Medical devices in legal metrology

Badnjević, Almir; Gurbeta, Lejla; Bošković, Dušanka; Džemić, Zijad

doi:10.1109/meco.2015.7181945

Cited by 27 publications

(11 citation statements)

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“…These ventilators belong to class IIb of medical devices defined by the European Community regulation (Council Directive 93/42/EEC) and are thus operated under this framework and the national one. 6 These devices benefit from a yearly maintenance performed by the manufacturer together with regular inspections and maintenance performed by the hospital biomedical department, according to the legal French regulation framework (decree n°2001-1154, December 5, 2001, regarding maintenance obligations and quality control of medical devices mentioned in article L. 5212–1 of the Public Health Code). In the ICU, before being used to ventilate a new patient in the ICU, ventilators are checked through the classical self-test procedure according to the manufacturer instructions.…”

Section: Methodsmentioning

confidence: 99%

<p>When a Ventilator Takes Autonomous Decisions without Seeking Approbation nor Warning Clinicians: A Case Series</p>

Dufour¹,

Fadel²,

Gelée³

et al. 2020

IMCRJ

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Background: Complexity and functions of automated medical devices used to support life (eg, ventilators, dialysis machines, monitors, insulin pump with continuous blood glucose monitoring system, etc.) increase over time. Until recently, devices were partially automated by very simple feedback loops, with no or few software dependence (such as the simplest home thermostat). For the last two decades, devices have been increasingly driven by complex algorithms devoted to improve patient's treatment and monitoring as well as users experience. Methods: We report the unexpected and inappropriate operation of two recent ventilators, associated to potential harmful consequences. We provide both a description of the clinical situations (five ICU patients, archetypal situations) and a test bench analysis. Results: While set in volume mode, these ventilators activated an algorithm dedicated to limit airway pressure when an increase in airway resistance occurred. In such situations, a pressure-like mode was activated (with decelerating inspiratory flow and set pressure, with target of volume). The main consequences observed were that the tidal volume was no longer guaranteed or delivered and that the pressure limitation operated by the algorithm prevented the airway pressure from reaching the high-pressure alarm threshold. Conclusion: This led to the silent takeover of commands by the ventilator without clinicians or nurses being aware of it and without any warnings or alarms emission adapted to the severity of the event. Generally speaking, such an algorithm questions the place of automation and its limit when users are not aware of its presence as well as the need for regulation and additional tests before its implementation. Intensivists and respiratory care specialists should remain vigilant regarding the risk of rare but critical events related to unexpected functioning or insufficiently tested equipment during the pre-clinical development phases. They should not neglect misunderstood critical events without having performed sufficient investigations.

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Section: Methodsmentioning

confidence: 99%

<p>When a Ventilator Takes Autonomous Decisions without Seeking Approbation nor Warning Clinicians: A Case Series</p>

Dufour¹,

Fadel²,

Gelée³

et al. 2020

IMCRJ

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“…On suggestion of the members of DMBIUBIH and to set a base for management of technology in healthcare system and to reduce the percentage of deaths, as well as injuries caused by defective medical devices, National Metrology Institute (NMI) in Bosnia and Herzegovina [18] introduced 10 groups of medical devices in legal metrology [19]. In this way, independent inspection body specialized in medical devices provides technical support for healthcare institutions and professional staff, and ensure the reliability and safety of the Medical Devices, prevents bad practice, where manufacturer and distributors supervised their own equipment.…”

Section: Iiibiomedical Engineering In Bosnia and Herzegovinamentioning

confidence: 99%

“…In this way, independent inspection body specialized in medical devices provides technical support for healthcare institutions and professional staff, and ensure the reliability and safety of the Medical Devices, prevents bad practice, where manufacturer and distributors supervised their own equipment. For the purpose of independent inspection of medical devices unique laboratory Verlab was established [19]. In the first year of their work more than 50% of all public and private healthcare institutions verificated their medical devices.…”

Section: Iiibiomedical Engineering In Bosnia and Herzegovinamentioning

confidence: 99%

Development and perspectives of biomedical engineering in South East European countries

Badnjević

Gurbeta

2016

2016 39th International Convention on Information and Communication Technology, Electronics and Microelectronics (MIPRO)

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In respect with growing population, chronical disease management and aging population, the medicine and health care have drastically changed over the past decades. Engineering became more involved in medicine resulting in development of new discipline, Biomedical Engineering. As new engineering solution for problems in medicine regarding therapy, diagnosis and treatment have emerged, the need for new interdisciplinary educational curriculums evolved. Today, South East Countries are focused on developing new educational curriculums in Biomedical Engineering, following the models established in other European and United States Countries, and recognizing the new discipline -Biomedical Engineering as a professional discipline. International Federation for Medical and Biological Engineering, supported by United Nations (UN), gives support for national societies that are focused on Biomedical Engineering. In this article, overview of development and perspectives of Biomedical Engineering in South East European (SEE) countries is given, with focus on Bosnia and Herzegovina.

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“…The delivery of healthcare services to the communities are significantly affected without effective management implementation ( 3 – 5 ). Medical equipment is a crucial asset that substantially contributes to the effectiveness and healthcare services quality enhancement ( 6 , 7 ). As the medical equipment aids various services in the healthcare sector, the management representative, such as clinical engineers, must monitor and upkeep the assets by performing several maintenances works throughout the equipment life cycle ( 8 , 9 ).…”

Section: Introductionmentioning

confidence: 99%

A Systematic Review of Medical Equipment Reliability Assessment in Improving the Quality of Healthcare Services

Zamzam

Wahab

Azizan

et al. 2021

Front. Public Health

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Medical equipment highly contributes to the effectiveness of healthcare services quality. Generally, healthcare institutions experience malfunctioning and unavailability of medical equipment that affects the healthcare services delivery to the public. The problems are frequently due to a deficiency in managing and maintaining the medical equipment condition by the responsible party. The assessment of the medical equipment condition is an important activity during the maintenance and management of the equipment life cycle to increase availability, performance, and safety. The study aimed to perform a systematic review in extracting and categorising the input parameters applied in assessing the medical equipment condition. A systematic searching was undertaken in several databases, including Web of Science, Scopus, PubMed, Science Direct, IEEE Xplore, Emerald, Springer, Medline, and Dimensions, from 2000 to 2020. The searching processes were conducted in January 2020. A total of 16 articles were included in this study by adopting Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA). The review managed to classify eight categories of medical equipment reliability attributes, namely equipment features, function, maintenance requirement, performance, risk and safety, availability and readiness, utilisation, and cost. Applying the eight attributes extracted from computerised asset maintenance management system will assist the clinical engineers in assessing the reliability of medical equipment utilised in healthcare institution. The reliability assessment done in these eight attributes will aid clinical engineers in executing a strategic maintenance action, which can increase the equipment's availability, upkeep the performance, optimise the resources, and eventually contributes in providing effective healthcare service to the community. Finally, the recommendations for future works are presented at the end of this study.

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Medical devices in legal metrology

Cited by 27 publications

References 0 publications

<p>When a Ventilator Takes Autonomous Decisions without Seeking Approbation nor Warning Clinicians: A Case Series</p>

<p>When a Ventilator Takes Autonomous Decisions without Seeking Approbation nor Warning Clinicians: A Case Series</p>

Development and perspectives of biomedical engineering in South East European countries

A Systematic Review of Medical Equipment Reliability Assessment in Improving the Quality of Healthcare Services

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