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The existence of inrush current poses a significant problem during the start-up process within three-phase voltage-source rectifiers. To address this problem, this study proposes a strategy to suppress the inrush current effectively based on the virtual-resistor- control method, while preventing the increase in cost of the system and complexity of the algorithm. First, a mathematical model is established based on the dq coordinate frame, and the primary cause of the inrush current is analyzed. Then, the design process of the virtual-resistor-control method is detailed. Finally, the accuracy and effectiveness of the proposed method are verified by simulations and experiments. The results show that the inrush current can be more than two times the rated current before the addition of the virtual resistor. The start-up process can be realized without the inrush current after the addition of the virtual resistor, it does not need to increase hardware costs, there is no secondary inrush current, and the sensitivity of the parameters and the complexity of control are low.

Objectives Terrain park riders use contact features such as fun boxes and rails. Typical fun box and rail features have a design characteristic that can be changed to improve safety. Fun box edge coping and edges of rails are typically constructed of soft steel. Ski/snowboard edges (HRC50) can easily become engaged in the softer metal, causing a chip to develop, suddenly stopping the rider, probably causing a fall and possible injury. The aim of the study is to examine the effect of terrain park running surface hardness on chip development. Design Testing on steel specimens was performed to research chip development generated by a ski/snowboard edge on steel used in the construction of contact features and on steel that is proposed for such use. An apparatus was constructed to simulate a ski/snowboard edge moving perpendicular to the long axis of coping or rail edge. Methods The author performed observation, photographic documentation, metallurgical testing and environmental testing of various contact features at different ski area terrain parks. Several steel specimens of varying hardness were tested at various load levels to study the propensity of chip development by ski/snowboard edges. Results Testing of steel samples showed that increasing the hardness of the rail steel or coping steel reduced the propensity for a ski/snowboard edge to engage in the coping or rail. Conclusions Increasing steel coping and rail contact surface hardness to HRC 50 and above will likely reduce engagement by steel snowboard/ski edges, which in turn is expected to reduce the chance of a fall and injury.

Transjugular intrahepatic portosystemic shunt (TIPS) is well established as a salvage therapy for refractory esophageal variceal hemorrhage (EVH). A more controversial issue is the upper limit of Model for End-Stage Liver Disease (MELD) scores at which this procedure can be performed safely. We present 2 cases of TIPS performed for EVH in patients with severely high MELD scores as a successful intervention for hemostatic and hemodynamic stabilization, and as a bridge to urgent liver transplantation. Both patients had endoscopically confirmed EVH with high blood product transfusion and vasopressor needs despite standard medical therapy. Each received narrow bore TIPS at MELD 42 and 44, respectively, with subsequent resolution of hemorrhage despite worsening synthetic liver function. Detrimental consequences of metabolic acidosis associated with minimal residual hepatic function were avoided via continuous renal replacement therapy and mechanical ventilation, with a goal to maintain cardiopulmonary stability and favorable acid base balance. Liver transplant followed TIPS 4 and 3 days, respectively, with both patients maintaining good functional status at discharge. Both cases suggest that in patients deemed otherwise appropriate for liver transplantation, a severely high MELD score alone should not preclude TIPS as salvage therapy for refractory EVH bleeds.

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.

