A Roundtable Discussion: Home Healthcare—Not A Hospital in the Home

2013 ◽  
Vol 47 (s1) ◽  
pp. 10-15 ◽  
Author(s):  
Mary K. Logan
Keyword(s):  
Medical Devices ◽  
The United States ◽  
Home Healthcare ◽  
Continuing Care ◽  
Draft Guidance ◽  
Clinical Environment ◽  
Roundtable Discussion ◽  
Design Considerations ◽  
Radiological Health ◽  
Effective Use

Home healthcare is vital for a large percentage of the population. According to data from the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC), 7 million people in the United States receive home healthcare annually. The use of medical devices in the home and other nonclinical environments is increasing dramatically. By the year 2050, an estimated 27 million people will need continuing care in the home or in the community and not in a controlled clinical environment.1 The FDA recently announced its Home Use Devices Initiative and issued the document, “Draft Guidance for Industry and FDA Staff—Design Considerations for Devices Intended for Home Use” on Dec. 12, 2012.2 The Center for Devices and Radiological Health (CDRH) regulates medical devices, but that regulatory authority alone is not enough to ensure safe and effective use of devices in the home. To address these and other issues, AAMI and FDA will co-host a summit on healthcare technology in nonclinical settings Oct. 9–10, 2013.

scholarly journals Making the invisible visible: New perspectives on the intersection of human-environment interactions of clinical teams in intensive care

2021 ◽  
Author(s):  
Sheena Visram ◽  
Laura Potts ◽  
Neil J Sebire ◽  
Yvonne Rogers ◽  
Emma Broughton ◽  
...  
Keyword(s):  
Intensive Care ◽  
Medical Devices ◽  
New Technologies ◽  
Clinical Team ◽  
Clinical Environment ◽  
Healthcare Staff ◽  
Human Environment ◽  
New Approach ◽  
Design Considerations ◽  
New Interactions

Understanding human behaviour is essential to the adoption practices for new technologies that promote safer care. This requires capturing the detail of clinical workflows to inform the design of new interactions including those with touchless technologies that decipher human-speech, gesture and motion and allow for interactions that are free of contact. Many environments in hospitals are sub-optimally designed, with a poor layout of work surfaces, cumbersome equipment that requires space and effort to manoeuvre, designs that require healthcare staff to reach awkwardly and medical devices that require extensive touch. This suggests there is a need to better understand how they can be designed. Here, we employ a new approach by installing a single 360 degree camera into a clinical environment to analyse touch patterns and human-environment interactions across a clinical team to recommend design considerations for new technologies with potential to reduce avoidable touch.

Use of QSAR Modeling to Predict the Carcinogenicity of Color Additives

2013 ◽  
Author(s):  
Ronald Brown ◽  
Shannon White ◽  
Jennifer Goode ◽  
Prachi Pradeep ◽  
Stephen Merrill
Keyword(s):  
Medical Devices ◽  
Safety Evaluation ◽  
Toxicity Testing ◽  
Quantitative Structure Activity Relationship ◽  
Draft Guidance ◽  
Qsar Modeling ◽  
Wide Range ◽  
Qsar Models ◽  
Us Fda ◽  
Radiological Health

Patients may be exposed to potentially carcinogenic color additives released from polymers used to manufacture medical devices; therefore, the need exists to adequately assess the safety of these compounds. The US FDA Center for Devices and Radiological Health (CDRH) recently issued draft guidance that, when final, will include FDA’s recommendations for the safety evaluation of color additives and other potentially toxic chemical entities that may be released from device materials. Specifically, the draft guidance outlines an approach that calls for evaluating the potential for the color additive to be released from the device in concert with available toxicity information about the additive to determine what types of toxicity information, if any, are necessary. However, when toxicity data are not available from the literature for the compounds of interest, a scientific rationale can sometimes be provided for omission of these tests. Although the FDA has issued draft guidance on this topic, the Agency continues to explore alternative approaches to understand when additional toxicity testing is needed to assure the safety of medical devices that contain color additives. An emerging approach that may be useful for determining the need for further testing of compounds released from device materials is Quantitative Structure Activity Relationship (QSAR) modeling. In this paper, we have shown how three publically available QSAR models (OpenTox/Lazar, Toxtree, and the OECD Toolbox) are able to successfully predict the carcinogenic potential of a set of color additives with a wide range of structures. As a result, this computational modeling approach may serve as a useful tool for determining the need to conduct carcinogenicity testing of color additives intended for use in medical devices.

scholarly journals DONATED HUMAN TISSUE: IS IT A MEDICAL DEVICE OR JUST TISSUE?

Obiter ◽  
2016 ◽  
Vol 37 (3) ◽  
Author(s):  
M Slabbert
Keyword(s):  
Medical Devices ◽  
United States Of America ◽  
Human Tissue ◽  
Tissue Bank ◽  
The United States ◽  
Tissue Banks ◽  
Draft Guidance ◽  
Related Substances ◽  
Legislative Framework ◽  
National Health Act

Donated human tissue can be used in various ways. Bone and skin received by an authorised Tissue Bank are preserved and processed in order to be used in transplantations later. The question arises whether these products derived from human tissue stays just human tissue or do they become medical devices. The importance of this distinction is mainly to determine which legislative framework applies. Neither the National Health Act nor the Medicines and Related Substances Act give guidance on how to classify products as medical devices or human tissue. A Draft Guidance from the United States of America is analysed as well as a Directive from the European Communities. It is recommended that South Africa should change its current laws to give clarity to Tissue Banks.

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

scholarly journals Towards a conceptual model for the use of home healthcare medical devices: The multi-parameter monitor case

PLoS ONE ◽  
2018 ◽  
Vol 13 (12) ◽  
pp. e0208723
Author(s):  
Pablo Reyes ◽  
Dominique Larée ◽  
Alejandro Weinstein ◽  
Álvaro Jara
Keyword(s):  
Conceptual Model ◽  
Medical Devices ◽  
Home Healthcare

The Conundrum of Reform: A Comparative Analysis

1988 ◽  
Vol 8 (3) ◽  
pp. 3-16 ◽  
Author(s):  
Patricia W. Ingraham ◽  
B. Guy Peters
Keyword(s):  
Cultural Differences ◽  
Policy Design ◽  
The United States ◽  
Civil Service Reform ◽  
Political Processes ◽  
Design Considerations ◽  
The United Kingdom ◽  
Procedural Reform ◽  
The Relationship ◽  
Cross National

Despite obvious cross-national political and cultural differences, civil service reform policies exhibit strong similarities. An examination of reform efforts in the United States, the United Kingdom and Australia emphasizes the centrality of politics and political processes to administrative reform. This is true for mechanical or procedural reform, structural reform and what we termed “relational reforms,” or, reforms aimed at restructuring the relationship between politicians and career civil servants. The overriding influence of politics reduces policy design considerations and often results in solutions that do not match the problems being addressed. The outcomes are new bureaucratic problems and the need for additional reforms.

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