scholarly journals Medical Device Regulation from a Health Service Provider’s Perspective

Prosthesis ◽  
2021 ◽  
Vol 3 (3) ◽  
pp. 261-266
Author(s):  
Man Ting Kwong ◽  
David Stell ◽  
Emmanuel Akinluyi
Keyword(s):  
Health Service ◽  
Medical Device ◽  
Medical Devices ◽  
Clinical Setting ◽  
Service Providers ◽  
Healthcare Providers ◽  
Current Trends ◽  
Health Service Providers ◽  
The Uk ◽  
Medical Device Regulation

Unfamiliarity with medical device regulations can sometimes be a barrier to deploying technology in a clinical setting for researchers and innovators. Health service providers recognise that innovation can happen within smaller organisations, where regulatory support may be limited. This article sets out to increase transparency and outline key considerations on medical device regulations from a UK healthcare provider’s perspective. The framework used by Guy’s and St Thomas’ NHS Foundation Trust (GSTFT) for assessing research devices is presented to give an overview of the routes that R&D medical devices take to enter a clinical setting. Furthermore, current trends on research studies involving medical devices were extracted from the GSTFT internal R&D database and presented as the following categories (i) commercial vs. non-commercial, (ii) assessment type and (iii) software vs. non-software. New medical devices legislation will be introduced within the UK in July 2023. It is anticipated regulating software as a medical device may become more challenging for healthcare providers and device manufacturers alike. It is therefore important for different stakeholders involved to work together to ensure this does not become a barrier to innovation.

Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices

2021 ◽  
Vol 10 (1) ◽  
pp. 64-88
Author(s):  
James I. J. Green
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Transition Period ◽  
Eu Directive ◽  
Custom Made ◽  
Dental Setting ◽  
The Uk ◽  
Dental Professionals ◽  
The Eu ◽  
Medical Device Regulation

A custom-made device (CMD) is a medical device intended for the sole use of a particular patient. In a dental setting, CMDs include prosthodontic devices, orthodontic appliances, bruxism splints, speech prostheses and devices for the treatment of obstructive sleep apnoea, trauma prevention and orthognathic surgery facilitation (arch bars and interocclusal wafers). Since 1993, the production and provision of CMDs have been subject to European Union (EU) Directive 93/42/EEC (Medical Device Directive, MDD) given effect in the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618), and its subsequent amendments. Regulation (EU) 2017/745 (Medical Device Regulation, EU MDR) replaces the MDD and the other EU Directive pertaining to Medical Devices, Council Directive 90/385/EEC (Active Implantable Medical Device Directive, AIMDD). The EU MDR was published on 5 April 2017, came into force on 25 May 2017 and, following a three-year transition period was due to be fully implemented and repeal the MDD on 26 May 2020, but was deferred until 26 May 2021 due to the coronavirus disease 2019 (COVID-19) pandemic. In the UK, in preparation for the country’s planned departure from the EU, the EU MDR, with necessary amendments, was transposed into UK law (Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, UK MDR). The UK left the Union on 31 January 2020 and entered a transition period that ended on 31 December 2020, meaning that, from 1 January 2021, dental professionals in Great Britain who prescribe and manufacture CMDs are mandated to do so in accordance with the new legislation while Northern Ireland remains in line with the EU legislation and implementation date. This paper sets out the requirements that relate to the production and provision of CMDs in a UK dental setting.

scholarly journals A human right to be detained? Mental healthcare after ‘Savage’ and ‘Rabone'

2013 ◽  
Vol 37 (9) ◽  
pp. 294-296 ◽  
Author(s):  
Mohammad Shaiyan Rahman ◽  
Nadya Wolferstan
Keyword(s):  
Mental Health ◽  
Mental Health Service ◽  
Service Providers ◽  
Healthcare Providers ◽  
Mental Healthcare ◽  
Case Law ◽  
Human Right ◽  
Health Service Providers ◽  
The Uk ◽  
Suicidal Patients

SummaryThe UK courts have recently considered the management of suicidal patients in the cases of Savage and Rabone. As a result of these judgments, the case law has extended significantly the responsibilities of mental healthcare providers. In this article we discuss the repercussions of these landmark decisions which are likely to have significant consequences for mental health service providers in the UK.

A Strategic Approach for Patient-Centric E-Healthcare Development

2019 ◽  
pp. 211-237
Author(s):  
Abdallah Qusef ◽  
Mohammad Daradkeh ◽  
Sharefa Murad
Keyword(s):  
Health Service ◽  
Service Providers ◽  
Cloud Model ◽  
Healthcare Providers ◽  
Quality Of Healthcare ◽  
Healthcare Services ◽  
Health Service Providers ◽  
Strategic Approach ◽  
Proposed Model ◽  
Healthcare It

Different types of industries, strategic thinking, planning, and management in healthcare have become cornerstones of providing high quality of healthcare services among the rapidly changing competitive environment and the emerging technologies, which is pushing health service providers to adopt the eHealth solutions to automate the treatment workflows during health service. This chapter introduces a new healthcare IT cloud model called HealthGate Cloud (HGC), which is specially designed as a central repository for patients' EHRs. The proposed model provides a technical and business framework for a centralized enterprise healthcare information system and data sharing between all participated healthcare providers in the country or region, which makes them all as if they are one big hospital having one single repository and database for all patients' medical records. It can be used by any HA in any country or region to provide this solution for HSPs through subscriptions business model.

