less volume. Finally, if the norm of the report's submission without going to tedious approval process is accepted, that will ease work of the subsoil users’ because it accelerates further preparation of field development project. The study is done due to recent changes of the RoK subsoil usage regulations, where the requirement for reserves reporting system's transition to the new international standards is mentioned. However, the issue is not much highlighted in technical publications from the operating companies’ point of view. Thus, having experience with GKZ, SPE-PRMS and SEC systems the authors take this opportunity to show challenges and benefits of the decision.


2018 ◽  
Vol 31 (7) ◽  
pp. 556-562 ◽  
Author(s):  
Anna RÅBERUS ◽  
Inger K HOLMSTRÖM ◽  
Kathleen GALVIN ◽  
Annelie J SUNDLER

Abstract Objective The aim of this study was to explore the nature, potential usefulness and meaning of complaints lodged by patients and their relatives. Design A retrospective, descriptive design was used. Setting The study was based on a sample of formal patient complaints made through a patient complaint reporting system for publicly funded healthcare services in Sweden. Participants A systematic random sample of 170 patient complaints was yielded from a total of 5689 patient complaints made in a Swedish county in 2015. Main outcome measure Themes emerging from patient complaints analysed using a qualitative thematic method. Results The patient complaints reported patients’ or their relatives’ experiences of disadvantages and problems faced when seeking healthcare services. The meanings of the complaints reflected six themes regarding access to healthcare services, continuity and follow-up, incidents and patient harm, communication, attitudes and approaches, and healthcare options pursued against the patient’s wishes. Conclusions The patient complaints analysed in this study clearly indicate a number of specific areas that commonly give rise to dissatisfaction; however, the key findings point to the significance of patients’ exposure and vulnerability. The findings suggest that communication needs to be improved overall and that patient vulnerability could be successfully reduced with a strong interpersonal focus. Prerequisites for meeting patients’ needs include accounting for patients’ preferences and views both at the individual and organizational levels.


Diagnosis ◽  
2017 ◽  
Vol 4 (2) ◽  
pp. 79-86 ◽  
Author(s):  
Veronica Restelli ◽  
Annemarie Taylor ◽  
Douglas Cochrane ◽  
Michael A. Noble

AbstractBackground:This article reports on the findings of 12,278 laboratory related safety events that were reported through the British Columbia Patient Safety & Learning System Incident Reporting System.Methods:The reports were collected from 75 hospital-based laboratories over a 33-month period and represent approximately 4.9% of all incidents reported.Results:Consistent with previous studies 76% of reported incidents occurred during the pre-analytic phase of the laboratory cycle, with twice as many associated with collection problems as with clerical problems. Eighteen percent of incidents occurred during the post-analytic reporting phase. The remaining 6% of reported incidents occurred during the actual analytic phase. Examination of the results suggests substantial under-reporting in both the post-analytic and analytic phases. Of the reported events, 95.9% were reported as being associated with little or no harm, but 0.44% (55 events) were reported as having severe consequences.Conclusions:It is concluded that jurisdictional reporting systems can provide valuable information, but more work needs to be done to encourage more complete reporting of events.


Author(s):  
Nafiseh Esmaeeli ◽  
Fereshteh Sattari ◽  
Lianne Lefsrud ◽  
Renato Macciotta

Canada’s rail transportation network is a critical part of Canada’s integrated supply chain which connects industries, consumers, and resource sectors to ports on the Atlantic and Pacific coasts. One transportation activity that is essential to most industries, especially oil and manufacturing, is the rail transport of dangerous goods (DG). Although rail transportation of DG is beneficial to Canada’s economy, not paying attention to the safe transportation of these types of goods can have irreparable effects on the economy, human lives, and the environment. Recent rail accidents, such as Lake Wabamun in 2005 and Lac-Mégantic in 2013, have shown that there is still room to increase the safety of transportation of DG by rail through improving railways’ safety management systems (SMS). As a result, investigations to increase the safety of rail transportation of DG have been started. This work is part of these initiatives focusing on enhancing railways’ SMS, particularly DG main-track train derailments. The current study applied detailed root cause analysis (RCA), the bow tie analysis (BTA), and incident databases to identify the main causes and consequences of these types of accidents (2007–2017). Then, the relationship between these factors and gaps in SMS elements were identified and the frequency of each factor was investigated. The results showed that the main gaps are related to process and equipment integrity, incident investigation, and company standards, codes, and regulations. Furthermore, some useful recommendations are presented to improve the management of each SMS element and reduce these gaps.


2010 ◽  
Vol 2010 ◽  
pp. 1-5 ◽  
Author(s):  
Subramanian Vaidyanathan ◽  
Bakul M. Soni ◽  
Peter L. Hughes ◽  
Gurpreet Singh ◽  
Tun Oo

Never Events are serious, largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented. We propose that a list of “Never Events” is created for spinal cord injury patients in order to improve the quality of care. To begin with, following two preventable complications related to management of neuropathic bladder may be included in this list of “Never Events.” (i) Severe ventral erosion of glans penis and penile shaft caused by indwelling urethral catheter; (ii) incorrect placement of a Foley catheter leading to inflation of Foley balloon in urethra. If a Never Event occurs, health professionals should report the incident through hospital risk management system to National Patient Safety Agency's Reporting and Learning System, communicate with the patient, family, and their carer as soon as possible about the incident, undertake a comprehensive root cause analysis of what went wrong, how, and why, and implement the changes that have been identified and agreed following the root cause analysis.


