Product Failures in Respirators and Consumables: Analysis of Field Safety Notices of 2005–2013 Publicized by the Federal Institute for Drugs and Medical Devices in Germany

2015 ◽  
pp. 87-100 ◽  
Author(s):  
Jürgen Hannig ◽  
Rüdiger Siekmeier
Keyword(s):  
Medical Devices ◽  
Federal Institute

scholarly journals Medical device safety: Investigating contributions of human factors

2016 ◽  
Author(s):  
Kathrin Lange
Keyword(s):  
Adverse Events ◽  
Human Factors ◽  
Medical Device ◽  
Medical Devices ◽  
Human Error ◽  
Long Term Memory ◽  
Serious Adverse Events ◽  
True Value ◽  
Federal Institute ◽  
Medical Device Safety

The core tasks of the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte [BfArM]) with respect to medical device safety include evaluating risks arising from the use or application of medical devices (based on incident reports), assessing and coordinating the counter-measures to be taken (i.e. corrective actions), and authorizing clinical trials of medical devices and evaluating the corresponding serious adverse events. Additionally, the BfArM also conducts research on medical device safety, specifically on the possibilities and challenges of data-driven approaches to detect and evaluate risk and on the contribution of human factors to device safety – i.e. factors that may have an impact on how users interact with a device. The present talk focuses on this latter issue. The significance of addressing human factors relating to the use of medical devices results from the contribution of human error to adverse events. For instance, an involvement of human error could be identified in a good 10% of the reports of suspected device-related incidents evaluated by the BfArM between 2005 and 2014. For several reasons, it may be assumed that the true value of device-related incidents involving human error is even larger and that the potential for human error is likely to increase in the future. To effectively reduce the risk for human error – or block its negative outcome - it is imperative to not only identify human error as a significant cause of adverse events, but rather understand the causation of the error, including the conditions under which errors are likely to occur. This requires the analysis of the perceptual, cognitive (e.g. attention, working memory, long term memory), motor or motivational processes involved and the identification of relevant factors at the various levels of the socio-technical system. In our research, we currently pursue two selected human factors issues, selected based on the incident-data collected at the BfArM and on the current literature: Insufficient device knowledge and the multi-faceted issue of device alarms, the latter including both the users’ interactions with alarming devices and their perceptual, cognitive, or motor responses to the devices’ alarms.

scholarly journals Medical device safety: Investigating contributions of human factors

2016 ◽  
Author(s):  
Kathrin Lange
Keyword(s):  
Adverse Events ◽  
Human Factors ◽  
Medical Device ◽  
Medical Devices ◽  
Human Error ◽  
Long Term Memory ◽  
Serious Adverse Events ◽  
True Value ◽  
Federal Institute ◽  
Medical Device Safety

The core tasks of the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte [BfArM]) with respect to medical device safety include evaluating risks arising from the use or application of medical devices (based on incident reports), assessing and coordinating the counter-measures to be taken (i.e. corrective actions), and authorizing clinical trials of medical devices and evaluating the corresponding serious adverse events. Additionally, the BfArM also conducts research on medical device safety, specifically on the possibilities and challenges of data-driven approaches to detect and evaluate risk and on the contribution of human factors to device safety – i.e. factors that may have an impact on how users interact with a device. The present talk focuses on this latter issue. The significance of addressing human factors relating to the use of medical devices results from the contribution of human error to adverse events. For instance, an involvement of human error could be identified in a good 10% of the reports of suspected device-related incidents evaluated by the BfArM between 2005 and 2014. For several reasons, it may be assumed that the true value of device-related incidents involving human error is even larger and that the potential for human error is likely to increase in the future. To effectively reduce the risk for human error – or block its negative outcome - it is imperative to not only identify human error as a significant cause of adverse events, but rather understand the causation of the error, including the conditions under which errors are likely to occur. This requires the analysis of the perceptual, cognitive (e.g. attention, working memory, long term memory), motor or motivational processes involved and the identification of relevant factors at the various levels of the socio-technical system. In our research, we currently pursue two selected human factors issues, selected based on the incident-data collected at the BfArM and on the current literature: Insufficient device knowledge and the multi-faceted issue of device alarms, the latter including both the users’ interactions with alarming devices and their perceptual, cognitive, or motor responses to the devices’ alarms.

