Creating an Infrastructure to Promote the Development and Commercialization of Class IV Medical Devices: Initiatives and Training Regulatory Scientists at Waseda University TWIns

2021 ◽  
Vol 91 (3) ◽  
pp. 303-309
Author(s):  
清隆 岩﨑
Author(s):  
Jan Persson ◽  
Lars Borgquist

An inventory of the availability of medical devices and laboratory tests at primary health care centers in Sweden is reported. The availability is shown to depend on a number of medical, economic, societal, and organizational factors describing primary health care. Technical performance of devices, risk management, and training of users need special attention with regard to these applications.


Author(s):  
Delma P. Thomas ◽  
Dianne E. Godar

Ultraviolet radiation (UVR) from all three waveband regions of the UV spectrum, UVA (320-400 nm), UVB (290-320 nm), and UVC (200-290 nm), can be emitted by some medical devices and consumer products. Sunlamps can expose the blood to a considerable amount of UVR, particularly UVA and/or UVB. The percent transmission of each waveband through the epidermis to the dermis, which contains blood, increases in the order of increasing wavelength: UVC (10%) < UVB (20%) < UVA (30%). To investigate the effects of UVR on white blood cells, we chose transmission electron microscopy to examine the ultrastructure changes in L5178Y-R murine lymphoma cells.


Author(s):  
B.D. Tall ◽  
K.S. George ◽  
R. T. Gray ◽  
H.N. Williams

Studies of bacterial behavior in many environments have shown that most organisms attach to surfaces, forming communities of microcolonies called biofilms. In contaminated medical devices, biofilms may serve both as reservoirs and as inocula for the initiation of infections. Recently, there has been much concern about the potential of dental units to transmit infections. Because the mechanisms of biofilm formation are ill-defined, we investigated the behavior and formation of a biofilm associated with tubing leading to the water syringe of a dental unit over a period of 1 month.


1965 ◽  
Vol 29 (4) ◽  
pp. 409-418
Author(s):  
WE Montague
Keyword(s):  

1999 ◽  
Vol 63 (3) ◽  
pp. 257-262 ◽  
Author(s):  
JJ Clarkson
Keyword(s):  

2019 ◽  
Vol 4 (5) ◽  
pp. 991-1016
Author(s):  
Shameka Stanford ◽  
Ovetta Harris

Purpose In 2011, the United Nations estimated there were between 180 and 220 million youth with disabilities living around the world, and 80% of them resided in developing countries. Over the last 6 years, this number has increased significantly, and now, over 1 million people live in the Caribbean with some form of disability such as communication disorders resulting in complex communication needs (CCN). Method This publication discusses the benefits of an exploratory, descriptive, nonexperimental study on augmentative and alternative communication (AAC) classroom integration training for 8 special educators in the Bahamas who work with children with CCN. Results The results of this study revealed that 100% of the participants reported the study to be effective in increasing their knowledge and skill in the area of implementing AAC into their classrooms, enhancing their ability to team teach and incorporate AAC opportunities for all students with CCN within their classrooms, and increasing their knowledge and skill overall in the areas of AAC and CCN. Conclusion The findings highlight an important area of potential professional development and training that can be replicated in other English-speaking Caribbean territories focused on AAC classroom integration training program for special educators who teach students with CCN.


2019 ◽  
Vol 28 (4) ◽  
pp. 993-1005 ◽  
Author(s):  
Gitte Keidser ◽  
Nicole Matthews ◽  
Elizabeth Convery

Purpose The aim of this study was to examine how hearing aid candidates perceive user-driven and app-controlled hearing aids and the effect these concepts have on traditional hearing health care delivery. Method Eleven adults (3 women, 8 men), recruited among 60 participants who had completed a research study evaluating an app-controlled, self-fitting hearing aid for 12 weeks, participated in a semistructured interview. Participants were over 55 years of age and had varied experience with hearing aids and smartphones. A template analysis was applied to data. Results Five themes emerged from the interviews: (a) prerequisites to the successful implementation of user-driven and app-controlled technologies, (b) benefits and advantages of user-driven and app-controlled technologies, (c) barriers to the acceptance and use of user-driven and app-controlled technologies, (d) beliefs that age is a significant factor in how well people will adopt new technology, and (e) consequences that flow from the adoption of user-driven and app-controlled technologies. Specifically, suggested benefits of the technology included fostering empowerment and providing cheaper and more discrete options, while challenges included lack of technological self-efficacy among older adults. Training and support were emphasized as necessary for successful adaptation and were suggested to be a focus of audiologic services in the future. Conclusion User perceptions of user-driven and app-controlled hearing technologies challenge the audiologic profession to provide adequate support and training for use of the technology and manufacturers to make the technology more accessible to older people.


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