Introduction Of New Medical Technologies Research Articles

Recurrent failure of ART, thrombosis and thrombophilia

In recent years, the number of risk factors for thrombosis associated with pregnancy has increased substantially due to the active introduction of new medical technologies not used 30 years ago or because their role in emerging thrombosis has not been studied, e.g., during pregnancy after assisted reproductive technologies (ART) particularly in vitro fertilization (IVF). The risk of venous thromboembolic complications (VTEС) related to ovarian hyperstimulation during ART is often overlooked. We present the case of a 37-year-old woman who developed thrombosis of the right internal jugular vein 3 weeks after embryo transfer within the IVF protocol. Ovarian hyperstimulation during hormonal IVF protocols provokes procoagulant changes in the hemostasis and fibrinolysis system able to result in venous and arterial thrombosis. The localization of VTEС typical to ART is more often located in the internal jugular vein being accompanied by neck pain and edema. Thrombosis risk factors should be assessed in all women in the IVF program, and appropriate thromboprophylaxis should be carried out to all high risk subjects.

PP403 New Medical Technology Adoption In Asia Pacific: Focused On South Korea And Japan

IntroductionThis study is the first to analyze and compare the distinctive market access process of new medical technologies focused on technical fee creation in South Korea and Japan. The purpose of this study is to derive implications for each country through analysis and comparison of the market access process and propose improvements of new medical technology adoption program by referring the United States’ incentive program for innovative technology.MethodsIdentification and review the published articles and health polices, and reports related to the medical procedure (medical technologies) coding and payment rule in South Korea, Japan and the United States.ResultsIn Korea, for the rapid introduction of new medical technologies, a One-Stop Service program (aka parallel review process) is operated that simultaneously conducts regulatory approval and new health technology assessment (nHTA) process. In Japan, the Sakigake designation program aims to give patients better access to innovative pharmaceuticals, medical technologies, and regenerative medicines by streamlining the approval and pricing process but it doesn't provide immediate coverage after approval. Medicare Coverage for Innovative Technology (MCIT) is one of the incentive programs for innovative technology which aims to improve patient access to new medical technologies through rapid market access process in the United States. Medical technologies designated a Breakthrough Device receive immediate Medicare Coverage for 4 years by MCIT.ConclusionsIt is recommended for Korea and Japan to actively implement the accelerated patient access process and grant affordable premium prices for the innovative medical technologies. MCIT can be considered as a breakthrough for innovative medical technology adaption.

Совершенствование процедуры внедрения новых медицинский технологий в Казахстане на примере экстракорпоральной мембранной оксигенации

The process of introduction of new medical technologies in Kazakhstan is regulated by a number of normative and legal acts, and is aimed at allowing the use of drugs and medical devices that meet high standards of safety, quality and efficiency. This article examines the process of such introduction based on the extracorporeal membrane oxygenation technology, with an analysis of all stages of the process and recommendations for its improvement. Given the high efficiency of new medical technologies (on the example of extracorporeal membrane oxygenation), when their limited use is due to the lack of funds of a medical organization, the involvement of additional intellectual resources seems expedient. Key words: Health Technology Assessment, Extracorporeal Life Support, Extracorporeal Membrane Oxygenation, Health Service Assessment

Biopsychosocial Model of Activating Care for Elderly and Senile Individuals at Home

Due to the introduction of new medical technologies, there is an increase in the number of people, including those of elderly and senile age, who have extended their lives but need constant care at home from medical and social services. Research on age differences in biological needs with home care found for middle-aged people, when compared with elderly and senile-aged individuals, that the greatest difficulties and the greatest contribution to a reduction of the quality of life were made by insufficient nutrition, limited independence in the performance of household manipulations due to joint damage, pain, and other biological causes, as well as hypothermia syndrome. People of older age groups were characterized by the need to bridge the lack of communication, to enhance the role of the family in the implementation of care, and to increase confidence in caregivers and the availability of medicines and religious services. The original model of biopsychosocial, activating, home care for the geriatric contingent of patients differs from traditional approaches in the use of activating kinesiotherapy and cognitive exercises. Developed on the basis of identified age-based determinants of the quality of life, it contributes to the achievement of a higher level of functionality and independence of the geriatric patient, which is accompanied by an improved quality of life.

