Risk Management in Magnetic Resonance: Failure Mode, Effects, and Criticality Analysis

Petrillo, Antonella; Fusco, Roberta; Granata, Vincenza; Filice, Salvatore; Raiano, Nicola; Amato, Daniela; Zirpoli, Maria; Finizio, Alessandro di; Sansone, Mario; Russo, Anna Paola; Covelli, Eugenio Maria; Pedicini, Tonino; Triassi, Maria

doi:10.1155/2013/763186

Cited by 9 publications

(8 citation statements)

References 8 publications

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“…MR examinations were performed with a 1.5-T MR system (Magnetom Symphony, upgraded to Total Imaging Matrix Package, Siemens, Erlangen, Germany) using an eighteen-channel body surface phased-array coil. With all studies being performed in the same MR suite, all pre-, intra-, and post-MR steps were made using a constant and homogeneous procedure, as reported in our previous work on the topic [ 7 ].…”

Section: Methodsmentioning

confidence: 99%

Immediate Adverse Reactions to Gadolinium-Based MR Contrast Media: A Retrospective Analysis on 10,608 Examinations

Granata

Cascella

Fusco

et al. 2016

BioMed Research International

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Background and Purpose. Contrast media (CM) for magnetic resonance imaging (MRI) may determine the development of acute adverse reactions. Objective was to retrospectively assess the frequency and severity of adverse reactions associated with gadolinium-based contrast agents (GBCAs) injection in patients who underwent MRI. Material and Methods. At our center 10608 MRI examinations with CM were performed using five different GBCAs: Gd-BOPTA (MultiHance), Gd-DTPA (Magnevist), Gd-EOBDTPA (Primovist), Gd-DOTA (Dotarem), and Gd-BTDO3A (Gadovist). Results. 32 acute adverse reactions occurred, accounting for 0.3% of all administration. Twelve reactions were associated with Gd-DOTA injection (0.11%), 9 with Gd-BOPTA injection (0.08%), 6 with Gd-BTDO3A (0.056%), 3 with Gd-EOB-DTPA (0.028%), and 2 with Gd-DTPA (0.018%). Twenty-four reactions (75.0%) were mild, four (12.5%) moderate, and four (12.5%) severe. The most severe reactions were seen associated with use of Gd-BOPTA, with 3 severe reactions in 32 total reactions. Conclusion. Acute adverse reactions are generally rare with the overall adverse reaction rate of 0.3%. The most common adverse reactions were not severe, consisting in skin rash and hives.

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Section: Methodsmentioning

confidence: 99%

Immediate Adverse Reactions to Gadolinium-Based MR Contrast Media: A Retrospective Analysis on 10,608 Examinations

Granata

Cascella

Fusco

et al. 2016

BioMed Research International

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“…(i) Applying FMEA approach to many more particular fields for risk analysis: except for those applications mentioned above, FMEA is also used as a risk assessment tool in other particular fields like agriculture and food domain [18], environment protection [19], and so on [20,21].…”

Section: Introductionmentioning

confidence: 99%

A Modified Model of Failure Mode and Effects Analysis Based on Generalized Evidence Theory

Zhou

Tang

Jiang

2016

Mathematical Problems in Engineering

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Due to the incomplete knowledge, how to handle the uncertain risk factors in failure mode and effects analysis (FMEA) is still an open issue. This paper proposes a new generalized evidential FMEA (GEFMEA) model to handle the uncertain risk factor, which may not be included in the conventional FMEA model. In GEFMEA, not only the conventional risk factors, the occurrence, severity, and detectability of the failure mode, but also the other incomplete risk factors are taken into consideration. In addition, the relative importance among all these risk factors is well addressed in the proposed method. GEFMEA is based on the generalized evidence theory, which is efficient in handling incomplete information in the open world. The efficiency and some merit of the proposed method are verified by the numerical example and a real case study on aircraft turbine rotor blades.

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“…The resulting Fuzzy FMECA has been widely used in the medical field [9] Decimal value for the risk priority number which decreases the presence of gaps in its range of admissible values × Occurrence and Detectability. Since these criteria are not appropriate to the medical field, we adopted specific criteria obtained through an analysis of the literature in this field and adapted them to this application [33] [34] [35]. Section II-B3 describes this selection.…”

Section: B Fuzzy Fmecamentioning

confidence: 99%

Fuzzy FMECA Process Analysis for Managing the Risks in the Lifecycle of a CBCT Scanner

et al. 2021

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The Failure Mode, Effects, and Criticality Analysis (FMECA) is one of the risk analysis techniques proposed by the ISO 14971 Standard. This analysis allows to identify and assess the consequences of faults that affect each component of a complex system. The FMECA is a forward-type technique used for highlighting critical points and classifying them by priority. It also makes it possible to evaluate the extent of failures by means of numerical indices. It can be applied to a product or to a work process. In the latter case we talk about Process-FMECA. The application of the Process-FMECA to bioengineering is of particular interest because this procedure provides an analysis related to risk management during all the different phases of the medical device life cycle. However, practical applications of this method have revealed some shortcomings that can lead to inaccuracies and inconsistencies regarding the risk analysis and consequent risk prioritization. This paper presents an example of application of a Fuzzy Process-FMECA, an improved Process-FMECA based on fuzzy logic, to a small computerized tomography (CT) device prototype designed for studying the extremities of the human body. This prototype is a CT device that uses the Cone Beam CT (CBCT) technology. The Fuzzy Process-FMECA analysis has made it possible to produce a table of risks, that are quantified according to the specifications of the method. The analysis has shown that each phase or activity is fundamental to guarantee a correct functioning of the device. The methodology applied to this specific device can be paradigmatic for analyzing the process risks for any other medical device.

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Risk Management in Magnetic Resonance: Failure Mode, Effects, and Criticality Analysis

Cited by 9 publications

References 8 publications

Immediate Adverse Reactions to Gadolinium-Based MR Contrast Media: A Retrospective Analysis on 10,608 Examinations

Immediate Adverse Reactions to Gadolinium-Based MR Contrast Media: A Retrospective Analysis on 10,608 Examinations

A Modified Model of Failure Mode and Effects Analysis Based on Generalized Evidence Theory

Fuzzy FMECA Process Analysis for Managing the Risks in the Lifecycle of a CBCT Scanner

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