Patient safety related to the use of medical devices: a review and investigation of the current status in the medical device industry

Geißler, Norman; Byrnes, Trevor; Lauer, Wolfgang; Radermacher, Klaus; Kotzsch, Susanne; Korb, Werner; Hölscher, Uvo

doi:10.1515/bmt-2012-0040

Cited by 12 publications

(11 citation statements)

References 2 publications

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“…In the current context of the national reporting system, it is worth mentioning that errors in usage could result from poor usability research and design by the manufacturer, which could result in recall of the product because usability and human factor issues are considered sources of hazards that need to be eliminated or controlled based on the International Electrotechnical Commission (IEC) requirements. [1, 15, 19–21]…”

Section: Discussionmentioning

confidence: 99%

Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital

et al. 2019

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Intensive care units (ICU) rely on multiple technical resources with extensive use of different medical devices, such as ventilators, vital sign monitors, infusion, and injection pumps. This study explored how ICU nurses approach adverse events related to medical devices in a single tertiary center and identify their level of awareness of the national reporting system for adverse events related to medical devices beside their source for risk information updates. Totally, 297 nurses working in the ICU at King Saud University Medical City completed a survey on medical devices and adverse events reporting and 198 reported experiencing an adverse event related to equipment failure. However, 195 nurses were unaware of an official national reporting system for reporting such events. It is important to develop a framework of safe operation of medical devices based on international standards. This reporting system should include the national patients’ safety authorities, and should be anonymous, confidential, and non-punitive.

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Section: Discussionmentioning

confidence: 99%

Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital

et al. 2019

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“…Clinical examination and surgery assisted by medical device have been the main method of modern medical diagnostics and treatment [1]. However, broad challenges exist when fundamental research to study frictional characteristics between medical device and biological tissue is no exception.…”

Section: Introductionmentioning

confidence: 99%

Modeling of Frictional Resistance of a Capsule Robot Moving in the Intestine at a Constant Velocity

Zhang

Líu

2013

Tribol Lett

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Capsule robot is the direction for future development of capsule endoscopy. The imperfection of friction model between the capsule robot and the intestine has been one of the biggest obstacles of its development. Uniform motion is the main mode of the capsule robot in the intestine. However, the frictional resistance variation of the capsule robot in this period has not been understood completely until now. This is the research content in the paper. First, some experiments are conducted to measure actual frictional resistance with a homemade experiment platform. Next, the model of the frictional resistance at a constant velocity is established based on the hyperelasticity of the intestinal material and the interactive features between the capsule robot and the intestine. At last, the theoretical result of the model is proved to be reasonable by simulation analysis. The model is efficient to describe the frictional resistance variation at a constant velocity and can be seen as another kind of stick-slip motion. The work is hoped to perfect the friction model between the capsule robot and the intestine and contribute to the development of the capsule robot.

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“…Therefore a careful analysis, based on Reason's Swiss Cheese Model of Accident Causation [2] is necessary to improve the patient safety. Technological competence is a crucial aspect of the risk management, the risk communication, the analysis of the causes of critical incidents as well as of the risk-adjusted training and the customized procurement processes [3] Surgeons are not engineers and therefore they don`t have, in general, the knowledge about the theoretical models beyond the used medical devises. A competent user is absolutely necessary to control the system and to (re)act adequately in critical situations [4] This shows the necessity of an analysis of the impact from the knowledge about technological models and concepts on a safe use of a medical device (i.e.…”

Section: Introductionmentioning

confidence: 99%

Technological competence for surgeons – results of an international study

Geißler¹,

Machno²,

Kotzsch³

et al. 2013

Biomedical Engineering / Biomedizinische Technik

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A modern operating room consists of many different medical devices. Therefore an adequate technological competence of surgeons is needed for the improvement of patient safety. A Cognitive Task Analysis (CTA) was performed to analyse the technological competence of spinal and ENT surgeons. In an international study 6 ENT and 4 spinal surgeons in Germany and Spain were interviewed. The results show the need and the relevance to develop specific trainings in technological competence for surgeons.

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Patient safety related to the use of medical devices: a review and investigation of the current status in the medical device industry

Cited by 12 publications

References 2 publications

Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital

Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital

Modeling of Frictional Resistance of a Capsule Robot Moving in the Intestine at a Constant Velocity

Technological competence for surgeons – results of an international study

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