How to make the most of failure mode and effect analysis

Current accreditation standards issued by the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) require hospitals to carry out a proactive risk assessment on at least 1 high-risk activity each year for each accredited program. Because hospital risk managers and patient safety managers generally do not have the knowledge or level of comfort for conducting a proactive risk assessment, they will appreciate the expertise offered by biomedical equipment technicians (BMETs), occupational safety and health professionals, and others. The skills that have been developed by BMETs and others while conducting job safety analyses or failure mode effect analysis can now be applied to a health care proactive analysis. This article touches on the Health Care Failure Mode and Effect Analysis (HFMEA) model that the Department of Veterans Affairs (VA) National Center for Patient Safety developed for proactive risk assessment within the health care community. The goal of this article is to enlighten BMETs and others on the growth of proactive risk assessment within health care and also on the support documents and materials produced by the VA. For additional information on HFMEA, visit the VA website at www.patientsafety.gov/HFMEA.html.     

Technological developments and approaches to improving service quality

In summary, major paradigm shifts in the health care industry are altering the way technology is maintained and supported. Service organizations are now responsible for maintaining a broader base of technology within the health care delivery network and must to this on an extremely rapid, efficient, and productive basis. A number of new technologies are coming on-line, which can allow a health care technology service organization to experience significant improvements in profitability, efficiency, and productivity. To realize maximum benefit from these technologies, service organizations may find themselves re-engineering their service processes. The author believes that this is a requirement for many service organizations, regardless of whether new technology is implemented. The traditional approaches to service delivery are ineffective in managing the new structural realities and service requirements of today's health care environment. New strategies and tactics are required for ensuring that these requirements are met. These approaches will no doubt improve the overall quality, productivity, and efficiency of service and are based on best practices utilized by leading OEMs and ISOs in the medical electronics and other high technology service industry such as information technology and telecommunications, where the service organization is responsible for supporting a broad array of the technology over a large geography with a densely populated installed base, not unlike the typical health care delivery service environment. Once operational improvements are made, a service organization can take advantage of the productivity and efficiency gains brought on by new technology. Organizations interested in doing so are urged to thoroughly research the current state-of-the-art and best practices, because there are numerous systems currently available off-the-shelf. The author believes that new technology will be a basic requirement for competing in the health care technology service marketplace, because it can significantly affect the profitability of service organizations. This technology will help level the playing field between ISOs, OEMs, and biomedical personnel. As our research suggests, efficiently operating biomedical personnel can achieve a significantly higher utilization and profitability than efficiently operating OEMs, due to the advantages of lower overhead and operating cost structure. In general, the process to improve service productivity and efficiency involves a review of current service operations and understanding of the customer environment perceptions as well as understanding of key service factors parameters. From there, service organizations should identify the current state-of-the-art service and infrastructure systems and technology. Based on this assessment, a service organization can evaluate best practices and identify new strategies and tactics for improving service delivery. Through better service management control and education of users on the improvement in service, which the new processes and technologies provide, the service organization can realize real, quantifiable improvements in service quality, productivity, and profitability.     

Telemedicine: lessons remain unheeded.

Telemedicine, the delivery of health care with the patient and health professional at different locations, has been around for over 30 years. Its driving force has been developments in communications technology, and as new communications systems are developed health applications are proposed such as supporting the delivery of primary health care to geographically remote areas or regions underserved through the maldistribution of professional expertise. Despite rapid technological advances, evaluations of such systems have been largely superficial, and more thorough evaluations have failed to show significant advantages for more advanced and expensive technology over older technology such as the telephone. Methods for evaluating the impact of particular technologies on the health care system need to be developed and clearer benefits shown in terms of improved standards of care.     

Quantification Methodology of “Health Human Resources” Related to “Health Technologies” Based on Indicators “RhSan”, “TechSan” and “RhTech”: Application to Senegal

