Equipment in anaesthesia

2017 ◽  
Author(s):  
Antony R. Wilkes
Keyword(s):  
Risk Management ◽  
Medical Device ◽  
Medical Devices ◽  
Healthcare Workers ◽  
Small Children ◽  
Management Procedures ◽  
Different Types ◽  
First Time ◽  
Work First ◽  
Subsequent Patient

The anaesthetist will routinely use many different types of medical devices during normal working practice, and will have access to many other devices for more challenging use in emergency and other difficult scenarios. The anaesthetist will expect and rely on each medical device to work first time and not to compromise the safety of the user, the patient, their relatives, or other healthcare workers in the vicinity. The equipment will also be expected to be effective, that is, that it will perform as expected when used in a defined population of patients (e.g. small children). Manufacturers and users of equipment use risk management procedures to reduce the risk to patients and others of using the equipment. Following use, the equipment will need to be reprocessed to make it safe for use for a subsequent patient, or disposed of safely.

Embracing Cybersecurity Risk Management in the Industry of Medical Devices

2018 ◽  
pp. 177-197 ◽  
Author(s):  
Maria Lai-Ling Lam ◽  
Kei Wing Wong
Keyword(s):  
Risk Management ◽  
Local Government ◽  
Medical Device ◽  
Medical Devices ◽  
Industry 4.0 ◽  
Life Cycles ◽  
Shared Responsibility ◽  
Operating Environments ◽  
Set Up ◽  
Industry Needs

The promises of Industry 4.0 in the medical device industry needs to be built on sound cybersecurity infrastructures, polices, and practices. During 2011-2017, the authors interviewed many manufacturers of medical devices in China, Germany, Israel, Japan, Taiwan, and U.S. about their attitude towards cybersecurity. Many manufacturers are not committed to cybersecurity risk management because they pursue lower cost and shorter product life cycles; do not have sufficient knowledge of operating environments of hospitals; have defensive attitude toward vulnerability disclosure; and reap quick benefits from the low-trust level among stakeholders and unequal power between manufacturers and distributors. Only a few large U.S. manufacturers of medical devices have set up robust secure platforms and interoperable optimal standards which benefit the users. As cybersecurity is a shared responsibility, many small and medium-sized enterprises need to be empowered through the support of international organizations and local government policies.

scholarly journals EU MDR 2017/745 will reduce the Risk of Medical Devices. Does MDCG got it Right?

2021 ◽  
Vol 9 (4) ◽  
pp. 33-36
Author(s):  
Vidya Sagar ◽  
Piyush Patel ◽  
Avni Rana ◽  
Bhavin Trivedi ◽  
Deepak Patel ◽  
...  
Keyword(s):  
Risk Management ◽  
Medical Device ◽  
Medical Devices ◽  
Management Plan ◽  
European Database ◽  
Periodic Safety ◽  
Post Market ◽  
Periodic Safety Update Report ◽  
Medical Device Regulation

Under the new European Union Medical Device Regulation (EU MDR), framed by Medical Device Coordination Group (MDCG), for each device manufacturers must have a documented risk management plan, identify and analyse the known and foreseeable hazards, estimate and evaluate the associated risks and eliminate or control those risks. In contrast with the MDD, the new EU MDR contains an explicit obligation in the new Article 10 (2), that manufacturers establish, document, implement and maintain a system for risk management. The detailed requirements of which are listed in the new Annex I Chapter I. Compared to MDD there is more emphasis on Post Market Surveillance (PMS) activities with the inclusion of European Databank or European Database for Medical Devices (EUDAMED) and mandatory submission of Periodic Safety Update Report (PSUR) to all the actors in the possession with the medical devices. A poll conducted by Aegis Lifesciences Pvt. Ltd, Ahmedabad, India concludes that the relevant annexures and sections in MDR 2017/745 have more emphasis on PMS, Vigilance, PSUR, EUDAMED, tracking, Implantation card etc. that are directed in regard to the safety of the Medical Device.

Embracing Cybersecurity Risk Management in the Industry of Medical Devices

2021 ◽  
pp. 2044-2064
Author(s):  
Maria Lai-Ling Lam ◽  
Kei Wing Wong
Keyword(s):  
Risk Management ◽  
Local Government ◽  
Medical Device ◽  
Medical Devices ◽  
Industry 4.0 ◽  
Life Cycles ◽  
Shared Responsibility ◽  
Operating Environments ◽  
Set Up ◽  
Industry Needs

The promises of Industry 4.0 in the medical device industry needs to be built on sound cybersecurity infrastructures, polices, and practices. During 2011-2017, the authors interviewed many manufacturers of medical devices in China, Germany, Israel, Japan, Taiwan, and U.S. about their attitude towards cybersecurity. Many manufacturers are not committed to cybersecurity risk management because they pursue lower cost and shorter product life cycles; do not have sufficient knowledge of operating environments of hospitals; have defensive attitude toward vulnerability disclosure; and reap quick benefits from the low-trust level among stakeholders and unequal power between manufacturers and distributors. Only a few large U.S. manufacturers of medical devices have set up robust secure platforms and interoperable optimal standards which benefit the users. As cybersecurity is a shared responsibility, many small and medium-sized enterprises need to be empowered through the support of international organizations and local government policies.

