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 impact by clinical engineers on global patients outcomes.

The intersection of technological changes and societal evolution has transformed every aspect of human life. Technological advancements are transforming how healthcare knowledge is expanding and accelerating the outreach of critical medical services delivery (Jamal et al. in Health Information Management Journal 38(3):26-37, 2009). While this transformation facilitates new opportunities simultaneously it also introduces challenges (Jacobzone and Oxley, 2001). Appropriate Health Technology (HT) is vital to new and existing global health care programs. Therefore, qualified professionals who can safely guide the development, evaluation, installation, integration, performance assurance, and risk mitigation of HT must be in position to lead. Trained Clinical Engineers (CE) and Biomedical Engineers (BE) have been recognized by the World Health Organization (WHO) as the essential practitioners to providing this critically needed guidance. Over the past four years, a senior professional group participated in an international project that seeks evidence for the hypothesis - that the engagement of CE and BE in guiding HT - impacts positively on patient outcomes, while the alternative is that there is no difference. The group collected published data that was subjected to peer review screening; additional data qualification conditions are described in this paper. The project was initiated at the Global CE Summit during the first International Clinical Engineering and Health Technology Management Congress (ICEHTMC) in Hangzhou, China in October 2015 (Global Clinical Engineering Summit at the First International Clinical Engineering and Health Technology Management Congress, 2015). Following the adoption of a resolution to investigate CE contributions to the improvement of world health status, an international survey and literature survey were initiated. During the first two years of this project 150 case studies from 90 countries were identified covering the previous ten years. The results of this survey were presented to health leaders at the World Health Organization (WHO) World Health Assembly in 2016. Last year, 250 case studies were added including 35 more countries covering the 2016-2017 period. The combined project contains 400 qualified submissions from 125 countries. The conclusion was that engagement of CE and BME is critical for successful investment in HT and for achieving intended patient outcomes. This paper describes the project's plan, the results of the literature review performed, and the evidence identified during the process.

Attitudes and Practices Related to Clinical Alarms: A Follow-up Survey.

BACKGROUND: Alarm fatigue is a widely acknowledged patient safety concern in hospitals. In 2013, The Joint Commission issued a National Patient Safety Goal on Alarm Management, making addressing alarm management a priority. To capture changes in attitudes and practices related to alarms, the Healthcare Technology Foundation conducted and reported findings from national online surveys in 2006 and 2011 and completed a third survey in 2016. OBJECTIVES: The goal of the 2016 survey was to identify how hospital practices and clinicians' perceptions of alarms have changed since 2006. METHODS: The online survey was distributed via national health care organizations during a 2-month period. Results of the 2016 survey (N = 1241) were compared with results of the 2006 and 2011 surveys by using χ2 and Kruskal-Wallis analyses. RESULTS: Responses were significantly different for almost all items across the 3 surveys. Respondents in 2016 were more likely to agree that nuisance alarms occur frequently and disrupt patient care and were less likely to agree that clinical staff responds quickly to alarms. Compared with respondents in 2011, those in 2016 were almost twice as likely to report that their hospitals had experienced adverse events related to alarms in the past 2 years. However, in 2016 a much higher proportion of respondents indicated that their hospitals had implemented alarm improvement initiatives. CONCLUSIONS: Although survey findings show disappointing trends in the past 10 years, including worsening perceptions of nuisance alarms and more alarm-related adverse events, the increase in alarm improvement initiatives is encouraging.

Nurses' Perspectives on Clinical Alarms.

BACKGROUND: Alarm hazards are a critical issue in patient safety. Of all health care providers, nurses are the ones most directly affected by the multitude of clinical alarms. OBJECTIVES: To qualitatively explore nurses' experiences with clinical alarms. METHODS: The Krippendorff method for content analysis was used to analyze comments provided by 406 nurses in a national survey on perceptions of clinical alarms. RESULTS: Six interrelated themes emerged: dissonance and desensitization; pollution, panic, and pathology; calling for accountability; calling for authority of nurses; clinical alarm management is crucial but not a panacea; and hope for the future. CONCLUSIONS: Nurses are concerned about the impact of alarm fatigue on nurses and patients, recognize the importance of nurses' role in reducing noise pollution, and offer valuable insight into strategies that can mitigate alarm hazards.

