Medical devices and patient safety

2007 ◽  
Author(s):  
A. Murray
Keyword(s):  
Patient Safety ◽  
Medical Devices

Clinical Cybersecurity Training Through Novel High Fidelity Simulations (Preprint)

2018 ◽  
Author(s):  
Christian Dameff ◽  
Jordan Selzer ◽  
Jonathan Fisher ◽  
James Killeen ◽  
Jeffrey Tully
Keyword(s):  
Patient Safety ◽  
Patient Care ◽  
Medical Devices ◽  
Healthcare Systems ◽  
High Fidelity ◽  
Protected Health Information ◽  
Patient Harm ◽  
Security Vulnerabilities ◽  
Clinical Simulations ◽  
Medical Infrastructure

BACKGROUND Cybersecurity risks in healthcare systems have traditionally been measured in data breaches of protected health information but compromised medical devices and critical medical infrastructure raises questions about the risks of disrupted patient care. The increasing prevalence of these connected medical devices and systems implies that these risks are growing. OBJECTIVE This paper details the development and execution of three novel high fidelity clinical simulations designed to teach clinicians to recognize, treat, and prevent patient harm from vulnerable medical devices. METHODS Clinical simulations were developed which incorporated patient care scenarios with hacked medical devices based on previously researched security vulnerabilities. RESULTS Clinician participants universally failed to recognize the etiology of their patient’s pathology as being the result of a compromised device. CONCLUSIONS Simulation can be a useful tool in educating clinicians in this new, critically important patient safety space.

Medical Device Regulation and the Proposed Therapeutic Products Bill: Devising a New Regime

2021 ◽  
Vol 52 (2) ◽  
pp. 319-342
Author(s):  
Laura Hardcastle
Keyword(s):  
Patient Safety ◽  
New Zealand ◽  
Medical Devices ◽  
Cosmetic Products ◽  
Regulatory Oversight ◽  
Speed To Market ◽  
The Government ◽  
The Right ◽  
Promote Patient Safety ◽  
Medical Device Regulation

Despite medical devices being integral to modern healthcare, New Zealand's regulation of them is decidedly limited, with repeated attempts at reform having been unsuccessful. With the Government now indicating that new therapeutic products legislation may be introduced before the end of the year, the article considers the case for change, including to promote patient safety, before analysing the draft Therapeutic Products Bill previously proposed by the Ministry of Health, and on which any new legislation is expected to be based. It concludes that, while the proposed Bill is a step in the right direction, introducing regulatory oversight where there is currently next to none, there is still significant work to be done. In particular, it identifies a need to clarify whether the regime is indeed to be principles-based and identifies further principles which might be considered for inclusion. It further proposes regulation of cosmetic products which operate similarly to medical devices to promote safety objectives, while finding a need for further analysis around the extent to which New Zealand approval processes should rely on overseas regulators. Finally, it argues that, in an area with such major repercussions for people's health, difficult decisions around how to develop a framework which balances safety with speed to market should not be left almost entirely to an as yet unknown regulator but, rather, more guidance from Parliament is needed.

Patient safety reports analysis: post COVID-19

2020 ◽  
Vol 29 (15) ◽  
pp. 906-907
Author(s):  
John Tingle
Keyword(s):  
Patient Safety ◽  
Medical Devices ◽  
Law School

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham discusses the recently published Cumberlege report on medicines and medical devices safety

scholarly journals The impact of calibration on medical devices performance and patient safety

2018 ◽  
Vol 29 (12) ◽  
Author(s):  
Altayyar Saleh S ◽  
Mousa MA ◽  
Alfaifi AM ◽  
Negm AE ◽  
Ali MO
Keyword(s):  
Patient Safety ◽  
Medical Devices ◽  
The Impact

scholarly journals Usability evaluation of a locomotor therapy device considering different strategies

2016 ◽  
Vol 2 (1) ◽  
pp. 67-69
Author(s):  
Sonja Langthaler ◽  
Alexander Lassnig ◽  
Christian Baumgartner ◽  
Jörg Schröttner
Keyword(s):  
Patient Safety ◽  
Medical Devices ◽  
Usability Evaluation ◽  
Evaluation Procedures ◽  
Determining Factors ◽  
Weak Points ◽  
Normative Requirements ◽  
Errors In Treatment ◽  
Testing And Evaluation

AbstractUsability of medical devices is one of the main determining factors in preventing use errors in treatment and strongly correlates to patient safety and quality of treatment. This thesis demonstrates the usability testing and evaluation of a prototype for locomotor therapy of infants. Therefore, based on the normative requirements of the EN 62366, a concept combined of evaluation procedures and assessing methods was created to enable extensive testing and analysis of the different aspects of usability. On the basis of gathered information weak points were identified and appropriate measures were presented to increase the usability and operating safety of the locomotor prototype. The overall outcome showed an usability value of 77.4% and an evaluation score of 6.99, which can be interpreted as “satisfactory”.

scholarly journals Patient safety and interactive medical devices: Realigning work as imagined and work as done

Clinical Risk ◽  
2014 ◽  
Vol 20 (5) ◽  
pp. 107-110 ◽  
Author(s):  
Ann Blandford ◽  
Dominic Furniss ◽  
Chris Vincent
Keyword(s):  
Patient Safety ◽  
Medical Devices

scholarly journals Medical Device Regulation and the Proposed Therapeutic Products Bill: Devising a New Regime

2021 ◽  
Vol 52 (1) ◽  
pp. 319-342
Author(s):  
Laura Hardcastle
Keyword(s):  
Patient Safety ◽  
New Zealand ◽  
Medical Devices ◽  
Cosmetic Products ◽  
Regulatory Oversight ◽  
Speed To Market ◽  
The Government ◽  
The Right ◽  
Promote Patient Safety ◽  
Medical Device Regulation

Despite medical devices being integral to modern healthcare, New Zealand's regulation of them is decidedly limited, with repeated attempts at reform having been unsuccessful. With the Government now indicating that new therapeutic products legislation may be introduced before the end of the year, the article considers the case for change, including to promote patient safety, before analysing the draft Therapeutic Products Bill previously proposed by the Ministry of Health, and on which any new legislation is expected to be based. It concludes that, while the proposed Bill is a step in the right direction, introducing regulatory oversight where there is currently next to none, there is still significant work to be done. In particular, it identifies a need to clarify whether the regime is indeed to be principles-based and identifies further principles which might be considered for inclusion. It further proposes regulation of cosmetic products which operate similarly to medical devices to promote safety objectives, while finding a need for further analysis around the extent to which New Zealand approval processes should rely on overseas regulators. Finally, it argues that, in an area with such major repercussions for people's health, difficult decisions around how to develop a framework which balances safety with speed to market should not be left almost entirely to an as yet unknown regulator but, rather, more guidance from Parliament is needed.

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

2016 ◽  
Vol 61 (2) ◽  
Author(s):  
Kathrin Lange ◽  
Miriam Nowak ◽  
Wolfgang Lauer
Keyword(s):  
Patient Safety ◽  
Medical Devices ◽  
Human Perception ◽  
Face Validity ◽  
Healthcare Personnel ◽  
Future Research ◽  
Patient Needs ◽  
Alarm Management ◽  
Key Aspects ◽  
Main Message

AbstractMedical 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.

Sign in / Sign up

Export Citation Format

Share Document