Background Fluid Resistant Surgical Masks have been implemented in UK personal protective equipment (PPE) guidelines for COVID-19 for all care sites that do not include aerosol-generating procedures (AGPs). FFP3 masks are used in AGP areas. Concerns from the ENT and plastic surgery communities out with intensive care units have questioned this policy. Emerging evidence on cough clouds and health care worker deaths has suggested that a review is required. Aims To test the efficacy of Fluid Resistant Surgical Mask with and without adaptions for respiratory protection. To test the efficacy of FFP and FFP3 regarding fit testing and usage. Methods A smoke chamber test of 5 min to model an 8-h working shift of exposure while wearing UK guideline PPE using an inspiratory breathing mouthpiece under the mask. Photographic data were used for comparison. Results The Fluid Resistant Surgical Mask gave no protection to inhaled smoke particles. Modifications with tape and three mask layers gave slight benefit but were not considered practical. FFP3 gave complete protection to inhaled smoke but strap tension needs to be ‘just right’ to prevent facial trauma. Facial barrier creams are an infection risk. Conclusions Surgical masks give no protection to respirable particles. Emerging evidence on cough clouds and health care worker deaths suggests the implementation of a precautionary policy of FFP3 for all locations exposed to symptomatic or diagnosed COVID-19 patients. PPE fit testing and usage policy need to improve to include daily buddy checks for FFP3 users

Coronavirus disease-19 (COVID-19) is a pathogen that has shown an ability for sustained community transmission. To ensure utmost safety, radiology services will need to adapt to this disease in the coming months and possibly years ahead. This will include learning how to perform radiographs and CT in a safe and sustainable manner. Due to the risk of nosocomial spread of disease, the judicious use and implementation of strict infection protocols is paramount to limit healthcare worker and patient transmission. Between 28 January 2020 and 8 June 2020, our institution performed 12,034 radiographs and 178 CT scans for suspected or confirmed COVID-19 patients. As of 8 June 2020, there have been no documented instances of healthcare staff acquiring COVID-19 during the course of work. In this article, we present the indications and operational considerations used by our institution to safely image patients with suspected or confirmed COVID-19. Alternative practices for imaging radiographs are also discussed.

COVID-19 is caused by the coronavirus SARS-CoV-2. Ocular manifestations have been reported including conjunctivitis and retinal changes. Therefore, it is of the utmost importance to clarify eye involvement in COVID-19 in order to help with its diagnosis and to further prevent its transmission. The purpose of this review is to describe the structure and transmission of SARS-CoV-2, reported ocular findings and protection strategies for ophthalmologists.Literature search on PubMed for relevant articles using the keywords 'COVID-19', 'coronavirus', and 'SARS-CoV-2' in conjunction with 'ophthalmology' and 'eye'. Moreover, official recommendations of ophthalmological societies were reviewed.Although the conjunctiva is directly exposed to extraocular pathogens, and the mucosa of the ocular surface and upper respiratory tract are connected by the nasolacrimal duct, the eye is rarely involved in human SARS-CoV-2 infection and the SARS-CoV-2 RNA positive rate by RT-PCR test in tears and conjunctival secretions from patients with COVID-19 is also extremely low.The eye can be affected by SARS-CoV-2, which is supported by some reports of conjunctivitis and retinal changes, but its role in the spread of the disease is still unknown.Given the current scarce evidence, more research is needed to clarify the relationship between SARS-CoV-2 and the eye.Introdução: COVID-19 é o nome atribuído à doença causada pelo novo coronavírus - SARS-CoV-2. Esta infeção rapidamente atingiu uma disseminação mundial, face ao aumento da globalização e adaptação do vírus a ambientes distintos. Foram descritas manifestações oftalmológicas em doentes com COVID-19, nomeadamente, conjuntivite e alterações retinianas. Assim, é fundamental esclarecer o envolvimento ocular na COVID-19, contribuindo para o seu diagnóstico precoce e limitando a sua transmissão. O objetivo desta revisão é descrever a estrutura e o modo de transmissão do SARS-CoV-2, assim como manifestações oculares reportadas e estratégias de proteção para oftalmologistas. Material e Métodos: Revisão dos artigos relevantes publicados na PubMed usando as palavras-chave ‘COVID-19’, ‘coronavirus’ e ‘SARS-CoV-2’ em associação com as palavras ‘ophthalmology’ e ‘eye’. Além disso, foi feita uma revisão das recomendações oficiais de várias sociedades oftalmológicas a nível mundial. Resultados: Apesar da conjuntiva estar diretamente exposta a patógenos exógenos, e da mucosa da superfície ocular e do trato respiratório superior estarem conectados pelo canal nasolacrimal, o olho raramente parece ser afetado pelo SARS-CoV-2. A infeção por SARS-CoV-2 e a taxa de positividade para a pesquisa do RNA do SARS-CoV-2 pelo teste de RT-PCR em lágrimas e secreções conjuntivais de pacientes com COVID-19 também são extremamente baixas. Discussão: O olho pode ser afetado pelo SARS-CoV-2, dada a descrição de casos de conjuntivite e alterações retinianas, mas o seu papel na disseminação da doença ainda é desconhecido. Conclusão: Dada a escassa evidência atual, são necessários mais estudos para esclarecer a relação entre o SARS-CoV-2 e o globo ocular.

