CE accreditation and barriers to CE marking of paediatric drug calculators for mobile devices: a scoping review and qualitative analysis (Preprint)

2021 ◽  
Author(s):  
Charlotte Koldeweij ◽  
Jonathan Clarke ◽  
Joppe Nijman ◽  
Calandra Feather ◽  
Saskia de Wildt ◽  
...  
Keyword(s):  
The Netherlands ◽  
Medical Device ◽  
Medical Devices ◽  
Scoping Review ◽  
Drug Dosage ◽  
Paediatric Drug ◽  
The United Kingdom ◽  
Patients At Risk ◽  
European Standards ◽  
Application Developers

BACKGROUND Paediatric drug calculators (PDCs) intended for clinical use qualify as medical devices under the Medical Device Directive and the Medical Device Regulation. The extent to which they comply with European standards on quality and safety is unknown. OBJECTIVE Determine the number of PDCs available as mobile applications for use in the Netherlands that bear a CE mark and explore the factors influencing the CE marking of such devices among application developers. METHODS A scoping review of the Google Play and App stores was conducted to identify PDCs available for download in the Netherlands. CE accreditation of the sampled applications was determined by consulting the application landing pages on application stores, by screening the United Kingdom Medicines and Healthcare products Regulatory Agency online registry of medical devices and by surveying application developers. The barriers to CE accreditation were also explored through a survey of application developers. RESULTS Out of 632 screened applications, 74 were eligible, including 60 paediatric drug dosage calculators and 14 infusion rate calculators. One application was CE marked. Of the twenty (34%) respondents to the survey, eight considered their application not to be a medical device based on its intent of use or functionality. Three developers had not aimed to make their application available for use in Europe. Other barriers that may explain the limited CE accreditation of sampled PDC applications included poor awareness of European regulations among developers and a lack of restrictions when placing PDCs in application stores. CONCLUSIONS The compliance of paediatric drug calculators with European standards on medical devices is poor. This puts clinicians and their patients at risk of medical errors resulting from the largely unrestricted use of these applications.

scholarly journals Regulating Environmental Impact of Medical Devices in the United Kingdom—A Scoping Review

Prosthesis ◽  
2021 ◽  
Vol 3 (4) ◽  
pp. 370-387
Author(s):  
Pranay Arun Kumar
Keyword(s):  
United Kingdom ◽  
National Health Service ◽  
Health Service ◽  
Environmental Impact ◽  
Medical Device ◽  
National Health ◽  
Medical Devices ◽  
Scoping Review ◽  
Pathogen Transmission ◽  
The United Kingdom

Medical devices are highly regulated to ensure safety and efficacy of the products and minimize the risk of harm to users and patients. However, the broader impacts of these devices on the environment have scarcely been questioned until recently. The United Kingdom National Health Service intends to achieve a “net zero” emissions service by 2040 and has identified specific targets to achieve through this process. However, medical device manufacturers do not see sufficient incentives to invest in reducing greenhouse gas emissions unless enforced by legislation. Furthermore, there is little evidence on the legislation required to reduce emissions from medical devices. This study addresses the relationship of medical device regulations and the environmental impact of the devices throughout their lifecycle. A scoping review was conducted on academic literature on the topic, followed by a critical review of the current medical device regulations and associated guidelines in the United Kingdom. The challenges to regulating environmental impact of medical devices were identified under seven themes. These challenges were contextualized with the National Health Service target of achieving zero emissions by 2040. The review indicates that current guidelines support single-use disposal of devices and equipment as the best approach to prevent pathogen transmission and landfilling and incineration are the most used waste management strategies. Manufacturers need to be guided and educated on reducing their emissions while ensuring the development of safe and effective devices.

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 Strategies for the assessment of competences during rheumatology training across Europe: results of a qualitative study

RMD Open ◽  
2020 ◽  
Vol 6 (2) ◽  
pp. e001183 ◽  
Author(s):  
Aurélie Najm ◽  
Alessia Alunno ◽  
Francisca Sivera ◽  
Sofia Ramiro ◽  
Catherine Haines
Keyword(s):  
The Netherlands ◽  
Current Practice ◽  
Online Discussion ◽  
Qualitative Approach ◽  
Formative Feedback ◽  
Competence Assessment ◽  
The United Kingdom ◽  
Online Focus Groups ◽  
Assessment Systems ◽  
Insight Into

ObjectivesTo gain insight into current methods and practices for the assessment of competences during rheumatology training, and to explore the underlying priorities and rationales for competence assessment.MethodsWe used a qualitative approach through online focus groups (FGs) of rheumatology trainers and trainees, separately. The study included five countries—Denmark, the Netherlands, Slovenia, Spain and the United Kingdom. A summary of current practices of assessment of competences was developed, modified and validated by the FGs based on an independent response to a questionnaire. A prioritising method (9 Diamond technique) was then used to identify and justify key assessment priorities.ResultsOverall, 26 participants (12 trainers, 14 trainees) participated in nine online FGs (2 per country, Slovenia 1 joint), totalling 12 hours of online discussion. Strong nationally (the Netherlands, UK) or institutionally (Spain, Slovenia, Denmark) standardised approaches were described. Most groups identified providing frequent formative feedback to trainees for developmental purposes as the highest priority. Most discussions identified a need for improvement, particularly in developing streamlined approaches to portfolios that remain close to clinical practice, protecting time for quality observation and feedback, and adopting systematic approaches to incorporating teamwork and professionalism into assessment systems.ConclusionThis paper presents a clearer picture of the current practice on the assessment of competences in rheumatology in five European countries and the underlying rationale of trainers’ and trainees’ priorities. This work will inform EULAR Points-to-Consider for the assessment of competences in rheumatology training across Europe.

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