scholarly journals The ethics of explantation

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sven Ove Hansson
Keyword(s):  
Clinical Trial ◽  
Quality Assurance ◽  
Medical Devices ◽  
Ethical Issues ◽  
Body Parts ◽  
Medical Implants ◽  
Ethical Problems ◽  
Manufacturing Defects ◽  
Wide Range ◽  
Implanted Medical Devices

Abstract Background With the increased use of implanted medical devices follows a large number of explantations. Implants are removed for a wide range of reasons, including manufacturing defects, recovery making the device unnecessary, battery depletion, availability of new and better models, and patients asking for a removal. Explantation gives rise to a wide range of ethical issues, but the discussion of these problems is scattered over many clinical disciplines. Methods Information from multiple clinical disciplines was synthesized and analysed in order to provide a comprehensive approach to the ethical issues involved in the explantation of medical implants. Results Discussions and recommendations are offered on pre-implantation information about a possible future explantation, risk–benefit assessments of explantation, elective explantations demanded by the patient, explantation of implants inserted for a clinical trial, patient registers, quality assurance, routines for investigating explanted implants, and demands on manufacturers to prioritize increased service time in battery-driven implants and to market fewer but more thoroughly tested models of implants. Conclusion Special emphasis is given to the issue of control or ownership over implants, which underlies many of the ethical problems concerning explantation. It is proposed that just like transplants, implants that fulfil functions normally carried out by biological organs should be counted as supplemented body parts. This means that the patient has a strong and inalienable right to the implant, but upon explantation it loses that status.

scholarly journals Systemic toxicity of metal ions release from specific types of implanted medical devices: Systemic review of clinical studies

2021 ◽  
Vol 12 (2) ◽  
pp. 401-415
Author(s):  
Henryk Matusiewicz ◽  
Magdalena Richter
Keyword(s):  
Metal Ions ◽  
Medical Devices ◽  
Metal Ion ◽  
Systemic Toxicity ◽  
Systemic Review ◽  
Medical Implants ◽  
Ion Release ◽  
Wear And Corrosion ◽  
Metal Ion Release ◽  
Implanted Medical Devices

There is public concern over the long term systemic health effects of metal released from implanted medical devices that use metal alloys. Systemic toxic side effects have been associated with excessive metal ion release from implants into human biological specimen's circulation, in which cobalt and chromium plays an important role. Cobalt intoxication has become more frequent due to the wide use of metallic medical implants. Despite the technological improvements in replacement metallic medical implants, wear and corrosion products associated with the metal compounds of these implants may result in systemic reactions and toxicities. The current review encompasses a literature of the systemic toxicity studies concerning the effect of metallic wear debris released from wear and corrosion of specific types of implanted medical devices, resulting in a postoperative increase in metal ion levels in bodily fluids and at different organ sites. Release of metallic debris is mainly in the form of particles and ions of different valences, and oxides composed of cobalt and chromium. Toxicological, clinically significant, data regarding "potential hazards" of circulating metals after systemic chronic exposure to the metal ions from metals have been included. This review further highlights some of the clinical features of cobalt toxicity.

Ethical Problems in Cartography: A Roundtable Commentary

1990 ◽  
pp. 3-13 ◽  
Author(s):  
Patrick McHaffie ◽  
Sona Karentz Andrews ◽  
Michael Dobson ◽  
Anonymous Anonymous
Keyword(s):  
Quality Assurance ◽  
Product Quality ◽  
Ethical Issues ◽  
Conflicts Of Interest ◽  
Copyright Law ◽  
Ethical Conduct ◽  
Ethical Problems ◽  
Ethical Discourse

The problem of defining and actualizing standards of ethical conduct troubles many professions, including cartography. In an attempt to formalize the ethical discourse in cartography the editors of Cartographic Perspectives invited five contributors to discuss what they perceive as important ethical problems in the discipline. The contributors were selected from the three major sectors of the cartographic enterprise: commercial mapping organizations, government mapping agencies, and university geography departments offering cartography programs. The contributors identify personal and institutional vigilance in product quality assurance, map plagiarism through violation of copyright law, and conflicts of interest as important ethical issues. The commentary concludes by questioning the nature and validity of cartography's claim to truth ("accuracy"), and asserts that cartographic ethics cannot be extricated from the values of the larger society which commissions the production of cartographic information.

Nanoscale Forces at the Heart of Staphylococcus Infections

2007 ◽  
Vol 1025 ◽  
Author(s):  
Ruchirej Yongsunthon ◽  
Francis Paul Vellano ◽  
Brian H. Lower ◽  
Vance G. Fowler ◽  
Emily Alexander ◽  
...  
Keyword(s):  
Medical Devices ◽  
Nanometer Scale ◽  
Medical Implants ◽  
Force Microscopy ◽  
Binding Force ◽  
Healthy Humans ◽  
Atomic Force ◽  
Implanted Medical Devices ◽  
Staphylococcus Infections ◽  
Binding Forces

AbstractStaphylococcus aureus is one of the most frequently isolated bacteria from infected medical implants. S. aureus has the capacity to adhere to the surface of an implant where it forms a biofilm. We used atomic force microscopy to probe binding forces between a fibronectin-coated tip and isolates of S. aureus, which were obtained from either patients with infected prostheses or healthy humans. A unique force-signature was observed for binding events between the tip and the cells. There is a strong distinction (p=0.01) in the binding force-signature observed for S. aureus isolated from the infected vs. healthy populations. This observation suggests a fundamental correlation between nanometer scale binding forces and the clinical outcome of patients with implanted medical devices.

