Safety and performance of MR-conditional pacing systems with automated MRI mode at 1.5 and 3 Tesla.

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.

Safety Considerations of 7-T MRI in Clinical Practice.

Although 7-T MRI has recently received approval for use in clinical patient care, there are distinct safety issues associated with this relatively high magnetic field. Forces on metallic implants and radiofrequency power deposition and heating are safety considerations at 7 T. Patient bioeffects such as vertigo, dizziness, false feelings of motion, nausea, nystagmus, magnetophosphenes, and electrogustatory effects are more common and potentially more pronounced at 7 T than at lower field strengths. Herein the authors review safety issues associated with 7-T MRI. The rationale for safety concerns at this field strength are discussed as well as potential approaches to mitigate risk to patients and health care professionals.

Cardiovascular magnetic resonance imaging in patients with cardiac implantable electronic devices: best practice and real-world experience.

AIMS: Cardiovascular magnetic resonance (CMR) imaging has long been a contraindication for patients with a cardiac implantable electronic device (CIED). Recent studies support the feasibility and safety for non-thoracic magnetic resonance imaging, but data for CMR are sparse. The aim of the current study was to determine the safety in patients with magnetic resonance (MR)-conditional or non-MR-conditional CIED and to develop a best practice approach. METHODS AND RESULTS: All patients with a CIED undergoing CMR imaging (1.5 T) between April 2014 and April 2017 were included in the study. Devices were programmed according to the standardized protocol directly before and after the CMR examination. Follow-up interrogation was performed 6 months after CMR examination. Results were compared with a large, reference cohort of CIED patients not undergoing any MR examination. A total of 200 consecutive patients with a CIED (non-MR-conditional, n = 103) were included in the study. Directly after CMR imaging, one device failure (0.5%, battery status = end of service) was noted necessitating premature generator replacement. In three patients (2%) of pacemaker/implantable cardioverter-defibrillator (ICD) carriers a sustained ventricular tachycardia (VT) occurred during CMR imaging. Ten ICD showed a decrease in battery capacity immediately after CMR. Overall, the reference cohort showed comparable changes of CIED function during follow-up. CONCLUSION: With adherence to a standardized protocol and established exclusion criteria CMR imaging could safely be performed in patients with a CIED. The potential risks of device malfunction necessitate the presence of a device trained individual during the entire CMR examination. If there is a history of VT storm the attendance of an experienced cardiologist, should be mandatory.

Incidence of appropriate implantable cardioverter-defibrillator therapy and mortality after implantable cardioverter-defibrillator generator replacement: results from a real-world nationwide cohort.

AIMS: The safety of omitting implantable cardioverter-defibrillator (ICD) generator replacement in patients with no prior appropriate therapy, comorbid conditions, and advanced age is unclear. The aim was to investigate incidence of appropriate ICD therapy after generator replacement. METHODS AND RESULTS: We identified patients implanted with a primary prevention ICD (n = 4630) from 2007 to 2016, who subsequently underwent an elective ICD generator replacement (n = 670) from the Danish Pacemaker and ICD Register. The data were linked to other databases and evaluated the outcomes of appropriate therapy and death. Predictors of ICD therapy were identified using multivariate Cox regression analyses. A total of 670 patients underwent elective ICD generator replacement. Of these, 197 (29.4%) patients had experienced appropriate therapy in their 1st generator period. During follow-up of 2.0 ± 1.6 years, 95 (14.2%) patients experienced appropriate therapy. Predictors of appropriate therapy in 2nd generator period was low initial left ventricular ejection fraction (≤25%) [hazard ratio (HR) 1.87, confidence interval (CI) 1.13-1.95] and appropriate therapy in 1st generator period (HR 3.95, CI 2.57-6.06). For patients with appropriate therapy in 1st generator period, 4-year incidence of appropriate therapy was 50.6% vs. 16.4% in those without (P < 0.001). Among patients >80 years with no prior appropriate therapy 8.8% of patients experienced appropriate therapy after replacement. Comorbidity burden and advanced age were associated with reduced device utilization after replacement and a high competing risk of death without preceding appropriate therapy. CONCLUSION: A significant residual risk of appropriate therapy in the 2nd generator was present even among patients with advanced age and with a full prior generator period without any appropriate ICD events.

