Euroquality

Medical devices are a very large family of instruments, machines, systems, reagents and much more, all characterized by having a specific medical purpose. This definition is not univocal and there are changes in the different regulatory contexts of individual countries. In this chapter we will mainly refer to the definitions of medical devices according to European legislation, but we will also make some references to other nations, namely the United States and China. We will also describe the different categories of medical devices and some of their characteristics. The classification rules defined by the European MDR and IVDR regulations will be introduced, both for medical devices and for in vitro diagnostics, and numerous examples of devices will be reported with the indication of the corresponding risk class. Finally, we will present the typical development process of a medical device, from conception to placing it on the market.

Abstract There is a steep linear increase in patients surviving a cancer diagnosis. Clinical solutions that address the high prevalence of cancer-related treatment effects (CRTE) are urgently needed. A stark example of this need is the dearth of screening and treatment programs for cancer related cognitive impairment (CRCI) (colloquially called “chemo-brain”). Up to 75% of cancer patients report neurocognitive changes that leave patients unable to cope with the expectations of employers, colleagues, families, and friends. The prevalence of neurological disorders is 275% higher among adult cancer patients, when compared to an adult cancer-free population. For many adolescent and young adult cancer patients, the onset of CRCI occurs during "cognitive prime time"; a time when individuals are pursuing education, careers, and raising families. To address a gap in CRTE we have implemented a virtual multi-disciplinary intervention to measure and treat CRCI. Our CRCI intervention follows National Comprehensive Cancer Network and American Society of Clinical Oncology (ASCO) guidelines for CRCI. These guidelines indicate a multi-disciplinary approach with emphasis on increasing physical activity levels, cognitive-behavioral therapy, memory adaptive training, mood management, and sleep optimization. Our approach also follows recent ASCO guidelines for nutrition counseling. Our CRCI program utilizes medical oncologists, physician assistants, mental health therapists, registered dietitians, and occupational therapists. A nationally validated patient reported outcome (PRO) measurement, analysis, and reporting platform informs clinical treatment pathways, monitors patient progress, guides clinical decision making, and improves patient/provider communication. Using health status measures for CRCI, and following American Cancer Society and ASCO guidelines, patients are risk-stratified into three personalized cancer survivor care pathways: 1) low-complexity patients; 2) medium-complexity patients; and 3) high-complexity patients. Low-complexity patients baseline PROs score in the normal range, medium-complexity patients are those who score below the norm (moderate to large effect size difference from normal), and high-complexity patients are those who score well below the norm (greater than larger effect size difference from normal). Low-complexity patients are enrolled into a self-management and continuation of care program. Medium-complexity patients are enrolled into a shared care program. High-complexity patients are enrolled into an acute care program. All three clinical pathways include continued risk-factor vital-sign surveillance. Nearly 100% (99%) of patients who enroll in our primary cancer survivor care program complete our PRO baseline (N=80). From a convenient sample of breast cancer patients (N=42), provisional results of patient-specific segmentation analyses reveal a nearly perfect bell-shaped curve, with 51% of the population classified within the definition of medium-complexity and even split of outliers (high-complexity 24% and low-complexity 24%). Additionally, of all patients in our primary cancer survivor care program who completed at least three measurement time points for health status measures of cognitive impartment (N=38), 92% had a positive experience, 71% had a clinically significant improvement in cognitive health, 21% had a no change in cognitive status, and only 8% had a decline in cognitive health. If these data, and PRO implementation approach hold true, this program could be scaled to national and international cancer survivor population suffering from CRCI. Citation Format: John Librett, Mark Kosinski, Gregory Litton. Use of a standardized tool for the evaluation and treatment of cancer related cognitive impairment (chemo-brain) among breast cancer patients [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-11-10.

This paper analyses the transformation of electoral cleavages in Brazil since 1989 using a novel assembly of electoral surveys. Brazilian political history since redemocratization is largely a history of the rise and fall of the Workers' Party (Partido dos Trabalhadores, PT). We show that the election of Lula da Silva as President in 2002, followed by the implementation of redistributive policies by successive PT governments, was at the origin of the marked socioeconomic cleavages that emerged. In a relatively short space of time the PT transformed itself from a party of the young, highly educated, high-income elite of the Southern party of the country, to a party of the poor and lesser educated voters, increasingly located in the disadvantaged region of the Northeast. Controlling for a host of socio-demographic factors, a voter in the Northeast was 20 percentage points more likely to vote for the PT in 2018 than voters in other regions, compared to being 5 percentage points less likely to do so in 1989. In sharp contrast to other western democracies, political conflict in Brazil has followed an increasingly unidimensional class-based path. This culminated in the unification of elites and large parts of the middle class behind Bolsonaro in the 2018 presidential election. We argue that contextual policy-driven factors and programmatic alliances are key to understand the PT's singular evolution, and thus the transformation of electoral cleavages in Brazil.

The recommendations that we formulate in this document come from LABAC, SFBC and FAEEQ. They describe the different steps from the initial application of quality controls, based on risk analysis: the changes of reagent batches or internal quality controls (IQC) batches, the course when IQC are not in accordance with references, the choice of external quality evaluation and the interpretation of its results, the comparability of results obtained in several analysers used in the same laboratory. Lastly, measurement uncertainty, robustness of methods and specificities of near-patient biology and rapid tests are described. Note that these recommendations cannot develop all cases that we could find in laboratories. It remains necessary to carry out an objective strategy, supported with documentary evidences.