scholarly journals MRI safety management in patients with cardiac implantable electronic devices: Utilizing failure mode and effects analysis for risk optimization

2020 ◽  
Vol 32 (7) ◽  
pp. 431-437
Author(s):  
James W Ryan ◽  
Aoife S Murray ◽  
Paddy J Gilligan ◽  
James M Bisset ◽  
Chris Nolan ◽  
...  
Keyword(s):  
Risk Analysis ◽  
Failure Mode ◽  
Failure Modes ◽  
Electronic Devices ◽  
Adverse Outcomes ◽  
Process Map ◽  
Targeted Interventions ◽  
Cardiac Implantable Electronic Devices ◽  
Mr Conditional ◽  
Mri Protocol

Abstract Introduction Cardiac implantable electronic devices (CIEDs) are increasing in prevalence. Exposing patients with CIEDs to magnetic resonance imaging (MRI) can lead to adverse outcomes. This has led certain radiology departments to not accept MRI referrals related to patients with CIEDs. Patients with MR-conditional CIEDs can be safely scanned under specific conditions. Our institution has accepted such referrals since 2014. The aim of this study was to systematically identify and reduce risk in our CIED-MRI protocol using failure mode and effects analysis (FMEA). Methods A multidisciplinary FMEA team was assembled and included senior stakeholders from the CIED-MRI protocol. A process map was constructed followed by risk analysis and scoring. Targeted interventions were formulated and implemented; high-risk failure modes were prioritized. A new process map and protocol were drafted and repeat risk analysis was performed. Monitoring and re-evaluation of the CIED-MRI pathway were instigated at departmental quality assurance (QA) meetings. Results Interventions included direct CIED characterization using wireless technology pre-MRI, CIED programming and reprogramming in the MRI suite before and immediately after MRI reducing device downtime and continuous patient monitoring during MRI by a cardiac physiologist. The cumulative risk priority number (RPN) decreased from 1190 pre-FMEA to 492 post-FMEA. Discussion Despite the risk of exposing CIEDs to the MR environment, patients with MR-conditional CIEDs can be safely scanned with an appropriate multidisciplinary support. We found FMEA an indispensable tool in identifying and minimizing risk with no adverse events recorded since FMEA recommendations were implemented.

scholarly journals Preventive risk analysis in the maintenance of patency of the peripherally inserted central catheter

2019 ◽  
Vol 53 ◽  
Author(s):  
Antônio Fernandes Costa Lima ◽  
Amanda Saba ◽  
Simone Berger ◽  
Silvia Sauaia Bianchini ◽  
Fernando Tobal Berssaneti
Keyword(s):  
Risk Analysis ◽  
Failure Mode ◽  
Failure Modes ◽  
Saline Solution ◽  
Hospital Costs ◽  
Peripherally Inserted Central Catheter ◽  
Central Catheter ◽  
Risk Priority Number ◽  
Effect Analysis ◽  
Nursing Professional

ABSTRACT This theoretical and reflexive study analyzed the risks related to the maintenance of patency of the Peripherally Inserted Central Catheter with the use of saline solution in comparison with saline-filled syringes, through the application of the Healthcare Failure Mode and Effect Analysis - HFMEA. The process was mapped, detailing the failure modes of each step. For the calculation of the Risk Priority Number, the severity and probability of the failure modes were analyzed. This analysis gave rise to the severity and probability matrix. Finally, actions to reduce the failure modes in the maintenance of patency were proposed, considering the use of saline-filled syringes in comparison to the use of saline ampoules. It was verified that the use of saline ampoules is associated with a greater risk, since it requires four stages more than saline-filled syringe does not, increasing the risk of contamination and the level of three different risks, which would result in additional hospital costs. The use of the saline-filled syringe would avoid risks that could negatively affect the patient’s health, the nursing professional and the health institution.

scholarly journals Risk analysis of warehouse operation in a power plant through a Modified FMEA

