scholarly journals Regulation EU 2017/745 on medical devices – implementation analysis in Portugal by the distributors

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
H Vilaça
Keyword(s):  
Public Health ◽  
Medical Devices ◽  
Stakeholder Involvement ◽  
Implementation Process ◽  
Regulatory Framework ◽  
Theory And Practice ◽  
Structured Interviews ◽  
Public Health Action ◽  
Study Implementation ◽  
Implementation Analysis

Abstract The Regulation responds to legislation failures in the European regulatory framework on medical devices (MD), which in turn led to public health issues. Two media scandals triggered the final actions on the elaboration of this EU Regulation, which was already being thought off in a context of fast MD development, and on the commitment of member-states to harmonize legislation in order to better manage resources. This Regulation is expected to address detected gaps, and contribute to the protection of European citizens' health by ensuring high quality and safety of MD, through advocating for more transparency, vigilance, and traceability. A technique to evaluate policies is the implementation analysis, as it links theory and practice. By understanding it, it is possible to ascertain if, in fact, the Regulation will contribute, as proposed, to improve public health. The implementation analysis framework I developed can be used in other countries affected by this Regulation, and may even be extrapolated to other scenarios. Entry into force 25/05/17.Full application 05/20. This qualitative study uses document analysis and semi-structured interviews to collect data, and literature review to frame the situation and to study implementation analysis. The questions are: identify the facilitators and resistance points of the implementation; explore perceptions of the Portuguese MD distributors; understand the policy implementation pathway; and have a picture of the implementation status in Portugal. The results can be summarized as: implementers are interested in complying with the Regulation; there is stakeholder involvement in policy making and throughout the implementation process; the main points of resistance, difficulties and the facilitators are identified; and the Regulation is being implemented according to the timelines. The public health action brought by the policy is that each economic operator is an active actor on vigilance and patient safety across MD lifecycle. Key messages If we are interested in the extent to which a particular polity is able to solve the problems with which it is confronted, we need to study the way in which the law is executed in practice. Focus on the effective implementation of the new regulatory framework on medical devices to protect patients and ensure it addresses new and emerging challenges.

Corporate Social Responsibility Implementation - Lessons from Uganda

10.33117/512 ◽  
2017 ◽  
Vol 13 (1) ◽  
pp. 47-69
Keyword(s):  
Sustainable Development ◽  
Corporate Social Responsibility ◽  
Social Responsibility ◽  
Stakeholder Involvement ◽  
Implementation Process ◽  
Structured Interviews ◽  
Implementation Success ◽  
Success Model ◽  
Strategic Csr ◽  
Corporate Social

Purpose: This paper presents aspects of a Corporate Social Responsibility (CSR) Implementation Success Model to guide CSR engagements. Design/methodology/approach: A qualitative case methodology is used to investigate two CSR companies in Uganda. Semi-structured interviews with managers and stakeholders are conducted. Data triangulation includes reviewing CSR reports and documents, and visiting communities and CSR activities/projects mentioned in the case companies’ reports. Grounded theory guides the data analysis and aggregation. Findings: The findings culminate into a “CSR Implementation Success Model. ” Key aspects of CSR implementation success are identified as: (i) involvement of stakeholders and management (i.e., co-production) at the start and during every stage of CSR implementation; (ii) management of challenges and conflicts arising within/outside of the company itself; and (iii) feedback management or performance assessment—i.e., accountability via CSR communications and reporting. Stakeholder involvement and feedback management (accountability) are pivotal, though all three must be considered equally. Research limitations: The studied companies were large and well-established mature companies, so it is unclear whether newer companies and small and medium-sized enterprises would produce similar findings. Practical implications: Successful CSR implementation starts with a common but strategic understanding of what CSR means to the company. However, CSR implementation should (i) yield benefits that are tangible, and (ii) have a sustainable development impact because these two aspects form implementation benchmarks. Additionally, top management should be involved in CSR implementation, but with clear reasons and means. Originality/value: This paper unearths a CSR Implementation Success Model that amplifies views of “creating shared value” for sustainable development. It guides organizations towards strategic CSR, as opposed to the responsive CSR (returning profits to society) that largely dominates in developing countries. Additionally, it explains how to add value to the resource envelope lubricating the entire CSR implementation process

