Applicability domain of the GARD® skin Medical Device test for in vitro skin sensitization testing of medical devices

2021 ◽  
Vol 350 ◽  
pp. S92
Author(s):  
R.-M. Jenvert ◽  
R. Brown ◽  
H. Johansson
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Applicability Domain ◽  
Skin Sensitization ◽  
Device Test

Nanostructured Selenium for Preventing Biofilm Formation on Medical Devices

2012 ◽  
Vol 1415 ◽  
Author(s):  
Qi Wang ◽  
Thomas J. Webster
Keyword(s):  
Staphylococcus Aureus ◽  
Medical Device ◽  
Medical Devices ◽  
Biofilm Formation ◽  
In Vitro Study ◽  
Common Cause ◽  
Persistent Infections ◽  
Wide Range ◽  
Novel Material

ABSTRACTBiofilms are a common cause of persistent infections on medical devices as they are easy to form and hard to treat. Selenium and its compounds are considered to be a novel material for a wide range of applications including anticancer applications and antibacterial applications. The objective of this study was to coat selenium nanoparticles on the surface of polycarbonate medical devices and examine their effectiveness at preventing biofilm formation. The results of this in vitro study showed that the selenium coating significantly inhibited Staphylococcus aureus growth on the surface of polycarbonate after 24 hours. Thus, this study suggests that coating polymers with nanostructured selenium is a fast and effective way to reduce bacteria functions leading to medical device infections.

scholarly journals New medical device regulations: the regulator’s view

2019 ◽  
Vol 4 (6) ◽  
pp. 351-356 ◽  
Author(s):  
Tom Melvin ◽  
Marina Torre
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Clinical Investigation ◽  
Pool Data ◽  
Critical Function ◽  
Core Dataset ◽  
Medical Device Manufacturers ◽  
In Vitro Diagnostic ◽  
And Performance

Advances in medical device technology have been dramatic in recent years resulting in both an increased number of medical devices and an increase in the invasiveness and critical function which devices perform. Two new regulations entered into force in Europe in May 2017, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR). These regulations will replace the current directives over the coming years. These regulations, for the first time introduce requirements relating to registries. Medical device manufacturers are required to have systematic methods for examining their devices once available on the market, by systematically gathering, recording and analysing data on safety and performance. Registries can assist public health protection in very practical ways, for example, to help urgently identify patients or devices. Registries can also be powerful tools for collecting and appraising real-world clinical evidence concerning medical devices. Clinical investigations are limited in terms of the sample size and the duration of follow-up which can reasonably be expected. Registries may also be the only available tool to examine rare adverse effects, sub-populations or for time durations which it is not possible or feasible to study in a clinical investigation. By ensuring that a core dataset is collected which can be compared to other registries or trial data, it is possible to pool data to better examine outcomes. There are a range of excellent initiatives which have aimed at ensuring the appropriate regulatory application of registry data. Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180061

scholarly journals A Study on Immunological and Molecular Genetic Test Methods of Bacterial Sexually Transmitted Diseases Reagents

2017 ◽  
Author(s):  
Geun Soo Kim ◽  
San Kim ◽  
Hye Youn Han ◽  
Eunji Kwon
Keyword(s):  
Performance Evaluation ◽  
Sexually Transmitted Diseases ◽  
Medical Device ◽  
Medical Devices ◽  
Test Methods ◽  
Test Method ◽  
Quality And Safety ◽  
Sexually Transmitted ◽  
In Vitro Diagnosis

Chlamydia trachomatis is usally isolated only from humans and is often infected together with other sexually transmitted diseases(STD). C. trachomatis is a serious disease which infects 500 million people per year globally and causes blindness in 7 to 9 million people per year due to continuous infection. Thus, it is urgent to develop (draft) guidelines on the test methods for performance evaluation of medical devices for in vitro diagnosis of bacterial STD(C. trachomatis) based on molecular diagnosis. In this study, in reference to the U.S. FDA Guidance, has derived essential methods for testing performance which are applicable to medical device for in vitro diagnosis of bacterial STD which are used in the field of melecular diagnosis. Because of the establish of the test method for performance evaluation of medical devices, it could provide consistent performance evaluation standards for the approval and examination of products, promote the improvement of the quality and safety of products. This will contribute to the development of the quality and safety of products. This will contribute to the development of medical device for in vitro diagnosis in Korea

Pre-validation of SENS-IS assay for in vitro skin sensitization of medical devices

2021 ◽  
Vol 71 ◽  
pp. 105068
Author(s):  
C. Pellevoisin ◽  
F. Cottrez ◽  
J. Johansson ◽  
E. Pedersen ◽  
K. Coleman ◽  
...  
Keyword(s):  
Medical Devices ◽  
Skin Sensitization

scholarly journals Biological Evaluation of Medical Devices in the Form of Suppositories for Rectal and Vaginal Use

