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PubMed Journals Articles About "Medical Devices Device Combination Products Voluntary Malfunction Summary" RSS

16:33 EDT 23rd March 2019 | BioPortfolio

Medical Devices Device Combination Products Voluntary Malfunction Summary PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Medical Devices Device Combination Products Voluntary Malfunction Summary articles that have been published worldwide.

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Showing "Medical Devices Device Combination Products Voluntary Malfunction Summary" PubMed Articles 1–25 of 19,000+

Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers. Notification; order granting alternative.

The Food and Drug Administration’s (FDA, Agency, or we) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research are announcing that the Agency is granting an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. We refer to this alternative as the "Voluntary Malfunction Summary Reporting Program." This voluntary program reflects goals for streamlining malfunction reporting outlin...


An Analysis of Foot and Ankle Device Recalls by the Food and Drug Administration.

Introduction Orthopaedic devices represent 12% of all medical device recalls. Products are approved through pre-market approval (PMA) or the 510(k) premarket notification process. No previous evaluation was found in the literature evaluating foot and ankle device recalls. The field of foot and ankle subspecialty has seen a rapid growth in innovation related to implants in recent years. Methods The Food and Drug Administration (FDA) Device Recall database was evaluated for all foot and ankle devices from 20...

Unique device identification and traceability for medical software: A major challenge for manufacturers in an ever-evolving marketplace.

Similarly to what already established and implemented in the United States, the concept of the Unique Device Identification (UDI) system has been introduced with the European Regulations for medical devices MDR (EU) 2017/745 and in-vitro diagnostic medical devices IVDR (EU) 2017/746 and it is on the way to become a worldwide standard. The aim of this work was to provide a possible approach for the implementation of UDI and traceability in Europe for standalone software medical devices according to lifecycle...


Fabrication of Electrochemical-Based Bioelectronic Device and Biosensor Composed of Biomaterial-Nanomaterial Hybrid.

The field of bioelectronics has paved the way for the development of biochips, biomedical devices, biosensors and biocomputation devices. Various biosensors and biomedical devices have been developed to commercialize laboratory products and transform them into industry products in the clinical, pharmaceutical, environmental fields. Recently, the electrochemical bioelectronic devices that mimicked the functionality of living organisms in nature were applied to the use of bioelectronics device and biosensors....

Tackling the concept of symbiotic implantable medical devices with nanobiotechnologies.

This review takes an approach to implanted medical devices that considers whether the intention of the implanted device is to have any communication of energy or materials with the body. The first part describes some specific examples of 3 different classes of implants, analysed with regards to the type of signal sent to cells. Through several examples, we describe that a one way signalling to the body leads to encapsulation or degradation. In most cases, those phenomena do not lead to major problems. Howev...

Analytical strategy for assessment of usability of medical devices from the user's perspective: a study of hemodialysis patients.

Studies have shown the importance of including the user's experience in measuring the usability of medical devices. Still, the user's assessment depends on the context of use for the treatment received. To measure the usability in such a way as to separate these effects and understand the sources affecting users' perceptions, the article proposes an analytical strategy that assesses the effect of the context of use on measuring the device's usability. Next, we create indicators that are free of these effect...

Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures. Final rule.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is also making additional changes unrelated to the FDASIA requirements, to update its regulations governing the classification and reclassification of medical...

Bring-your-own-device in medical schools and healthcare facilities: A review of the literature.

Enabling personal mobile device use through a bring-your-own device (BYOD) policy can potentially save significant costs for medical schools and healthcare facilities, as they would not always have to acquire facility-owned devices. The BYOD policy is also perceived as a driver for balancing user needs for convenience with institutional needs for security. However, there seems to be a paucity in the literature on BYOD policy development, policy evaluation, and evaluation of mobile device implementation proj...

Reducing levels of medical device contamination through package redesign and opening technique.

The goal of this research was to evaluate how material curl, package structure and handling of pouches containing medical devices affect rates of contact between non-sterile surfaces and sterile devices during aseptic transfer.

The Ethics of Smart Pills and Self-Acting Devices: Autonomy, Truth-Telling, and Trust at the Dawn of Digital Medicine.

Digital medicine is a medical treatment that combines technology with drug delivery. The promises of this combination are continuous and remote monitoring, better disease management, self-tracking, self-management of diseases, and improved treatment adherence. These devices pose ethical challenges for patients, providers, and the social practice of medicine. For patients, having both informed consent and a user agreement raises questions of understanding for autonomy and informed consent, therapeutic miscon...

Consumer protection provided by the European medical device and cosmetic legislation for condoms and lubricants.

Personal lubricants and lubricants used in condoms contain a number of ingredients which are also present in cosmetic products. They have to comply with the medical device regulation (745/2017). It is assumed that they provide the same level of consumer protection, if not more, as foreseen in the legal framework of cosmetics (1223/2009). In the current study we developed an analytical method capable of identifying and quantifying 15 ingredients, commonly found in lubricants and cosmetics. Based upon their m...

Bone Overgrowth Causing a Proximal Ventriculoperitoneal Shunt Malfunction.

Hydrocephalus is an international disease process that is commonly treated surgically with a ventriculoperitoneal shunt. This device may be prone to malfunction, most commonly from obstruction, disconnection, or infection.

Economics of Medical Devices in India.

Most of the industrial sectors of India have undergone major changes in the post-liberalization period. During this period, India has become self-reliant in drugs; however, still, 75% of the medical devices are imported in India. According to WHO, almost all devices present in the developing countries have been designed for use in the industrialized countries. With the increase in incidence of non-communicable diseases and decrease in communicable diseases; increase in survival rates and decrease in mortali...