INNOVATIVE TECHNOLOGIES IN PERSONNEL DEVELOPMENT

The aim of the article is to substantiate the innovative approaches in the work of nurses, because their competence ensures availability and quality of medical and preventive care to the population. The subject is defined as the stages of development of nursing personnel, including education, career growth, and employee motivation. In order to achieve the set aim and to solve the chosen tasks, modern research methods have been used. They include scientific abstraction (in the study of the categories of “core competencies”, “competence”); systematic approach (to substantiate the principles influencing the professional development of the worker), sociological survey (questionnaire) (to determine the methods of motivating nursing personnel), etc. The provisions and conclusions of the work are presented as a system of measures aimed at improving the competence, capacity building and utilization of the intellectual capital of health institutions. It is revealed that the core professional competencies of nursing staff are the basis of employee development in the organization, and they help determine the level of professional competence of nurses, their practical skills. Innovative technologies for the development of nursing staff are disclosed, including: building core competencies, individual development plan, performance appraisal, career planning, training and staff development, employee motivation. It is established that the employee clearly defines his needs, goals, expectations in the individual development plan to know how to develop in the future and properly plan the steps and necessary measures to achieve the goals. Performance appraisal allows the assessor to determine the professional competence of the nurse. When planning nursing careers, it is necessary to take into account the specifics of the healthcare sector, the constant increase of requirements for the quality of medical services, the introduction of new medical technologies, etc. Motivation behind the career choice is often founded upon the principles of charity, assistance, care, compassion, and being altruistic.

A Survey on Reducing Costs Vs Improving Outcomes and Opportunities in Health Care Field Using Big Data

In recent years, the total amount of medical data collected has grown exponentially, mainly because of the introduction of new medical technologies and the increased use of IT to manage medical health records of patients. These technologies have been introduced not only to provide higher quality of care but also to help solve some of the major healthcare problems in developed countries: the lack of productivity and efficiency, the increasing costs and the relatively low accessibility of the system. Big Data, or the capability to develop, analyze and visualize huge and complex data sets for various research interests and applications, has the promise to radically impact the speed and direction in tackling these problems. Health care field grows tremendously in last few decades. The health care field has generated huge amounts of data that has huge volume, enormous velocity and vast variety. Also it comes from a variety of new sources as hospitals are now tend to implemented electronic health record (EHR) systems. These sources have strained the existing capabilities of existing conventional relational database management systems. In such scenario, Big Data solutions offer to harness these massive, heterogeneous and complex data sets to obtain more meaningful and knowledgeable information. This paper basically studies the impact of implementing the big data solutions on the healthcare field, the potential opportunities, challenges and available platform and tools to implement Big data analytics in health care field.

Balancing innovation and medical device regulation: the case of modern metal-on-metal hip replacements.

Due to problems with wear particle generation and subsequent loosening using conventional metal-on-polyethylene total hip replacements, there has been a shift toward alternative bearing systems, including metal-on-metal (MoM), for younger, more active patients with degenerative joint disease. Based on positive results from early short-term clinical studies, MoM hip replacements were readily adopted by orthopedic surgeons with thousands being implanted worldwide over the past decade. Unacceptably high revision rates reported by two national joint registries called into question the rigorousness of the regulatory approval process for these implants, particularly with respect to premarket data requirements to prove safety, effectiveness, and the appropriateness of the regulatory pathway chosen. The purpose of this review was to investigate the balance between facilitating the introduction of new medical technologies and the need to ensure safety and effectiveness through comprehensive regulatory assessment. The case of MoM hip replacement devices was used to frame the investigation and subsequent discussions. The regulatory approval processes and post-market surveillance requirements associated with three common MoM hip replacements (two resurfacings: the Birmingham and articular surface replacement and the articular surface replacement XL total hip replacement) were investigated. With respect to modern MoM hip replacement devices, the balance between facilitating the introduction of these new medical technologies and the need to ensure safety and effectiveness through comprehensive regulatory assessment was not achieved. The lessons learned from these experiences have application beyond joint replacements to the introduction of new medical technologies in general, particularly for those who have a significant potential for harm. In this regard, a series of recommendations have been developed to contribute to the evolution of the medical device regulatory process.

