Clinical Engineering Department Research Articles

Examining the Relation of Transformational Leadership in Clinical Engineering on the Performance of Medical Equipment: A Neural Network Approach

In the realm of healthcare administration, heightened expectations can lead to stress, therefore impacting working conditions. Specifically, studies on leadership styles have provided a valuable understanding of the factors that hinder performance, particularly in relation to the implementation of transactional leadership. Despite its crucial significance, there is a dearth of research on the management styles employed in clinical engineering. This study examines the impact of leadership styles on the functioning of medical equipment. We assess leadership styles and the performance of medical equipment from the perspective of end-users using a cross-sectional survey and questionnaires that consider many significant criteria. A neural network model is employed to classify the leadership styles exhibited by the Clinical Engineering Department (CED) and to analyze the correlation between these styles and the equipment’s performance. The results suggest a significant correlation between the leadership styles of those in charge of CED and the functioning of medical equipment. A strong and favorable correlation exists between transformative leadership and equipment performance (r = 0.856**, P = 0.000). The data suggests that transformative leadership is highly significant, with a mean score of 3.07 ± 0.817.

Application of statistical processes control for the performance improvement of a clinical engineering department

This article addresses the fundamental role of Statistical as a quality tool in the field of clinical engineering, to improve and optimize internal processes. This study describes the methodology used to apply the SPC in a reference hospital's clinical engineering department. Data was collected over an extensive period, involving multiple medical equipment and verification procedures. These data were analyzed using various statistical tools, such as control charts, Pareto charts, and descriptive statistics. The results showed stability in the department's processes, which made it possible to identify areas for potential improvement. Statistical analyses revealed behavior patterns and trends that were not previously apparent. Based on these conclusions, specific modifications were proposed in the department's processes to optimize efficiency, reduce costs, and improve service quality. The implementation of these modifications based on evidence suggests that they would positively impact the general performance of the clinical engineering department if applied Key indicators could improve significantly, reflecting increased medical equipment reliability and availability, decreased unscheduled downtime, and increased satisfaction for department staff and equipment users. In summary, this study highlights the importance of using SPC as a powerful improvement tool in clinical engineering. By adopting an approach based on data and scientific evidence, clinical engineering departments can achieve more efficient and effective management of their processes, contributing to higher-quality medical care and patient safety.

Building a Clinical Engineering Department

Building a Clinical Engineering Department

Strategic Budget Planning for Complex Medical Devices: A Case Study on Surgical Microscopes

Dramatic developments in medical device technologies significantly influence the cost of equipment acquisition and operating expenses. Sometimes the budget estimation needed for rudimentary medical equipment can be complicated, even more so for a complex device with several add-on features. In Canada, the budget allocated to capital equipment purchases is challenging because the budget comes from the provincial government to the hospitals. The capital equipment budget amount is challenging because of the public healthcare funding model, whereby fiscal budgets come from the provincial government to the hospitals. The capital equipment budget allocation is limited and restricted in hospital as “big ticket” items compete with other capital requests. Having a strategic budgeting plan, completed by a clinical engineer, ensures a sufficient budget for the capital request. A strategic budgeting plan was central to this study to estimate the required funding for replacing aged existing surgical microscopes at the Children's Hospital of Eastern Ontario. This study demonstrates the development of a methodology to guide budget planning and includes inventory assessment, market analysis, the identification of clinical requirements, cost analysis, and the utilization of the outputs of these steps for capital planning requests. A basic step-by-step approach can be followed by any clinical engineering department before submitting a capital planning request for complex medical devices.

Development of Low-Cost Portable Defibrillator for Sudden Cardiac Arrest Management

Defibrillation is the mainstay of treatment of cardiac arrest especially ventricular fibrillation (VF) which occurs in more than 70%. The survival in out of hospital cardiac arrest is 30–35% in the western world whereas it is low in low socioeconomic countries. At present patients/persons suffering from cardiac arrest especially outside the hospital settings has high mortality of 70% or more. As per American Heart Association guidelines, early defibrillation within minutes is the prime treatment to improve the survival. In a country like India, defibrillators are not available and it may take hours for a victim to reach appropriate centres for defibrillation causing loss of life. However, defibrillators are currently expensive, not readily available. In a vast country, it is difficult for patient to access the major hospitals, lack of beds and other facility causes delay in treatment and death of patients. Hence there is high demand for the development of an alternate defibrillator readily available everywhere. The aim of this paper is development of a low-cost portable disposable defibrillator for the management of cardiac arrest victims. The design consists of an encasing a portable battery with capacitor which stores and delivers biphasic shock of 50 J for paediatric and 150 J for adult via two paddles attached to the assembly. Up to 6 shocks can be delivered with the stored energy. The casing will have a facility to view the heart rhythm such as VF and sinus rhythm via small display. Hence the project is aimed to develop a low-cost ultraportable defibrillator that aims to provide widespread availability, early defibrillation and improve survival. The proposed diagnosing system in hardware design was tested on safety analyser and defibrillator analysers in Clinical Engineering department of Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) and the accuracy was achieved of 98.03%.

