Chapter 18—Evaluating Medical Devices for the Clinical Environment

2009 ◽  
pp. 178-178-3
Author(s):  
RJ Jones
Keyword(s):  
Medical Devices ◽  
Clinical Environment

scholarly journals A Component Based Framework to Enable Medical Devices Communication

2021 ◽  
Vol 26 (3) ◽  
pp. 295-302
Author(s):  
Imad Eddine Touahria ◽  
Abdallah Khababa
Keyword(s):  
Medical Devices ◽  
Improve Patient Safety ◽  
Data Communication ◽  
Modern Medicine ◽  
Medical Applications ◽  
Clinical Environment ◽  
Major Goal ◽  
Software Applications ◽  
Standard Interface ◽  
Improve Patient

The interconnection of medical devices is emerging as a new requirement in modern medicine. The final goal of connecting heterogeneous medical devices in a wider network of computational servers is to monitor and improve patient safety, where it also constitutes a major goal in the Integrated Clinical Environment (ICE) framework. The heterogeneity of medical devices provided by different suppliers is a key challenge in ICE-based systems, where interoperability and data communication across devices is still under study and specification. ICE aims to create a standard interface that covers medical devices heterogeneity, hence, achieving interoperability in a safe way. It focuses on defining an interoperable bus between the patient, medical devices, software applications, and the clinician. Given the lack of realization of ICE standard, this paper presents a component-based framework for making ICE usable for medical applications. This work illustrates the component model in detail and validates it with a prototype implementation that focuses on the integration of heterogeneous medical devices as the most relevant requirements faced by ICE.

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.

Application of the IEC80001 standard towards integration of a real time alarm communication and management system

2015 ◽  
Vol 27 (4) ◽  
pp. 397-411 ◽  
Author(s):  
Kyle Eckhardt ◽  
Andrew Hayes ◽  
Michael Hamilton ◽  
Tidimogo Gaamangwe
Keyword(s):  
Risk Management ◽  
Medical Devices ◽  
Care Home ◽  
Clinical Environment ◽  
Clinical Workflow ◽  
Term Care ◽  
Content Type ◽  
Future State ◽  
The Future ◽  
Leadership Committee

Purpose – The purpose of this paper is to report on use of the IEC80001 standard, Application of Risk Management for Information Technolody (IT) Networks Incorporating Medical Devices, to deploy a wireless alarm management solution in a long-term care home facility. Design/methodology/approach – The standard suggests the use of a unique responsibility matrix and a continuous quality improvement approach for analysis, evaluation and control of risks. A unique leadership committee and workgroup were formed to develop processes and procedures for integrating medical devices with IT systems; as well as execution of the project itself. The leadership committee oversaw the phased approach of assessing the technology, the clinical environment, proponent technology-based solutions and a specified risk management file. The project expanded its scope beyond the standard to include a risk focussed analysis of clinical workflow to evaluate the usability of the solution. Findings – The standard focussed approach identified numerous risks associated with the technical and network solution and the future state workflow. Medical devices proved to be the most limiting technology needing to be incorporated into the solution. Although faced with a daunting list of network related risks, it was concluded that all residual risks would have been acceptable. The analysis of the future state workflow identified various risks related to usability (human factors), battery management and the absence of additional operating dollars for supplementary staffing duties and new operational expenses. Originality/value – To the best of the authors knowledge, this paper is the first one to detail the process of following the IEC80001 standard in Canada. It offers insight into building an organizational framework around the standard and identifies gaps that should be considered by executive and project sponsors before proceeding with a project.

Promoting Safe Use of Medical Devices

2011 ◽  
Vol 17 (1) ◽  
Author(s):  
Sonia Swayze ◽  
Suzanne Rich
Keyword(s):  
Medical Device ◽  
Patient Outcomes ◽  
Medical Devices ◽  
Point Of Care ◽  
Professional Associations ◽  
Adverse Event Reporting ◽  
Clinical Environment ◽  
Future Directions ◽  
Professional Nurses ◽  
Nursing Associations

Although patient safety initiatives in the clinical environment have focused primarily on medication errors to date, medical devices also contribute significantly to patient injuries and deaths. This article addresses the Food and Drug Administration’s (FDA) efforts to promote safe use of medical devices by nurses at the point of care. The nurses with whom we have discussed the effects of medical devices, and also those surveyed by the medical device industry and professional nursing associations, are concerned about the profound effects, both desired and undesired, that medical devices have on patient outcomes. We believe that professional nurses, individually and through their professional associations, can help address these concerns by becoming aware of how to share their observations with the FDA and by working with their professional associations to develop position statements that focus on achieving safe and desired patient outcomes. In this article we will identify factors contributing to adverse events related to medical devices, address the need for more medical device adverse-event reporting, describe position statements that have already been made by some professional associations, and share insights regarding future directions along with ideas for educating staff to use medical devices safely.

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.

Ultrastructural changes in murine lymphoma cells exposed to ultraviolet-A radiation

1991 ◽  
Vol 49 ◽  
pp. 104-105
Author(s):  
Delma P. Thomas ◽  
Dianne E. Godar
Keyword(s):  
Medical Devices ◽  
Blood Cells ◽  
White Blood Cells ◽  
Consumer Products ◽  
Ultrastructural Changes ◽  
Ultraviolet A ◽  
Uv Spectrum ◽  
Lymphoma Cells ◽  
Murine Lymphoma ◽  
Transmission Electron

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.

Bacterial biofilm behavior in water-supply lines of dental units

1992 ◽  
Vol 50 (1) ◽  
pp. 882-883
Author(s):  
B.D. Tall ◽  
K.S. George ◽  
R. T. Gray ◽  
H.N. Williams
Keyword(s):  
Water Supply ◽  
Medical Devices ◽  
Biofilm Formation ◽  
Bacterial Biofilm

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.

Structured Interview for Hoarding Disorder (SIHD)

2019 ◽  
Vol 35 (4) ◽  
pp. 512-520
Author(s):  
Caterina Novara ◽  
Paolo Cavedini ◽  
Stella Dorz ◽  
Susanna Pardini ◽  
Claudio Sica
Keyword(s):  
Convergent Validity ◽  
Structured Interview ◽  
Diagnostic Process ◽  
Schizophrenia Spectrum Disorders ◽  
Clinical Environment ◽  
Obsessive Compulsive ◽  
Rater Reliability ◽  
Hoarding Disorder ◽  
Compulsive Disorder ◽  
Schizophrenia Spectrum

Abstract. The Structured Interview for Hoarding Disorder (SIHD) is a semi-structured interview designed to assist clinicians in diagnosing a hoarding disorder (HD). This study aimed to validate the Italian version of the SIHD. For this purpose, its inter-rater reliability has been analyzed as well as its ability to differentiate HD from other disorders often comorbid. The sample was composed of 74 inpatients who had been diagnosed within their clinical environment: 9 with HD, 11 with obsessive-compulsive disorder (OCD) and HD, 22 with OCD, 19 with major depressive disorder (MDD), and 13 with schizophrenia spectrum disorders (SSD). The results obtained indicated “substantial” or “perfect” inter-rater reliability for all the core HD criteria, HD diagnosis, and specifiers. The SIHD differentiated between subjects suffering from and not suffering from a HD. Finally, the results indicated “good” convergent validity and high scores were shown in terms of both sensitivity and specificity for HD diagnosis. Altogether, the SIHD represents a useful instrument for evaluating the presence of HD and is a helpful tool for the clinician during the diagnostic process.

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