A Structured Framework for Adaptive Management: Bridging Theory and Practice in the Olympic Experimental State Forest

2019 ◽  
Vol 66 (4) ◽  
pp. 478-489
Author(s):  
Teodora V Minkova ◽  
Jennifer S Arnold
Keyword(s):  
Pacific Northwest ◽  
Adaptive Management ◽  
Stakeholder Involvement ◽  
Implementation Process ◽  
Time Frame ◽  
Theory And Practice ◽  
Multiple Use ◽  
Management Planning ◽  
The Pacific ◽  
High Level

Abstract Adaptive management is a systematic approach to learning from outcomes to improve management. Although its virtues are commonly praised, it has been implemented infrequently in natural resource management because of the challenges of developing a feasible process that can be sustained over time. Our analysis of regional experiences from private, state, and federal lands in the Pacific Northwest (United States and Canada) finds that the questions addressed by private organizations tend to be more specific, associated with a narrower scope of uncertainties, and addressed in a shorter time frame with limited stakeholder involvement. On publicly managed lands, questions tend to be more complex and open-ended, usually driven by their mandate for multiple use and high level of stakeholder engagement. We present a structured adaptive management framework that translates theory into action by describing an implementation process and organizational structure, explicitly linking learning to management planning and implementation, and integrating the technical and social aspects of adaptive management. Forest managers and policymakers can customize our example according to their mandate and management objectives. The framework is particularly relevant to land management for multiple uses, where the uncertainties are abundant and complex, and the decisionmakers increasingly use mathematical modeling to inform their decisions.

scholarly journals A framework for the management of donated medical devices based on perspectives of frontline public health care staff in Ghana

2020 ◽  
Vol 4 ◽  
pp. 239920262094136
Author(s):  
Dinsie B Williams ◽  
Jillian C Kohler ◽  
Andrew Howard ◽  
Zubin Austin ◽  
Yu-Ling Cheng
Keyword(s):  
Public Health ◽  
Health Care ◽  
Medical Devices ◽  
Hospital Staff ◽  
Public Health Care ◽  
Care Staff ◽  
Health Care Staff ◽  
Structured Interviews ◽  
National Guidelines ◽  
Delivery Of Care

Background: Transnational funders provide up to 80% of funds for medical devices in resource-limited settings, yet sustained access to medical devices remains unachievable. The primary goal of this study was to identify what factors hinder access to medical devices through the perspectives of frontline public hospital staff in Ghana involved in the implementation of transnational funding initiatives. Methods: A case study was developed that involved an analysis of semi-structured interviews of 57 frontline technical, clinical and administrative public health care staff at 23 sites in Ghana between March and April 2017; a review of the national guidelines for donations; and images of abandoned medical devices. Results: Six key themes emerged, demonstrating how policy, collaboration, quality, lifetime operating costs, attitudes of health care workers and representational leadership influence access to medical devices. An in-depth assessment of these themes has led to the development of an enterprise-wide comprehensive acquisition and management framework for medical devices in the context of transnational funding initiatives. Conclusion: The findings in this study underscore the importance of incorporating frontline health care staff in developing solutions that are targeted at improving delivery of care. Sustained access to medical devices may be achieved in Ghana through the adoption of a rigorous and comprehensive approach to acquisition, management and technical leadership. Funders and public health policy makers may use the study’s findings to inform policy reform and to ensure that the efforts of transnational funders truly help to facilitate sustainable access to medical devices in Ghana.

scholarly journals Shifting the Gravity of Spending: Assessing the impact of PHE’s Prioritisation Framework

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
G Maniatopoulos ◽  
D J Hunter ◽  
J Gray
Keyword(s):  
Public Health ◽  
Local Authority ◽  
Participant Observation ◽  
Implementation Process ◽  
The Political ◽  
Political Environment ◽  
Adoption Process ◽  
Early Adopter ◽  
Structured Interviews ◽  
The Impact