An Overview on the Considerations for the Planning of Nonclinical Necropsies for Medical Device Studies.

The terminal collection and histological processing of medical devices is an expensive, labor-, and material-intensive endeavor, which requires adequate experience, innovation, and preparation for success. It is also an exciting endeavor that continually challenges, intellectually engages, and improves the skills and knowledge of the pathologist. Awareness of the importance of the medical device pathologist's involvement, communication, and oversight throughout the development, implementation, and execution of a nonclinical assessment of a medical device is in the best interest of the test facility, the histopathology laboratory, the pathologist, the sponsor, and, ultimately, the patients. This article serves to present as a primer of key considerations for the approach and conduct of "nontoxicological" studies, defined as studies involving animal models of deployment or implantation of medical devices as well as surgical animal models.

Regional Draining Lymph Nodes: Considerations for Medical Device Studies.

Lymph nodes and associated lymphatics filter extracellular fluid and lymph to maintain tissue-fluid balance and detect distant tissue injury. Examination of regional draining lymph nodes (RDLs; lymph nodes that drain the route of article dosing) is an important step in detecting immunotoxicity and other associated changes during general toxicology studies. Similarly, evaluation of RDLs is often a key component of evaluating medical devices. Nonclinical medical device studies can present challenges for RDL evaluation, due to the wide variety of tissues and organs that are implanted with devices, the potential for wear debris/degradation products, and the likely disruption of normal lymphatic drainage by surgical procedures. This article discusses concepts for consideration when designing a nonclinical medical device study that includes the macroscopic evaluation, collection, histologic processing, microscopic assessment, and documentation of findings within RDLs. References describing RDLs for common implantation sites are reported, as are considerations for specific tissues and species commonly used in medical device biocompatibility and functional testing.

Pathology of Bioabsorbable Implants in Preclinical Studies.

Bioabsorbable implants can be advantageous for certain surgical tissue bioengineering applications and implant-assisted tissue repair. They offer the obvious benefits of nonpermanence and eventual restoration of the native tissue's biomechanical and immunological properties, while providing a structural scaffold for healing and a route for additional therapies (i.e., drug elution). They present unique developmental, imaging, and histopathological challenges in the conduct of preclinical animal studies and in interpretation of pathology data. The bioabsorption process is typically associated with a gradual decline (over months to years) in structural strength and integrity and may also be associated with cellular responses such as phagocytosis that may confound interpretation of efficacy and safety end points. Additionally, as these implants bioabsorb, they become increasingly difficult to isolate histologically and thus imaging modalities such as microCT become very valuable to determine the original location of the implants and to assess the remodeling response in tandem with histopathology. In this article, we will review different types of bioabsorbable implants and commonly used bioabsorbable materials; additionally, we will address some of the most common challenges and pitfalls confronting histologists and pathologists in collecting, handling, imaging, preparing tissues through histology, evaluating, and interpreting study data associated with bioabsorbable implants.

Evaluation of Magnesium-based Medical Devices in Preclinical Studies: Challenges and Points to Consider.

Absorbable metallic implants have been under investigation for more than a century. Animal and human studies have shown that magnesium (Mg) alloys can be safely used in bioresorbable scaffolds. Several cardiovascular and orthopedic biodegradable metallic devices have recently been approved for use in humans. Bioresorbable Mg implants present many advantages when compared to bioabsorbable polymer or nonabsorbable metallic implants, including similar strength and mechanical properties as existing implant-grade metals without the drawbacks of permanence or need for implant removal. Imaging visibility is also improved compared to polymeric devices. Additionally, with Mg-based cardiovascular stents, the risk of late stent thrombosis and need for long-term anti-platelet therapy may be reduced as the host tissue absorbs the Mg degradation products and the morphology of the vessel returns to a near-normal state. Absorbable Mg implants present challenges in the conduct of preclinical animal studies and interpretation of pathology data due to their particular degradation process associated with gas production and release of by-products. This article will review the different uses of Mg implants, the Mg alloys, the distinctive degradation features of Mg, and the challenges confronting pathologists at tissue collection, fixation, imaging, slide preparation, evaluation, and interpretation of Mg implants.

