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Developmental Medicine and Child... Apr 2015The aim of this study was to critically synthesize qualitative evidence regarding the child and family experience of power mobility, and to examine how this evidence... (Review)
Review
AIM
The aim of this study was to critically synthesize qualitative evidence regarding the child and family experience of power mobility, and to examine how this evidence fits with current theoretical concepts.
METHOD
Electronic database/hand searches were undertaken in September 2012 and updated in February 2014. The searches were restricted to qualitative studies published in English before February 2014 that included at least one child under the age of 19 with a disability and described an outcome related to the use of power mobility. Inclusion criteria were set a priori. Two reviewers independently screened titles, abstracts, and full-text articles and extracted data. McMaster qualitative review forms were used for quality appraisal.
RESULTS
Of 259 titles, 21 met inclusion criteria. From 143 codes, 15 second-order themes were developed using constant comparison and analysis. Three overarching themes emerged: power mobility experience promotes developmental change and independent mobility; power mobility enhances social relationships and engagement in meaningful life experiences; and power mobility access and use is influenced by factors in the physical, social, and attitudinal environment.
INTERPRETATION
This qualitative research provides rich and rigorous evidence supporting the benefits of power mobility for children and families. Numerous factors, which warrant careful consideration, influence power mobility access and use.
Topics: Child; Disabled Children; Electrical Equipment and Supplies; Family; Humans; Mobility Limitation; Wheelchairs
PubMed: 25403793
DOI: 10.1111/dmcn.12633 -
Archives of Physical Medicine and... Jun 2018To assess rehabilitation infrastructure in Peru in terms of the World Health Organization (WHO) health systems building blocks.
OBJECTIVE
To assess rehabilitation infrastructure in Peru in terms of the World Health Organization (WHO) health systems building blocks.
DESIGN
Anonymous quantitative survey; questions were based on the WHO's Guidelines for Essential Trauma Care and rehabilitation professionals' input.
SETTING
Large public hospitals and referral centers and an online survey platform.
PARTICIPANTS
Convenience sample of hospital personnel working in rehabilitation and neurology (N=239), recruited through existing contacts and professional societies.
INTERVENTIONS
Not applicable.
MAIN OUTCOME MEASURES
Outcome measures were for 4 WHO domains: health workforce, health service delivery, essential medical products and technologies, and health information systems.
RESULTS
Regarding the domain of health workforce, 47% of physical therapists, 50% of occupational therapists, and 22% of physiatrists never see inpatients. Few reported rehabilitative nurses (15%) or prosthetist/orthotists (14%) at their hospitals. Even at the largest hospitals, most reported ≤3 occupational therapists (54%) and speech-language pathologists (70%). At hospitals without speech-language pathologists, physical therapists (49%) or nobody (34%) perform speech-language pathology roles. At hospitals without occupational therapists, physical therapists most commonly (59%) perform occupational therapy tasks. Alternate prosthetist/orthotist task performers are occupational therapists (26%), physical therapists (19%), and physicians (16%). Forty-four percent reported interdisciplinary collaboration. Regarding the domain of health services, the most frequent inpatient and outpatient rehabilitation barriers were referral delays (50%) and distance/transportation (39%), respectively. Regarding the domain of health information systems, 28% reported rehabilitation service data collection. Regarding the domain of essential medical products and technologies, electrophysical agents (88%), gyms (81%), and electromyography (76%) were most common; thickened liquids (19%), swallow studies (24%), and cognitive training tools (28%) were least frequent.
CONCLUSIONS
Rehabilitation emphasis is on outpatient services, and there are comparatively adequate numbers of physical therapists and physiatrists relative to rehabilitation personnel. Financial barriers seem low for accessing existing services. There appear to be shortages of inpatient rehabilitation, specialized services, and interdisciplinary collaboration. These may be addressed by redistributing personnel and investing in education and equipment for specialized services. Further examination of task sharing's role in Peru's rehabilitation services is necessary to evaluate its potential to address deficiencies.
Topics: Allied Health Personnel; Delivery of Health Care; Equipment and Supplies; Health Information Systems; Health Workforce; Humans; Inpatients; Outpatients; Peru; Quality of Health Care; Rehabilitation; World Health Organization
PubMed: 29162468
DOI: 10.1016/j.apmr.2017.10.020 -
Annales de Biologie Clinique Apr 2017
Topics: Calibration; Equipment and Supplies; France; Humans; Medical Device Legislation; Product Surveillance, Postmarketing
PubMed: 28377325
DOI: 10.1684/abc.2017.1231 -
Advanced Drug Delivery Reviews Mar 2017Blood contact with biomaterials triggers activation of multiple reactive mechanisms that can impair the performance of implantable medical devices and potentially cause... (Review)
Review
Blood contact with biomaterials triggers activation of multiple reactive mechanisms that can impair the performance of implantable medical devices and potentially cause serious adverse clinical events. This includes thrombosis and thromboembolic complications due to activation of platelets and the coagulation cascade, activation of the complement system, and inflammation. Numerous surface coatings have been developed to improve blood compatibility of biomaterials. For more than thirty years, the anticoagulant drug heparin has been employed as a covalently immobilized surface coating on a variety of medical devices. This review describes the fundamental principles of non-eluting heparin coatings, mechanisms of action, and clinical applications with focus on those technologies which have been commercialized. Because of its extensive publication history, there is emphasis on the CARMEDA BioActive Surface (CBAS Heparin Surface), a widely used commercialized technology for the covalent bonding of heparin.