Computer-controlled electrical stimulation for quantitative mapping of human cortical function.

Cortical mapping with electrical stimulation (ES) in neurosurgical patients typically involves the manually controlled delivery of suprathreshold electrical current to a discrete area of the brain. Limited numbers of trials and imprecise current delivery methods increase the variability of the behavioral response and make it difficult to collect quantitative mapping data, which is especially important in research studies of human cortical function. To overcome these limitations, the authors developed a method for computer-controlled delivery of defined electrical current to implanted intracranial electrodes. They demonstrate that stimulation can be time locked to a behavioral task to rapidly and systematically measure the detection threshold for ES in human visual cortex over many trials. Computer-controlled ES is well suited for the systematic and quantitative study of the function of virtually any region of cerebral cortex. It may be especially useful for studying human cortical regions that are not well characterized and for verifying the presence of stimulation-evoked percepts that are difficult to objectively confirm.

TRENDS IN CLINICAL ENGINEERING PRACTICES

Appropriate deployment of technological tools contributes to improvement in the quality of healthcare delivered, the containment of cost, and better access to healthcare systems. Hospitals have been allocating significant portion of their resources to procuring and managing capital assets; they are continuously faced with demands for new biomedical technology while asked to manage existing inventory for which they are not well prepared. To effectively manage their investments, hospitals are developing medical technology management programs that need expertise and planning methodology for safe and efficient deployment of healthcare technological tools. Clinical engineers are practitioners that can lead such programs and deliver technological solutions based on carefully determined needs and specified set of organization objectives and abilities. The successful practice of clinical engineering is dependent on the ability of these practitioners to transfer knowledge from the engineering and life sciences to the support of clinical applications. As rapid changes in the complexity and variety of technological tools and in the measurement of patient care outcomes taking place, it is best to facilitate transfer of such knowledge having well defined body of knowledge. This can be accomplished only when the goals of the profession are clearly described and uniformly accepted accommodating profession vision and commitment. Such a commitment must include the promotion of safe and effective application of science and technology in patient care and on the acceptance of professional accountability demonstratable by the achievement of competency recognition by national professional certification program. To be ready, clinical engineers must participate in continuing education activities and maintain wide level of expertise, demonstrate ability for leading and effectively executing complex projects and functions, and be accountable for maintaining safe technological tools/systems used in the patient environment. As systems complexity and integration continues to increase, now is the time to demonstrate that the required competencies do contribute to desired outcomes.

La adecuada implementación y aplicación de herramientas tecnológicas contribuye al mejoramiento de la calidad en la prestación de los servicios de salud, la minimización de los costos de dichos servicios, y el aumento de la accesibilidad al sistema hospitalario. En las últimas décadas los hospitales han venido asignando una considerable porción de sus recursos al cuidado y administración de sus bienes de capital; enfrentan continuamente la necesidad de adquirir nuevas tecnologías biomédicas al tiempo que deben administrar la existente, situación para la que no están bien preparados. Con el fin de orientar eficientemente sus inversiones, los hospitales han venido desarrollando programas de administración de tecnología médica que requieren expertos en el tema y la aplicación de metodologías específicas para un aprovechamiento seguro y eficiente de estas herramientas en el sector salud. Los ingenieros clínicos son quienes pueden liderar estos programas al proveer soluciones tecnológicas basadas en las necesidades prioritarias, cuidadosamente establecidas, y en los objetivos organizacionales específicos. El éxito en la práctica de la ingeniería clínica radica en la habilidad de estos profesionales de transferir los conocimientos del campo de la ingeniería y de las ciencias de la salud al entorno hospitalario para servir de soporte en las aplicaciones médicas. A medida que se dan grandes y rápidos cambios en la complejidad y variedad de las herramientas tecnológicas disponibles y en las formas de evaluar el cuidado que se le brinda a los pacientes, la mejor forma de transferir dichos desarrollos es mediante un completo conocimiento del tema. Esto se puede lograr sólo cuando los objetivos de la profesión han sido claramente definidos y son coherentes con el compromiso y la visión profesional. Tal compromiso debe incluir la promoción del uso seguro y eficaz de la ciencia y la tecnología al servicio del cuidado de los pacientes y la aceptación de la necesidad de demostrar sus capacidades como ingeniero clínico al adquirir el reconocimiento de sus competencias profesionales mediante el programa de certificación profesional nacional. Para estar preparados para estos desafíos los ingenieros clínicos deben participar en actividades de educación continua, mantener su pericia y habilidades profesionales, demostrar capacidad para liderar y ejecutar eficientemente proyectos y funciones complejas, y velar por el seguro mantenimiento de las herramientas y sistemas tecnológicos utilizados en el sector salud. A medida que aumenta la integración y la complejidad de los sistemas, es el momento de demostrar que las competencias de los ingenieros clínicos realmente contribuyen al cumplimiento de las metas establecidas.