2018 ◽  
Vol 154 ◽  
pp. 01089
Author(s):  
Sri Indrawati ◽  
Kharina Novia Karunia Ningtyas ◽  
Alfina Budi Khoirani ◽  
Riadho Clara Shinta
Keyword(s):  
Power Plant ◽  
Risk Analysis ◽  
Needs Assessment ◽  
Failure Mode ◽  
Failure Modes ◽  
Basic Needs ◽  
Risk Priority Number ◽  
West Java ◽  
Warehouse Operation ◽  
Fmea Method

Currently, electricity becomes basic needs for human’s life sustainability. Most of activities require electricity. Some power plant are demanded to be able to fulfil above necessity by distributing electricity as it required within time. Therefore, to accommodate good performance, it needs assessment on risk analysis, specifically at the warehousing division. A risk analysis is needed for assuring a good performance warehouse. A Modified FMEA method is used to analyse the risk. This method id done by identifying sources and root causes of a problem based on the value of risk priority number (RPN). The research is conducted in an Indonesian power plant, located in West Java. There are 10 types of failure modes. The result shows that the failure mode priority is inventory discrepancies. There are no difference ranking on the most impacted failure to be prioritized using FMEA and modified FMEA method.

scholarly journals Assessing access to mri in patients with cardiac implantable electronic devices in australia

2021 ◽  
Vol 22 (Supplement_2) ◽  
Author(s):  
N Page ◽  
K Chia ◽  
D Brazier ◽  
C Manisty ◽  
R Kozor
Keyword(s):  
Patient Monitoring ◽  
Life Support ◽  
Electronic Devices ◽  
Advanced Cardiac Life Support ◽  
Adverse Outcomes ◽  
Public Hospitals ◽  
National Guidelines ◽  
Tertiary Referral ◽  
Cardiac Implantable Electronic Devices ◽  
Mri Conditional

Abstract Funding Acknowledgements Type of funding sources: None. Background "Legacy" cardiac implantable electronic devices (CIEDs) have historically been considered non-MRI-conditional. However, a number of recent studies indicate that if certain protocols are followed, patients with such devices may undergo MRI without significant adverse outcomes. Nowadays, industry standards dictate that "modern" CIEDs are MRI compatible. Despite these developments, some patients with CIEDs are denied MRI. Paucity of access to this vital service has been shown to increase expense, lead to more invasive imaging and later diagnosis, and poorer patient outcomes.  This study aims to identify if Australian public hospitals provide MRI services for patients with modern and legacy CIEDs, the characteristics of the services, and the barriers to implementing such a service.  Methods This study surveyed all Australian Tertiary Referral Public Hospitals (n = 38), with a mixed qualitative and quantitative questionnaire.  Results 35 of the 38 sites completed the survey. Figure 1A shows that the majority of hospitals (30/35, 85.7%) offer MRIs for modern MRI-conditional CIEDs. In contrast, Figure 1B shows that only a minority of hospitals (3/35, 8.6%) offer MRIs for legacy CIEDs.  Protocols governing patient eligibility vary greatly among hospitals that scan modern devices. Locations either allow all CIEDs to be scanned, only non-dependent CIEDs, or only pacemaker CIEDs. 1.5 Tesla is the preferred strength to scan Modern CIEDs (59%), however a sizeable proportion scan at only 3.0 Tesla (10%) or both strengths (31%). A majority (80%) of staff in attendance of the scan were ACLS-trained (Advanced Cardiac Life Support), with no correlation to strength of MRI used. A range of different personnel attend the scan with varied patient monitoring strategies, and a majority (79%) offer thoracic as well as extra-thoracic scanning.  The few hospitals that scan legacy devices only scan at 1.5 tesla, and follow individualised protocols. These sites offer more personnel in attendance for the scan than for modern CIED scans, with all staff ACLS-trained including a physician who can direct CIED programming of required. These sites have more involved patient monitoring, and all also offer thoracic and extra-thoracic MRI scanning.  The predominant barrier identified was an absence of National Guidelines, followed by a lack of formal training or logistical device support. Conclusions The majority (85.7%) of Australian Tertiary Referral Public Hospitals have a MRI service for patients with modern CIEDs, but only 8.6% offer this service to patients with legacy CIEDs.  This highlights the need for a national effort to guide the provision of MRI services for patients with CIEDs, and address the identified barriers.

