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.

Human Factors Applications to Health Care Systems

1989 ◽  
Vol 33 (17) ◽  
pp. 1167-1167
Author(s):  
Susan Meadows
Keyword(s):  
Human Factors ◽  
Medical Device ◽  
Medical Devices ◽  
Human Error ◽  
Health Care Systems ◽  
Healthcare Systems ◽  
Instructional Materials ◽  
Design Standards ◽  
Demonstration Program ◽  
Care Systems

This demonstration program shows how human factors design and evaluation principles can be applied to the area of medical device and healthcare systems. The objective is to provide examples of evaluations and new designs for healthcare products which reduce human error and improve medical devices and instructional materials. International performance and design standards incorporating human factors principles are gaining more attention because of the efforts of the European medical device industry to standardize products.

scholarly journals Medical device risk management and its economic impact

2013 ◽  
Vol 59 ◽  
pp. 49-60 ◽  
Author(s):  
Katerina Krsteva Jakimovska ◽  
Marija Glavas-Dodov ◽  
Jasmina Tonic-Ribarska ◽  
Suzana Trajkovic-Jolevska
Keyword(s):  
Risk Management ◽  
Adverse Events ◽  
Medical Device ◽  
Medical Devices ◽  
Economic Losses ◽  
Serious Adverse Events ◽  
Safety Level ◽  
Management Standards ◽  
Medical Device Manufacturers ◽  
Potential Risks

The importance of medical devices in everyday users/patients lives is imensse. This is the reason why emphasis must be put on safety during their use. Satisfactory safety level can be achived by implementation of quality and risk management standards. Medical device manufacturers must learn to deal with the potential risks by using theoretical and practical examples and measures in order to protect their users/patients and themselves from suffering huge losses arising from adverse events or recall of their products. The best moment for implementation of risk management methods and analysis begins from the device design and development through manufacturing, sales and distribution. These way medical device manufacturers will succseed in protecting their users/patients from serious adverse events and at the same time protect their brand and society status, while minimizing economic losses

Reducing and Mitigating Human Error in Medicine

2005 ◽  
Vol 1 (1) ◽  
pp. 254-296 ◽  
Author(s):  
Daniel Morrow ◽  
Robert North ◽  
Christopher D. Wickens
Keyword(s):  
Health Care ◽  
Adverse Events ◽  
Human Factors ◽  
Medical Device ◽  
Human Error ◽  
Health Care Systems ◽  
Medication Use ◽  
Human Factors Engineering ◽  
Work Practices ◽  
Theoretical Frameworks

Although precise definitions and models of human error in medicine remain elusive, there is little doubt that adverse events, sometimes involving human error, threaten patient safety and can be addressed by human factors approaches to error. In this chapter, we combine an information-processing framework that identifies perceptual, cognitive, and behavioral requirements of operators involved in health care activities with a system-based perspective that helps define when these needs are met by the health care context. We focus on errors and adverse events related to four broad areas of medical activities: medical device use, medication use, team collaboration, and diagnostic/decision support. For each area, we review evidence for specific error types, operator and system factors that contribute to these errors, and possible mitigating strategies related to design and training interventions that enable health care systems to better meet operators' perceptual, cognitive, and behavioral needs. This review reveals progress in identifying sources of human error and developing mitigating strategies in the areas of medical device and medication use, in part because of tools from human factors engineering that identify user needs and how to design environments to support them. Much less is known about how error emerges from work practices in complex settings, such as collaboration among team members. There is a need for theoretical frameworks to analyze error in the context of routine work practices. Such frameworks will bridge cognitive analyses of individual operators and tasks and more comprehensive theories of organizations, to guide interventions that target medical error at multiple levels.

A Regulatory and Safety Perspective on Medical Devices

2021 ◽  
pp. 1815-1826
Author(s):  
Carla Pires ◽  
Dinah Duarte
Keyword(s):  
European Union ◽  
Adverse Events ◽  
Member State ◽  
Medical Devices ◽  
Future Development ◽  
The European Union ◽  
Serious Adverse Events ◽  
International Laws ◽  
Counterfeit Products

In the European Union (EU), medical devices (MD) industry is a representative employer, with the MD sales accounting for EUR 100 billion. This chapter presents the classification and give some examples of MD in EU and describes and analyzes all safety alerts on MD of a member state of EU in 2017. International laws were used to define MD. Examples and safety alerts of MD of the Portuguese medicine agency were considered. MD are not medicines, but they have a medicinal application. MD are classified in Classes I-III. Only 32 safety alerts were identified in Portugal, none related to serious adverse events, and 6 related to devices voluntarily withdrawal from the market, for example, counterfeit products. The concept of MD is clearly defined in regulations. Although alerts on MD are limited, falsified products were identified in EU market, which is extremely regulated. For instance, future development of safety, traceable, and economic devices is very important to assure, patients' safety and access.