Abstract Background Findings are presented from the evaluation of Public Health England’s (PHE) new Prioritisation Framework (PF) conducted between September 2017 and December 2018 aimed to help local authority commissioners with their public health investment and disinvestment decisions. The study explored the take up of the PF in three early adopter local authority settings. Methods Data collection was based on semi-structured interviews (n = 30) across three local authorities supplemented by participant observation of workshops and data concerning the implementation process as well as spend and outcomes both before and, where possible, after using the PF. Results Participants acknowledged that the PF provided a systematic way to guide prioritisation decisions and one that encouraged transparency over investment and disinvestment decisions. The role performed by PHE and its regional teams in facilitating the process was especially welcomed and considered to be critical to the adoption process. However, uptake of the PF required a significant investment of time and commitment from public health teams at a time when resources were stretched. The impact of the political environment in local government was a major factor determining the likely uptake of the PF. Ensuring committed leadership and engagement from senior politicians and officers was regarded as critical to success. Conclusions The study assessed the value of the PF and the processes surrounding its implementation and use. Further research could further explore the value of the tool in aiding investment and disinvestment decisions and its impact on spending. Key messages The PF provides a platform for engaged and informed deliberation about priorities and does so in an open, structured and transparent manner. Organisational and political context in which prioritisation occur shape the adoption of the PF tool.

Perceptions on Job Requirements of LIS Graduates in Public Libraries: A Reflection on Public Libraries in KwaZulu-Natal, South Africa

Mousaion ◽  
2019 ◽  
Vol 36 (4) ◽  
Author(s):  
Mpilo Siphamandla Mthembu ◽  
Dennis Ngong Ocholla
Keyword(s):  
Work Experience ◽  
Computer Literacy ◽  
Industrial Revolution ◽  
Information Science ◽  
Public Libraries ◽  
Knowledge Society ◽  
Professional Services ◽  
Theory And Practice ◽  
Library And Information Science ◽  
Structured Interviews

Public libraries play a crucial role in the information and knowledge society. Their access and services in the fourth industrial revolution require review as well as the knowledge of the competency requirements for Library and Information Science (LIS) graduates to offer professional services. This paper presents the competencies LIS graduates require for work. It also seeks to examine the challenges they encounter in public libraries. The study is driven by the notion that a skills gap and a lack of training for LIS professionals are still daunting challenges in most public libraries. The post-positivism paradigm was employed through the triangulation of both qualitative and quantitative methodologies in data collection and analysis. Content analysis and a survey were employed as research methods. The study scanned job advertisements in four newspapers spanning a three-year period (from January 2015 to December 2017). Semi-structured interviews were conducted with assistant directors and structured questionnaires were administered to LIS graduates. Grade 12, one to three years of work experience, computer literacy and communication skills are the most required competencies to work at public libraries. There seems to be no balance between theory and practice offered in most LIS schools, which suggests the need for curricula revision. Employed LIS graduates are facing several challenges, which include lack of practical exposure or knowledge, lack of qualification recognition and individual promotions, and lack of ICT skills and knowledge.

Estimating the number of cases during COVID-19 pandemics using a web-based tool: first week results of “COVID-19 TRENDS” social media project in the Araba-Alava province in Basque country, Spain. (Preprint)

2020 ◽  
Author(s):  
Ignacio Garitano ◽  
Manuel Linares ◽  
Laura Santos ◽  
Ruth Gil ◽  
Elena Lapuente ◽  
...  
Keyword(s):  
Public Health ◽  
Social Media ◽  
Response Rate ◽  
Basque Country ◽  
Case Definition ◽  
Public Health Action ◽  
Web Based ◽  
Health Action ◽  
Estimate Number ◽  
Media Project

UNSTRUCTURED On 28th February a case of COVID-19 was declared in Araba-Álava province, Spain. In Spain, a confinement and movement restrictions were established by Spanish Government at 14th March 2020. We implemented a web-based tool to estimate number of cases during the pandemic. We present the results in Áraba-Álava province. We reached a response rate of 10,3% out a 331.549 population. We found that 22,4 % fulfilled the case definition. This tool rendered useful to inform public health action.