Research: How Medical Device Instructions for Use Engage Users

2020 ◽  
Vol 54 (4) ◽  
pp. 258-268
Author(s):  
Naomi Cherne ◽  
Rebecca Moses ◽  
Sarah M. Piperato ◽  
Carmen Cheung
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Time Use ◽  
Online Survey ◽  
Control Measures ◽  
Extensive Experience ◽  
Design Elements ◽  
User Groups ◽  
Instructions For Use ◽  
First Time

Abstract Instructions for use (IFUs) often are used as risk control measures for medical devices with the potential to expose users or others to use-related hazards and hazardous situations that are not entirely mitigated by device design. In the authors' extensive experience observing representative users interact with medical devices in simulated-use studies, individuals' engagement with medical device IFUs varies widely. This variance raises questions regarding how various user groups use IFUs and the factors that make an IFU stronger or weaker for its intended users, uses, and use environments. An online survey was conducted to examine (1) first-time use of medical device IFUs, (2) how first-time use strategies vary across typical user groups for medical devices (e.g., patients, lay caregivers, and healthcare professionals), and (3) which design elements promote initial engagement with IFUs. The results showed that IFUs are used in a variety of ways, including as preparation before use, as guides during use, and as troubleshooting resources during use, as well as that IFUs are not used at all. Overall, the user groups tested responded similarly across all of the survey questions. Bullet point organization, figures, and logical flow were reported to be the most engaging design elements. Small font size and poor organization and flow were reported to be the least engaging design elements. IFU designers can use various usability testing methods to assess their assumptions regarding how a product's users will use the IFU and to make the IFU more engaging.

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

Training Decay Selection for Usability Validation

2016 ◽  
Vol 5 (1) ◽  
pp. 76-83
Author(s):  
Shannon E. Clark
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Validation Studies ◽  
Future Research ◽  
Medical Device Manufacturers ◽  
Selection For ◽  
The Moment ◽  
High Level ◽  
First Time ◽  
Validation Testing

When conducting usability validation testing, representative users must use the device in the expected conditions of use in the field. There is usually a period of time—days or weeks—between the point in time a user is trained, and the moment they use the device for the first time. For this reason, the FDA acknowledges the need for “training decay” as part of usability validation testing, but manufacturers face challenges simulating real-time decays. In response to challenges associated with lags of days or weeks between training and usability validation testing, medical device manufacturers typically simulate shortened training decay periods. This paper discusses the theory behind the shapes of various training decay curves and the variables that drive differences between training decay curves. The author proposes to use a task-based approach for defining training decay curves in usability validation studies and sets out generalized training decay curves at a high level. Future research could reveal detailed and generalizable training decay curves. Identifying generalizable training decay curves could standardize the usability testing required for medical devices, and ultimately improve use error identification while avoiding an undue toll on manufacturer resources.

scholarly journals Risk management for medical devices in research projects

2015 ◽  
Vol 1 (1) ◽  
pp. 543-546
Author(s):  
Christian Sauter ◽  
Marion Heinloth ◽  
Andreas Tobola ◽  
Nadine Pensky ◽  
Christian Weigand
Keyword(s):  
Risk Management ◽  
Medical Device ◽  
Medical Devices ◽  
Applied Research ◽  
Relevant Aspect ◽  
Research Projects ◽  
Technical Documentation ◽  
Commercial Products ◽  
Research Teams

AbstractIn applied research for medical devices exists a conflict between effective research and regulations. While researchers need sufficient freedom the regulations require a complex technical documentation for a medical device. One relevant aspect of the regulations is risk management which takes time and therefore is ignored in many research projects. With adoptions to the standard the effort can be reduced: Identifying of risks can be focused on critical risks, measures can be categorised and only some categories need to be implemented. Research teams using this method can provide results which can be transferred into commercial products easier, cheaper and faster.

scholarly journals TAXONOMY OF MEDICAL DEVICES IN THE LOGIC OF HEALTH TECHNOLOGY ASSESSMENT

2015 ◽  
Vol 31 (5) ◽  
pp. 324-330 ◽  
Author(s):  
Cornelia Henschke ◽  
Dimitra Panteli ◽  
Matthias Perleth ◽  
Reinhard Busse
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Decision Makers ◽  
One Dimension ◽  
Specific Procedure ◽  
Policy Makers ◽  
Classification Schemes ◽  
Different Types ◽  
The Matrix ◽  
Device Classification