Topics: Animals; Anticoagulants; Biocompatible Materials; Blood Coagulation; Equipment and Supplies; Heparin; Humans
PubMed: 28042080
DOI: 10.1016/j.addr.2016.12.002 -
Value in Health Regional Issues May 2019Most of the industrial sectors of India have undergone major changes in the post-liberalization period. During this period, India has become self-reliant in drugs;...
Most of the industrial sectors of India have undergone major changes in the post-liberalization period. During this period, India has become self-reliant in drugs; however, still, 75% of the medical devices are imported in India. According to WHO, almost all devices present in the developing countries have been designed for use in the industrialized countries. With the increase in incidence of non-communicable diseases and decrease in communicable diseases; increase in survival rates and decrease in mortality rates, and increase in ageing population, the healthcare demands have changed in the last decade. In addition to these parameters, aware patients and healthcare professionals, requirement of achieving national targets of healthcare and close proximity to the developed world, is giving a push to the development of indigenous medical device industry. However, the rules and regulations governing medical devices are ambiguous and vague. The Health Ministry of India has notified Medical Devices Rules, 2016, for regulating manufacturing/import/sale/clinical investigation and other related matters concerning medical devices. In addition, the government is funding the start-up industries in medical devices sector. Furthermore, government has taken the initiative of inverted duty structure in India. Also, special med tech zones are being set-up, which will enhance the production at local levels for the local population and will also generate employment for local people.
Topics: Developing Countries; Equipment and Supplies; Humans; India; Industrial Development
PubMed: 30412914
DOI: 10.1016/j.vhri.2018.06.004 -
Annales de Biologie Clinique Oct 2019In order to achieve regulatory compliance and acquire authorisation for sale in Europe, each medical device must be supported by a clinical evaluation report (CER) which... (Review)
Review
In order to achieve regulatory compliance and acquire authorisation for sale in Europe, each medical device must be supported by a clinical evaluation report (CER) which documents the clinical evaluation process in its entirety. This is not a new requirement but highly publicised scandals caused by defective medical devices increased scrutiny of notified bodies (the organisations designated by the European Union to evaluate medical device compliance) meaning they are more liable and must strengthen their inspections of medical device manufacturers. Manufacturers are already under increased pressure due to the new EU Medical device regulation published in 2017. The scope of the new regulation requires many manufacturers to evaluate the documentation for their whole product portfolio. CERs are an important part of regulatory compliance and are also one of the biggest challenges for manufacturers who do not have sufficient resources and do not dedicate enough time to this task. This article examines the background of this requirement while offering medical device manufacturers advice for successful clinical evaluation reports.
Topics: Documentation; Equipment Safety; Equipment and Supplies; European Union; Guideline Adherence; Humans; Manufacturing Industry; Medical Device Legislation; Patient Safety
PubMed: 31466939
DOI: 10.1684/abc.2019.1473 -
Yakugaku Zasshi : Journal of the... 2016In this presentation, as a member of the Harmonization by Doing (HBD) project, I discuss the significance of regulatory science in global medical device development and... (Review)
Review
In this presentation, as a member of the Harmonization by Doing (HBD) project, I discuss the significance of regulatory science in global medical device development and our experience in the international collaboration process for medical devices. In Japan, most innovative medical therapeutic devices were previously developed and exported by foreign-based companies. Due to this device lag, Japanese had minimal opportunities for receiving treatment with innovative medical devices. To address this issue, the Japanese government has actively accepted foreign clinical trial results and promoted global clinical trials in projects such as HBD. HBD is a project with stakeholders from academia, regulatory authorities, and industry in the US and Japan to promote global clinical trials and reduce device lags. When the project started, medical device clinical trials were not actively conducted in Japan at not just hospitals but also at medical device companies. We started to identify issues under the concept of HBD. After 10 years, we have now become key members in global clinical trials and able to obtain approvals without delay. Recently, HBD has started promoting international convergence. Physicians and regulatory authorities play central roles in compiling guidelines for the clinical evaluation of medical device development, which will be a more active field in the near future. The guidelines compiled will be confirmed with members of academia and regulatory authorities in the United Sates.
Topics: Clinical Trials as Topic; Device Approval; Equipment Design; Equipment Safety; Equipment and Supplies; Guidelines as Topic; Internationality; Japan; United States
PubMed: 27040333
DOI: 10.1248/yakushi.15-00224-1 -
The Journal of Clinical Endocrinology... Oct 2020Burgeoning evidence over the last 25 years has identified myriad synthetic chemicals with the capacity to alter various aspects of hormone synthesis and action. These...