[Establishment of Sampling Inspection Scheme Paradigm for Medical Device Sampling Inspection].

This paper introduces the sampling scheme and the inspection scheme paradigm followed in organizing the sampling inspection of medical devices. The sampling scheme paradigm includes the definition and operation guidelines for sampling products, the regulations for individual sampling batches and related model specifications, accessory data, validity period, storage conditions, etc., the requirements for sampling areas, places and quantities, and the requirements for samples to be sent to inspection institutions. The inspection scheme paradigm includes the provisions for inspection basis, inspection items and determination principles.

Access to magnetic resonance imaging of patients with magnetic resonance-conditional pacemaker and implantable cardioverter-defibrillator systems: results from the Really ProMRI study.

Aims: The Really ProMRI study evaluates magnetic resonance imaging (MRI) access for patients with cardiac implantable electronic devices (CIEDs) as well as the performance of magnetic resonance (MR)-conditional leads when undergoing MRI. Methods and results: Patients either with an MR-conditional pacemaker or implantable defibrillator (ICD) system or with at least a component (device or one or more leads) from an MR-conditional system, were asked to fill in a questionnaire when they were referred to a MR scan. The rate of prescription, denial, or execution of MR examinations was evaluated in a 1-year follow-up visit. In total, 555 patients [median age (interquartile range) 72.2 (62.2-78.6); 72% male] were enrolled, 49% (270) with a pacemaker, 51% (285) with an ICD system. Five-hundred and ten patients completed the follow-up period. A total of 37 MRI referrals were reported in 35 patients, with a consequent event rate of 7.0/100 patient-years (CI, 4.9-9.7). Fourteen were denied, while 23 [66%; (CI, 48-81%)] were performed. The number of patients with MR referrals was not statistically different between pacemaker and ICD groups (21 vs. 14; P = 0.178). The rate of scans performed was higher in the pacemaker subjects (19/23 vs. 4/14, P = 0.003), while it was similar between patients with or without a complete MR-conditional system (19/30 vs. 4/7, P = 0.606). Conclusion: In this study, we reported a 7.0/100 patient-year's event rate of MR prescriptions in CIED patients. Many examinations were denied, despite MR-conditional systems, especially in ICD patients. Regulatory and cultural changes are needed to allow wider access to MR imaging in CIED patients with MR-conditional systems.

Toxicologic Pathology Forum Opinion Paper: Considerations for Toxicologic Pathologists Evaluating the Safety of Biomaterials and Finished Medical Devices.

Safety ("biocompatibility") assessment of medical devices has evolved along a different path than that of drugs, being historically governed more by the considerations and needs of engineers rather than chemists and biologists. As a result, the involvement of veterinary pathologists has been much more limited-almost entirely to evaluating tissue responses in tissues in direct contact with implanted devices. As devices have become more complex in composition, structure, placement, and use, concerns as to adverse systemic responses in patients have called for more comprehensive and thoughtful evaluations of effects throughout the body. Further complexities arise from the increasing marriage of devices and drug/biologic therapeutics to achieve either better dose control and, specifically, in delivery to target organs/tissues or better tolerance of the body to medical devices (i.e., minimization of the foreign body response). The challenge to pathologists is to integrate in new technologies (such as in vivo imaging and immunology) and ways of viewing interactions with patient bodies. To fail to do so will allow the methods and standards for medical device safety evaluation to be based on chemical analysis and then the limited details inherent in literature-based risk assessments.

Regulatory Considerations for Physiological Closed-Loop Controlled Medical Devices Used for Automated Critical Care: Food and Drug Administration Workshop Discussion Topics.

