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Additive manufacturing (AM) has continuously grown in recent decades. Enhanced quality, further development of technology, and fall in prices make AM applicable and capable for various industrial applications, also for the manufacture of medical devices. 3D printing offers the possibility for an unprecedented adaptation to the anatomy of each patient, generating medical devices on a case-by-case basis. In many jurisdictions, custom-made devices qualify for an exemption to pre-market approval standards. This regulation is called into question by new technologies, like AM. Therefore, this article compares the current regulatory requirements for custom-made devices in Europe, the United States, and Australia and discusses the impact on 3D printed devices. It concludes that not all jurisdictions have yet adjusted their regulatory framework for custom-made devices to technological advances. Remaining uncertainties must be eliminated in order to help manufacturers comply with the regulatory requirements, emphasizing key aspects of AM.
Die computergestützte Modellierung und Simulation (CMS) ist in vielen Bereichen der Industrie gängige Praxis und hat das Potenzial die Medizintechnikbranche zu revolutionieren. Die Markteinführung neuer Produkte kann erheblich beschleunigt und entstehende Kosten können reduziert werden, ohne die Patientensicherheit negativ zu beeinflussen. Dennoch beruhen die Entwicklungs- und Zulassungsprozesse in der Medizintechnik bis dato überwiegend auf experimentell ermittelten Daten, was in Europa unter anderem auf die bestehenden regulatorischen Unsicherheiten zurückzuführen ist. Verglichen mit der FDA hat die EU-Kommission die Möglichkeiten der CMS bisher nicht erkannt – es fehlt an rechtlichen Vorgaben. Der folgende Artikel soll daher eine Übersicht der aktuellen regulatorischen Situation bieten.
Background: Electronic medical records (EMRs) play a key role in improving documentation and quality of care in paediatric palliative care (PPC). Inadequate EMR design can cause incorrect prescription and administration of medications. Due to the fact of complex diseases and the resulting high level of medical complexity, patients in PPC are vulnerable to medication errors. Consequently, involving users in the development process is important. Therefore, the aim of this study was to evaluate the acceptance of a medication module from the perspective of potential users in PPC and to involve them in the development process. Methods: A qualitative observational study was conducted with 10 nurses and four physicians using a concurrent think-aloud protocol and semi-structured qualitative interviews. A qualitative content analysis was applied based on a unified theory of acceptance and use of technology. Results: Requirements from the user’s perspective could be identified as possible influences on acceptance and actual use. Requirements were grouped into the categories “performance expectancies” and “effort expectancies”. Conclusions: The results serve as a basis for further development. Attention should be given to the reduction of display fragmentation, as it decreases cognitive load. Further approaches to evaluation should be taken.
Background: Electronic medical records (EMRs) play a key role in improving documentation and quality of care in paediatric palliative care (PPC). Inadequate EMR design can cause incorrect prescription and administration of medications. Due to the fact of complex diseases and the resulting high level of medical complexity, patients in PPC are vulnerable to medication errors. Consequently, involving users in the development process is important. Therefore, the aim of this study was to evaluate the acceptance of a medication module from the perspective of potential users in PPC and to involve them in the development process. Methods: A qualitative observational study was conducted with 10 nurses and four physicians using a concurrent think-aloud protocol and semi-structured qualitative interviews. A qualitative content analysis was applied based on a unified theory of acceptance and use of technology. Results: Requirements from the user’s perspective could be identified as possible influences on acceptance and actual use. Requirements were grouped into the categories “performance expectancies” and “effort expectancies”. Conclusions: The results serve as a basis for further development. Attention should be given to the reduction of display fragmentation, as it decreases cognitive load. Further approaches to evaluation should be taken.
Background: Paediatric palliative care (PPC) is a noncurative approach to the care of children and adolescents with life-limiting and life-threatening illnesses. Electronic medical records (EMRs) play an important role in documenting such complex processes. Despite their benefits, they can introduce unintended consequences if future users are not involved in their development. Aim: The aim of this study was to evaluate the acceptance of a novel module for nursing documentation by nurses working in the context of PPC. Methods: An observational study employing concurrent think-aloud and semi-structured qualitative interviews were conducted with 11 nurses working in PPC. Based on the main determinants of the unified theory of acceptance and use of technology (UTAUT), data were analysed using qualitative content analysis. Results: The main determinants of UTAUT were found to potentially influence acceptance of the novel module. Participants perceived the module to be self-explanatory and intuitive. Some adaptations, such as the reduction of fragmentation in the display, the optimization of confusing mouseover fields, and the use of familiar nursing terminology, are reasonable ways of increasing software adoption. Conclusions: After adaptation of the modules based on the results, further evaluation with the participation of future users is required.
Approaches to Improvement of Digital Health Literacy (eHL) in the Context of Person-Centered Care
(2022)
The skills, knowledge and resources to search for, find, understand, evaluate and apply health information is defined as health literacy (HL). If individuals want to use health information from the Internet, they need Digital Health Literacy (eHL), which in addition to HL also includes, for example, media literacy. If information cannot be found or understood by patients due to low (e)HL, patients will not have the opportunity to make informed decisions. In addition, many health apps for self-management or prevention also require (e)HL. Thus, it follows that active participation in healthcare, in terms of Person-Centered Care (PCC) is only possible through (e)HL. Currently, there is a great need to strengthen these competencies in society to achieve increased empowerment of patients and their health. However, at the same time, there is a need to train and improve competencies in the field of healthcare professionals so that they can counsel and guide patients. This article provides an overview with a focus on HL and eHL in healthcare, shows the opportunities to adapt services and describes the possible handling of patients with low (e)HL. In addition, the opportunities for patients and healthcare professionals to improve (e)HL are highlighted.
Abstract The development and application of digital interventions in health-related topics are gaining momentum in health service research. Digital interventions are often complex and need to be evaluated and implemented in complex settings. Due to their characteristics, this poses methodological challenges for health services research that have to be identified and addressed. Hence, the Working Group on Digital Health of the German Network for Health Services Research (DNVF) has prepared a discussion paper. This paper discusses methodological, practical and theoretical challenges associated with the development and evaluation of digital interventions from the perspective of health services research. Possible solutions are suggested and future research needs to address these methodological challenges are identified.
Abstract The methodological challenges of evaluating digital interventions (DI) for health services research are omnipresent. The Digital Health Working Group of the German Network for Health Services Research (DNVF) presented and discussed these challenges in a two-part discussion paper. The first part addressed challenges in definition, development and evaluation of DI. In this paper, which represents the second part, the definition of outcomes, reporting of results, synthesis of evidence, and implementation are addressed as methodological challenges of DI. Potential solutions are presented and the need to address these challenges in future research are discussed.