2019 ◽  
pp. 61-69
Author(s):  
Matthew Taylor ◽  
Rebecca Jones

The risk of medication errors with infusion pumps is well established, yet a better understanding is needed of the scenarios and factors associated with the errors. Our study explored the frequency of medication errors with infusion pumps, based on events reported to the Pennsylvania Patient Safety Reporting System (PA-PSRS) during calendar year 2018. Our study identified a total of 1,004 events involving a medication error and use of an infusion pump, which occurred at 132 different hospitals in Pennsylvania. Fortunately, a majority of medication errors did not cause patient harm or death; however, we did find that 22% of events involved a high-alert medication. Our study shows that the frequency of events varies widely across the stages of medication process and types of medication error. In a subset of our data, we manually reviewed a free-text narrative field in each event report to better understand the nature of errors. For example, we found that a majority of wrong rate errors led to medication being infused at a faster rate than intended, and user programming was the most common contributing factor. Overall, results from our study can help providers identify areas to target for risk mitigation related to medication errors and the use of infusion pumps.


2020 ◽  
pp. 16-27
Author(s):  
Matthew Taylor ◽  
Shawn Kepner ◽  
Lea Anne Gardner ◽  
Rebecca Jones

COVID-19 (i.e., coronavirus disease 2019) was declared a pandemic and has had a profound impact on healthcare systems, which may increase the risk of patient harm. We conducted a query of the Pennsylvania Patient Safety Reporting System (PA-PSRS) database to identify COVID-19–related events submitted by acute care hospitals between January 1 and April 15, 2020. We identified 343 relevant event reports from 71 hospitals and conducted a descriptive study to identify the prevalence of and relationships between 13 categories of associated factors and 6 categories of event outcomes. We found that 36% (124 of 343) of events had more than one associated factor and 24% (83 of 343) had more than one outcome. The most frequently identified factors were Laboratory Testing (47%; 161 of 343), Process/Protocol (25%; 87 of 343), and Isolation Integrity (22%; 74 of 343). The two most frequent outcomes were Exposure to COVID-19 Positive or Suspected Positive Patient (50%; 173 of 343) and Missed/Delayed Test or Result (31%; 108 of 343). Finally, the findings showed that seven of the associated factors had a notable impact on the frequency of Exposure to COVID-19 Positive or Suspected Positive Patient outcome. Overall, we anticipate that the results can be used to identify areas of greatest need and risk, which could help to guide allocation of resources to mitigate risk of patient harm.


2021 ◽  
Vol 92 ◽  
pp. 01028
Author(s):  
Peter Majercak

Research background: Design of a methodology for the measurement of logistics processes in production plants to plan, control and manage logistic chain links. The article develops theoretical knowledge in the field of logistics chain management and methods of monitoring them. Purpose of the article: Material flow and logistics performance management is one of the most important areas for a manufacturing company, which significantly contributes to the overall results of the company’s management and its competitiveness. In order for the company to have its resources to use effectively, it needs to have information on its performance and weaknesses in the chain. The condition for obtaining this data is a system for measuring performance in accordance with the company’s goals. Methods: For the analysis of the current state and the identification of weak points in the measurement process, the root cause analysis will also be used, which aims to identify weak points in the process. Findings & Value added: The aim of the paper will be to create a brief theoretical a basis that will enable the analysis of the current system of evaluation of logistics performance and supply chain in the selected company and the identification of weaknesses with regard to the strategy and philosophy of the company and a proposal for changes that would increase the efficiency and effectiveness of the Supply chain. The most significant contribution can be attributed to the proposal for implementation systematic evaluation of suppliers using a scoring model designed specifically for company.


Author(s):  
T. Saravanan ◽  
N. Nagadeepa

The aim of this research paper is to study the user interface design of web learning system. This paper also analyzes the opinion of the users to improve the current web learning system. There are many web learning portals are available to the learners with and without pay and learn option. But the user interface design of the web learning system has no specific standards. There are many possibilities to improve the current system. User generated content is a new area to explore and study. The users of the system can give an opinion and also able to modify some design aspects according to their preferences and likes. In this research paper, we have studied two different web learning systems and its design aspects. Cognitive aspects and the flexibility of the design plays a very important role in learning. Cloud sharing and downloading time play a very vital role in learners’ preferences. Many free course learners withdraw learning modules due to the pure connectivity from the cloud learning environment. Web design principles, color principles, basic design principles and user interface design considerations should be studied and applied to create a well-constructed user-friendly environment.User generated and user participated design plays a very important role in the effectiveness of learning.


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