ObjectivesAfter a century of spectacular advances, healthcare systems are facing unprecedented crisis, linked to shortage of health human resources and health technologies. In fact, availability of care depends on both technological and human resources of health. The objective of this study is to develop indicators that can measure qualitatively human resources and technologies of health in healthcare facilities, in order to assess availability of care in sub-Saharan African countries.Materials and MethodsRegarding “health technology” related to “medical devices”, an indicator called “TechSan” for “Technologies de Santé” was previously developed and published (Ndione FB et al. (2019) [6]). To address the deficiencies in usual indicators related to health human resources, a second indicator called “RhSan” for “Ressources humaines de santé” in French is proposed. This indicator assigns a weight to each health worker taking into account his specific “level of medical knowledge” and “experience”. In order to correlate “RhSan” with “TechSan”, a third indicator called “RhTech” is also developed to assess matches between “health technologies” and “health human resources” and establish realistic availability of care. These indicators have the advantage to be consolidated by specialty such as laboratory, imaging, surgery, and “mother and child care”.ResultsThe application of TechSan, RhSan and RhTech to data collected in Senegal in 2016, enabled to assess the distribution of “health technology” and “health human resources” in this country. They also permit the mapping of care availability per specialty in Senegal. The results show a strong oversupply of Dakar in terms of both human resources and technologies of health compared to other Senegalese regions. Oppositely, Sedhiou, Kaffrine, Matam and Kédougou are poorly endowed showing limits of the Senegalese health pyramid system.ConclusionTechSan, RhSan and RhTech can provide reliable decision-making tools in order to elaborate health policies in sub-Saharan African countries on more rigorous basis.     

Measuring and improving the quality of mental health care: a global perspective

Mental disorders are common worldwide, yet the quality of care for these disorders has not increased to the same extent as that for physical conditions. In this paper, we present a framework for promoting quality measurement as a tool for improving quality of mental health care. We identify key barriers to this effort, including lack of standardized information technology‐based data sources, limited scientific evidence for mental health quality measures, lack of provider training and support, and cultural barriers to integrating mental health care within general health environments. We describe several innovations that are underway worldwide which can mitigate these barriers. Based on these experiences, we offer several recommendations for improving quality of mental health care. Health care payers and providers will need a portfolio of validated measures of patient‐centered outcomes across a spectrum of conditions. Common data elements will have to be developed and embedded within existing electronic health records and other information technology tools. Mental health outcomes will need to be assessed more routinely, and measurement‐based care should become part of the overall culture of the mental health care system. Health care systems will need a valid way to stratify quality measures, in order to address potential gaps among subpopulations and identify groups in most need of quality improvement. Much more attention should be devoted to workforce training in and capacity for quality improvement. The field of mental health quality improvement is a team sport, requiring coordination across different providers, involvement of consumer advocates, and leveraging of resources and incentives from health care payers and systems.     

Personalized health care: from theory to practice

The practice of medicine stands at the threshold of a transformation from its current focus on the treatment of disease events to an emphasis on enhancing health, preventing disease and personalizing care to meet each individual's specific health needs. Personalized health care is a new and strategic approach that is driven by personalized health planning empowered by personalized medicine tools, which are facilitated by advances in science and technology. These tools improve the capability to predict health risks, to determine and quantify the dynamics of disease development, and to target therapeutic approaches to the needs of the individual. Personalized health care can be implemented today using currently available technologies and know-how and thereby provide a market for the rational introduction of new personalized medicine tools. The need for early adoption of personalized health care stems from the necessity to reduce the egregious and wasteful burden of preventable chronic diseases, which is not effectively addressed by our current approach to care.     

Biological safety considerations in the production of health care products from recombinant organisms

Safety considerations in the field of recombinant technology and rDNA production of health care products have been under discussion since the beginning of this technology in 1973 and will certainly go on. However no adverse effects, which could have been attributed to rDNA technology have been observed. On the other hand many life-saving and life-improving drugs have been on the market for many years to the benefit of many patients. New technologies and products thereof often provoke uncertainties about their impact on the environment or society. This article discusses some potential risks in the application of rDNA technology to drugs as well as some benefits for patients, society and environment.     

Minimally invasive surgery. Implications for hospitals,health workers,and patients.

Minimally invasive surgery is one of the great innovations of health care in the 20th century. It promises to revolutionise surgery by allowing many more operations to be performed with minimal hospitalisation. Pressure from patients has caused many techniques to spread rapidly before they have been adequately assessed. This must be resisted, and policy makers must pay more attention to minimally invasive surgery to ensure that good assessments are made. The widespread use of minimally invasive techniques has important implications for hospitals and health workers. As more patients are treated on an outpatient basis, fewer hospital beds will be needed, and traditional operating rooms will have to adapt to a greater turnover of patients. Surgeons will have to acquire new operating skills, possibly requiring formal training and accreditation, and, as different specialties fight for control of new technologies, surgery may eventually be merged with internal medicine so that specialists will deal with organ systems. Postoperative care will have to be carried out in the community rather than in hospitals, and policy makers will need to reorganise their health systems to cope with these developments.     

Prospective health care: the second transformation of medicine

Emerging scientific technologies provide rich sources of predictive biomarkers, which could transform health care. Identification of causal biomarkers will enable the development of tools to quantify risk and anticipate disease. Accurate health risk analysis is rapidly becoming feasible, so health care can become rational, preventive and personalized.     

