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The article presents the discussion on introduction of a new Sterile Barrier System (SBS) constituting a significant change to the instrumentation circuit. Topics include decision having implications for the entire workflow patterns of the nursing personnel in the operating room (OR); and risk of perforation while using sheet packaging being reduced by fitting edge protection aids.

The article presents the discussion on job description setting out tasks, powers, and competencies. Topics include management board, economic operator, RUMED management, and shift management with reference to an organigram; management of incoming contaminated medical devices destined for automated and manual cleaning or disinfection; and inspection and release of sterile supplies.

The article presents the discussion on Quality assurance in the RUMED through well-targeted personnel qualification. Topics include reducing disruptions in the overall supply chain process such as postponement of surgical procedures; and personnel support, process observation, and quality control being additional quality assurance tools.

The article highlights the recommendations of Germany's Quality Task Force for maintaining hygiene standards when dealing with external persons in the Reprocessing Unit for Medical Devices (RUMED). Topics discussed include health risks facing external persons in the RUMED, hazard assessment as per the Biological Agents Regulation, and mandatory protective measures for external persons.

The article examines the implications of the Medical Device Regulation (MDR) for operators of medical devices in healthcare institutions in the European Union (EU). Topics discussed include important changes introduced by the MDR for medical device operators and manufacturers, implications of changes to the classification system, and the Medical Device Law Implementing Act in Germany.

The article presents the transport and storage not adversely affecting the medical device characteristics. Topics include sterilized medical devices (MDs) being protected against contamination when transported between the reprocessing department and the site of use; using MDs harbor potentially infectious contaminants against which the must be protected; and sterilized MDs must be transported separately from non-sterilized MDs in ruling out contamination.

The article offers information related to the implications of Medical Device Regulation (MDR) for the economic operator. It mentions about the changes introduced by MDR for economic operators including medical device identification system changes with the incorporation of a Unique Device Identifier; and need of additional documentation obligations due to new class III devices.

Currently, heat-sensitive flexible endoscopes are reprocessed in central RUMEDs, a RUMED situated within the endoscopy department as well as in decentral RUMEDs. Before deciding where reprocessing is to be carried out, structural and technical prerequisites, manpower as well as organizational and logistical structures must be considered. Regardless of the choice of reprocessing site, reprocessing must meet the same quality requirements. Following manual precleaning and cleaning, flexible endoscopes should preferably undergo automated reprocessing in an automated endoscope reprocessor (AER) using validated processes (EN ISO 15883-4 [5]). Depending on the type of endoscope used, validated reprocessing processes must meet various requirements and include manual precleaning , automated cleaning and disinfection in an AER, drying, and possibly sterilization and storage. That calls for personnel with commensurate specialist knowledge and qualifications. The structural and technical facilities are the key to consistent separation between unclean and clean work steps, reprocessing safety and infection prevention. If sterilization is indicated for medical and hygiene reasons for heat-sensitive components, a suitable low-temperature process should be chosen in accordance with the manufacturer's instructions. [ABSTRACT FROM AUTHOR]