scholarly journals Transvenous Extraction and Removal of Pacing Leads Placed after Cardiac Transplantation

2019 ◽  
Vol 2019 ◽  
pp. 1-4
Author(s):  
Caleb Norton ◽  
Benjamin Holmes ◽  
Asad Al Aboud ◽  
Eun-Jeong Kim ◽  
Holly Gonzales ◽  
...  
Keyword(s):  
Cardiac Transplantation ◽  
Electronic Devices ◽  
Extraction Procedure ◽  
Adverse Outcomes ◽  
Lead Extraction ◽  
Lead Removal ◽  
Cardiac Implantable Electronic Devices ◽  
Life Saving ◽  
One Year ◽  
Pacing Leads

There is an increasing prevalence of cardiac implantable electronic devices (CIEDs) due to expanding adoption and availability of these evidence-based therapies. With the increased prevalence of these life-saving devices, there has also been an increased demand for lead removal and lead extraction. Understanding the specific subgroups of patients at high risk for complications during and after lead extraction has become imperative to properly manage endovascular CIED leads. There have been multiple published studies describing clinical variables that predict adverse outcomes in CIED system extractions; however, the risk of complications in leads placed after cardiac transplantation has not specifically been addressed to date. We present four cases of transvenous extraction and removal of pacing leads placed after cardiac transplantation. There were no major complications related to extraction in these four cases; however, three of the four patients died within one year after the procedure. While the etiology of death in these cases seemed to be unrelated to the extraction procedure, the indications for extraction (infection in the setting of immunosuppression and calcineurin-associated ESRD and poor sensing/capture possibly secondary to chronic rejection and/or frequent right heart biopsies) likely contributed at least indirectly to the subsequent death.

scholarly journals Failure Mode and Effect Analysis in Automotive Industry: A Case Study

2019 ◽  
Vol 19 (2) ◽  
pp. 10-15
Author(s):  
L. Petrescu ◽  
E. Cazacu ◽  
Maria-Cătălina Petrescu
Keyword(s):  
Failure Mode ◽  
Automotive Industry ◽  
Failure Modes ◽  
Action Plan ◽  
Electronic Devices ◽  
Area Network ◽  
Risk Priority Number ◽  
Effect Analysis ◽  
Iso 26262

AbstractNowadays, Failure Mode and Effect Analysis (FMEA) is more present in any standard evaluation of a product or process. In automotive industry, the IEC 61508 Standard adapted the ISO 26262 restrictions for Electrical and Electronic Devices. Conducting an FMEA reduces the costs by focusing on preventing failures, improving safety and increasing customer satisfaction. This paper presents a case study of a FMEA on a CAN (Controller Area Network) Bus Harness considering the entire process from defining the scope and building the team, to the action plan that will reduce the Risk Priority Number below the acceptable risk value. Also, the brainstorming that identifies the possible failure modes is presented.

scholarly journals Cartilage Tissue Engineering by Extrusion Bioprinting: Process Analysis, Risk Evaluation, and Mitigation Strategies

Materials ◽  
2021 ◽  
Vol 14 (13) ◽  
pp. 3528
Author(s):  
Mauro Petretta ◽  
Giovanna Desando ◽  
Brunella Grigolo ◽  
Livia Roseti
Keyword(s):  
Tissue Engineering ◽  
Risk Analysis ◽  
Failure Mode ◽  
Failure Modes ◽  
Process Analysis ◽  
Cartilage Tissue Engineering ◽  
Cartilage Tissue ◽  
Risk Level ◽  
Main Process ◽  
Criticality Analysis