Genetic screening for the next decade: application of present and new technologies.

Molecular genetic technology is diffusing from the research laboratory to the clinical laboratory, where it has already begun to influence prenatal diagnosis and counseling. In the very near future, this technology will be applied more generally, using population-based screening strategies. Pilot programs are beginning to evaluate the technical feasibility and efficacy of recombinant DNA techniques for newborn screening follow-up. DNA-based population screening is being considered for heterozygous carriers of an autosomal recessive disorder such as cystic fibrosis in order to identify carrier couples at risk of having an affected child. We will review the current DNA methodologies in the context of three genetic disorders: sickle-cell disease, Duchenne muscular dystrophy, and cystic fibrosis. We will then consider the requirements for implementation of these new technologies. We will conclude that implementation will require two key factors: machines and people. Machines are required to automate molecular genetic procedures, which are currently personnel-intensive, so that the expense can be reduced and the procedures made more cost-effective. The people who are required are health professionals knowledgeable in the clinical aspects of the target disorders, as well as in the DNA laboratory testing. These professionals will be able to facilitate sample acquisition and information exchange among the laboratory, the primary health care provider, and the families requesting consultation.     

The promise of e-Health – a Canadian perspective

Canadians value their health care system above any other social program. Canada's system of health care faces significant financial and population pressures, relating to cost, access, quality, accountability, and the integration of information and communication technologies (ICTs). The health-system also faces certain unique challenges that include care delivery within a highly decentralised system of financing and accountability, and care delivery to a significant portion of the population sparsely distributed across a landmass of 10 million square kilometres, in areas of extreme climatic conditions. All of these challenges are significant catalysts in the development of technologies that aim to significantly mitigate or eliminate these selfsame challenges.The system is undergoing widespread review, nationally, and within each province and territory, where the bulk of care provision is financed and managed. The challenges are being addressed by national, regional and provincial initiatives in the public, private and not-for-profit sectors.The promise of e-Health lies in the manner and degree to which it can mitigate or resolve these challenges to the health system and build on advancements in ICTs supporting the development of a health infostructure. Canada is actively developing and implementing technological solutions to deliver health information and health care services across the country. These solutions, while exciting and promising, also present new challenges, particularly in regard to acceptable standards, choice of technologies, overcoming traditional jurisdictional boundaries, up-front investment, and privacy and confidentially.Many organisations and governments are working to address these challenges. The Canadian Institute for Health Information (CIHI) will play an increasingly significant role in these initiatives, as the management of health information becomes a more crucial factor in the successful delivery of health care services in the new millennium.     

Communication systems in healthcare

The care of patients now almost inevitably seems to involve many different individuals, all needing to share patient information and discuss their management. As a consequence there is increasing interest in, and use of, information and communication technologies to support health services. Yet, while there is significant discussion of, and investment in, information technologies, communication systems receive much less attention and the clinical adoption of even simpler services like voice-mail or electronic mail is still not commonplace in many health services. There remain enormous gaps in our broad understanding of the role of communication services in health care delivery. Laboratory medicine is perhaps even more poorly studied than many other areas, such as the interface between primary care and hospital services. Given this lack of specific information about laboratory communication services, this paper will step back and generally review the components of a communication system, including the basic concepts of a communication channel, service, device and interaction mode. The review will then try and summarise some of what is known about specific communication problems that arise across health services in the main, including the community and hospital service delivery.     

Molecular diagnostics: hurdles for clinical implementation

In the coming years, molecular diagnostics will continue to be of critical importance to public health worldwide. It will facilitate the detection and characterization of disease, as well as monitoring of the drug response, and will assist in the identification of genetic modifiers and disease susceptibility. A wide range of molecular-based tests is available to assess DNA variation and changes in gene expression. However, there are major hurdles to overcome before the implementation of these tests in clinical laboratories, such as which test to employ, the choice of technology and equipment, and issues such as cost-effectiveness, accuracy, reproducibility, personnel training, reimbursement by third-party payers and intellectual property. At present, PCR-based testing predominates; however, alternative technologies aimed at reducing genome complexity without PCR are anticipated to gain momentum in the coming years. Furthermore, development of integrated chip devices ("lab-on-a-chip") should allow point-of-care testing and facilitate genetic readouts from single cells and molecules. Together with proteomic-based testing, these advances will improve molecular diagnostic testing and will present additional challenges for implementing such testing in health care settings.     