SIGNIFICANCE This study affirms the long-term safety and efficacy of scleral contact lens use in patients with keratoconus. PURPOSE This study aimed to evaluate the safety and efficacy of contemporary scleral contact lenses in the visual rehabilitation of the keratoconic population. METHODS A retrospective study of keratoconic subjects examined between 2013 and 2018 was conducted. Subjects were included regardless of age, sex, pre-existing morbidity, or scleral lens design. Only eyes fit successfully with scleral contact lenses for ≥1 year were included. Exclusion criteria were prior corneal surgery, dystrophy, degeneration, and trauma. RESULTS A total of 157 eyes of 86 subjects met the study criteria. The mean Keratoconus Severity Score at initial fitting was 3.6 ± 1.0. Lenses were gas-permeable and nonfenestrated, with a mean overall diameter of 15.8 ± 0.6 mm and 70.1% toric scleral periphery. Physiological adverse events occurred in 9.6% of eyes, including microbial keratitis (0.6%), phlyctenulosis (0.6%), corneal abrasion (1.3%), contact lens–induced acute red eye (1.3%), corneal infiltrative events (1.3%), pingueculitis (1.3%), and hydrops (3.2%). Lens-related adverse events were documented in 55.4% of eyes. Adverse events related to surface issues included poor wetting in 1.9%, handling in 3.8%, reservoir fogging in 7.0%, lens intolerance in 7.6%, deposit in 8.9%, and broken lenses in 26.1% of eyes. The most common management strategies involved refits (54.0% of interventions), patient reeducation (29.5%), medical treatment (5.5%), surgical referral (6.8%), adjustment to wear time (2.5%), surface treatment (1.2%), and lens replacement (0.6%). Best-corrected distance logMAR visual acuity improved significantly from a mean of 0.50 in spectacles to a mean of 0.08 in scleral lenses (P < .0001). During the study period, 14.6% of eyes lost best-corrected scleral lens visual acuity, all from keratoconus progression. CONCLUSIONS Consistent with other groups, our study demonstrates excellent safety and efficacy of scleral contact lenses in subjects with keratoconus.

Magnetic resonance imaging (MRI) at 3.0 T is becoming more common, but there is a lack of sufficient evidence on the safety of a 3.0 T scan in patients with pacemakers. This study aimed to investigate the safety and practical concerns of 3.0 T scans for patients with MR-conditional pacemakers. Twenty consecutive patients were enrolled. A standardized protocol was developed by cardiologists, pacemaker engineers, and radiologists. Pacemaker interrogation was performed immediately before and after the scan. Scan-related adverse events were documented, and imaging quality was graded as level 1 to 4 by radiologists. Twenty-three MRI scans of different body regions (brain = 13, lumbar spine = 4, cervical spine = 2, and heart = 4) were performed, and the average time of a scan was 25 ± 11 min. No significant changes in sensing amplitude (atrial 3.1 ± 1.1 mV vs. 2.9 ± 1.2 mV, P = 0.71; ventricular 9.3 ± 3.5 mV vs. 10.2 ± 3.4 mV, P = 0.46), lead impedances (atrial 647 ± 146 Ω vs. 627 ± 151 Ω, P = 0.7; ventricular: 780 ± 247 Ω vs.711 ± 226 Ω, P = 0.36), or pacing threshold (atrial 0.6 ± 0.2 V/0.4 ms vs. 0.6 ± 0.2 V/0.4 ms, P = 0.71; ventricular 0.7 ± 0.3 V/0.4 ms vs. 0.7 ± 0.2 V/0.4 ms, P = 0.85) were observed pre- and postscan. No adverse events were detected. Image quality review showed grade 1 quality in 16 patients and grade 2 quality in 4 patients with artifacts of pulse generators and leads in cardiac MRI scan and no impact on diagnostic value. Our initial data indicated that 3.0 T scanning might be feasible under a standardized protocol with good diagnostic imaging quality irrespective of body region in patients with MR-conditional pacemakers.