How Scientists Communicate

2020 ◽  
Author(s):  
Alan Kelly
Keyword(s):  
Ethical Issues ◽  
Scientific Communication ◽  
Scientific Publication ◽  
Good Communication ◽  
Wide Range ◽  
Conference Presentations ◽  
Scientific Papers ◽  
History Of ◽  
The Media ◽  
Broad Overview

What is scientific research? It is the process by which we learn about the world. For this research to have an impact, and positively contribute to society, it needs to be communicated to those who need to understand its outcomes and significance for them. Any piece of research is not complete until it has been recorded and passed on to those who need to know about it. So, good communication skills are a key attribute for researchers, and scientists today need to be able to communicate through a wide range of media, from formal scientific papers to presentations and social media, and to a range of audiences, from expert peers to stakeholders to the general public. In this book, the goals and nature of scientific communication are explored, from the history of scientific publication; through the stages of how papers are written, evaluated, and published; to what happens after publication, using examples from landmark historical papers. In addition, ethical issues relating to publication, and the damage caused by cases of fabrication and falsification, are explored. Other forms of scientific communication such as conference presentations are also considered, with a particular focus on presenting and writing for nonspecialist audiences, the media, and other stakeholders. Overall, this book provides a broad overview of the whole range of scientific communication and should be of interest to researchers and also those more broadly interested in the process how what scientists do every day translates into outcomes that contribute to society.

An Overview of Ethics and Environmental Health

2019 ◽  
pp. 697-703
Author(s):  
David B. Resnik
Keyword(s):  
Public Health ◽  
Environmental Health ◽  
Environmental Ethics ◽  
Ethical Issues ◽  
Biomedical Ethics ◽  
Public Health Ethics ◽  
Social Utility ◽  
Toxic Substances ◽  
Health Ethics ◽  
Wide Range

This chapter provides an overview of the ethics of environmental health, and it introduces five chapters in the related section of The Oxford Handbook of Public Health Ethics. A wide range of ethical issues arises in managing the relationship between human health and the environment, including regulation of toxic substances, air and water pollution, waste management, agriculture, the built environment, occupational health, energy production and use, environmental justice, population control, and climate change. The values at stake in environmental health ethics include those usually mentioned in ethical debates in biomedicine and public health, such as autonomy, social utility, and justice, as well as values that address environmental concerns, such as animal welfare, stewardship of biological resources, and sustainability. Environmental health ethics, therefore, stands at the crossroads of several disciplines, including public health ethics, environmental ethics, biomedical ethics, and business ethics.

Ethical Issues in Clinical Psychology

2010 ◽  
pp. 183-210
Author(s):  
Kenneth S. Pope
Keyword(s):  
Clinical Psychology ◽  
Ethical Decision ◽  
Ethical Decision Making ◽  
Ethical Issues ◽  
American Psychological Association ◽  
Future Research ◽  
Ethical Problems ◽  
Basic Assumptions ◽  
Ethics Code ◽  
Canadian Psychological Association

This chapter examines how ethical issues are approached differently by two prominent psychological associations, how they are encountered by psychologists, the formal complaints they give rise to, and how they can be approached systematically to avoid missteps. Included are basic assumptions about ethics; the unique approaches to developing a ethics code taken by the American Psychological Association (APA) and the Canadian Psychological Association (CPA), and what each of these two codes provides; empirical data about what ethical problems psychologists encounter and what formal complaints they face; four major sets of ethical issues that are particularly complex and challenging (confidentiality, informed consent, competence, and boundaries); an area of major controversy (clinical psychology and national security); steps in ethical decision-making; and four possible lines of future research.

scholarly journals In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aldo Badano
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Devices ◽  
In Silico ◽  
Lessons Learned ◽  
Patient Access ◽  
High Quality ◽  
Virtual Imaging ◽  
Regulatory Evaluation

AbstractImaging clinical trials can be burdensome and often delay patient access to novel, high-quality medical devices. Tools for in silico imaging trials have significantly improved in sophistication and availability. Here, I describe some of the principal advantages of in silico imaging trials and enumerate five lessons learned during the design and execution of the first all-in silico virtual imaging clinical trial for regulatory evaluation (the VICTRE study).

scholarly journals Clinical Perspectives and Trends: Microperimetry as a trial endpoint in retinal disease

2021 ◽  
Author(s):  
Yesa Yang ◽  
Hannah Dunbar
Keyword(s):  
Clinical Trial ◽  
Retinal Disease ◽  
Age Related Macular Degeneration ◽  
Gene Therapies ◽  
Age Related ◽  
Wide Range ◽  
Trial Endpoints ◽  
Visual Acuity Loss ◽  
Psychophysical Test ◽  
Trial Endpoint

