Research and Projects on Medical Device Safety
BfArM contributes to the safety of medical devices by performing risk assessments of such devices (Medical Device Vigilance) and by the approval of clinical studies on medical devices. These regulatory tasks are complemented and supported by research activities. The unit Medical Devices Methods Research focuses on different approaches: On the one hand, the unit develops IT tools and methods for automated, algorithmic and AI-based risk assessment in order to support its regulatory work. In addition to this, the unit investigates risk due to errors in the use of medical devices. As medical devices are used in complex medical-technical contexts, these risks depend on many different factors and can rarely be attributed to a single cause. We are currently also addressing the topic of incident reporting (which is the primary source of risk information for medical device vigilance) from a research perspective: What motivates professional users to submit a report to BfArM – or keeps them from reporting? Can we have a positive influence on this reporting behaviour?
Head of the Unit
PD Dr. rer. nat. Kathrin Lange
Telephone: +49 (0)228 99 307-4008
E-Mail:
kathrin.lange@bfarm.de
Dr. Robin Seidel
Telephone: +49 (0)228 99 307-5639
E-Mail:
robin.seidel@bfarm.de
Medical Devices Methods Research - Topics
I Database-supported risk identification and risk assessment for medical devices
Contact: Dr. Robin Seidel
Among other tasks, the BfArM's Medical Devices unit is concerned with the approval of applications for conducting clinical studies with mostly new, innovative medical devices as well as with the central registration, analysis and assessment of risk reports on devices already on the market. Timely and reliable identification and assessment of potential risks for patients, users, or third parties, requires the analysis of extensive complex and extremely heterogeneous data sets for potentially risk-relevant patterns. Scientific research is focused on the development of intelligent, adaptive analytical algorithms and the efficient support of human risk assessment by tailored data analysis and delivery of results.
II Risk due to errors in the use of medical devices
Contact: PD Dr. Kathrin Lange
Medical device safety has a significant impact on the health of patients, users, and third parties. Safety is not restricted to the device being technically intact. An increasingly important factor for device safety is the usability of a device.
The usability of a medical device is the result of the fit between product, user, task, and use context. Due to complex interdependences, it is not always possible to identify and quantify the specific contribution of any of these components. This may complicate decisions on corrective actions in medical device vigilance. In the context of our research on risks due to errors in the use of medical devices, we explicitly consider characteristics of the users, the specific task and the working context - in addition to features of the device itself.
Examples
- Assessment of activities, multi-tasking and task-switching in intensive care
- Assessment of relevant context factors and user perspectives with respect to device diversity
- Analysis and Assessment of user interfaces of physiological monitors
III Improvement of incident reporting
Contact: PD Dr. Kathrin Lange
In order to fulfill its regulatory tasks in medical device vigilance, BfArM needs a comprehensive and up-to-date overview of the risks associated with the use of medical devices. The primary source of corresponding information are reports of serious incidents according to Article 87 paragraph 1 of regulation (EU) 2017/745 (Medical Device Regulation, MDR) and Article 82 paragraph 1 of regulation (EU) 2017/746 (In-vitro-diagnostic device regulation, IVDR) by medical device manufacturers and reports of suspected serious incidents according to paragraph 3 of the German „Medizinprodukte-Anwendermelde- und Informationsverordnung (MPAMIV) by persons who professionally use or operate medical devices.
Reports issued by professional users (e.g. doctors, nurses) and operators (e.g. hospitals) are important for a variety of reasons. In practice, fewer than 10% of the cases submitted to the BfArM included direct reports by professional users or operators. Moreover, informal statements of users or user organisations reveal concerns regarding the legal reporting system which is suggestive of potential underreporting.
For this reason, the unit Medical Devices Methods Research is implementing the project "Improving Incident Reporting", funded by the Federal Ministry of Health. It is the goal of this project to increase professional users’ motivation to report incidents to directly the BfArM, while ensuring high data quality of the reports at the same time. In order to reach this goal, we are developing, testing, and evaluating scientifically sound solutions and proposals for hands-on measures.
IV Risk Reporting 4.0 - Piloting a reporting app
Contact: PD Dr. Kathrin Lange, Dr. Anika Thielmann
The reporting system for risk detection and assessment of so-called "serious incidents" in medical devices (e.g. implants, catheters) contributes significantly to the safety of medical devices in Germany and Europe. These incidents are events that occur with medical devices that are already on the market with regular CE marking and where a product defect is considered to be the cause of a death or a serious deterioration in the state of health of, for example, a patient. A particularly important reporting source of risk information are professional users and operators of medical devices, such as physicians and nurses in hospitals, because only professional users and operators can directly experience the relevant incidents and transmit essential information.
Incident reports are currently transmitted online to the Federal Institute for Drugs and Medical Devices (BfArM) using reporting forms. Using the new available mobile communication standard, the reporting system is taken to the next level: Risk Reporting 4.0. In the project, the BfArM is developing a reporting app for hospital employees that supports hospital-internal reporting processes. The core functionality is the supported creation of an incident report including additional multimedia information. Reports can be transmitted directly to the BfArM or are first forwarded to a hospital-internal central office.
The project is part of the joint project GIGA FOR HEALTH funded by the Ministry of Economic Affairs, Industry, Climate Action and Energy of the State of North Rhine-Westphalia, in which the first 5G-medical campus in Europe is being developed at a university hospital.
Funding
V RegCDx – Regulatory Research on Companion Diagnostics
Contact: PD Dr. Kathrin Lange, Dr. Camilla Lambertz
Companion diagnostics (CDx) are diagnostic tests used to determine biomarkers that allow conclusions about the efficacy of a specific drug or an increased risk of serious adverse drug reactions. A test can only be defined as CDx if such a diagnostic procedure is mandatory for the therapy decision.
CDx belong to in vitro diagnostic medical devices (IVD) and are defined and explicitly mentioned in regulatory terms for the first time in the new IVDR regulation ((EU) 2017/746), valid since May 26, 2022. Introduced are far-reaching regulations on information exchange that result from the above-mentioned novel dependence of the safe and effective use of certain medicinal products on the safety and performance of corresponding medical devices. At the same time, amendments to the national Medizinprodukterecht-Durchführungsgesetz (MPDG) came into force, which regulate and supplement the implementation of the IVDR in Germany. This changed many legal requirements and practical frameworks for placing on the market, approving and conducting performance studies, and assessing the risk associated with the use of the devices. The legal requirements for CDx require a close exchange between the experts of the authorities involved on the side of the medicinal product and IVD. More information can be found here (in German language):
The German Federal Ministry of Health is funding a project on "Regulatory Research on Companion Diagnostics". The aim of the project strand, which is located in FG95, is to identify content-related, organizational and process-related requirements for the exchange of information according to IVDR. The results are used to support the establishment of an information exchange between experts from BfArM, PEI and the IVDR implementation partners involved.
A second project strand is located in the Research Department (division 5) and is concerned with gaining methodological competence through own investigations on high-throughput sequencing in ADR cases.
Funded by the German Federal Ministry of Health, grant no.: ZMVI1-2519FSB404.
