scholarly journals Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care

2021 ◽  
Vol Volume 14 ◽  
pp. 411-421
Author(s):  
Natalia A Wilson ◽  
James E Tcheng ◽  
Jove Graham ◽  
Joseph P Drozda Jr
Keyword(s):  
Patient Safety ◽  
Health System ◽  
Medical Devices ◽  
Point Of Care ◽  
Device Identification

Clinical Cybersecurity Training Through Novel High Fidelity Simulations (Preprint)

2018 ◽  
Author(s):  
Christian Dameff ◽  
Jordan Selzer ◽  
Jonathan Fisher ◽  
James Killeen ◽  
Jeffrey Tully
Keyword(s):  
Patient Safety ◽  
Patient Care ◽  
Medical Devices ◽  
Healthcare Systems ◽  
High Fidelity ◽  
Protected Health Information ◽  
Patient Harm ◽  
Security Vulnerabilities ◽  
Clinical Simulations ◽  
Medical Infrastructure

BACKGROUND Cybersecurity risks in healthcare systems have traditionally been measured in data breaches of protected health information but compromised medical devices and critical medical infrastructure raises questions about the risks of disrupted patient care. The increasing prevalence of these connected medical devices and systems implies that these risks are growing. OBJECTIVE This paper details the development and execution of three novel high fidelity clinical simulations designed to teach clinicians to recognize, treat, and prevent patient harm from vulnerable medical devices. METHODS Clinical simulations were developed which incorporated patient care scenarios with hacked medical devices based on previously researched security vulnerabilities. RESULTS Clinician participants universally failed to recognize the etiology of their patient’s pathology as being the result of a compromised device. CONCLUSIONS Simulation can be a useful tool in educating clinicians in this new, critically important patient safety space.

scholarly journals Optical-Based Biosensors and Their Portable Healthcare Devices for Detecting and Monitoring Biomarkers in Body Fluids

Diagnostics ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 1285
Author(s):  
Anh Tran Tam Pham ◽  
Angus Wallace ◽  
Xinyi Zhang ◽  
Damian Tohl ◽  
Hao Fu ◽  
...  
Keyword(s):  
Medical Devices ◽  
Point Of Care ◽  
Body Fluids ◽  
Optical Measurements ◽  
Mobile Technologies ◽  
Detection Methods ◽  
Portable Devices ◽  
Bodily Fluids ◽  
Clinical Measurements ◽  
Distinct Features

The detection and monitoring of biomarkers in body fluids has been used to improve human healthcare activities for decades. In recent years, researchers have focused their attention on applying the point-of-care (POC) strategies into biomarker detection. The evolution of mobile technologies has allowed researchers to develop numerous portable medical devices that aim to deliver comparable results to clinical measurements. Among these, optical-based detection methods have been considered as one of the common and efficient ways to detect and monitor the presence of biomarkers in bodily fluids, and emerging aggregation-induced emission luminogens (AIEgens) with their distinct features are merging with portable medical devices. In this review, the detection methodologies that use optical measurements in the POC systems for the detection and monitoring of biomarkers in bodily fluids are compared, including colorimetry, fluorescence and chemiluminescence measurements. The current portable technologies, with or without the use of smartphones in device development, that are combined with optical biosensors for the detection and monitoring of biomarkers in body fluids, are also investigated. The review also discusses novel AIEgens used in the portable systems for the detection and monitoring of biomarkers in body fluid. Finally, the potential of future developments and the use of optical detection-based portable devices in healthcare activities are explored.

scholarly journals Quality in crisis: a systematic review of the quality of health systems in humanitarian settings

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Keely Jordan ◽  
Todd P. Lewis ◽  
Bayard Roberts
Keyword(s):  
Systematic Review ◽  
Health System ◽  
Health Systems ◽  
Point Of Care ◽  
System Level ◽  
System Quality ◽  
High Quality ◽  
Humanitarian Settings ◽  
Quality Health