The Digital Healthcare Act – a Turning Point in the German Digitisation Strategy?

2020 ◽  
Author(s):  
Florian Dittrich ◽  
Urs-Vito Albrecht ◽  
Ute von Jan ◽  
Christin Malinka ◽  
Jörg Ansorg ◽  
...  
Keyword(s):  
Medical Devices ◽  
Online Survey ◽  
Digital Health ◽  
Positive Health ◽  
Health Apps ◽  
Federal Institute ◽  
German Speaking ◽  
Potential Risks ◽  
Trauma Surgeons ◽  
Digital Healthcare

AbstractThe recently ratified Digital Healthcare Act – DVG – has paved the way, among other issues, for the prescription of health apps. The German DVG creates an entitlement to health apps for the very first time. However, this entitlement is initially limited to low-risk medical devices that have been included in the publicly accessible Register for Digital Health Applications by the German Federal Institute for Drugs and Medical Devices. Listing in the register is granted, if the manufacturer has submitted a health app and verified that it meets basic requirements for medical devices and data security as well as positive health care effects. It is questionable, whether the DVG will lead to sustainable improvements in future patient care. In order to pursue this question and align the DGOUCʼs digitization strategy closely with its basis, an online survey was conducted among the respective members on the DVGʼs content and its associated opportunities and risks. A total of 461 German-speaking, predominantly male, experienced and elderly physicians in leading positions took part in the survey. In this study, it was shown that the majority of the participating German orthopaedic and trauma surgeons is not familiar with the DVGʼs contents. Despite a fundamentally positive attitude towards digitization, scepticism about the use of “apps on prescription” and potential risks still prevails at present. The closing of ranks between medicine, IT and the legislature via interdisciplinary expert groups and the involvement of medical societies might be obligatory.

Incident reporting to BfArM – regulatory framework, results and challenges

2016 ◽  
Vol 61 (2) ◽  
Author(s):  
Robin Seidel ◽  
Ekkehard Stößlein ◽  
Wolfgang Lauer
Keyword(s):  
Risk Assessment ◽  
Medical Device ◽  
Medical Devices ◽  
Critical Incident ◽  
Competent Authority ◽  
Risk Identification ◽  
Regulatory Framework ◽  
Root Cause ◽  
Federal Institute ◽  
And Performance

AbstractMedical 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.

Ultrastructural changes in murine lymphoma cells exposed to ultraviolet-A radiation

1991 ◽  
Vol 49 ◽  
pp. 104-105
Author(s):  
Delma P. Thomas ◽  
Dianne E. Godar
Keyword(s):  
Medical Devices ◽  
Blood Cells ◽  
White Blood Cells ◽  
Consumer Products ◽  
Ultrastructural Changes ◽  
Ultraviolet A ◽  
Uv Spectrum ◽  
Lymphoma Cells ◽  
Murine Lymphoma ◽  
Transmission Electron

Ultraviolet radiation (UVR) from all three waveband regions of the UV spectrum, UVA (320-400 nm), UVB (290-320 nm), and UVC (200-290 nm), can be emitted by some medical devices and consumer products. Sunlamps can expose the blood to a considerable amount of UVR, particularly UVA and/or UVB. The percent transmission of each waveband through the epidermis to the dermis, which contains blood, increases in the order of increasing wavelength: UVC (10%) < UVB (20%) < UVA (30%). To investigate the effects of UVR on white blood cells, we chose transmission electron microscopy to examine the ultrastructure changes in L5178Y-R murine lymphoma cells.

Bacterial biofilm behavior in water-supply lines of dental units

1992 ◽  
Vol 50 (1) ◽  
pp. 882-883
Author(s):  
B.D. Tall ◽  
K.S. George ◽  
R. T. Gray ◽  
H.N. Williams
Keyword(s):  
Water Supply ◽  
Medical Devices ◽  
Biofilm Formation ◽  
Bacterial Biofilm

Studies of bacterial behavior in many environments have shown that most organisms attach to surfaces, forming communities of microcolonies called biofilms. In contaminated medical devices, biofilms may serve both as reservoirs and as inocula for the initiation of infections. Recently, there has been much concern about the potential of dental units to transmit infections. Because the mechanisms of biofilm formation are ill-defined, we investigated the behavior and formation of a biofilm associated with tubing leading to the water syringe of a dental unit over a period of 1 month.

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