scholarly journals An Analysis of FDA Adverse Event Reporting Data for Trends in Medical Device Use Error

2020 ◽  
Vol 9 (1) ◽  
pp. 130-134
Author(s):  
Benjamin M. Knisely ◽  
Camille Levine ◽  
Kush C. Kharod ◽  
Monifa Vaughn-Cooke
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Medical Device ◽  
Medical Devices ◽  
Product Life Cycle ◽  
Risk Mitigation ◽  
Adverse Event Reporting ◽  
Mitigation Strategies ◽  
Event Reporting ◽  
Device Use

Humans can contribute to error at all stages of the medical device product life-cycle. Use error associated with medical devices can result in catastrophic consequences for end users and inefficient use of healthcare system resources. Industry-wide statistics about medical device use error has the potential to aid in identifying opportunities for human factors intervention, however publicly available statistics are sparse. The Food and Drug Administration (FDA) requires medical device manufactures, importers, and device user facilities to track and report adverse events for post-market surveillance through medical device reports (MDRs). This data is available in an online database: Manufacturer and User Facility Experience (MAUDE). This study provides a comprehensive evaluation of use error adverse events in MAUDE (2010-2018) based on device class, device operator, and event outcome, to address the lack of industry-wide statistics on medical device use error. Results indicate that use error is significantly represented in adverse event reporting, constituting 28.1% of reports labeled with device problem codes. Events associated with patient device operators were predominately associated with diabetes-related medical devices, while provider operators were associated with a wider array of devices. Additionally, it was found that most use error reports were attributed to issues with device output; using the device in accordance with manufacturer expectations; and physically activating, positioning, or separating device components. This work demonstrates the viability of using MAUDE to attain industry wide statistics on medical device use error for later integration in industry-wide or device-specific risk mitigation strategies.

scholarly journals Use of a new transanal irrigation device for bowel disorder management by patients familiar with the irrigation technique: a prospective, interventional, multicenter pilot study

2020 ◽  
Vol 24 (7) ◽  
pp. 731-740
Author(s):  
K. Charvier ◽  
V. Bonniaud ◽  
D. Waz ◽  
C. Desprez ◽  
A.-M. Leroi
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Medical Device ◽  
Bowel Dysfunction ◽  
Secondary Outcome ◽  
Electric Pump ◽  
Open Label ◽  
Serious Adverse Events ◽  
New Device ◽  
Transanal Irrigation

Abstract Background The aim of this study was to evaluate the feasibility of transanal irrigation (TAI) with a new medical device incorporating an electric pump, the IryPump®R Set. Methods An interventional, prospective, open-label, non-comparative, multicenter pilot study on TAI was conducted at three French university hospitals. Patients with experience of TAI were enrolled for a 1-month period during which 5 consecutive TAIs were performed using the IryPump®R Set (B.Braun Melsungen AG Melsungen, Germany). The study’s primary efficacy criterion was successful TAI, defined as (i) use of the patient’s usual irrigation volume of water, (ii) stool evacuation, and (iii) the absence of leakage between TAIs. The first two TAIs were not taken into account in the main analysis. The secondary outcome measures were device acceptability, bowel dysfunction scores, tolerability, and safety. Results Fifteen patients were included between November 2016 and May 2017, and 14 were assessed in the main analysis. The TAI success rate was 72.4% (21 out of 29 procedures). The bowel dysfunction scores at the end of the study did not differ significantly from those recorded on inclusion. A high proportion of patients (> 70%) reported that TAI was feasible with the new medical device. There were no serious adverse events or device-related adverse events. At the end of the study, 50% of the participants were willing to consider further use of the new device. Conclusions In patients familiar with TAI, using a new medical device incorporating an electric pump was feasible. Levels of patient satisfaction were high, especially with regard to comfort of use and a feeling of security during TAI.

scholarly journals Medical Device Human Factors Standards: Finding Them and What They Contain

2019 ◽  
Vol 63 (1) ◽  
pp. 592-596
Author(s):  
Molly Follette Story
Keyword(s):  
Human Factors ◽  
Medical Device ◽  
Medical Devices ◽  
Task Force ◽  
Technical Information ◽  
Engineering Practice ◽  
Human Factors Engineering ◽  
Development Organizations ◽  
Working Groups ◽  
Technical Specifications

An HFES Task Force is considering if, when, which, and how HFES research publications should require the citation of relevant standards, policies, and practices. To support Task Force activities, papers are being written about how to find relevant standards produced by various development organizations (such as ISO, IEC and AAMI) and the content of those standards. This paper describes ISO’s, IEC’s, and AAMI’s standards programs and their technical committees and working groups that produce standards, recommended practices, technical specifications, technical information reports, guides and other publications for medical devices. This paper focuses on those medical device publications that are relevant to human factors engineering practice and explains where and how to find them.

Sign in / Sign up

Export Citation Format

Share Document