Assessment procedures as basis of reimbursement decisions for medical devices- an international overview

2013 ◽  
Vol 75 (08/09) ◽  
Author(s):  
K van der Linde ◽  
J Wasem ◽  
B Buchberger
Keyword(s):  
Medical Devices ◽  
Assessment Procedures

scholarly journals APPROACHES TO REGULATION OF MEDICAL PRODUCTS AS A CONDITION OF PREVENTION OF RISKS THEIR USE

2018 ◽  
pp. 166-170
Author(s):  
V. Horachuk ◽  
A. Krut ◽  
V. Michaltchuk
Keyword(s):  
Medical Devices ◽  
System Analysis ◽  
Legal Regulation ◽  
The European Union ◽  
Market Surveillance ◽  
Medical Products ◽  
Control Functions ◽  
Public Health Institutions ◽  
Quality Of Medical Care ◽  
Assessment Procedures

We studied domestic technical regulations for medical products, harmonized with European approaches to regulate their treatment. The materials of the study were documents on technical regulation, standardization, metrology, accreditation, conformity assessment procedures and market surveillance of the European Union and Ukraine (24 units). Methods of system approach and system analysis, descriptive modeling are used. It is established that the regulatory legal regulation of the circulation of medical devices in Ukraine does not contain the full scope of requirements with guarantees of their safety when used by health care institutions and could serve as the criteria for compliance with the performance of control functions by state market surveillance authorities. A list of technical documents formed in a technical file is proposed. Its purpose is to document the circulation of medical devices (manufacture, conduct clinical trials, use in public health institutions, market surveillance). Thus, there are opportunities to confirm the safety of medical devices, which is a component of ensuring the quality of medical care.

scholarly journals The importance of medical devices in preventing and combating SARS-CoV-2 and cooperation between national regulators, academy and industry - Perspectives from the Portuguese reality

2020 ◽  
Vol 17 (2) ◽  
pp. 1-12
Author(s):  
Isabel Maria Martins Portugal de Abreu
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Market Surveillance ◽  
Strategic Vision ◽  
Science Technology ◽  
Medical Device Manufacturers ◽  
Medical Markets ◽  
National Industry ◽  
Assessment Procedures ◽  
Opinion Article

In view of the scarcity of medical devices necessary to combat the outbreak crisis caused by the new SARS-CoV-2 coronavirus pandemic, an exceptional regime regarding applicable device conformity assessment procedures and market surveillance was established through Recommendation (EU) 2020/403 of the European Commission of 13 March. This was adopted by Portugal through the publication of Decree-Law no. 14-E / 2020 of 13 April. Many guidelines were issued during the pandemic by INFARMED and with the cooperation of other national entities (Ministry of Economy, Ministry of Science, Technology and Higher Education, national Industry and General Directorate of Health) to support medical device manufacturers and importers. It is important that these guidelines are reflected in the development of the Portuguese medical device industry in order to promote its international recognition and to ease access to other medical markets. A detailed analysis of all variables here included in this opinion article, together with some proposals, aims to promote a national strategic vision in the area of the development and production of medical devices, in order to enhance ideas and gains that resulted from these responses to the crisis, serving for future analysis to be published in due course.

scholarly journals ExosCE: A legal-based computational system for compliance with exoskeletons’ CE marking

2020 ◽  
Vol 11 (1) ◽  
pp. 414-427
Author(s):  
Sofia Almpani ◽  
Theodoros Mitsikas ◽  
Petros Stefaneas ◽  
Panayiotis Frangos
Keyword(s):  
Open Source ◽  
Medical Devices ◽  
Real Life ◽  
Conformity Assessment ◽  
Medical Applications ◽  
Computational System ◽  
Python Script ◽  
Wearable Robots ◽  
Assessment Procedures