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Objectives: Study objective was to map the current literature on the economic effects of priority setting at the system level in healthcare., Design: The study was conducted as a scoping review., Data Sources: Scopus electronic database was searched in June 2023., Eligibility Criteria: We included peer-reviewed articles published 1 January 2020-1 January 2023. All study designs that contained empirical evidence on the financial effects or opportunity costs of healthcare priority setting were included excluding disease, condition, treatment, or patient group-specific studies., Data Extraction and Synthesis: Two independent researchers screened the articles, and two additional researchers reviewed the full texts and extracted data. We used Joanna Briggs Institute checklists to assess the quality of qualitative, quasi-experimental and economic evaluations and the mixed methods appraisal tool for the mixed method studies. Synthesis was done qualitatively and through descriptive statistics., Results: 8869 articles were screened and 15 fulfilled the inclusion criteria. The most common study focus was health technology assessment (7/15). Other contexts were opportunity costs, effects of programme budgeting and marginal analysis, and disinvestment initiatives. Priority setting activities analysed in the studies did not achieve cost savings or cost containment (4/15) or have mixed findings at best (8/15). Only five studies found some indication of cost savings, cost containment or increased efficiency. Also, many of the studies consider costs only indirectly or qualitatively., Conclusions: All in all, there is very little research addressing the pressing question of whether explicit priority setting and priority-setting methods can support cost containment on a health service system level (regional or national). There is limited evidence of the economic effects of priority setting., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Users' feedback is a key asset for organizations that want to improve their services. Studying how organizations are enabling their users to participate in evaluation activities is particularly important, especially when there are vulnerable or disadvantaged people, and the services to be evaluated can be life-changing. This is the case in the coassessment by pediatric patients experiencing hospital stay. The international literature reports a few attempts and several challenges in systematically collecting and using the pediatric patient experience with respect to hospitalization, to undertake quality improvement actions., Objective: This paper describes the research protocol of a European project intended to develop and implement a systematic pediatric patient-reported experience measures (PREMs) observatory that will be shared by 4 European children's hospitals in Finland, Italy, Latvia, and the Netherlands., Methods: The VoiCEs (Value of including the Children's Experience for improving their rightS during hospitalization) project uses a participatory action research approach, based on a mixture of qualitative and quantitative methods. It consists of 6 different phases, including a literature review, an analysis of the previous experiences of pediatric PREMs reported by project partners, a Delphi process, a cycle of focus groups or in-depth interviews with children and their caregivers, a series of workshops with interactive working groups, and a cross-sectional observational survey. The project guarantees the direct participation of children and adolescents in the development and implementation phases of the project., Results: The expected results are (1) a deeper knowledge of published methodologies and tools on collecting and reporting pediatric patients' voice; (2) lessons learnt from the analysis of previous experiences of pediatric PREMs; a consensus reached through a participatory process (3) among experts, (4) pediatric patients and caregivers about a standard set of measures for the evaluation of hospitalization by patients; (5) the implementation of a European observatory on pediatric PREMs; and (6) the collection and comparative reporting of the pediatric patients' voice. In addition, the project is aimed at studying and proposing innovative methodologies and tools for capturing the pediatric patients' feedback directly, avoiding the intermediation of parents/guardians., Conclusions: Over the last decade, the collection and use of PREMs have gained importance as a research field. Children and adolescents' perspectives have also been increasingly taken into consideration. However, to date, there are limited experiences regarding the continuous and systematic collection and use of pediatric PREMs data for implementing timely improvement actions. In this perspective, the VoiCEs project provides room for innovation, by contributing to the creation of an international, continuous, and systematic pediatric PREMs observatory that can be joined by other children's hospitals or hospitals with pediatric patients, and foresees the return of usable and actionable data in benchmarking., International Registered Report Identifier (irrid): DERR1-10.2196/42804., (©Sabina De Rosis, Manila Bonciani, Veronica Spataro, Ilaria Corazza, Elisa Conti, Barbara Sibbles, Jan A Hazelzet, Pekka Lahdenne, Katariina Gehrmann, Francesca Menegazzo, Michela Sica, Vita Šteina, Guna Esenberga, Elise M Chapin, Stefania Solare, Milena Vainieri. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 03.04.2023.)

Over a decade ago, the participants at the International Consensus Conference on Intersex proposed Disorders of Sex Development (DSD) as an umbrella term for "congenital conditions in which the development of chromosomal, gonadal, or anatomical sex is atypical". The Group recommended the terminology be sensitive to concerns of individuals having these conditions. Yet, controversy rages over the term DSD. This multicentre clinical evaluation study was initiated as part of the European research group dsd-LIFE to evaluate patient-reported outcome. In total, 1,040 individuals with conditions labeled as Disorders of Sex Development were recruited in Poland, Sweden, Germany, France, United Kingdom and the Netherlands. All participants were asked to rate the terms describing their conditions. Overall, a large majority of participants (69%) reported that the term Disorders of Sex Development applied to their condition or that they felt neutral about it. Most participants preferred terms that were specific to their somatic condition. Overall, our data do not support the view that, in general, the term Disorders of Sex Development is insensitive to concerns of affected persons and that it should therefore be abandoned. However, in the clinical encounter, we recommend that clinicians evaluate each patient's preferences.