Burgeoning evidence over the last 25 years has identified myriad synthetic chemicals with the capacity to alter various aspects of hormone synthesis and action. These endocrine-disrupting chemicals (EDCs) have been linked to various diseases, including reproductive disorders, metabolic diseases, and developmental abnormalities, among others. Exposure to EDCs arises from industrial activity, use of personal and home care products, and consumption of contaminated food and water; however, the role of healthcare in exposing individuals to EDCs is grossly underappreciated. Indeed, through the use of medications as well as medical equipment and devices, healthcare providers are unknowing mediators of exposure to EDCs, chemicals that might not only promote disease but that may also antagonize the efficacy of treatments. The ethical implications of provider-dependent exposure are profound. A failure to disclose the endocrine-disrupting properties of medical interventions violates core principles of nonmaleficence, patient autonomy, and justice as well as the practice of informed consent. Furthermore, physicians' lack of knowledge regarding EDCs in medical practice artificially skews risk-benefit calculations that are fundamental to informed medical decision-making. To combat this underappreciated ethical challenge, urgent action is required. Healthcare providers must be educated about endocrine disruption. Known EDCs, defined by endocrinologists, should be clearly labeled on all medical products, and all medication components and devices should be screened for endocrine-disrupting properties. Finally, communication strategies must be devised to empower patients with knowledge about these risks. Providing ethically competent care requires an open acknowledgment of endocrine risks imposed by the medical community that have heretofore been ignored.
Topics: Drug Labeling; Endocrine Disruptors; Endocrine System; Environmental Exposure; Equipment and Supplies; Humans; Iatrogenic Disease; Informed Consent; Patient Care; Pharmaceutical Preparations; Truth Disclosure
PubMed: 32614432
DOI: 10.1210/clinem/dgaa358 -
BMJ Open Jun 2024The development of paediatric medical devices continues to lag adult medical devices and contributes to issues of inequity, safety, quality and patient outcomes. New...
INTRODUCTION
The development of paediatric medical devices continues to lag adult medical devices and contributes to issues of inequity, safety, quality and patient outcomes. New legislation and funding mechanisms have been introduced over the past two decades, but the gap remains. Clinical trials have been identified as a pain point, but components of effective clinical research infrastructure are poorly understood. As part of a multimodal research strategy, the Pediatric Device Consortia (PDC) will conduct a scoping review to better understand infrastructural barriers to and facilitators of paediatric medical device clinical research identified in the health sciences literature.
METHODS AND ANALYSIS
The following databases will be included for this review: Medline, Embase, Cochrane CENTRAL, Web of Science and IEEE Xplore. Additional grey literature will be sought out through Google Scholar and reviewing the citations of included studies. Included studies will discuss medical devices according to the U.S. Food and Drug Administration classification, focus on the paediatric population (ages 0-21 years) and involve human premarket or postmarket research. All study types that were published in 2007-present in English, Spanish, French or Italian will be included. Using Covidence web-based software, two independent reviewers will screen the resulting titles, abstracts and the full text of potential studies. Conflicts will be resolved by the primary investigator during both phases. REDCap will be used for quantitative and qualitative data charting, generating data tables and narrative synthesis.
ETHICS AND DISSEMINATION
This research did not require research ethics board consideration as it does not involve human participants and all data will be collected from published literature. We will share our findings through peer-reviewed manuscripts, clinical and research conference presentations and professional networks available to the PDC.
STUDY REGISTRATION
Open Science Framework (https://osf.io/k72bn).
Topics: Humans; Child; Equipment and Supplies; Pediatrics; Research Design; Adolescent; Inventions; Review Literature as Topic
PubMed: 38839390
DOI: 10.1136/bmjopen-2023-081541 -
Trials Sep 2017Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal... (Review)
Review
BACKGROUND
Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. The medical device industry argues that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the barriers for randomised clinical trials on medical devices.
METHODS
Systematic literature searches without meta-analysis and internal European Clinical Research Infrastructure Network (ECRIN) communications taking place during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project.
RESULTS
In addition to the barriers that exist for all trials, we identified three major barriers for randomised clinical trials on medical devices, namely: (1) randomisation, including timing of assessment, acceptability, blinding, choice of the comparator group and considerations on the learning curve; (2) difficulties in determining appropriate outcomes; and (3) the lack of scientific advice, regulations and transparency.
CONCLUSIONS
The present review offers potential solutions to break down the barriers identified, and argues for applying the randomised clinical trial design when assessing the benefits and harms of medical devices.
Topics: Endpoint Determination; Equipment and Supplies; Humans; Randomized Controlled Trials as Topic; Research Design; Risk Assessment; Time Factors; Treatment Outcome
PubMed: 28903769
DOI: 10.1186/s13063-017-2168-0