AbstractWearable robots are devices intended to improve the quality of users’ life by augmenting, assisting, or substituting human functions. Exoskeletons are one of the most widespread types of wearable robots, currently used extensively in medical applications (and also for industrial, assistive, or military purposes), thus governed by regulations for medical devices and their conformity assessment. On top of that, manufacturers must also specify if their exoskeletons can be categorized as machines and, therefore, additionally apply a number of requirements mandated from machinery regulations. This work focuses on capturing both the abovementioned requirements enacted by the Medical Devices Directive 2017/745 and the Machinery Directive 2006/42 into a single framework. It formalizes into Rules the Conformity Assessment procedures regarding the marketability of exoskeletons indicated by the CE marking (“Conformité Européene”). These Rules, expressed in the Positional-Slotted Object-Applicative (PSOA) RuleML code, were complemented by representative Facts based on real-life cases of commercialized exoskeletons. Additional Exoskeletons Facts can be included by users from other forms (such as MS Excel) and translated into the PSOA RuleML code through the provided Python script. The open-source Exoskeletons’ CE mark (ExosCE) Rules KB was tested by querying in the open-source PSOATransRun system. The ExosCE Rules prototype can assist in the compliance process of stakeholders and in the registration of exoskeletons with a CE mark.

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.

The Need for a Broad-Based Model of Phonological Disorders

1992 ◽  
Vol 23 (3) ◽  
pp. 261-268 ◽  
Author(s):  
Alan G. Kamhi
Keyword(s):  
Speech Production ◽  
Phonological Disorders ◽  
Production Processes ◽  
Assessment And Treatment ◽  
Speech Delays ◽  
Explanatory Adequacy ◽  
State Of Affairs ◽  
Assessment Procedures ◽  
Treatment Procedures

My response to Fey’s article (1985; reprinted 1992, this issue) focuses on the confusion caused by the application of simplistic phonological definitions and models to the assessment and treatment of children with speech delays. In addition to having no explanatory adequacy, such definitions/models lead either to assessment and treatment procedures that are similarly focused or to procedures that have no clear logical ties to the models with which they supposedly are linked. Narrowly focused models and definitions also usually include no mention of speech production processes. Bemoaning this state of affairs, I attempt to show why it is important for clinicians to embrace broad-based models of phonological disorders that have some explanatory value. Such models are consistent with assessment procedures that are comprehensive in nature and treatment procedures that focus on linguistic, as well as motoric, aspects of speech.

Leadership in Teaching: Using Student Perspectives on Administration, Supervision and Private Practice

2011 ◽  
Vol 14 (1) ◽  
pp. 21-28
Author(s):  
Mary J. Emm ◽  
Christine P. Cecconi
Keyword(s):  
Student Perceptions ◽  
Clinical Supervision ◽  
Private Practice ◽  
Universal Design ◽  
Professional Preparation ◽  
Learning Activities ◽  
Functional Information ◽  
Course Content ◽  
Group Activities ◽  
Assessment Procedures

Clinical supervision is recognized as a distinctive area of practice and expertise, yet professional preparation in this area remains inadequate. This paper presents functional information describing the development and implementation of an experimental course on administration, supervision, and private practice, based on graduate student perceptions and preferences for course content and types of learning activities. Current pedagogical trends for universal design in learning and fostering student engagement were emphasized, including problem-based and collaborative learning. Results suggest that students were highly pleased with course content, interactive and group activities, as well as with assessment procedures used.

Assessing Language and Literacy Skills of School-Aged Children

2008 ◽  
Vol 9 (2) ◽  
pp. 66-70
Author(s):  
Jennifer Walz Garrett
Keyword(s):  
Literacy Skills ◽  
Assessment Tools ◽  
Treatment Goals ◽  
Miscue Analysis ◽  
Language And Literacy ◽  
Speech Language Pathologists ◽  
School Aged Children ◽  
School Based ◽  
Assessment Procedures ◽  
Tools And Methods

Abstract School-based speech-language pathologists assess students to establish eligibility, collect baselines for treatment goals, determine progress during intervention and verify generalization of skills. Selecting appropriate assessment tools and methods can be challenging due to time constraints, agency regulations, and availability of tests. This article will describe legal considerations, types of assessments, and the factors involved with the selection and use of various assessment procedures and tools. In addition, speech-language pathologists will learn to calculate words correct per minute (WCPM) and perform miscue analysis, which can provide additional language and literacy information about a child's educational needs.

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