A Roadmap to an Equitable Digital Diabetes Ecosystem

ObjectivesDiabetes management presents a substantial burden to individuals living with the condition and their families, health care professionals, and health care systems. Although an increasing number of digital tools are available to assist with tasks such as blood glucose monitoring and insulin dose calculation, multiple persistent barriers continue to prevent their optimal use.MethodsAs a guide to creating an equitable connected digital diabetes ecosystem, we propose a roadmap with key milestones that need to be achieved along the way.ResultsDuring the Coronavirus 2019 pandemic, there was an increased use of digital tools to support diabetes care, but at the same time, the pandemic also highlighted problems of inequities in access to and use of these same technologies. Based on these observations, a connected diabetes ecosystem should incorporate and optimize the use of existing treatments and technologies, integrate tasks such as glucose monitoring, data analysis, and insulin dose calculations, and lead to improved and equitable health outcomes.ConclusionsDevelopment of this ecosystem will require overcoming multiple obstacles, including interoperability and data security concerns. However, an integrated system would optimize existing devices, technologies, and treatments to improve outcomes.     

American Association of Clinical Endocrinology Clinical Practice Guideline: The Use of Advanced Technology in the Management of Persons With Diabetes Mellitus

ObjectiveTo provide evidence-based recommendations regarding the use of advanced technology in the management of persons with diabetes mellitus to clinicians, diabetes-care teams, health care professionals, and other stakeholders.MethodsThe American Association of Clinical Endocrinology (AACE) conducted literature searches for relevant articles published from 2012 to 2021. A task force of medical experts developed evidence-based guideline recommendations based on a review of clinical evidence, expertise, and informal consensus, according to established AACE protocol for guideline development.Main Outcome MeasuresPrimary outcomes of interest included hemoglobin A1C, rates and severity of hypoglycemia, time in range, time above range, and time below range.ResultsThis guideline includes 37 evidence-based clinical practice recommendations for advanced diabetes technology and contains 357 citations that inform the evidence base.RecommendationsEvidence-based recommendations were developed regarding the efficacy and safety of devices for the management of persons with diabetes mellitus, metrics used to aide with the assessment of advanced diabetes technology, and standards for the implementation of this technology.ConclusionsAdvanced diabetes technology can assist persons with diabetes to safely and effectively achieve glycemic targets, improve quality of life, add greater convenience, potentially reduce burden of care, and offer a personalized approach to self-management. Furthermore, diabetes technology can improve the efficiency and effectiveness of clinical decision-making. Successful integration of these technologies into care requires knowledge about the functionality of devices in this rapidly changing field. This information will allow health care professionals to provide necessary education and training to persons accessing these treatments and have the required expertise to interpret data and make appropriate treatment adjustments.     

How attractive does a new technology have to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations.

Because economic evaluations of health care services are being published with increasing frequency it is important to (a) evaluate them rigorously and (b) compare the net benefit of the application of one technology with that of others. Four "levels of evidence" that rate economic evaluations on the basis of their methodologic rigour are proposed. They are based on the quality of the methods used to estimate clinical effectiveness, quality of life and costs. With the use of the magnitude of the incremental net benefit of a technology, therapies can also be classified into five "grades of recommendation." A grade A technology is both more effective and cheaper than the existing one, whereas a grade E technology is less or equally effective and more costly. Those of grades B through D are more effective and more costly. A grade B technology costs less than $20,000 per quality-adjusted life-year (QALY), a grade C one $20,000 to $100,000/QALY and a grade D one more than $100,000/QALY. Many issues other than cost effectiveness, such as ethical and political considerations, affect the implementation of a new technology. However, it is hoped that these guidelines will provide a framework with which to interpret economic evaluations and to identify additional information that will be useful in making sound decisions on the adoption and utilization of health care services.     

Coronavirus Disease 2019 (COVID-19) Diagnostic Tools: A Focus on Detection Technologies and Limitations

The ongoing coronavirus disease (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) poses a severe threat to human health and the global economy and has resulted in overwhelming stress on health care systems worldwide. Despite the global health catastrophe, especially in the number of infections and fatalities, the COVID-19 pandemic has also revolutionized research and discovery with remarkable success in diagnostics, treatments, and vaccine development. The use of many diagnostic methods has helped establish public health guidelines to mitigate the spread of COVID-19. However, limited information has been shared about these methods, and there is a need for the scientific community to learn about these technologies, in addition to their sensitivity, specificity, and limitations. This review article is focused on providing insights into the major methods used for SARS-CoV-2 detection. We describe in detail the core principle of each method, including molecular and serological approaches, along with reported claims about the rates of false negatives and false positives, the types of specimens needed, and the level of technology and the time required to perform each test. Although this study will not rank or prioritize these methods, the information will help in the development of guidelines and diagnostic protocols in clinical settings and reference laboratories.