The digitization process and the evolution of Clinical Risk Management concept: The role of Clinical Engineering in the operational management of biomedical technologies.

Digital transformation and technological innovation which have influenced several areas of social and productive life in recent years, are now also a tangible and concrete reality in the vast and strategic sector of public healthcare. The progressive introduction of digital technologies and their widespread diffusion in many segments of the population undoubtedly represent a driving force both for the evolution of care delivery methods and for the introduction of new organizational and management methods within clinical structures. The CS Clinical Engineering of the "Spedali Civili Hospital in Brescia" decided to design a path that would lead to the development of a software for the management of biomedical technologies within its competence inside the hospital. The ultimate aim of this path stems from the need of Clinical Engineering Department to have up-to-date, realistic, and systematic control of all biomedical technologies present in the company. "Spedali Civili Hospital in Brescia" is not just one of the most important corporate realities in the city, but it is also the largest hospital in Lombardy and one of the largest in Italy. System development has followed the well-established phases: requirement analysis phase, development phase, release phase and evaluating and updating phase. Finally, cooperation between the various figures involved in the multidisciplinary working group led to the development of an innovative management software called "SIC Brescia". The contribution of the present paper is to illustrate the development of a complex implementation model for the digitization of processes, information relating to biomedical technologies and their management throughout the entire life cycle. The purpose of sharing this path is to highlight the methodologies followed for its realization, the results obtained and possible future developments. This may enable other realities in the healthcare context to undertake the same type of pathway inspired by an accomplished model. Furthermore, future implementation and data collection related to the proposed Key Performance Indicators, as well as the consequent development of new operational management models for biomedical technologies and maintenance processes will be possible. In this way, the Clinical Risk Management concept will also be able to evolve into a more controlled, safe, and efficient system for the patient and the user.

Need for Improvements in Medical Device Management in Low- and Middle-Income Countries: Applying Learnings from Japan's Experience.

Medical devices provide important infrastructural support in modern healthcare systems. However, in low- and middle-income countries (LMICs), inadequate maintenance and management of devices due to a shortage of healthcare personnel (not only doctors and nurses but also other professionals including biomedical engineers [BMEs]) has resulted in inefficient and weak healthcare systems. High-income countries, including Japan, have resolved these problems by developing human resources and technologies to maintain and manage these systems. In this paper, we discuss the possibility of mitigating these problems in LMICs through human resource development and technology, based on lessons from Japan's experience. The problem of medical device management in LMICs stems from the fact that there are few professionals, such as BMEs, in charge of the management of medical devices and that clinical engineering departments in charge of device management have not been established. Since the 1980s, Japan has introduced a licensing system for BMEs, establishing operational guidelines to clarify their responsibilities within hospitals and using technology to utilize data and reduce workloads. Nevertheless, workload problems and high costs required to introduce computerized management systems persist. Moreover, it would be difficult to implement the same measures as those adopted in Japan in LMICs where there is an overwhelming shortage of medical personnel. It may be necessary to further reduce workloads for data entry and device management; use up-to-date, inexpensive, and user-friendly technology; and train non-BME personnel to operate and maintain equipment.

CMMS Database Migration in Clinical Engineering: Penn Medicine's Experience.

Database migration involves the transferring of data from one system to another system and typically is associated with information systems, database administration, relational databases, analytics, and business intelligence. Database migration requires careful planning and poses many challenges related to data assessment and cleansing, migration, testing, and managing risks throughout the project. This article describes the database migration activities associated with Penn Medicine's initiative to insource the clinical engineering department at Princeton Health into the health system's corporate information services department. Achieving established milestones throughout the project was pivotal to its successful execution. Defining key goals and making business decisions that would positively affect and support the migration also was imperative. Moreover, the experience described here highlights multiple stages of a computerized maintenance management system (CMMS) database migration project, conveys the importance of building internal and external relationships, and addresses additional ways to improve on future migration projects.