Part of the mission of the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration is to facilitate medical device innovation. Therefore, CDRH plays an important role in helping its stakeholders such as manufacturers, health care professionals, patients, patient advocates, academia, and other government agencies navigate the regulatory landscape for medical devices. This is particularly important for innovative physiological closed-loop controlled (PCLC) devices used in critical care environments, such as intensive care units, emergency settings, and battlefield environments. CDRH's current working definition of a PCLC medical device is a medical device that incorporates physiological sensor(s) for automatic manipulation of a physiological variable through actuation of therapy that is conventionally made by a clinician. These emerging devices enable automatic therapy delivery and may have the potential to revolutionize the standard of care by ensuring adequate and timely therapy delivery with improved performance in high workload and high-stress environments. For emergency response and military applications, automatic PCLC devices may play an important role in reducing cognitive overload, minimizing human error, and enhancing medical care during surge scenarios (ie, events that exceed the capability of the normal medical infrastructure). CDRH held an open public workshop on October 13 and 14, 2015 with the aim of fostering an open discussion on design, implementation, and evaluation considerations associated with PCLC devices used in critical care environments. CDRH is currently developing regulatory recommendations and guidelines that will facilitate innovation for PCLC devices. This article highlights the contents of the white paper that was central to the workshop and focuses on the ensuing discussions regarding the engineering, clinical, and human factors considerations.

Prevention of Medical Device-Related Pressure Injuries Associated With Respiratory Equipment Use in a Critical Care Unit: A Quality Improvement Project.

Medical devices have been identified as an extrinsic risk factor for development of pressure injuries, with as many as 30% to 70% of medical device-related pressure injuries resulting from respiratory equipment. This article describes a quality improvement project undertaken to reduce the occurrence of respiratory device-related pressure injuries in a critically care unit. Multiple actions were implemented to achieve this goal. Respiratory therapists were trained to document occurrences on a daily basis, and apparent cause analyses were conducted on each occurrence. An interdisciplinary team conducted biweekly rounds on patients with respiratory devices and consulted other professionals as indicated. Nurses and respiratory therapists attended an evidence-based, collaborative, educational offering and completed a measure of team functioning before the program and at the end of the study period. The occurrence rates of respiratory device-related pressure injuries were reduced over the project period, and these changes were sustained over the subsequent 12 months.

Straight ladder inclined angle in a field environment: the relationship among actual angle, method of set-up and knowledge.

Ladder inclined angle is a critical factor that could lead to a slip at the base of portable straight ladders, a major cause of falls from heights. Despite several methods established to help workers achieve the recommended 75.5° angle for ladder set-up, it remains unclear if these methods are used in practice. This study explored ladder set-up behaviours in a field environment. Professional installers of a company in the cable and other pay TV industry were observed for ladder set-up at their worksites. The results showed that the actual angles of 265 ladder set-ups by 67 participants averaged 67.3° with a standard deviation of 3.22°. Although all the participants had training on recommended ladder set-up methods, only 3 out of 67 participants applied these methods in their daily work and even they failed to achieve the desired 75.5° angle. Therefore, ladder set-up remains problematic in real-world situations. Practitioner Summary: Professional installers of a cable company were observed for portable straight ladder set-up at their worksites. The ladder inclined angle averaged 67.3° with a standard deviation of 3.22°, while the recommended angle is 75.5°. Only a few participants used the methods that they learned during training in their daily work.

[CHOICE OF SANITARY-INDICATIVE MICROORGANISMS FOR THE ASSESSMENT OF THE SAFETY OF SPLIT-SYSTEMS].