Objectives: The suitability of general HTA methodology for medical devices is gaining interest as a topic of scientific discourse. Given the broad range of medical devices, there might be differences between groups of devices that impact both the necessity and the methods of their assessment. Our aim is to develop a taxonomy that provides researchers and policy makers with an orientation tool on how to approach the assessment of different types of medical devices.Methods: Several classifications for medical devices based on varying rationales for different regulatory and reporting purposes were analyzed in detail to develop a comprehensive taxonomic model.Results: The taxonomy is based on relevant aspects of existing classification schemes incorporating elements of risk and functionality. Its 9 × 6 matrix distinguishes between the diagnostic or therapeutic nature of devices and considers whether the medical device is directly used by patients, constitutes part of a specific procedure, or can be used for a variety of procedures. We considered the relevance of different device categories in regard to HTA to be considerably variable, ranging from high to low.Conclusions: Existing medical device classifications cannot be used for HTA as they are based on different underlying logics. The developed taxonomy combines different device classification schemes used for different purposes. It aims at providing decision makers with a tool enabling them to consider device characteristics in detail across more than one dimension. The placement of device groups in the matrix can provide decision support on the necessity of conducting a full HTA.

DIRECTIONS OF IMPROVEMENT OF RISK MANAGEMENT SYSTEM IN THE FIELD OF LOGISTICS ACTIVITIES

2017 ◽  
Author(s):  
Elena Lytvynenko ◽  
◽  
Taisiya Kozlova ◽  
Keyword(s):  
Risk Management ◽  
Practical Experience ◽  
Logistics System ◽  
Systematic Analysis ◽  
Qualitative And Quantitative ◽  
Different Types ◽  
Rational Management ◽  
Enterprise Logistics ◽  
Risk Acceptability ◽  
Logistics Activity

The changeable and unpredictable development of the enterprises’ external environment is one of the appearance causes of various types of business activities' risks, including logistics. The purpose of this article is to develop recommendations on improving the risk management of enterprises’ logistics activities in the context of instability. Achieving this goal requires consideration of the main stages of this process regarding the logistics activities' risks, providing advices on improving the process of risk management of logistics orientation. The article explores the process of analyzing the logistics activities' risks of the enterprise. Proceeding from the theoretical provisions of management and summarizing the practical experience of research in the field of systematic analysis of the enterprises' logistics activities risks, there are traced the organization's peculiarities of such analysis, and the main directions of its further improvement are proposed. All actions in the article, which are related to the analysis of the risk of enterprise logistics activity, are proposed to carry out in a certain sequence in the article. This sequence is given in the form of a structural scheme of systematic analysis of the risks of the enterprise logistics activities. Based on the objectivity of the existence of logistics activities' risks and the need to ensure the rational management of them, the algorithm of the risk management in the enterprise logistics system covers the stages of risks' identification, their qualitative and quantitative assessment, diagnostics, assessment of risk acceptability and application of neutralization measures to unacceptable logistical risks. It is concluded that the logistics activities risks combine different types of risks of all components and elements both in the process of changing material, financial and information flows, as well as in the process of managing the risks arising in the logistics system

Study of sharp injuries and blood splash exposures among healthcare workers in a tertiary hospital in Bangalore

2016 ◽  
Vol 12 (3) ◽  
Author(s):  
Shalini Sivananjiah Pradeep ◽  
Suman Gadicherla Raghu ◽  
Prathab A G ◽  
Banashankari G Rudresh ◽  
Radhika Kunnavil
Keyword(s):  
Healthcare Workers ◽  
Tertiary Hospital ◽  
Post Exposure Prophylaxis ◽  
Care Hospital ◽  
Post Exposure ◽  
Increased Risk ◽  
Management Procedures ◽  
Exposure Prophylaxis ◽  
Sharps Injury ◽  
Sharps Injuries

The working environment of healthcare workers (HCW) exposes them to sharp injuries. This communication attempts to examine the injury registers, incidence of sharps injuries and blood splash exposures, and the post-exposure prophylaxis status of employees in a tertiary care hospital. Analysis included records form 54 locations of two units of a tertiary hospital attached to a Medical College. Maintenance of the injury register overall was highly satisfactory in both units. Two hundred and nine injuries were recorded from both units of the hospital. The majority of injuries (60.5%) occurred in the age group of 20-30 years with 70% among females. Waste handlers were at increased risk during waste management procedures. Thirty two percent of sharps injury injuries occurred in wards. Of the ward nursing staff, 25.3% received sharps injuries. Post-exposure prophylaxis for Hepatitis B (primary dose) was given to 25 HCWs; 11 received booster doses. The basic regimen for HIV post-exposure prophylaxis was given to 4 HCWs. Awareness about records maintenance, regular documentation, awareness and training, and implementation of appropriate preventive measures can reduce the incidence of injuries. Key words: Sharps, injury register, Health care workers (HCW),Post exposure prophylaxis (PEP)

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