[Smartphone-based fundus photography from the perspective of medical product regulation and IT security]. / Smartphone-basierte Fundusfotografie aus medizinprodukterechtlicher und IT-sicherheitsbezogener Sicht.

Digital applications on mobile devices are also becoming more widespread in medicine and increasingly support the diagnostics and treatment. Smartphone-based fundus photography (SBF) is a mobile and cost-effective form of ocular fundus imaging and offers many new applications in healthcare. For its practical implementation there are various adapters that are connected to commercially available smartphones, so that the adapter can be used as an ophthalmoscope with the integration of the smartphone. The use of corresponding software applications and adapters for smartphones poses challenges in terms of both medical product law and IT security, which are discussed in this article from the perspective of the German Federal Institute for Drugs and Medical Devices (BfArM) and the German Federal Office for Information Security (BSI).

[Digitization of the healthcare system: the BfArM's contribution to the development of potential]. / Beitrag des BfArM zur Potenzialentfaltung der Digitalisierung im Gesundheitswesen ­ digital readiness@BfArM.

Digitalization is a clear megatrend of our time, also in the health sector, which is currently experiencing enormous acceleration due to the COVID-19 pandemic in addition to paving the way due to changes in the legal framework. Looking to the future, this trend will contribute to further digitalization and the merging of individual digital products, including medicinal products and medical devices, into a digital ecosystem. This will be supported by ever-shorter development cycles and technological progress. Digitization will not only strengthen patient sovereignty, but also enable more patient-centered medicine; artificial intelligence will improve and accelerate diagnoses and will contribute to a better understanding of disease patterns and underlying mechanisms or causes.In order to continue to enable innovations in the future, to focus on emerging trends, and, above all, to further improve patient safety, the BfArM is contributing in many places to transforming the opportunities associated with digitalization into possibilities - without losing sight of the risks. The following is an overview of how, for example, the expansion of the Research Data Center, activities addressing interoperability, research projects using artificial intelligence, (inter-)national cooperation, the utilization and inclusion of "Real World Data" in our benefit/risk assessments, and the evaluation of digital health and digital care applications among other activities of the BfArM contribute to "digital readiness" in Germany and Europe.

[Digital health applications (DiGA): assessment of reimbursability by means of the "DiGA Fast Track" procedure at the Federal Institute for Drugs and Medical Devices (BfArM)]. / Digitale Gesundheitsanwendungen (DiGA): Bewertung der Erstattungsfähigkeit mittels DiGA-Fast-Track-Verfahrens im Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).

With the Digital Health Care Act (DVG), the legislator has made it possible for digital health applications (DiGA) to be included in standard care and reimbursement in accordance with the Fifth Book of the German Social Code (SGB V). The prerequisite for the "app on prescription" is a listing in the DiGA directory after a positive evaluation procedure at the Federal Institute for Drugs and Medical Devices (BfArM). In addition to comprehensive quality and safety parameters, the manufacturers must also prove a positive healthcare effect.With the DiGA directory, the BfArM has been offering addressee-oriented comprehensive transparency on DiGA and their properties since October 2020. The article explains the path to the app on prescription from the support and advisory services offered by the BfArM to the evaluation procedure (DiGA Fast Track) and the evaluation criteria to the contents of the directory. It can be seen that there is great interest in the Fast Track procedure. The evidence of positive healthcare effects, i.e. an actual added value for patients, is balanced and at an appropriate level with predominantly randomised controlled trial evidence. The fact that the procedure can also be associated with challenges for the applicants, e.g. to adequately address deficiencies in the legally prescribed assessment period, is indicated by the numbers of withdrawn applications in relation to the listed DiGA. The BfArM is in close exchange with all parties involved regarding this new procedure. The conclusion of this article shows which considerations and potentials result from this for further development from the point of view of the BfArM.

Ontology-based specification and generation of search queries for post-market surveillance.

BACKGROUND: The vigilant observation of medical devices during post-market surveillance (PMS) for identifying safety-relevant incidents is a non-trivial task. A wide range of sources has to be monitored in order to integrate all accessible data about the safety and performance of a medical device. PMS needs to be supported by an efficient search strategy and the possibility to create complex search queries by domain experts. RESULTS: We use ontologies to support the specification of search queries and the preparation of the document corpus, which contains all relevant documents. In this paper, we present (1) the Search Ontology (SON) v2.0, (2) an Excel template for specifying search queries, and (3) the Search Ontology Generator (SONG), which generates complex queries out of the Excel template. Based on our approach, a service-oriented architecture was designed, which supports and assists domain experts during PMS. Comprehensive testing confirmed the correct execution of all SONG functions. The applicability of our method and of the developed tools was evaluated by domain experts. The test persons concordantly rated our solution after a short period of training as highly user-friendly, intuitive and well applicable for supporting PMS. CONCLUSIONS: The Search Ontology is a promising domain-independent approach to specify complex search queries. Our solution allows advanced searches for relevant documents in different domains using suitable domain ontologies.