A national online survey on the effectiveness of clinical alarms.

PURPOSE: To develop a national online survey to be administered by the American College of Clinical Engineers Healthcare Technology Foundation to hospitals and healthcare workers to determine the problems associated with alarms in hospitals. METHODS: An online survey was developed by a 16-member task force representing professionals from clinical engineering, nursing, and technology to evaluate the reasons health-care workers do not respond to clinical alarms. RESULTS: A total of 1327 persons responded to the survey; most (94%) worked in acute care hospitals. About half of the respondents were registered nurses (51%), and one-third of respondents (31%) worked in a critical care unit. Most respondents (>90%) agreed or strongly agreed with the statements covering the purpose of clinical alarms and the need for prioritized and easily differentiated audible and visual alarms. Likewise, many respondents identified nuisance alarms as problematic; most agreed or strongly agreed that the alarms occur frequently (81%), disrupt patient care (77%), and can reduce trust in alarms and cause caregivers to disable them (78%). CONCLUSIONS: Effective clinical alarm management relies on (1) equipment designs that promote appropriate use, (2) clinicians who take an active role in learning how to use equipment safely over its full range of capabilities, and (3) hospitals that recognize the complexities of managing clinical alarms and devote the necessary resources to develop effective management schemes.

Issues associated with off label use of medical devices.

Off label use as applied to medical devices is the application of the device for a purpose that is not included as an indication in the FDA and EC approved device labeling. Such applications are also called unapproved or new uses. Beyond a use not being indicated, some off label uses may be expressly contraindicated as well as explicitly warned against. One example here is the currently controversial topic of the reuse of devices labeled single use only, although off label use is a far more widespread issue than reuse. The justification for off label use can range from reasoned and studied applications beyond those for which the manufacturer has sought clearance or approval, to misapplication based on faulty analysis or ignorance. This paper will review the critical need to incorporate a risk assessment process for potential off label use.

Safe use of cellular telephones in hospitals: fundamental principles and case studies.

Many industries and individuals have embraced cellular telephones. They provide mobile, synchronous communication, which could hypothetically increase the efficiency and safety of inpatient healthcare. However, reports of early analog cellular telephones interfering with critical life-support machines had led many hospitals to strictly prohibit cellular telephones. A literature search revealed that individual hospitals now are allowing cellular telephone use with various policies to prevent electromagnetic interference with medical devices. The fundamental principles underlying electromagnetic interference are immunity, frequency, modulation technology, distance, and power Electromagnetic interference risk mitigation methods based on these principles have been successfully implemented. In one case study, a minimum distance between cellular telephones and medical devices is maintained, with restrictions in critical areas. In another case study, cellular telephone coverage is augmented to automatically control the power of the cellular telephone. While no uniform safety standard yet exists, cellular telephones can be safely used in hospitals when their use is managed carefully.

TeleHealth: operational issues to consider.