scholarly journals Barriers to Receiving the Recommended Standard Care During Pregnancy by Illiterate Women in Rural, Northern Tanzania

2020 ◽  
Author(s):  
Dismas Matovelo ◽  
Pendo Ndaki ◽  
Victoria Yohani ◽  
Rose Laisser ◽  
Respicious Bakalemwa ◽  
...  
Keyword(s):  
Public Health ◽  
Health Service ◽  
Patient Care ◽  
Service Providers ◽  
Healthcare Providers ◽  
Continuity Of Patient Care ◽  
Sub Saharan Africa ◽  
Health Crisis ◽  
Health Service Providers ◽  
Health Messaging

Abstract Background: In 2017, an estimated 540 women in Sub-Saharan Africa died every day from preventable causes related to pregnancy and childbirth. To stem this public-health crisis, the WHO recommends a maternal and neonatal health continuity of patient care, yet most women do not meet this recommendation. Surveys suggest that illiteracy limits uptake of the proposed maternal-newborn package, yet little is known about the association between illiteracy and healthcare seeking, particularly in rural regions of low-income countries. This knowledge gap compromises the ability of public health experts and healthcare providers to provide culturally relevant policy and practice. To begin to address this gap this study explores the experiences related to care-seeking by illiterate, pregnant women in rural Tanzania.Methods: A qualitative study was conducted in four communities encompassing eight focus group discussions with 81 illiterate women, 13 interviews with illiterate women of reproductive age and seven interviews with members of these communities perceived to have some influence on women’s decisions concerning perinatal care services. Themes were coded and their relative importance determined using frequency reports and cross-tabulations. Findings: Three key themes emerged, illiterate women (1) could not read their healthcare cards or public health messaging; (2) spoke the local language, not Swahili, the language used by healthcare providers, and (3) have endeavored to develop coping strategies to overcome these obstacles. In addition, health service providers are often unaware of who is illiterate.Recommendations: More health needs of this group could be met, in the short term, by developing a protocol for health service providers to determine who is illiterate, providing translation services for those unable to speak Swahili, and graphic public health messaging that does not require literacy. In the long term, this barrier may be addressed by ensuring that all Tanzanians receive a high-quality, formal education, supporting community health workers, and recruiting healthcare providers from rural areas. A failure of to address the needs of this at-risk group will likely mean that they will continue to experience barriers to achieving the recommended continuity of patient care with detrimental health outcomes for both mothers and newborns.

scholarly journals Selected Current Trends in Human Resource Management in Health Service Providers in the Czech Republic

2017 ◽  
Vol 65 (6) ◽  
pp. 1833-1840
Author(s):  
Jiří Bejtkovský
Keyword(s):  
Czech Republic ◽  
Resource Management ◽  
Health Service ◽  
Human Resource Management ◽  
Human Resource ◽  
Service Providers ◽  
The Czech Republic ◽  
Current Trends ◽  
Health Service Providers ◽  
Hr Managers

The article focuses on selected current trends in human resource management in health service providers in the Czech Republic. Its goal was the mapping and evaluation of these trends in selected health service providers by staff management experts (HR managers) in the Czech Republic. The contribution presents a view of some of the results of quantitative and qualitative research conducted in selected health service providers in the Czech Republic. These researches were conducted in 2016 from a sample of 47 respondents (HR managers of selected health service providers in the Czech Republic), and the results were analyzed. One research hypothesis and one research question have been formulated. The verification or rejection of the null research hypothesis was done through the statistical method of the Pearson’s Chi‑square test. The research results show differing levels of awareness and differentiations – primarily by owner, size as measured in number of beds and geographical segmentation of each health services provider among individual selected trends in human resource management in health service providers in the Czech Republic.

A UK medical devices regulator’s perspective on registries

2016 ◽  
Vol 61 (2) ◽  
Author(s):  
John Wilkinson ◽  
Andy Crosbie
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Sources Of Information ◽  
Implantable Medical Devices ◽  
Post Market ◽  
Adverse Incident ◽  
And Performance ◽  
The Uk ◽  
Medical Device Regulation

AbstractRegistries are powerful tools to support manufacturers in the fulfilment of their obligations to perform post-market surveillance and post-market clinical follow-up of implantable medical devices. They are also a valuable resource for regulators in support of regulatory action as well as in providing information around the safety of new and innovative technologies. Registries can provide valuable information on the relative performance of both generic types and manufacturer’s individual products and they complement other sources of information about device performance such as post-market clinical studies and adverse incident reporting. This paper describes the experience of the UK medical device regulator – the Medicines and Healthcare Products Regulatory Agency (MHRA) – of working with registries to monitor the safety and performance of medical devices. Based upon this experience, the authors identify a number of attributes for a registry which they consider to be key if the registry is to contribute effectively to the work of regulators on patient safety monitoring and medical device regulation.

Health service providers in psychology: Results of the 1978 APA Human Resources Survey.

1981 ◽  
Vol 36 (11) ◽  
pp. 1395-1418 ◽  
Author(s):  
Gary R. VandenBos ◽  
Joy Stapp ◽  
Richard R. Kilburg
Keyword(s):  
Health Service ◽  
Human Resources ◽  
Service Providers ◽  
Health Service Providers

2015 APA Survey of Psychology Health Service Providers

2016 ◽  
Author(s):  
Auntre Hamp ◽  
Karen Stamm ◽  
Luona Lin ◽  
Peggy Christidis
Keyword(s):  
Health Service ◽  
Service Providers ◽  
Health Service Providers

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.

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