Time-Motion Study to Evaluate the Impact of Purchasing within Clinical Engineering

Biomedical equipment technicians and clinical engineers order medical device parts in most hospitals because of the technical nature, knowledge, and expertise associated with medical equipment. But biomedical equipment technicians/clinical engineers can sometimes fail to source high-quality parts at the lowest prices, fill out work orders properly, or follow up when parts are not delivered on time. Moreover, the hours they spend on parts ordering could be better utilized on repairs to increase the uptime of critical equipment. Solutions include hiring specialized buyers within clinical engineering departments or contracting with an online marketplace to simplify the ordering process.

Generating Additional Innovation and Research Opportunities during COVID 19 in Device and Technology Development and Associated Clinical, Patient, and Research Activity Benefits through a Clinical Engineering Innovation and Research Team (CEIR)

One positive development from the trials supported during the COVID-19 period has been a much-strengthened relationship between the Research & Development (R&D) and Clinical Engineering departments. Companies seeking to develop new technologies needed to get rapid regulatory approval from the Medicine's & Healthcare Products Regulatory Agency (MHRA) for CE marking. Achieving such approval required the expert technical input of clinical scientists and engineers within the clinical engineering department, alongside the input of experienced researchers, adept at designing studies and gaining ethical approval. Simply put, we found our local supply chain could not interface with the NHS without Clinical Engineering and R&D support.

Generating Additional Innovation and Research Opportunities during COVID 19 in Device and Technology Development and Associated Clinical, Patient, and Research Activity Benefits through a Clinical Engineering Innovation and Research Team (CEIR)

One positive development from the trials supported during the COVID-19 period has been a much-strengthened relationship between the Research & Development (R&D) and Clinical Engineering departments. Companies seeking to develop new technologies needed to get rapid regulatory approval from the Medicine's & Healthcare Products Regulatory Agency (MHRA) for CE marking. Achieving such approval required the expert technical input of clinical scientists and engineers within the clinical engineering department, alongside the input of experienced researchers, adept at designing studies and gaining ethical approval. Simply put, we found our local supply chain could not interface with the NHS without Clinical Engineering and R&D support.

Quality assessment of emergency corrective maintenance of critical care ventilators within the context of COVID-19 in Sao Paulo, Brazil

This technical report presents the quality assessment process for the emergency corrective maintenance of critical care ventilators in a node, IPT-POLI, of a voluntary network that is part of the initiative +Maintenance of Ventilators, led by the National Service of Industrial Training (SENAI) and its Integrated Manufacturing and Technology Center (CIMATEC) to perform maintenance on unused mechanical ventilators in the context of the COVID-19 pandemic in Brazil. A procedure was established for the quality assessment of equipment subjected to corrective emergency maintenance, covering the essential aspects of the three primary standards (ABNT NBR IEC 60601-1: 2010+A1:2016, ABNT NBR ISO IEC 62353: 2019, and ABNT NBR ISO 80601-2-12:2014) for performance and safety assessment. A set of nine critical care ventilators was evaluated considering the following parameters: leakage current, protective ground resistance, control accuracy, delivered oxygen test, and alarms. The evaluated ventilators underwent corrective emergency maintenance before performance and safety assessments. In the electrical safety tests, all equipment presented values prescribed for the standard. However, the assessment of ventilator parameters revealed that their performance was below the standard. Finally, quality assessment reports were sent to the clinical engineering departments at hospitals. Thus, it can be concluded that criteria selection for the quality assessment in critical care ventilators is crucial and of great significance for future pandemic scenarios, such as the situation experienced during the COVID-19 pandemic.

PP498 Decision Support Tool For Investments In Health Technology Replacement: Experience Of A Public Teaching Hospital In Brazil