2021 ◽  
Vol 5 (4) ◽  
pp. 228-237
Author(s):  
Oleksandra Dmytrenko ◽  
Maryna Arkhypova ◽  
Darya Starosyla ◽  
Svitlana Rybalko ◽  
Michael Gevorkyan ◽  
...  
Keyword(s):  
Cell Culture ◽  
Vero Cell ◽  
Medical Device ◽  
Medical Devices ◽  
Biological Evaluation ◽  
Vero Cell Culture ◽  
Regulatory Status ◽  
Octenidine Dihydrochloride

Background. Programs of preclinical safety studies of the health care products depend on the regulatory status of the investigated products. The classification of such products, in particular suppositories for rectal and vaginal use, is a critical step of developing tactics for their biological evaluation. Adaptation of biological evaluation methods for the medical devices based on the combination of biologically active substances, as well as evaluation of the results of such studies is urgent task of biomedicine. Objective. To substantiate the regulatory status and to carry out a biological evaluation of medical devices in the form of vaginal suppositories based on octenidine dihydrochloride ("Prodexyn") and in the form of rectal suppositories based on Saw palmetto, Levisticum officinale and Calendula officinalis extracts ("Pravenor"). Methods. Biological evaluation was conducted according to the requirements of ISO 10993 standards using in vitro and in vivo biological test systems (cytotoxicity in cell culture and the MTT test, sensitizing and irritating effect in guinea pigs). Results. The cytotoxicity (СС50) of the medical device "Prodexyn" extract in Vero cell culture was 8.35 μg/ml calculated as octenidine dihydrochloride and 416.65 μg/ml calculated as dexpanthenol. "Pravenor" medical device was found to be non-toxic in Vero cell culture. According to the results of MMT assay CC50 for octenidine dihydrochloride was 1.67 μg/ml, and 83.33 μg/ml – for dexpanthenol. CC50 indicators calculated for the different active ingredients of the medical device "Pravenor" were the following: 50 mg/ml for the dwarf palm berries extract (Saw palmetto), 16.67 mg/ml for the lovage roots extract (Levisticum officinale), and 16.67 mg/ml for the calendula flowers extract (Calendula officinalis). No sensitizing or skin irritating effects were observed in guinea pigs. Conclusions. Biological evaluation of medical devices in the form of rectal suppositories "Pravenor" and vaginal suppositories "Prodexyn" performed using in vitro and in vivo biological systems. It was demonstrated an acceptable level of safety of the products. The MTT test was 5 times more sensitive than the Vero cell culture method in determination of cytotoxicity.

scholarly journals A Study on Immunological and Molecular Genetic Test Methods of Bacterial Sexually Transmitted Diseases Reagents

2017 ◽  
Author(s):  
Geun Soo Kim ◽  
San Kim ◽  
Hye Youn Han ◽  
Eunji Kwon
Keyword(s):  
Performance Evaluation ◽  
Sexually Transmitted Diseases ◽  
Medical Device ◽  
Medical Devices ◽  
Test Methods ◽  
Test Method ◽  
Quality And Safety ◽  
Sexually Transmitted ◽  
In Vitro Diagnosis

Chlamydia trachomatis is usally isolated only from humans and is often infected together with other sexually transmitted diseases(STD). C. trachomatis is a serious disease which infects 500 million people per year globally and causes blindness in 7 to 9 million people per year due to continuous infection. Thus, it is urgent to develop (draft) guidelines on the test methods for performance evaluation of medical devices for in vitro diagnosis of bacterial STD(C. trachomatis) based on molecular diagnosis. In this study, in reference to the U.S. FDA Guidance, has derived essential methods for testing performance which are applicable to medical device for in vitro diagnosis of bacterial STD which are used in the field of melecular diagnosis. Because of the establish of the test method for performance evaluation of medical devices, it could provide consistent performance evaluation standards for the approval and examination of products, promote the improvement of the quality and safety of products. This will contribute to the development of the quality and safety of products. This will contribute to the development of medical device for in vitro diagnosis in Korea

Legal and regulatory update

2005 ◽  
Vol 12 (1) ◽  
Author(s):  
John Wilkinson
Keyword(s):  
European Commission ◽  
Medical Device ◽  
Medical Devices ◽  
Public Consultation ◽  
Implantable Medical Devices ◽  
Post Market Surveillance ◽  
Post Market ◽  
Definition Of ◽  
Regulatory Update

The European Commission has launched a public consultation on its proposed amendments to the Medical Devices Directive (MDD) (Dir 93/42/EEC). The aim of the European Commission's proposals is to improve the coherence, transparency and effectiveness of the legislation governing medical devices in line with the recommendations of the report produced in 2002 by the European Commission's Medical Device Experts Group. This report recommended that the requirements for clinical evaluation of medical devices be clarified, transparency be increased by amending post-market surveillance requirements and that the decision making process be improved by empowering the European Commission to make binding decisions where individual national opinions differ on whether a product falls within the definition of 'medical device'. The report also recommended that the three directives governing medical devices (the MDD, the Active Implantable Medical Devices (AIMD) Directive 90/385/EEC and the In-vitro Medical Devices (IVDD) Directive 98/79/EC) should be made more consistent with each other.