[In search of a travel guide-results from a survey of E­health startup companies]. / Reiseführer gesucht ­ Ergebnisse einer Umfrage bei E­Health-Start-ups.

As is the case in other sectors, innovative digital products have started to enter the health market, too. If digital products like apps are considered medical devices, startups are often confronted with regulatory procedures that they deem to be slow and with which they are not familiar. This applies to both the certification procedures and the requirements and procedures for reimbursement, where problems could occur. The aim of this article is to better understand the startups' experience in navigating through these procedures, the hurdles they encounter, and their need for support. Therefore, the digital association Bitkom e. V. and the Federal Institute for Drugs and Medical Devices (BfArM) conducted a web-based survey on five themes with a total of 23 questions. These questions focused inter alia on the composition of the team, product planning, familiarity with regulatory requirements, experience with institutions and different sources of information, the assessment of challenges in the process, and the resulting need for support.The analysis on the basis of 18 complete replies has shown that startups work on products with documentation and communications functions, but also integrate diagnostic and therapeutic features. The latter are characteristics of medical devices. Startups consider themselves to be relatively familiar with regulatory requirements regarding medical devices. The largest hurdles are associated with reimbursement: long and costly processes until the startups' products could be reimbursed.Both with regard to reimbursement and certification, startups see a need for low-threshold, cost-efficient advisory services and a simplification and acceleration of existing procedures with regard to medical devices.

[Qualification and classification of medical apps : What should be noted and what is BfArM's contribution?] / Abgrenzung und Klassifizierung von Medical Apps : Was ist zu beachten und welche Unterstützung bietet das BfArM?

Smartphones and tablets with their nearly unlimited number of different applications have become an integral part of everyday life. Thus, mobile devices and applications have also found their way into the healthcare sector.For developers, manufacturers, or users as well, it is often difficult to decide whether a mobile health application is a medical device.In this context, it is extremely important for manufacturers to decide at an early stage of the development whether the product is to be introduced into the market as a medical device and is therefore subject to the legislation on medical devices.This article first presents the regulatory framework and subsequently introduces the reader to the Federal Institute for Drugs and Medical Devices' (BfArM) view of the criteria for differentiating between apps as non-medical products and apps as medical apps as well as the classification thereof. Various examples are presented to demonstrate how these criteria are applied practically and options that support developers and manufacturers in their decision making are shown. The article concludes with a reference to current developments and offers a perspective on the new European medical device regulations MDR/IVDR (Medical Device Regulation/In-Vitro Diagnostic Regulation) as well as on future challenges regarding medical apps.

[Monitoring devices and their alarms: incident reports suggest problems with device knowledge]. / Umgang mit Patientenmonitoren und ihren Alarmen: Vorkommnismeldungen liefern Hinweise auf Probleme mit Gerätewissen.

Missing or false device alarms pose a risk in clinical practice. Publications from the United States suggest that alarm errors are not only caused by technical issues but to a considerable degree result from user-device interaction problems. To safely operate a medical device, users have to thoroughly understand both device behavior and device functioning. They also need to foresee the exact consequences of their interactions with the device. This can be challenging, especially if a device has multiple functions, is applied in various use contexts or networked with other devices - as is often the case with patient monitors. In this case, human error in operating a device may not necessarily be detected, but is experienced as device failure. If medical device failures occur in German hospitals that are associated with a risk to the patient, the user, or other persons, they have to be reported to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). In the present study, we analyzed reports to the BfArM (received between 01/2009 and 12/2015) about loss or failure of the alarm function of patient monitors. It was found that the perceived 'faulty' behavior of the device was the device's intended behavior in almost half of these reports. Hence, the person who detected this fault was not sufficiently acquainted with the device and/or its configuration. Examples of knowledge deficits related to various aspects of device knowledge. Further studies are needed to find out whether these findings are suggestive of more general knowledge deficits among clinical staff and to explore the underlying reasons.

Incident reporting to BfArM - regulatory framework, results and challenges.

Medical devices are manifold and one of the most innovative fields of technology. As technologies advance, former limits cease to exist and complex devices become reality. Medical devices represent a very dynamic field with high economic relevance. The manufacturer of a medical device is obliged to minimize product-related risks as well as to demonstrate compliance with the so-called "essential requirements" regarding safety and performance before placing the device on the market. Any critical incident in relation to the application of a medical device has to be reported to the competent authority for risk assessment, which in Germany is either the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI) depending on the type of device. In this article, the German regulatory framework for medical devices and the resulting tasks for BfArM are described as well as the topics of its recently installed research and development group on prospective risk identification and application safety for medical devices. Results of failure mode and root cause analyses of incident data are presented as well as further data on cases with the result "root-cause analysis not possible". Finally an outlook is given on future challenges regarding risk assessment for medical devices.

A human factors perspective on medical device alarms: problems with operating alarming devices and responding to device alarms.