Purpose: Although sexuality has been reported to be impaired in females with congenital adrenal hyperplasia (CAH) resulting from 21-hydroxylase deficiency, sexuality in males with CAH so far has remained largely unconsidered., Patients: One of the largest European male cohorts of patients with CAH in which sexuality in male patients with CAH was assessed., Methods: Sexuality was evaluated in 91 sexually active male patients with CAH using questionnaires investigating sexual orientation, age at sexual initiation, sexual activity, satisfaction with sex life, and sexual problems, such as fears or dislike of sexual activity, lack or excessive sexual desire, difficulties getting aroused or reaching an orgasm, premature ejaculation, and no or incomplete erection., Results: Sexuality in male patients with CAH was similar to European reference populations. If sexuality problems were present, they were less frequently reported by the most severely affected CAH males. Adducing a holistic perspective, sexual problems showed substantial association to psychological problems, such as anxiety and depression., Conclusions: Sexuality in male patients with CAH in general was unaffected and sexuality problems seemed to be associated in particular with psychological problems. Because sexual health is a key factor of general health, we recommend that sexuality as well as psychological issues explicitly should be addressed in health care of patients with a CAH diagnosis, independent of sex.

Background: dsd-LIFE is a comprehensive cross-sectional clinical outcome study of individuals with disorders/differences of sex development (DSD). This study focuses on various rare genetic conditions characterized by impaired gonadal or adrenal functionality., Methods/design: The study aims to assess quality of life (QoL) as a measure of psychosocial adaptation, psychosexual and mental health aspects as major outcomes. Health status and functioning, medical and surgical therapies, participants' views on health care, psychological and social support, sociodemographic factors and their interrelations will be investigated as factors associated with the outcomes. In addition, ethical considerations in the field of DSD are addressed and previous experiences with health care were gathered. One thousand and forty participants with different DSD conditions were recruited by 14 study centres in 6 European countries (France, Germany, the Netherlands, Poland, Sweden and the United Kingdom) from February 2014 until September 2015. The conditions included were: Turner syndrome (n = 301); 45,X0/46,XY conditions (n = 45); Klinefelter syndrome (n = 218); 47,XYY (n = 1); 46,XY gonadal dysgenesis/ovotestes (n = 63); complete androgen insensitivity (CAIS) (n = 71); partial androgen insensitivity (PAIS) (n = 35) and androgen synthesis disorders (n = 20); severe hypospadias (n = 25); other or non-classified 46,XY DSD (n = 8); 46,XX congenital adrenal hyperplasia (CAH) (n = 226); 46,XX gonadal dysgenesis/ovotestis (n = 21); and 46,XX in males (n = 6). For an add-on study, 121 46,XY male-assigned individuals with CAH due to 21-hydroxylase deficiency were recruited. Mean age of participants' was 32.4 (+/- 13.6 years)., Discussion: Participation was high in conditions not commonly described as DSD, such as Turner and Klinefelter syndromes or CAH. Recruitment of individuals with XY DSD conditions proved to be more difficult. The data collection of PROs resulted in high data quality. Within medical and physical examination data, more missings and/or inaccurate data were found than expected. The European dsd-LIFE study recruited and evaluated the largest cross-sectional sample of individuals with different conditions classified under the term DSD. The data from this large sample will provide a sufficient basis for evidence-based recommendations for improvement of clinical care of individuals affected by a DSD condition., Trial Registration: German Clinical Trials Register DRKS00006072 .