UNLABELLED: Purpose of work is a compilation of data about the microflora which colonizes a split-system, with the aim of selection of sanitary-indicative microorganisms, whose presence in the sample would indicate to the need for cleaning and disinfection of split-systems. MATERIALS AND METHODS: In the article there were used data of five years author's scientific inquiry, related to the prevention of respiratory diseases, associated with the usage of a local air conditioning systems. We also use the data from the literature. RESULTS: For selection of "indicative" microorganisms, we proposed the usage of nine criteria, each of them have numeric value from 0 to 3 points (risk for health, prevalence rate of the disease, epidemiological link, speed of split system's colonization, difficulty of cultivation, resistance in the environment, resistance to disinfectants, frequency of detection in home air conditioning systems, frequency of detection in air conditioning systems of public buildings). After the calculation Pseudomonas aeruginosa and Staphylococcus aureus received maximal score (20 points). Therefore, these two types of bacteria are indicative microorganisms. The detection of these microorganisms in split systems will indicate to the contamination of air-conditioning system. This microflora also is a criterion of cleaning and disinfection quality--presence of these microorganisms in the samples after this process will mean that the processing of air conditioning systems was performed poorly. CONCLUSIONS: Split systems are very faster colonized by conditionally pathogenic and pathogenic microflora. To prevent the possible hazard for population's health it is necessary to develop the normative base, according to which sanitary-and-hygienic control over the split-systems working must be carried out. Proposed criteria suggest that Pseudomonas aeruginosa and Staphylococcus aureus are indicative microorganisms, and it's identification in the air-conditioning system would mean risk for health and necessity for cleaning and disinfection.

Security and privacy issues in implantable medical devices: A comprehensive survey.

Bioengineering is a field in expansion. New technologies are appearing to provide a more efficient treatment of diseases or human deficiencies. Implantable Medical Devices (IMDs) constitute one example, these being devices with more computing, decision making and communication capabilities. Several research works in the computer security field have identified serious security and privacy risks in IMDs that could compromise the implant and even the health of the patient who carries it. This article surveys the main security goals for the next generation of IMDs and analyzes the most relevant protection mechanisms proposed so far. On the one hand, the security proposals must have into consideration the inherent constraints of these small and implanted devices: energy, storage and computing power. On the other hand, proposed solutions must achieve an adequate balance between the safety of the patient and the security level offered, with the battery lifetime being another critical parameter in the design phase.

Making healthcare safer by understanding, designing and buying better IT.

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.

Safety Testing of Left Ventricular Vent Valves.

Vent vacuum relief valves (VRVs) are used to limit the negative pressure at the ventricular vent catheter tip as well as prevent reversal of blood flow and prevention of air embolism. The purpose of this study was to evaluate the performance of three commercially available ventricular vent valves. The negative pressure at which the vent valve opened was measured at the valve inlet using high-fidelity pressure transducers. Also, the flow rate at which air entrainment occurred due to valve opening was recorded. Using a 51.5 cm column of saline, the resistance for each valve was calculated. The mean ± SD opening negative pressures were -231.3 ± 35.2 mmHg for the Quest Medical valve, -219.8 mmHg ± 17.2 for the Sorin valve, and -329.6 · 38.0 mmHg for the Terumo valve. The red Quest Medical valve opened at a lower flow (1.44 ± .03 L/min) than the dark blue Sorin valve (2.93 ± .01 L/min) and light blue LH130 Terumo valve (2.36 ± .02 L/min). The Sorin valve had the least resistance of 34.1 dyn-s/cm, followed by the Terumo LH130 valve resistance of 58.1 dyn·s/cm5, and the Quest Medical VRV-II valve with a resistance of 66.5 dyn·s/cm. We found that the valves are significantly different in the negative pressure generated. Understanding the limitations of these devices is important to reduce the occurrence of adverse events associated with venting and to select the best device for a specific clinical application.

A Novel Method to Detect an Oxygenator Defect Prior to Cardiopulmonary Bypass Initiation.

Cardiopulmonary bypass (CPB) is a common practice in our era. The medical technology used for cardiac surgery goes through rigorous testing to ensure its safety. Unfortunately, it is not fail proof. Oxygenator failures are a rare occurrence but may lead to catastrophic events. We present a case where the preparation for initiating CPB was complicated by an oxygenator defect. After thorough examination, the oxygenator was found leaking from the gas exhaust port suggesting a disruption in continuity of the fibers. This was found by the vigilance of the perfusionist and a creative method to quickly assess the integrity of the oxygenation device. We describe a simple technique to help diagnose an oxygenator leak.