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Abdominal Radiology (New York) Mar 2016Magnetic resonance imaging (MRI) has a superior soft-tissue contrast compared to other radiological imaging modalities and its physiological and functional applications... (Review)
Review
Magnetic resonance imaging (MRI) has a superior soft-tissue contrast compared to other radiological imaging modalities and its physiological and functional applications have led to a significant increase in MRI scans worldwide. A comprehensive MRI safety training to protect patients and other healthcare workers from potential bio-effects and risks of the magnetic fields in an MRI suite is therefore essential. The knowledge of the purpose of safety zones in an MRI suite as well as MRI appropriateness criteria is important for all healthcare professionals who will work in the MRI environment or refer patients for MRI scans. The purpose of this article is to give an overview of current magnetic resonance safety guidelines and discuss the safety risks of magnetic fields in an MRI suite including forces and torque of ferromagnetic objects, tissue heating, peripheral nerve stimulation, and hearing damages. MRI safety and compatibility of implanted devices, MRI scans during pregnancy, and the potential risks of MRI contrast agents will also be discussed, and a comprehensive MRI safety training to avoid fatal accidents in an MRI suite will be presented.
Topics: Contrast Media; Equipment Safety; Female; Humans; Image Enhancement; Magnetic Resonance Imaging; Male; Occupational Diseases; Patient Safety; Pregnancy
PubMed: 26940331
DOI: 10.1007/s00261-016-0680-4 -
Journal of Diabetes Science and... Nov 2014Continuous subcutaneous insulin infusion pumps and continuous glucose monitors enable individuals with type 1 diabetes to achieve tighter blood glucose control and are... (Review)
Review
Continuous subcutaneous insulin infusion pumps and continuous glucose monitors enable individuals with type 1 diabetes to achieve tighter blood glucose control and are critical components in a closed-loop artificial pancreas. Insulin infusion sets can fail and continuous glucose monitor sensor signals can suffer from a variety of anomalies, including signal dropout and pressure-induced sensor attenuations. In addition to hardware-based failures, software and human-induced errors can cause safety-related problems. Techniques for fault detection, safety analyses, and remote monitoring techniques that have been applied in other industries and applications, such as chemical process plants and commercial aircraft, are discussed and placed in the context of a closed-loop artificial pancreas.
Topics: Equipment Failure; Equipment Safety; Humans; Pancreas, Artificial
PubMed: 25049365
DOI: 10.1177/1932296814543661 -
Anaesthesia Sep 1993
Topics: Anesthesiology; Equipment Safety; Humans; Respiration, Artificial
PubMed: 8214527
DOI: 10.1111/j.1365-2044.1993.tb07638.x -
Drug Safety Jan 2017Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some... (Comparative Study)
Comparative Study Review
Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features of the drug safety evaluation process could, if adopted and adapted for NAIMDs, lead to better and more systematic evaluations of the latter.
Topics: Adverse Drug Reaction Reporting Systems; Animals; Drug-Related Side Effects and Adverse Reactions; Equipment Safety; Equipment and Supplies; European Union; Humans; Product Surveillance, Postmarketing; Risk Assessment; United States
PubMed: 27928726
DOI: 10.1007/s40264-016-0474-1 -
Anaesthesia Jun 1990
Review
Topics: Anesthesiology; Documentation; Equipment Safety; Humans; Ireland; United Kingdom
PubMed: 2200297
DOI: 10.1111/j.1365-2044.1990.tb14325.x -
European Radiology Oct 2023To evaluate at 1.5 and 3 T MRI the safety and performance of trademarked ENO, TEO, or OTO pacing systems with automated MRI Mode and the image quality of non-enhanced...
OBJECTIVES
To evaluate at 1.5 and 3 T MRI the safety and performance of trademarked ENO, TEO, or OTO pacing systems with automated MRI Mode and the image quality of non-enhanced MR examinations.
METHODS
A total of 267 implanted patients underwent MRI examination (brain, cardiac, shoulder, cervical spine) at 1.5 (n = 126) or 3 T (n = 141). MRI-related device complications, lead electrical performances stability at 1-month post-MRI, proper functioning of the automated MRI mode and image quality were evaluated.
RESULTS
Freedom from MRI-related complications at 1 month post-MRI was 100% in both 1.5 and 3 T arms (both p < 0.0001). The stability of pacing capture threshold was respectively at 1.5 and 3 T (atrial:: 98.9% (p = 0.001) and 100% (p < 0.0001); ventricular: both 100% (p < 0001)). The stability of sensing was respectively at 1.5 and 3 T (atrial: 100% (p = 0.0001) and 96.9% (p = 0.01); ventricular: 100% (p < 0.0001) and 99.1% (p = 0.0001)). All devices switched automatically to the programmed asynchronous mode in the MRI environment and to initially programmed mode after the MRI exam. While all MR examinations were assessed as interpretable, artifacts deteriorated a subset of examinations including mostly cardiac and shoulder ones.