Abstract Background There is a growing concern that the quality of health systems in humanitarian crises and the care they provide has received little attention. To help better understand current practice and research on health system quality, this paper aimed to examine the evidence on the quality of health systems in humanitarian settings. Methods This systematic review was based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol. The context of interest was populations affected by humanitarian crisis in low- and middle- income countries (LMICs). We included studies where the intervention of interest, health services for populations affected by crisis, was provided by the formal health system. Our outcome of interest was the quality of the health system. We included primary research studies, from a combination of information sources, published in English between January 2000 and January 2019 using quantitative and qualitative methods. We used the High Quality Health Systems Framework to analyze the included studies by quality domain and sub-domain. Results We identified 2285 articles through our search, of which 163 were eligible for full-text review, and 55 articles were eligible for inclusion in our systematic review. Poor diagnosis, inadequate patient referrals, and inappropriate treatment of illness were commonly cited barriers to quality care. There was a strong focus placed on the foundations of a health system with emphasis on the workforce and tools, but a limited focus on the health impacts of health systems. The review also suggests some barriers to high quality health systems that are specific to humanitarian settings such as language barriers for refugees in their host country, discontinued care for migrant populations with chronic conditions, and fears around provider safety. Conclusion The review highlights a large gap in the measurement of quality both at the point of care and at the health system level. There is a need for further work particularly on health system measurement strategies, accountability mechanisms, and patient-centered approaches in humanitarian settings.

scholarly journals Countrywide survey on utilization of medical devices by GPs in Hungary: advantages of the cluster-practice model

2021 ◽  
Vol 22 ◽  
Author(s):  
Katalin Dózsa ◽  
Fruzsina Mezei ◽  
Tamás Tóth ◽  
Ábel Perjés ◽  
Péter Pollner
Keyword(s):  
Medical Devices ◽  
Point Of Care ◽  
Daily Practice ◽  
Evidence Based ◽  
Self Assessment ◽  
Practice Model ◽  
Practice Models ◽  
Integrate State ◽  
The Relationship ◽  
Further Development

Abstract Background: Expectations towards general practitioners (GPs) are continuously increasing to provide a more systematic preventive- and definitive-based care, a wider range of multidisciplinary team-based services and to integrate state-of-the-art digital solutions into daily practice. Aided by development programmes, Hungarian primary care is facing the challenge to fulfil its role as the provider of comprehensive, high quality, patient-centred, preventive care, answering the challenges caused by non-communicable diseases (NCDs). Aim: The article aims to provide an insight into the utilization of simple, digital, medical devices. We show the relationship between the primary health care (PHC) practice models and the used types of devices. We point at further development directions of GP practices regarding the utilization of evidence-based medical technologies and how such devices support the screening and chronic care of patients with NCDs in everyday practice. Methods: Data were collected using an online self-assessment questionnaire from 1800 Hungarian GPs registered in Hungary. Descriptive statistics, Wilcoxon’s test and χ2 test were applied to analyze the ownership and utilization of 32 types of medical devices, characteristics of the GP practices and to highlight the differences between traditional and cluster-based operating model. Findings: Based on the responses from 27.7% of all Hungarian GPs, the medical device infrastructure was found to be limited especially in single GP-practices. Those involved in development projects of GP’s clusters in the last decade reported a wider range and significantly more intensive utilization of evidence-based technologies (average number of devices: 5.42 versus 7.56, P<.001), but even these GPs are not using some of their devices (e.g., various point of care testing devices) due to the lack of financing. In addition, GPs involved in GPs-cluster development model programmes showed significantly greater willingness for sharing relatively expensive, extra workforce-demanding technologies (χ2 = 24.5, P<.001).

Medical Device Regulation and the Proposed Therapeutic Products Bill: Devising a New Regime

2021 ◽  
Vol 52 (2) ◽  
pp. 319-342
Author(s):  
Laura Hardcastle
Keyword(s):  
Patient Safety ◽  
New Zealand ◽  
Medical Devices ◽  
Cosmetic Products ◽  
Regulatory Oversight ◽  
Speed To Market ◽  
The Government ◽  
The Right ◽  
Promote Patient Safety ◽  
Medical Device Regulation