IntroductionBased on the needs assessment of the medical and non-medical departments, the Investment Committee of the Hospital de Clínicas de Porto Alegre (HCPA), a teaching hospital in Brazil, recommends on which technologies the limited financial resources should be invested. Technology inclusion requests are evaluated by the hospital's technology assessment unit. For technology replacement, we have found models to assess the criticality of medical equipment, but they were insufficient to support the decision, which involves all departments of our hospital. This study aimed to develop an automated tool to support decision making regarding investments in equipment replacement in the hospital.MethodsA working group was set up with professionals from healthcare administration, clinical engineering and research departments. From the hospital's inventory database, we developed the tool using Google SheetsR. We have defined three departments for pilot testing of the tool: hemodynamics, laundry, and basic research. These departments represent the areas of healthcare, support services, and teaching and research in the hospital.ResultsThe criticality of medical equipment is assessed based on the criteria of function, physical risk, impact, remaining equipment life cycle, intensity of use and number of corrective maintenance actions performed. For the equipment in the administrative, support and research areas, the function and physical risk criteria were replaced by the safety and by the risks to the quality of service criteria. The evaluation is carried out by a multidisciplinary team. The tool categorizes the equipment into low, medium and high criticality.ConclusionsThe tool prioritized the equipment based on objective criteria evaluated by the departments’ multidisciplinary team comprising experts who use the equipment in their activities, the department administrator and clinical engineers, and provided transparency regarding the decision-making of the hospital's Investment Committee. In 2019, the limited financial resources were invested only in the replacement of highly critical equipment. We believe the tool can be reproduced in hospitals in low and middle-income countries.

Evaluation of Clinical Engineering Department Services in Riyadh City Hospitals

<p><strong>BACKGROUND:</strong> Since its establishment, clinical engineering in healthcare facilities has evolved rapidly owing to increased employment of highly trained staff. Clinical engineering department represents a factor critical for successful healthcare management.</p><p><strong>OBJECTIVE:</strong> This study developed an integrated evaluation method for services rendered by clinical engineering departments using two questionnaires supplied to governmental hospitals in Riyadh, Saudi Arabia.</p><p><strong>METHODS:</strong> One questionnaire is evaluation for the end user (medical department staff), while the other is evaluation questionnaire for the clinical engineering department staff.</p><p><strong>RESULTS:</strong> The overall evaluation of administrative, training, technical skills for clinical engineering department staff by medical department staff was very good with mean 4.07±1.09, 3.98±0.74 and 3.8±1.14, respectively. Hospital size affects the technical and training skills for the clinical engineering department’s staff, with a p-value less than 0.05 at 95% confidence interval. This also affects maintenance management system. Professional role for medical department staff had no effect on their satisfaction on the services provided by clinical engineering department.</p><p><strong>CONCLUSION: </strong>The procedure, standards and basic requirements which established by Saudi Arabia ministry of health for Clinical engineering department services were applied on all hospital, but the maintenance management system should be fixed regardless of hospital size.<strong></strong></p>

Bright Ideas: HTM Team Realizes Major Time Savings by Devising the AEM 'Holy Grail'.

Bright Ideas: HTM Team Realizes Major Time Savings by Devising the AEM 'Holy Grail'.

Cover Story: Matters of Perspective: Appreciating Diversity and Promoting Inclusion in Health Technology Professions.

Cover Story: Matters of Perspective: Appreciating Diversity and Promoting Inclusion in Health Technology Professions.

Mathematical modeling of clinical engineering approach to evaluate the quality of patient care.

At present, the patient care delivery system (PCDS) in a hospital/medical institute/clinic is absolutely medical technology-dependent and this tendency is found to increase day by day. To ensure the quality of patient care (QPC) appropriate implementation of the patient care technology management system (PCTMS) is necessary. Unfortunately, it is found to be absent in the healthcare delivery system in most of the countries in the world. The situation is very much severe, particularly, in medium- and low-income countries like Malaysia, India, Sri Lanka, Bangladesh, Pakistan, etc. The opposite scenario is found in high-income countries, specifically, in Japan where QPC has been improved significantly by adopting the clinical engineering approach (CEA) in their PCDS. Up to now, QPC is determined based on prediction as there are no mathematical ways to evaluate it properly. In this study, we for the first time, propose a mathematical model to evaluate the QPC quantitatively based on feedback control analogy taking into account of CEA in PCTMS, particularly, for clinical and surgical equipment. The model consists of three subsections: the clinical engineering department (CED), PCTMS, and health care engineering directorate (HCED). The correlation among the subsections and their performance parameters are defined and standardized. Multiple linear regression method is applied to derive the least square normal equations for each of the subsections and then the regression coefficients are solved by the standard data taken from 1000 beds hospitals of different countries. The model is applied to reveal the present status of QPC for 18 different countries including high-, middle-, and low-income countries of the world. The results obtained from the model demonstrate that the present status of QPC in Japan is 84.69% and in Pakistan, it is only 0.20%. This huge discrepancy is identified to be caused by the inclusion of CEA in PCDS of Japan. The proposed model can be applied to evaluate the QPC of a hospital/in a country and hence to take necessary steps accordingly for establishing the proposed research methodology. It is to be mentioned here that the proposed model cannot be applied to evaluate the QPC in some countries like Bangladesh, Bhutan, Nepal, etc. due to the unavailability of data related to the model parameters.