Recent developments in the telecommunications and the information technology fields hold the promise of improved access to and better utilization of an integrated health care related resources. In addition, to these developments, the deployment of interactive distant training programs offer an opportunity to decrease the knowledge gap between the leading academic medical centers where new medical expertise is continuously being discovered and remote health care practitioners who find themselves pressed to deliver quality care that meets the needs of their communities in a competitive environment of limited resources.

Risk assessment - hospital view in selecting medical technology.

Appropriate deployment of technological innovation contributes to improvement in the quality of healthcare delivered, the containment of cost, and access to the healthcare system. Hospitals have been allocating a significant portion of their resources to procuring and managing capital assets; they are continuously faced with demands for new medical equipment and are asked to manage existing inventory for which they are not well prepared. To objectively direct their investment, hospitals are developing medical technology management programs that need pertinent information and planning methodology for integrating new equipment into existing operations as well as for mitigating patient safety issues and costs of ownership. Clinical engineers identify technological solutions based on the matching of new medical equipment with hospital's objectives. They review their institution's overall technological position, determine strengths and weaknesses, develop equipment-selection criteria, supervise installations, train users and monitor post procurement performance to assure meeting of goals. This program, together with consistent assessment methodology and evaluation analysis, will objectively guide the capital assets decision-making process. At Texas Children's Hospital we integrated engineering simulation, bench testing and clinical studies with financial information to assure the validity of risk avoidance practice and the promotion of medical equipment and supplies selection based on quantitative measurement process and product comparison practice. The clinical engineer's skills and expertise are needed to facilitate the adoption of an objective methodology for implementing the program, thus improving the match between the hospital's needs and budget projections, equipment performance and cost of ownership. The result of systematic planning and execution is a program that assures the safety and appropriateness of inventory level at the lowest life-cycle costs at the best performance.

Benchmarking clinical engineering program.

Professional labor shortage in healthcare delivery system and specifically the management of staffing effectiveness in clinical engineering field are recent developments where shortage of comparative information exist and almost no information on its impact on performance outcomes. We attempted over the past few years to define and measure optimal application of manpower to medical technology management in the hospital setting.

Dead space ventilation in critically ill children with lung injury.

STUDY OBJECTIVE: In children with acute lung injury, there is an increase in minute ventilation (E) and inefficient gas exchange due to a high level of physiologic dead space ventilation (VD/VT). Mechanical ventilation with positive end-expiratory pressure, when used in critically ill patients to correct hypoxemia, may contribute to increased VD/VT. The purpose of this study was to measure metabolic parameters and VD/VT in critically ill children. DESIGN: A cross-sectional study. SETTING: Pediatric ICU of a university hospital. PATIENTS: A total of 45 mechanically intubated children (mean age, 5.5 years). INTERVENTIONS: Indirect calorimetry was used to measure metabolic parameters. VD/VT parameters were calculated using the modified Bohr-Enghoff equation. ARDS was defined based on criteria by The American-European Consensus Conference. MEASUREMENTS AND RESULTS: The group mean (+/- SD) ventilatory equivalent for oxygen (VeqO(2)) and ventilatory equivalent for carbon dioxide (VeqCO(2)) were 2.9 +/- 1 and 3.3 +/- 1 L per 100 mL, respectively. The group mean VD/VT was 0.48 +/- 0.2. When compared to non-ARDS patients (33 patients), the patients with ARDS (12 patients) had a significantly higher VeqO(2) (3.3 +/- 1 vs 2.8 +/- 1 L per 100 mL, respectively; p < 0.05), a significantly higher VeqCO(2) (3.7 +/- 1 L/100 vs 3.1 +/- 1 L per 100 mL, respectively; p < 0.05), and a significantly higher VD/VT (0.62 +/- 0.14 vs 0.43 +/- 0.15, respectively; p < 0.0005). CONCLUSIONS: Critically ill children with ARDS have increased VD/VT. Increased VD/VT was the main cause of the excess of E demand in these patients. Increased metabolic demands, as shown by the VeqO(2), VeqCO(2), and ventilatory support, are the major determinants of E requirements in children with ARDS.