Innovative Approaches to the Treatment of Sleep Apnoea

Innovative approaches to the treatment of a number of important, common and high significance diseases play an increasingly crucial role in modern healthcare and medical services. The use of innovative approaches related to the application of new or improved drug forms, therapies and interventions, or to the introduction of new medical technologies, have improved the quality of healthcare, making treatment more efficient, modern and corresponding to the evolving needs of the patients. Innovative approaches to the treatment of patients with obstructive sleep apnoea syndrome, as the most common type of sleep disorder, which involve the creation of novel medicinal products, technologies and application of new therapies, are a crucial factor for the improvement of patients' health status and for maintaining a high standard of health and patient satisfaction. The use of innovative solutions in the treatment of sleep disorders is an essential condition and a prerequisite for the patients' better quality of life, considering the fact that this is a common disorder, which, according to the World Statistics, affects approximately 4% of men and 2% of women aged between 30 and 70 years, and which leads to a higher risk of cardio-vascular diseases and fatality, daytime sleepiness, impaired concentration and alertness, memory disorders and changes in one's personality and behaviour.

New evidence on factors affecting the level and growth of US health care spending

The dual problems of high and rising medical care expenditures and substantial differences in spending across geographic regions have long plagued the US health care system. We provide new evidence to explain why some states and regions of the country spend much more on medical care than others, and why health care spending for the nation as a whole has been growing rapidly over the last several decades. To do this, we estimate a health care spending panel data model using annual data on all 50 states for the period 1993–2009. Our model includes a number of socio-economic, health care provider, lifestyle and environmental variables that past studies indicate may affect the level or growth of aggregate health care spending. We exploit the time effect component of our model to obtain an upper-bound estimate of the effect of advances in medical technology. Our findings indicate that the most important factors influencing the level of spending are availability of providers, income, excessive alcohol consumption, Medicaid coverage, HMO health plans and the proportion of the population elderly and African-American. The principal drivers of growth have been the continual introduction of new medical technologies, and the growth of providers and income.

INTERACTION BETWEEN OBJECTIVE PERFORMANCE MEASURES AND SUBJECTIVE USER PERCEPTIONS IN THE EVALUATION OF MEDICAL DEVICES: A CASE STUDY.

Medical technology is a large and expanding industry. Introducing new medical devices is important but several challenges exist in implementing the optimal method of evaluation. Both objective and subjective measures can be used for evaluation. The former is the mainstay of evaluation, yet subjective assessment is often the basis for the introduction of new medical technology. The aim of this study was to determine the interaction and concordance between objective and subjective assessment of new medical technology. This study used both objective performance measures and subjective user perceptions in the evaluation of a new medical device designed to improve the accuracy of gravity-assisted delivery of intravenous fluids, compared with the current, widely used "roller-clamp" device. The concordance of objective and subjective assessments was evaluated using comparative analysis. Objective assessment of the accuracy of intravenous fluid delivery revealed no difference between the two devices (p = .636). Subjective assessment revealed that the new device was perceived to be significantly more accurate (p = .001). This lack of concordance can be partially explained by both device and demand characteristics. This case study reveals a significant discordance between the objective and subjective assessments. It provides some explanation for why new medical devices are adopted without objective evidence of benefit. This phenomenon has been termed "persuasive design" and its influence should be controlled for in the evaluation, purchase and introduction of new medical devices. This should help reduce the risk and associated cost of premature introduction.

PHP132 - Pharmaceutical Payment Reform Of Taiwan, Nhi

Background  Since National Health Insurance (NHI) Program being launched on March 1, 1995 in Taiwan, rapid population ageing, dramatic increases in the number of patients suffering from catastrophic diseases, and the incessant introduction of new medical technologies, pharmaceutical products and devices ,NHI program has faced a serious financial deficit in recent years.  The drug fees of NHI was about 4.4 billion USD in 2012, nearly 25% of total health insurance expenditure, and per capita was 204 USD. Over 16,000 drugs were listed in the Drug Fee Schedule, and the average growth rate on drug fees was 4.87% during 2000 to 2014.  The price was adjusted 8 times from 2000 to 2013.

P222 Evolution Of Evidence Grading Systems In The American Academy Of Ophthalmology’s Preferred Practice Patterns

BackgroundClinical practice guidelines are an important component of efforts to improve quality of care and rationalise the introduction of new medical technologies. As evidence-based medicine and comparative effectiveness research become...

