borderline medical devices

The Internet of Things (IoT) has emerged as a fundamental framework for interconnected device communication, representing a relatively new paradigm and the evolution of the Internet into its next phase. Its significance is pronounced in diverse fields, especially healthcare, where it finds applications in scenarios such as medical service tracking. By analyzing patterns in observed parameters, the anticipation of disease types becomes feasible. Stress monitoring with wearable sensors and the Internet of Things (IoT) is a potential application that can enhance wellness and preventative health management...

Background: Characteristics of patients undergoing outpatient evaluation for advanced cardiac therapies are largely unknown. Objective: To describe demographics, baseline quality of life, and frailty of patients undergoing evaluation for advanced therapies at the time of presentation for evaluation in an outpatient cardiac palliative care clinic and examine key quality of life differences across patients. Design: Retrospective chart review to report baseline demographics and quality of life. Settings/Subjects: Patients at a large academic medical center in the United States referred for advanced cardiac therapies in 2021...

BACKGROUND: The aim of this study was to evaluate the analytical performance of a new transcutaneous bilirubin (TcB) device - BiliCareTM (Gerium Medical, Yavne, Israel). METHODS: The neonatal TcB measurements were compared between BiliCareTM and the existing BiliChekTM systems (n = 40). TcB measured by BiliCareTM were also compared with total serum bilirubin (TSB) using a Roche Cobas702 chemistry analyzer (n = 31) and whole blood bilirubin using a Radiometer ABL 835 (n = 11)...

INTRODUCTION: The study aimed to evaluate the efficacy and safety in 4-year follow-up of Ex-PRESS P-200 mini-shunt implantation versus standard trabeculectomy. MATERIAL AND METHODS: A single-center retrospective study on patients diagnosed with open-angle glaucoma with failed medical treatment and who underwent Ex-PRESS device implantation or standard trabeculectomy was conducted. Seventy-three eyes were included in the analysis, 33 with Ex-PRESS P-200 implantation and 40 with standard trabeculectomy...

Value-based price is estimated quite frequently for medicines, but its application to medical devices is scarce. While some reports have been published in which this parameter has occasionally been determined for devices, no large-scale application has yet been reported. Our objective was to pursue a systematic analysis of the literature published on value-based prices of medical devices. Pertinent papers were selected upon the criterion that the value-based price was reported for the device examined...

OBJECTIVES: Nondimensional indices or numbers can provide a generalized approach for integrating several biological parameters into one Nondimensional Physiological Index (NDPI) that can help characterize an abnormal state associated with a particular physiological system. In this paper, we have presented four Nondimensional Physiological Indices (NDI, DBI, DIN, CGMDI) for the accurate detection of diabetes subjects. METHODOLOGY: The NDI, DBI, and DIN diabetes indices are based on the Glucose-Insulin Regulatory System (GIRS) Model, represented by the governing differential equation of blood glucose concentration response to the glucose input rate...

BACKGROUND: Borderline personality disorder (BPD) is characterized by frequent and intense moment-to-moment changes in affect, behavior, identity, and interpersonal relationships, which typically result in significant and negative deterioration of the person's overall functioning and well-being. Measuring and characterizing the rapidly changing patterns of instability in BPD dysfunction as they occur in a person's daily life can be challenging. Ecological momentary assessment (EMA) is a method that can capture highly dynamic processes in psychopathology research and, thus, is well suited to study intense variability patterns across areas of dysfunction in BPD...

This article has been retracted.

Automatic seizure detection technology has important implications for reducing the workload of neurologists for epilepsy diagnosis and treatment. Due to the unpredictable nature of seizures, the imbalanced classification of seizure and nonseizure data continues to be challenging. In this work, we first propose a novel algorithm named the borderline nearest neighbor synthetic minority oversampling technique (BNNSMOTE) to address the imbalanced classification problem and improve seizure detection performance...

BACKGROUND: Di(2-ethylhexyl) phthalate (DEHP) may produce toxicity, posing a risk to human health. Medical devices composed of DEHP are frequently used in catheterization, but few studies have investigated DEHP exposure during catheterization. The aim of this prospective series was to characterize the exposure pattern of DEHP during catheterization. METHODS: We enrolled 16 patients with congenital heart disease undergoing catheterization. Collection of urine was done to measure DEHP metabolites on hospitalization, before catheterization, after catheterization, and at discharge...