The Integration of ERM and Strategy: Implications for Corporate Governance

2017 ◽  
Vol 31 (2) ◽  
pp. 69-82 ◽  
Author(s):  
Therese R. Viscelli ◽  
Dana R. Hermanson ◽  
Mark S. Beasley
Keyword(s):  
Corporate Governance ◽  
Boards Of Directors ◽  
Implementation Process ◽  
Structured Interviews ◽  
Executive Management ◽  
Strategic Direction ◽  
Strategic Value ◽  
Enterprise Risk ◽  
Leadership Structure ◽  
Risk Oversight

SYNOPSIS Since the early 2000s, expectations have increased for organizations to strengthen corporate governance with enterprise risk management (ERM) processes, with the accounting profession playing a major role in these efforts. The ultimate goal of an effective ERM process is to help boards and senior executives to manage risks in the context of strategy so that the organization is more likely to achieve its key objectives. We conduct semi-structured interviews of 15 ERM champions to provide insights about whether the ERM process is integrated with the strategic-planning and execution processes of the firm. We find that while the decision to launch ERM often is based on a desire for ERM to provide strategic value, the integration of ERM with strategy typically is limited. We then examine the ERM implementation process to identify possible ERM implementation practices limiting ERM's integration with strategy. We find that organizations' (1) culture and approach to preparing for ERM's launch, (2) ERM leadership structure, and (3) management of key risks appear to limit the intersection of ERM and strategy. Our summary of key findings highlights important considerations for boards of directors, executive management, and auditors as they assess the effectiveness of their risk oversight efforts in overseeing the strategic direction of the enterprise.

scholarly journals Reconciling Epidemiology’s Aspirations and Capabilities

2020 ◽  
Author(s):  
David A Savitz
Keyword(s):  
Public Health ◽  
Epidemiologic Studies ◽  
Public Health Importance ◽  
Public Health Action ◽  
Action Current ◽  
Current Trends ◽  
The Face ◽  
Health Action ◽  
New Challenges ◽  
Health Applications

Abstract Interpreting the results of epidemiologic studies calls for objectivity and rigorous scrutiny, acknowledging the limitations that temper the applicability of the findings to public health action. Current trends have posed new challenges to balancing goal of scientific objectivity and validity with public health applications. The ongoing tension between epidemiology’s aspirations and capability has several sources: the need to overpromise in research proposals, compromising methodologic rigor because of public health importance, defending findings in the face of hostile critics, and appealing to core constituencies who have specific expectations from the research.

Considerations for Translating Medical Devices Under Development From the Clinic to the Home: A Case Study in Providing Chronic Wound Care

2021 ◽  
Vol 10 (1) ◽  
pp. 238-242
Author(s):  
Ellen J. Bass ◽  
Justine S. Sefcik ◽  
Elease McLaurin ◽  
Rose Ann DiMaria-Ghalili
Keyword(s):  
Medical Devices ◽  
Chronic Wound ◽  
Wound Care ◽  
Clinical Protocol ◽  
Structured Interviews ◽  
Home Setting ◽  
Ultrasound Application ◽  
Research Assistants ◽  
Current Device

A prototype medical device and protocol that work well in a clinic would not necessarily work reliably in the home setting. The goal of this work is to identify factors to consider when translating a device evaluated in a clinic for use by home caregivers providing chronic wound care for persons living with dementia. One must consider the current device, the associated bundle, the protocol and how they may need to be modified. Semi-structured interviews with the research assistants who have applied a prototype device were conducted to generate a list of known issues with the current clinical protocol in terms of ultrasound application The researchers performed a set of specified tasks by following the current device protocol and explaining any difficulties with use\execution. They embellished the descriptions with details about what had happened with actual patients in the clinic. Using thematic analysis, analysts identified themes and subthemes. Issues potentially relevant to translating medical devices to the home are discussed.

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