A Reference Architecture for Secure Medical Devices.

We propose a reference architecture aimed at supporting the safety and security of medical devices. The ISOSCELES (Intrinsically Secure, Open, and Safe Cyber-Physically Enabled, Life-Critical Essential Services) architecture is justified by a collection of design principles that leverage recent advances in software component isolation based on hypervisor and other separation technologies. The instantiation of the architecture for particular medical devices is supported by a development process based on Arch...

Combination and placement of sustainable drainage system devices based on zero-one integer programming and schemes sampling.

The combination and placement of sustainable drainage systems (SuDS) devices is important for system design, but differing site characteristics and device properties can make this a challenging task. Opinion-based and optimization-based approaches have the disadvantages of subjectivity and excessive computational burden respectively. This paper presents a new framework for SuDS device combination and placement in system design. It integrates zero-one integer programming, random sampling, scheme filtering an...

Treatment planning and dental technology for patients with implanted cardiac devices.

Implantable cardiac devices are increasingly common in the dental patient population. These devices include cardiac pacemakers, implantable cardioverters-defibrillators, and combination designs. To safely follow through with treatment, the clinician first must identify the patient's underlying medical condition warranting the device and consider the condition as well as the device in determining diagnosis, drug selection, appointment length, follow-up, and outcome expectations. Modern implantable devices ar...

Psychosocial characteristics of blood donors influence their voluntary nonmedical lapse.

Approximately 10% of Dutch donors lapse yearly. Common reasons are nonvoluntary medical issues (e.g., low hemoglobin), reaching the upper age limit, and voluntary (e.g., own request, nonresponse). Little is known about predictors of voluntary noncompliance (lapses). Psychosocial characteristics have been linked to various health behaviors, including voluntary noncompliance. Hence, we investigated whether psychosocial characteristics, measured before the first donation, similarly predict subsequent voluntary...

Is the PrePex device an alternative for surgical male circumcision in adolescents ages 13-17 years? Findings from routine service delivery during active surveillance in Zimbabwe.

Male circumcision devices have the potential to accelerate adolescent voluntary medical male circumcision roll-out. Here, we present findings on safety, acceptability and satisfaction from active surveillance of PrePex implementation among 618 adolescent males (13-17 years) circumcised in Zimbabwe.

E-cigarette devices used by high-school youth.

Background E-cigarette use rates are high among youth, but there is limited information on the types of e-cigarette devices that are used by youth. Methods During Spring 2017, students from 4 high schools completed surveys on use of e-cigarette devices (cig-a-like, vape/hookah pen, modified devices or mods, and JUUL). Among youth who endorsed ever (lifetime) use of an e-cigarette and of at least one device (n = 875), we assessed 1) prevalence rates of ever and current (past-month) use of each device, 2)...

Tolerability and efficacy of a medical device repairing emollient cream in adults with chronic hand dermatitis.

Emollients are recommended for managing chronic hand dermatitis (CHD). Medical device repairing emollient creams (MDRECs) are suitable for treating CHD-associated skin lesions, unlike most cosmetic emollient products that can only be used on healthy skin.

OpenCLIPER: an OpenCL-based C++ Framework for Overhead-Reduced Medical Image Processing and Reconstruction on Heterogeneous Devices.

Medical image processing is often limited by the computational cost of the involved algorithms. Whereas dedicated computing devices (GPUs in particular) exist and do provide significant efficiency boosts, they have an extra cost of use in terms of housekeeping tasks (device selection and initialization, data streaming, synchronization with the CPU and others), which may hinder developers from using them. This paper describes an OpenCL-based framework that is capable of handling dedicated computing devices s...

Legislative and regulatory framework of medical products circulation.

An important task of modern public health is improvement of quality of rendering of medical aid to the population. Means for its support at all stages of the serve of a medical device (instruments, apparatus, materials, etc.), quality, safety and efficacy which play a key role to maintain and improve the quality of life of the population.

Nanostim-leadless pacemaker.

Nanostim™ (St. Jude Medical Inc., Saint Paul, MN, USA; now Abbott Medical Inc. Abbott Park, IL, USA) was the first self-contained intracardiac pacemaker to be implanted in a human patient. A total of 1423 Nanostim devices were implanted worldwide between 2013 and 2016 and three clinical trials were initiated. Although the device was recalled in 2016 owing to rare but serious battery failures, the concept of leadless pacing has gained widespread acceptance and is expanding beyond the initial single-chamb...

Personal mobile device-based pocket echocardiograph-The diagnostic value and clinical utility.

A microUSB ultrasound probe, which can be connected to a personal mobile device constitutes a new class of diagnostic pocket-size imaging devices (PSID). The aim of this study was to assess the feasibility and diagnostic value of brief transthoracic echocardiographic examination (bTTE) performed with the use of such equipment.

Use of nutritional devices in Cornelia de Lange syndrome: Data from a large Italian cohort.

Cornelia de Lange syndrome (CdLS) is a genetic condition characterized by intellectual disability, peculiar facial dysmorphisms, multiorgan malformations, and growth problems. Majority cases of CdLS are caused by mutations in genes of Cohesin pathway. Although feeding problems are a well-known feature, no specific data have been published about the use of nutritional devices. We analyzed use, type, time of introduction, and duration of nutritional devices in 73 CdLS patients. In total, 29/73 (40%) used a de...


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