Medical devices emit alarms when a problem with the device or with the patient needs to be addressed by healthcare personnel. At present, problems with device alarms are frequently discussed in the literature, the main message being that patient safety is compromised because device alarms are not as effective and safe as they should - and could - be. There is a general consensus that alarm-related hazards result, to a considerable degree, from the interactions of human users with the device. The present paper addresses key aspects of human perception and cognition that may relate to both operating alarming devices and responding to device alarms. Recent publications suggested solutions to alarm-related hazards associated with usage errors based on assumptions on the causal relations between, for example, alarm management and human perception, cognition, and responding. However, although there is face validity in many of these assumptions, future research should provide objective empirical evidence in order to deepen our understanding of the actual causal relationships, and hence improve and expand the possibilities for taking appropriate action.

[Medical devices. Regulatory framework and contribution of the German Federal Institute for Drugs and Medical Devices (BfArM) to the safe application]. / Medizinprodukte. Regulatorischer Rahmen und Beitrag des BfArM zur sicheren Anwendung.

Medical devices are of great importance for the prevention, diagnosis and treatment of many diseases. With their broad range and interdisciplinarity, they represent both a very dynamic field of innovation and a significant sector of the economy. The European and thus the German Medical Devices Act aim in this context to make new medical devices for patients and users rapidly available while ensuring safety and performance at the same time. The main responsibility for this lies with the manufacturer. In addition, others are involved in a complex collaboration in the conformity assessment and also later in the marketing phase for the early identification, assessment and minimization of potential risks. This paper presents the legal framework for medical devices and the related roles and responsibilities of various stakeholders, especially the two federal agencies the German Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI). From the perspective of the BfArM the procedure and criteria for risk assessment of incident reports are explained and the experiences and wishes from regulatory practice are described. The active engagement of the BfArM to contribute knowledge from the incident report assessment within the relevant standards organisations and the medical profession is described using examples of medical devices from the field of out-of-hospital ventilation. The paper concludes with a look at future challenges, e.g. in combination products, IT networks and automatization, as well as on current developments to improve risk identification and assessment in a European context.

[Review: Patient safety as a national health goal: current state and essential fields of action for the German healthcare system]. / Übersichtsartikel: Patientensicherheit als nationales Gesundheitsziel: Status und notwendige Handlungsfelder für die Gesundheitsversorgung in Deutschland.

For some years patient safety has been an important topic for the design of the healthcare systems in many countries. In Germany we are still in the starting phase of this development. Here, patient safety is not a main focus for research and there is only little funding for these topics. Thus most findings on patient safety have been derived in foreign studies. Slowly, some find their way into the clinical routine in Germany. This paper summarises the state of development of patient safety from a trans-sectoral point of view and outlines essential fields of action for the German healthcare system.

Patient safety related to the use of medical devices: a review and investigation of the current status in the medical device industry.

To reduce the risk of application error, the federal legislator has demanded a development process which is oriented towards usability (DIN EN 62366). Therefore, the research question concerns the application of this standard by medical device manufacturers. Questionnaires were filled out by five trained interviewers in fully standardized face-to-face interviews at MEDICA Düsseldorf 2010. The results are based on 65 interviews. Almost all companies evaluated usability as relevant for product development; however, the understanding of usability through companies can still be improved as well as increasing the amount of trained usability experts in the process.

Evaluation of a synergistically controlled semiautomatic trepanation system for neurosurgery.

One of the most common procedures in neurosurgery is the trepanation of the skull. In this paper, a synergistically controlled handheld tool for trepanation is introduced. This instrument is envisioned to reduce problems of dural tears and wide cutting gaps by combining a soft tissue preserving saw with an automatic regulation of the cutting depth. Since usability and safety of the semi-automatic handheld device are of utmost importance, the complex interaction between the user and the system has been analyzed extensively. Based on prospective usability evaluation the user interaction design and the corresponding user-interface were developed. The compliance with the relevant factors effectiveness, efficiency, error tolerance, learnability and user satisfaction was measured in user-centered experiments to evaluate the usability of the semiautomatic trepanation system. The results confirm the user interaction design of the semiautomatic trepanation system and the corresponding safety strategy. The system seems to integrate itself smoothly into the existing workflow and keeps the surgeon aware of the process.

Combined endo- and exoscopic semi-robotic manipulator system for image guided operations.

This paper describes the development of a robotic assistance system for image guided operations. To minimize operation time, a multimodal user interface enables freehand robotic manipulation of an extracorporeal stereoscopic digital camera (exoscope) and an endoscope. The surgeon thereby wears a head-mounted unit with a binocular display, a head tracker, a microphone and earphones. Different view positioning and adjustment modes can be selected by voice and controlled by head rotation while pressing a miniature confirmation button with a finger. Initial studies focused on the evaluation and optimization of the intuitiveness, comfort and precision of different modes of operation, including a user test with neurosurgeons in a virtual reality simulation. The first labtype of the system was then implemented and demonstrated in the operating room on a phantom together with the clinical partners.