Endpoint development trials are underway across the spectrum of retinal disease. New validated endpoints are urgently required for the assessment of emerging gene therapies and in preparation for the arrival of novel therapeutics targeting early stages of common sight-threatening conditions such as age-related macular degeneration. Visual function measures are likely to be key candidates in this search. Over the last two decades, microperimetry has been used extensively to characterize functional vision in a wide range of retinal conditions, detecting subtle defects in retinal sensitivity that precede visual acuity loss and tracking disease progression over relatively short periods. Given these appealing features, microperimetry has already been adopted as an endpoint in interventional studies, including multicenter trials, on a modest scale. A review of its use to date shows a concurrent lack of consensus in test strategy and a wealth of innovative disease and treatment-specific metrics which may show promise as clinical trial endpoints. There are practical issues to consider, but these have not held back its popularity and it remains a widely used psychophysical test in research. Endpoint development trials will undoubtedly be key in understanding the validity of microperimetry as a clinical trial endpoint, but existing signs are promising.

scholarly journals Emory Roybal Center for Dementia Caregiving Mastery: Diverse Responses to Letter of Intent Call

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 254-254
Author(s):  
Kenneth Hepburn ◽  
Molly Perkins ◽  
Drenna Waldrop ◽  
Leila Aflatoony ◽  
Mi-Kyung Song ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lewy Body Dementia ◽  
Racial Groups ◽  
Dementia Caregiving ◽  
Wide Range ◽  
Great Heterogeneity ◽  
New Research ◽  
Stage 1 ◽  
Native Alaskan ◽  
Physical Care

Abstract This new NIA-supported Roybal Center seeks to support Stage 1 pilot clinical trials of programs aimed at promoting caregiving competence and confidence in the great heterogeneity of dementia caregiving contexts. During our first cycle, we received 26 letters of intent (LOI) for full applications. Responses reaffirmed the Center’s premise that dementia caregiving is remarkably varied in nature. While most proposed programs focused on generic caregiving, a number addressed caregiving issues facing specific ethnic/racial groups (African American; Korean American; Native Alaskan/American Indian; Latino), and several focused on specific dementing conditions (MCI, Lewy Body Dementia,TBI-based dementia). Most described programs centered on knowledge development and daily management skill issues (e.g., management of behaviors); others specified development of physical care skills. Decision-making and communication constituted the second most common topic. Over 40% proposed adaptation of existing programs; more than 25% proposed apps or technology interventions. Investigators represented a wide range of disciplines: 45% each from Health sciences (nursing, medicine, and social work) and Social/Behavioral sciences (principally psychology) and the rest from engineering and communications. LOIs varied most in their readiness to complete a clinical trial within a year. About 40% were in very preliminary stages; 25% were clearly poised for a Stage 1 trial; 15% did not sufficiently address the Center’s aims. Key criteria for invitations to submit full applications (n=4) included: specificity of context; clinical trial readiness; reasonableness of proposed adaptation. These criteria should guide future LOIs addressing the diversity of important new research and intervention perspectives on the multifaceted work of caregiving.

The Application of Multicriteria Decision Analysis Methods in Health Care: A Literature Review

2021 ◽  
pp. 0272989X2110190
Author(s):  
Ilyas Khan ◽  
Liliane Pintelon ◽  
Harry Martin
Keyword(s):  
Health Care ◽  
Decision Making ◽  
Decision Analysis ◽  
Medical Devices ◽  
Hybrid Methods ◽  
Multicriteria Decision Analysis ◽  
Multicriteria Decision ◽  
Health Care Decision ◽  
Wide Range ◽  
Care Decision

Objectives The main objectives of this article are 2-fold. First, we explore the application of multicriteria decision analysis (MCDA) methods in different areas of health care, particularly the adoption of various MCDA methods across health care decision making problems. Second, we report on the publication trends on the application of MCDA methods in health care. Method PubMed was searched for literature from 1960 to 2019 in the English language. A wide range of keywords was used to retrieve relevant studies. The literature search was performed in September 2019. Articles were included only if they have reported an MCDA case in health care. Results and Conclusion The search yielded 8,318 abstracts, of which 158 fulfilled the inclusion criteria and were considered for further analysis. Hybrid methods are the most widely used methods in health care decision making problems. When it comes to single methods, analytic hierarchy process (AHP) is the most widely used method followed by TOPSIS (technique for order preference by similarity to ideal solution), multiattribute utility theory, goal programming, EVIDEM (evidence and value: impact on decision making), evidential reasoning, discrete choice experiment, and so on. Interestingly, the usage of hybrid methods has been high in recent years. AHP is most widely applied in screening and diagnosing and followed by treatment, medical devices, resource allocation, and so on. Furthermore, treatment, screening and diagnosing, medical devices, and drug development and assessment got more attention in the MCDA context. It is indicated that the application of MCDA methods to health care decision making problem is determined by the nature and complexity of the health care problem. However, guidelines and tools exist that assist in the selection of an MCDA method.

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