Cancer's Next Frontier

Cancer's Next Frontier

Technology Assessment and Adoption in Orthopaedics: Lessons Learned

The rising cost and variable quality of health-care delivery in the U.S. have become the subject of great debate among policymakers, providers, payers, and patients1. Although health-policy experts and health-care researchers have identified numerous factors that contribute to rising costs, there is widespread agreement that the adoption and use of new health-care technologies are a major contributor to escalating health-care costs in the U.S.2. In addition to concerns about cost, the introduction of new medical technologies raises questions related to quality and safety, including how to minimize complications during the “learning curve” period through appropriate training and/or credentialing, how to appropriately communicate potential risks associated with new interventions to patients, and who should be responsible for postmarket surveillance and reporting. Over the past half century, the introduction of many orthopaedic technologies, including the Charnley low-friction arthroplasty, arthroscopy, and internal fixation devices for the treatment of fractures, has led to important advances in patient care. However, there are also numerous examples of orthopaedic technologies that were introduced with great enthusiasm and optimism but unfortunately did not perform as well in clinical practice as they had in the laboratory setting, in some cases resulting in poor patient outcomes and high rates of unanticipated complications. Furthermore, the widespread adoption of new, more costly orthopaedic technologies has resulted in a substantial increase in the overall cost of care associated with orthopaedic procedures3. Orthopaedic technologies are frequently introduced into the marketplace, often at a substantially higher cost, …

Outcomes-based education for a changing health service

Outcomes-based education for a changing health service

Ultrasonography and ectopic pregnancy — a review

In any resource-limited environment such as Ghana the introduction of new medical technology should be cost-effective and affordable. Ectopic pregnancy is still an important cause of maternal mortality. The accuracy of its diagnosis by the ultrasound scan is the subject of this systemic review derived from the MEDLINE database and the Cochrane library. A total of 11 studies 9 from developed countries and 2 from developing countries were identified and analyzed. The sensitivity and negative predictive values were greater than 70% in all the countries. The specificity and positive predictive values were above 80% in 9 countries. In addition serum B-hCG enhanced the diagnosis. The endovaginal scan identified ectopic pregnancies earlier than the abdominal probe. However the vaginal probe could not detect lesions high up in the pelvis or outside the pelvis. Culdocentesis and laparoscopy were useful adjuncts in these situations. In conclusion clinical suspicion is paramount in diagnosing ectopic pregnancy. Ultrasonography is very useful but it has its limitations. (full text modified)

Prognostic significance of pathological and biological factors in hepatocellular carcinoma.

Prognostic factors in hepatocellular carcinoma (HCC) conventionally consist of staging with the tumour node metastasis system and grading by tumour cellular differentiation. There are also other factors useful in prognostication but most of them are clinical. With new discoveries in the pathobiology of cancers and introduction of new medical technology, pathological and biological factors of HCC in relation to prognosis have been studied quite extensively. Morphological features of the tumour, both gross and histological, have been found to be significantly related to tumour recurrence and patient survival. Recently, applications of new antibodies and techniques have enabled studies on cellular proliferation using different antibodies such as those for proliferating cell nuclear antigen and Ki-67 protein. These studies on cellular proliferation, as well as assessment of argyrophilic nucleolar organizing regions, have been shown to provide good prognostic significance. Flow cytometric studies on DNA ploidy and studies on expression of genes including the p53 gene, hormone receptors and others show less unanimous results in their prognostic significance. The influence of gender on survival is also reviewed. In conclusion, pathological and biological factors are useful and help to guide clinicians in the management of patients and in assessment of long-term prognosis.

The impact of the UK NHS purchaser–provider split on the `rational' introduction of new medical technologies

This article uses evidence from case studies of the introduction of three new medical technologies to explore the impact of the UK NHS purchaser–provider split on the diffusion of new medical technologies. A desirable policy objective is assumed to be the `rational' diffusion of medical technologies according to evidence that they are clinically and cost effective. Theoretical mechanisms are identified through which diffusion could be controlled, and the case studies are used to explore the extent to which rational technology diffusion occurs in practice in the NHS. They illustrate the influence of purchasers and providers on the introduction and early use of new technologies and explore the extent to which research about clinical and cost effectiveness is used to inform decisions about technology adoption. The results demonstrate the limited influence of purchasers and the short term clinical and organisational objectives pursued by providers in relation to technology adoption. It is suggested that initiatives to promote rational technology diffusion might be most effective if they are focused on decision making in providers, and if they aim to balance the influence on decisions of administrative and financial information about the technologies with more systematic use of research about clinical and cost effectiveness.

Application of Critical Pathways in the Introduction of New Medical Technology: The Intracoronary Stent as a Model

Application of Critical Pathways in the Introduction of New Medical Technology: The Intracoronary Stent as a Model

Application of critical pathways in the introduction of new medical technology: the intracoronary stent as a model

Application of critical pathways in the introduction of new medical technology: the intracoronary stent as a model