CONCLUSION
This study demonstrates the safety and electrical stability of ENO, TEO, or OTO pacing systems at 1 month post-MRI at 1.5 and 3 T. Even if artifacts were noticed in a subset of examinations, overall interpretability was preserved.
CLINICAL RELEVANCE STATEMENT
ENO, TEO, and OTO pacing systems switch to MR-mode when detecting magnetic field and switch back on conventional mode after MRI. Their safety and electrical stability at 1 month post MRI were shown at 1.5 and 3 T. Overall interpretability was preserved.
KEY POINTS
• Patients implanted with an MRI conditional cardiac pacemaker can be safely scanned under 1.5 or 3 Tesla MRI with preserved interpretability. • Electrical parameters of the MRI conditional pacing system remain stable after a 1.5 or 3 Tesla MRI scan. • The automated MRI mode enabled the automatic switch to asynchronous mode in the MRI environment and to initial settings after the MRI scan in all patients.
Topics: Humans; Atrial Fibrillation; Equipment Safety; Prospective Studies; Pacemaker, Artificial; Magnetic Resonance Imaging
PubMed: 37195432
DOI: 10.1007/s00330-023-09650-9 -
Revista Brasileira de Enfermagem 2019To identify and analyze the scientific evidence regarding the occurrence of Medical Device-Related Pressure Injuries, considering the development sites; and to describe... (Review)
Review
OBJETIVES
To identify and analyze the scientific evidence regarding the occurrence of Medical Device-Related Pressure Injuries, considering the development sites; and to describe the devices of risk and the measures of prevention and treatment.
METHOD
Integrative, search-based review: CINAHL, PubMed, Wiley InterScience, Scopus, and Web Of Science. The terms "pressure ulcer" and "medical devices" were used, including original articles and case studies published between 2010 and 2015. Nine studies were selected.
RESULTS
Posterior cervical region and nose had the highest injury frequencies, respectively, 66.0% and 40.0%. Eleven risk devices were identified, with emphasis on Non-Invasive Ventilation masks and orotracheal tube. For prevention and treatment emerged recommendations specific to the device employed and general measures.
CONCLUSION
Medical Device-Related Pressure Injuries are frequent problems, however, they can be prevented and treated based on the recommendations of the articles raised in this review.
Topics: Equipment Safety; Humans; Pressure Ulcer
PubMed: 31017216
DOI: 10.1590/0034-7167-2018-0530 -
Heart Rhythm Mar 2021Remote monitoring of cardiac implantable electronic devices (CIEDs) has become routine practice as a result of the advances in biomedical engineering, the advent of... (Review)
Review
Remote monitoring of cardiac implantable electronic devices (CIEDs) has become routine practice as a result of the advances in biomedical engineering, the advent of interconnectivity between the devices through the Internet, and the demonstrated improvement in patient outcomes, survival, and hospitalizations. However, this increased dependency on the Internet of Things comes with risks in the form of cybersecurity lapses and possible attacks. Although no cyberattack leading to patient harm has been reported to date, the threat is real and has been demonstrated in research laboratory scenarios and echoed in patient concerns. The CIED universe comprises a complex interplay of devices, connectivity protocols, and sensitive information flow between the devices and the central cloud server. Various manufacturers use proprietary software and black-box connectivity protocols that are susceptible to hacking. Here we discuss the fundamentals of the CIED ecosystem, the potential security vulnerabilities, a historical overview of such vulnerabilities reported in the literature, and recommendations for improving the security of the CIED ecosystem and patient safety.
Topics: Arrhythmias, Cardiac; Computer Security; Equipment Safety; Humans; Pacemaker, Artificial; Patient Safety
PubMed: 33059076
DOI: 10.1016/j.hrthm.2020.10.009 -
Journal of Diabetes Science and... Jul 2018
Topics: Computer Security; Diabetes Mellitus; Equipment Safety; Equipment and Supplies; Humans; Medical Device Legislation; Wireless Technology
PubMed: 29575925
DOI: 10.1177/1932296818763634 -
Clinical Medicine (London, England) Jun 2015When nobody or nothing notices an error, it may turn into patient harm. We show that medical devices ignore many errors, and therefore do not adequately support patient... (Review)
Review
When nobody or nothing notices an error, it may turn into patient harm. We show that medical devices ignore many errors, and therefore do not adequately support patient safety. In addition to causing preventable patient harm, errors are often reported ignoring potential flaws in medical device design, and front line staff may therefore be inappropriately blamed. We present some suggestions to improve reporting and the procurement of hospital equipment.
Topics: Equipment Safety; Humans; Medical Errors; Medical Informatics; Patient Safety
PubMed: 26031976
DOI: 10.7861/clinmedicine.15-3-258