Extrusion bioprinting is considered promising in cartilage tissue engineering since it allows the fabrication of complex, customized, and living constructs potentially suitable for clinical applications. However, clinical translation is often complicated by the variability and unknown/unsolved issues related to this technology. The aim of this study was to perform a risk analysis on a research process, consisting in the bioprinting of a stem cell-laden collagen bioink to fabricate constructs with cartilage-like properties. The method utilized was the Failure Mode and Effect Analysis/Failure Mode and Effect Criticality Analysis (FMEA/FMECA) which foresees a mapping of the process to proactively identify related risks and the mitigation actions. This proactive risk analysis allowed the identification of forty-seven possible failure modes, deriving from seventy-one potential causes. Twenty-four failure modes displayed a high-risk level according to the selected evaluation criteria and threshold (RPN > 100). The results highlighted that the main process risks are a relatively low fidelity of the fabricated structures, unsuitable parameters/material properties, the death of encapsulated cells due to the shear stress generated along the nozzle by mechanical extrusion, and possible biological contamination phenomena. The main mitigation actions involved personnel training and the implementation of dedicated procedures, system calibration, printing conditions check, and, most importantly, a thorough knowledge of selected biomaterial and cell properties that could be built either through the provided data/scientific literature or their preliminary assessment through dedicated experimental optimization phase. To conclude, highlighting issues in the early research phase and putting in place all the required actions to mitigate risks will make easier to develop a standardized process to be quickly translated to clinical use.

Recent Advances in Pacing and Defibrillation

2011 ◽  
Vol 3 (1) ◽  
pp. 74
Author(s):  
Kathy L Lee ◽  
Keyword(s):  
Cardiac Death ◽  
Electronic Devices ◽  
Implantable Defibrillators ◽  
Cardiac Pacemakers ◽  
Cardiac Implantable Electronic Devices ◽  
Treatment And Prevention ◽  
Recent Advances ◽  
Pacing Lead ◽  
Leadless Pacing ◽  
Device Complications

Cardiac pacemakers have been the standard therapy for patients with bradyarrhythmias for several decades. The pacing lead is an integral part of the system, serving as a conduit for the delivery of energy pulses to stimulate the myocardium. However, it is also the Achilles’ heel of pacemakers, being the direct cause of most device complications both acutely during implant and chronically years afterwards. Leadless pacing with ultrasound-mediated energy has been demonstrated in animals and humans to be safe and feasible in acute studies. Implantable defibrillators revolutionised the treatment and prevention of sudden cardiac death. Subcutaneous implantable defibrillators have been under development for more than 10 years. A permanent implantable system has been shown to be feasible in treating induced and spontaneous ventricular tachyarrhythmias. These developments and recent advances in pacing and defibrillation will arouse further interest in the research and development of leadless cardiac implantable electronic devices.

Combine Nanoprobing Technique with Difference Analysis to Identify Nonvisual Failures

2006 ◽  
Author(s):  
Cha-Ming Shen ◽  
Tsan-Cheng Chuang ◽  
Jie-Fei Chang ◽  
Jin-Hong Chou
Keyword(s):  
Failure Mode ◽  
Failure Modes ◽  
Electrical Characteristic ◽  
The Novel ◽  
Difference Analysis ◽  
Original Idea ◽  
Deductive Method ◽  
Complete Measurement

Abstract This paper presents a novel deductive methodology, which is accomplished by applying difference analysis to nano-probing technique. In order to prove the novel methodology, the specimens with 90nm process and soft failures were chosen for the experiment. The objective is to overcome the difficulty in detecting non-visual, erratic, and complex failure modes. And the original idea of this deductive method is based on the complete measurement of electrical characteristic by nano-probing and difference analysis. The capability to distinguish erratic and invisible defect was proven, even when the compound and complicated failure mode resulted in a puzzling characteristic.

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