Despite medical devices being integral to modern healthcare, New Zealand's regulation of them is decidedly limited, with repeated attempts at reform having been unsuccessful. With the Government now indicating that new therapeutic products legislation may be introduced before the end of the year, the article considers the case for change, including to promote patient safety, before analysing the draft Therapeutic Products Bill previously proposed by the Ministry of Health, and on which any new legislation is expected to be based. It concludes that, while the proposed Bill is a step in the right direction, introducing regulatory oversight where there is currently next to none, there is still significant work to be done. In particular, it identifies a need to clarify whether the regime is indeed to be principles-based and identifies further principles which might be considered for inclusion. It further proposes regulation of cosmetic products which operate similarly to medical devices to promote safety objectives, while finding a need for further analysis around the extent to which New Zealand approval processes should rely on overseas regulators. Finally, it argues that, in an area with such major repercussions for people's health, difficult decisions around how to develop a framework which balances safety with speed to market should not be left almost entirely to an as yet unknown regulator but, rather, more guidance from Parliament is needed.

Connecting the clinical IT infrastructure to a service-oriented architecture of medical devices

2018 ◽  
Vol 63 (1) ◽  
pp. 57-68 ◽  
Author(s):  
Björn Andersen ◽  
Martin Kasparick ◽  
Hannes Ulrich ◽  
Stefan Franke ◽  
Jan Schlamelcher ◽  
...  
Keyword(s):  
Medical Devices ◽  
Service Oriented Architecture ◽  
Point Of Care ◽  
Qualitative Evaluation ◽  
It Infrastructure ◽  
It Systems ◽  
Service Oriented ◽  
Clinical Environments ◽  
Integrated Operating Room ◽  
Ieee 11073

AbstractThe new medical device communication protocol known as IEEE 11073 SDC is well-suited for the integration of (surgical) point-of-care devices, so are the established Health Level Seven (HL7) V2 and Digital Imaging and Communications in Medicine (DICOM) standards for the communication of systems in the clinical IT infrastructure (CITI). An integrated operating room (OR) and other integrated clinical environments, however, need interoperability between both domains to fully unfold their potential for improving the quality of care as well as clinical workflows. This work thus presents concepts for the propagation of clinical and administrative data to medical devices, physiologic measurements and device parameters to clinical IT systems, as well as image and multimedia content in both directions. Prototypical implementations of the derived components have proven to integrate well with systems of networked medical devices and with the CITI, effectively connecting these heterogeneous domains. Our qualitative evaluation indicates that the interoperability concepts are suitable to be integrated into clinical workflows and are expected to benefit patients and clinicians alike. The upcoming HL7 Fast Healthcare Interoperability Resources (FHIR) communication standard will likely change the domain of clinical IT significantly. A straightforward mapping to its resource model thus ensures the tenability of these concepts despite a foreseeable change in demand and requirements.

Evaluating Shared Governance: Measuring Functionality of Unit Practice Councils at the Point of Care

2011 ◽  
Vol 17 (2) ◽  
pp. 87-95 ◽  
Author(s):  
Beverly Fray
Keyword(s):  
Health System ◽  
Shared Governance ◽  
Point Of Care ◽  
Measurement Tool ◽  
Rare Occurrence ◽  
The Way

Measuring the functionality of Unit Practice Councils (UPCs) in institutions on the Magnet journey is a rare occurrence. The Jackson Health System Unit Practice Council Functionality Measurement Tool is one of the first such attempts to provide an objective way to assess whether UPCs function in the way they were envisioned to perform.

Resuscitating Team Roles within Wayburn Health System

2015 ◽  
pp. 921-931
Author(s):  
Jill E. Stefaniak
Keyword(s):  
Patient Safety ◽  
Health System ◽  
Instructional Designer ◽  
Administrative Leadership ◽  
Healthcare Team ◽  
Trauma Resuscitation ◽  
Emergency Center ◽  
Team Members ◽  
Communication Processes ◽  
Sentinel Events

Administrative leadership of Wayburn Health System decided to move forward with a training program to address communication between healthcare professionals within their emergency center. After a few sentinel events where errors had occurred that compromised patient safety due to miscommunication amongst healthcare team members, hospital administration decided that communication processes needed to be standardized within the emergency center during trauma resuscitations. Four hundred employees from various departments and disciplines would require training. An instructional designer was brought onto the project to ensure that training was customized to fit the specific needs of the trauma resuscitation team.

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