Regulation and Clinical Investigation of Medical Device in the European Union

2019 ◽  
Vol 6 (3) ◽  
pp. 163-181
Author(s):  
Manita ◽  
Aakash Deep ◽  
Vikram ◽  
Avtar C. Rana ◽  
Prabodh C. Sharma
Keyword(s):  
European Union ◽  
Clinical Trials ◽  
Medical Device ◽  
Medical Devices ◽  
Clinical Investigation ◽  
Controlled Trial ◽  
Healthcare Sector ◽  
World Population ◽  
The European Union

Background:: Medical devices are the machine, tool, instrument, apparatus, implant, calibrator in vitro, software, the similar or related object intended for use by the manufacturer alone or in combination becoming increasingly important in the healthcare sector as these are used to diagnosis, control, prevention or treatment of an illness. Safety of the world population is the highest priority in order to launch new medical devices for the treatment and diagnostic of several diseases. New innovation in industries and regulations work together to provide devices for different world market and to improve quality and safety of exiting devices in the market. The main key for devices is to classify the determination of actual regulatory pathway which ensures the safety standards and other regulatory requirements in a specific country. We perform clinical trials for medical device which are quite different from the clinical trials performed for drug analysis. For any high-risk devices, the new EU law states that the manufacturer has to prepare a complete summary for their evidence. The clinical trials regulation provides more transparency on clinical trials data. Complete transparency is required for the maximum possibility of informed decisions in order to use new medical devices. Objective:: The current manuscript will provide the information regarding the regulatory framework for the approval of medical devices and clinical investigation of medical device in European Union and comparison of approval process of medical device in USA, EU and India. The aim of this paper is to provide an overview of the most suitable and emerging requirements that manufacturers need for introducing their medical devices in the market in compliance with the MDR regulations. Conclusion:: The proposal for a modified regulation of medical devices aims to ensure more robust clinical data in support of the CE marking applications of the medical device. The clinical investigation requirements will be mandatory, and there will be an obligation to demonstrate the clinical benefits of the device and provide a rigorous equivalence test if the assessment is based on comparison devices. The new European legislation should require the premarket demonstration of clinical efficacy and safety, using a randomized controlled trial if possible, and a transparent clinical review, preferably centralized.

scholarly journals Medical device: a complete overview

2020 ◽  
Vol 7 (4) ◽  
pp. 285
Author(s):  
Rajganesh Ravichandran ◽  
Raveena Pachal Balakrishnan ◽  
Jaya Shree Dilli Batcha ◽  
Abarna Lakshmi Ravi ◽  
Nikhil Cherian Sam
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Medical Problem ◽  
Human Beings ◽  
Preclinical Testing ◽  
Novel Technologies ◽  
New Device ◽  
Post Marketing Surveillance ◽  
Post Marketing

<p class="abstract">Medical device means any instrument, apparatus, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose. Medical devices are generally classified based on risks; the actual risk-based classification of the medical device depends upon its intended use and purpose.<strong> </strong>Development of an entirely new device typically begins with a concept by a physician or bioengineer for a solution to a medical problem. If the idea is determined to be workable and practical (proof of concept) an early design of the device, known as a prototype, will be built. A prototype device will undergo a cycle of preclinical testing, redesigning, preclinical testing of the redesign and so forth, until the design has been refined and tested to a point that it is ready for production and testing in humans. Preclinical animal tastings are conducted to provide reasonable evidence that novel technologies and therapies are safe and effective. When studying medical devices, clinical trials are not always required, and whether or not one will be conducted depends on a risk assessment. Post marketing surveillance is the practice of monitoring the safety of a medical device after it has been released on the market.</p>

EU AND MEMBER STATE MEDICAL DEVICES REGULATION

2003 ◽  
Vol 19 (1) ◽  
pp. 228-248 ◽  
Author(s):  
Christa Altenstetter
Keyword(s):  
Member State ◽  
Medical Device ◽  
Prescription Drugs ◽  
Medical Devices ◽  
State Regulation ◽  
Surveillance Systems ◽  
Member States ◽  
Instructions For Use ◽  
The Eu

This article examines European Union (EU) and member state regulation of medical devices, particularly: a) the similarities and differences between medical devices and prescription drugs, including the respective industries, market authorization pathways, and boundary issues between the two sectors; b) the political background, current nature, and future prospects for EU medical device regulation; and c) regulatory responsibilities of the member states. Included are definitions of medical devices and in vitro diagnostics, and a brief history of their treatment by European law. The erosion of boundaries between exclusive and shared responsibilities of the EU and member states will be addressed, especially as it affects market approval of medical devices, clinical investigations, labeling and instructions for use, price setting and reimbursement, and evidence-based medicine and healthcare technology assessment. Finally, the article discusses medical device reporting and surveillance systems, which may be the weakest link in the EU integrative process. If patient safety is as important to the EU regulatory scheme as free movement and competitiveness, then both Brussels and member states will require additional resources, as well as measures to overcome obstacles to implementation, evaluation, and accountability.

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