Evidence-based medical equipment management: a convenient implementation

Maintenance is a crucial subject in medical equipment life cycle management. Evidence-based maintenance consists of the continuous performance monitoring of equipment, starting from the evidence—the current state in terms of failure history—and improvement of its effectiveness by making the required changes. This process is very important for optimizing the use and allocation of the available resources by clinical engineering departments. Medical equipment maintenance is composed of two basic activities: scheduled maintenance and corrective maintenance. Both are needed for the management of the entire set of medical equipment in a hospital. Because the classification of maintenance service work orders reveals specific issues related to frequent problems and failures, specific codes have been applied to classify the corrective and scheduled maintenance work orders at Careggi University Hospital (Florence, Italy). In this study, a novel set of key performance indicators is also proposed for evaluating medical equipment maintenance performance. The purpose of this research is to combine these two evidence-based methods to assess every aspect of the maintenance process and provide an objective and standardized approach that will support and enhance clinical engineering activities. Starting from the evidence (i.e. failures), the results show that the combination of these two methods can provide a periodical cross-analysis of maintenance performance that indicates the most appropriate procedures.Graphical abstractThe left side shows a block diagram of the process needed to calculate the proposed set of KPIs, starting from technological, organizational and financial data. On the upper right it is shown an example of scheduled maintenance analysis for a specific class of equipment (legend in the article body). The bottom right part shows how the KPIs can be implemented in a business intelligence dashboard.

Book review: « Clinical engineering financial management and benchmarking » subtitle: «Essential tools to manage finances and remain competitive for clinical engineering / health technology professionals » by Binseng Wang

Not so many books describe and model the effective budgeting and benchmarking of clinical engineering departments. The publications by Frize (Med Biol Eng Comput 28:153–9, 1990), (Med Biol Eng Comput 28:160–5, 1990) are insightful but they are now somewhat outdated. Therefore, an up-to-date systematic approach, based on real data is most useful. Benchmarking was described by Wang (J Clin Eng 33:24–37, 2008) in 2008 but now 10 years after, we obtain a clearer picture of how to perform this in current reality.

Evaluation of Performance Outcomes of Medical Equipment Technology Management and Patient Safety: Skilled Clinical Engineer’s Approach

With the rapid development of medical equipment technology, the quality of patient care becomes under the spotlight of clinical engineering management of medical equipment since the past 4 decades and it is continually. Researchers give in-depth attention to minimize undesired incidents which are associated with medical and surgical equipment such as patients' unnatural deaths and injuries. This proposed research work investigates the relationship between performance outcomes of medical equipment technology management/patient-care technology and the reduction in undesired events like injury and even unnatural deaths. This proposed research work investigates the effect of varying levels of performance on quality of patient care and uses an indicator such as patient safety (PS) and cost-effective care by applying mathematical modeling of clinical engineering approach methodology to medical equipment technology management. In this study the quality model of Clinical Engineering Departments is determined by educational qualification, Clinical Engineering (CE) certification, training, and duration of experiences in this field. The standard performance of patient-care technology management is determined by the parameters of medical devices and the outcomes performance of medical equipment is determined. Data for this study was collected from 18 countries including from high, upper and lower-middle income regions. We were able to collect and analyze data of different performance levels of CE and biomedical engineering programs. The analysts' report measures the performance outcomes of Medical Equipment Technology Management System (METMS) and its impact on patient-care outcomes specifically impact on the reduction of patient risk factors associated with medical and surgical equipment. The findings should encourage researchers and healthcare stakeholders to better integrate the clinical engineering professionals in a hospital in order to achieve a safe functional condition of medical equipment to keep its scheduled life span in compliance with recommended span declared by manufactures. Cost-effective Clinical Engineering Department (CED) model can be designed and monitored through the methodology of this study. We hope that this study will motivate the deployment of senescence methodology for conventional electro-medical assets, by biomedical engineering and medical professionals, healthcare policymakers, equipment users, and vendors to improve outcomes as proposed by the research work described in this paper.