INTRODUCTION: Borderline medical devices are products in a 'gray area,' this means due to their characteristics, they could belong to different 'legal products.' In addition, regulation is a controversial topic and may change depending on the country which may put public health at risk and distort the market. AREAS COVERED: This article analyzes how borderline medical devices are managed in the American and the European legislation. We compared the decisions made by both regulations on the devices of the Manual on Borderline and Classification Medical Devices of the European Commission for the first three sections, those which deal exclusively with medical devices...

BACKGROUND: The aim of this study was to describe clinical characteristics, course, and outcomes of the novel coronavirus disease 2019 (COVID-19) in heart failure patients with left ventricular assist device. METHODS: Between November 2020 and August 2021, a total of 20 patients (18 males, 2 females; mean age: 57.0+10.0 years; range, 30 to 71 years) with left ventricular assist device and who were diagnosed by the COVID-19 polymerase chain reaction testing were included...

Fifteen percent of couples of reproductive age suffer from infertility globally and the burden of infertility disproportionately impacts residents of developing countries. Assisted reproductive technologies (ARTs), including in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), have been successful in overcoming various reasons for infertility including borderline and severe male factor infertility which consists of 20%-30% of all infertile cases. Approximately half of male infertility cases stem from suboptimal sperm parameters...

BACKGROUND: Consumer-grade wearable devices enable detailed recordings of heart rate and step counts in free-living conditions. Recent studies have shown that summary statistics from these wearable recordings have potential uses for longitudinal monitoring of health and disease states. However, the relationship between higher resolution physiological dynamics from wearables and known markers of health and disease remains largely uncharacterized. OBJECTIVE: We aimed to derive high-resolution digital phenotypes from observational wearable recordings and to examine their associations with modifiable and inherent markers of cardiometabolic disease risk...

BACKGROUND: Sarcomas are a heterogeneous group of rare malignant tumors of mesenchymal origin in the musculoskeletal system. The main treatment is surgery often supplemented with pre-or postoperative radiotherapy. A retrospective study by Bedi et al. indicated that negative pressure wound therapy (NPWT) reduced the risk of postoperative wound complications in patients treated with preoperative radiation followed by surgical tumor removal of lower extremity soft tissue sarcomas (STS), and the use of NPWT was not associated with an increased risk of local recurrence...

OBJECTIVE: The medication administration process is complex and consequently prone to errors. Closed Loop Medication Administration solutions aim to improve patient safety. We assessed the impact of a novel medication scanning device (MedEye) on the rate of medication administration errors in a large UK Hospital. METHODS: We performed a feasibility before and after study on one ward at a tertiary-care teaching hospital that used a commercial electronic prescribing and medication administration system...

PURPOSE: Evaluating a real-time complementary bioelectrical diagnostic device based on electrical impedance spectroscopy (EIS) for improving breast imaging-reporting and data system (BI-RADS) scoring accuracy, especially in high-risk or borderline breast diseases. The primary purpose is to characterize breast tumors based on their dielectric properties. Early detection of high-risk lesions and increasing the accuracy of tumor sampling and pathological diagnosis are secondary objectives of the study...

Medical devices and medicinal products have many similarities in their nature, scope or specific medical purposes, and despite the differences in their principal means of action, they are often used in combination. Indeed, many medicinal products depend on medical devices for their administration, and it is increasingly common for medical devices to contain medicinal substances to support their action. Therefore, the combination of medicinal products and medical devices provides additional benefits for patients, but their higher technical complexity requires a strengthening of their authorisation and certification requirements...

OBJECTIVES: We investigated the relationship between lead in air (Pb-A) measured by personal sampling and blood lead (Pb-B) in workers with relatively low lead exposure to estimate the permissible air concentration of lead corresponding to the biological tolerance value of Pb-B of 15 µg/dL. METHODS: We collected air samples at a lead-acid battery factory in Japan by personal sampling devices attached to 32 workers (19 males and 13 females) and measured Pb-A by a graphite furnace atomic absorption spectrophotometer in 2017-2020...

In the UK, the Medicines and Healthcare products Regulatory Agency classifies 'pre-filled syringes' for flushing Intravenous (IV) cannulas and IV access devices as 'borderline' devices and offers some advice on how control measures can help mitigate risks. The Medicines Act (1968) and Medical Device Regulations try to address the legal position of these devices and allow each employer to identify those groups of staff allowed to use them. In turn, this may help address anomalies around the need to prescribe and document their use...