BACKGROUND Despite many studies on new tools and strategies for cavotricuspid isthmus (CTI) ablation, there is an unmet need to improve the CTI ablation procedure. Recently, high-power short-duration (HPSD) ablation has been widely used for pulmonary vein (PV) isolation in atrial fibrillation. We evaluated the effectiveness and safety of HPSD for CTI ablation in atrial flutter (AFL). METHODS Eighty-four patients who underwent CTI ablation with or without simultaneous PV isolation between January 2018 and February 2019 were enrolled in this prospective cohort study. We compared procedural characteristics, periprocedural complications, and recurrence of atrial tachyarrhythmia (ATa) between the HPSD group (50 W for 15 s) and conventional group (30 W for 60 s). RESULTS A total of 84 patients were divided into the HPSD (n = 42) and conventional (n = 42) groups. Bidirectional CTI block was achieved in all patients and 95% achieved bidirectional block after the first-line ablation in both groups. Although there was no difference in the total number of ablation lines between the two groups (1.17 ± 0.7 vs 1.38 ± 0.8, P = .067), HPSD ablation significantly reduced total ablation time compared to the conventional group (236.0 ± 85.6 vs 534.2 ± 235.2 s, P

Author(s): Gildea, Thomas H.; Anderson, Kenton L.; Niknam, Kian R.; Gharahbaghian, Laleh; Williams, Sarah R.; Angelotti, Timothy; Auerbach, Paul S.; Lobo, Viveta | Abstract: Introduction: Grayscale ultrasound (US) imaging has been used as an adjunct for confirming endotracheal tube (ETT) placement in recent years. The addition of color Doppler imaging (CDI) has been proposed to improve identification but has not been well studied. The aim of this study was to assess whether CDI improves correct localization of ETT placement.Methods: A convenience sample of emergency and critical care physicians at various levels of training and experience participated in an online assessment. Participants viewed US video clips of patients, which included either tracheal or esophageal intubations captured in grayscale or with CDI; there were five videos of each for a total of 20 videos. Participants were asked to watch each clip and then assess the location of the ETT.Results: Thirty-eight subjects participated in the online assessment. Levels of training included medical students (13%), emergency medicine (EM) residents (50%), EM attendings (32%), and critical care attendings (5%). The odds ratio of properly assessing tracheal placement using color relative to a grayscale imaging technique was 1.5 (p = 0.21). Regarding the correct assessment of esophageal placement, CDI had 1.4 times the odds of being correctly assessed relative to grayscale (p = 0.26). The relationship between training level and correct assessments was not significant for either tracheal or esophageal placements.Conclusion: In this pilot study we found no significant improvement in correct identification of ETT placement using color Doppler compared to grayscale ultrasound; however, there was a trend toward improvement that might be better elucidated in a larger study.

Introduction Saw-related injuries can be found in all parts of the body. Especially hand saw-related injuries are frequently encountered in the literature. The aim of the study is to present our demographic data, treatment strategy and prevention of the saw-related injuries in the lower extremity. Methods A retrospective analysis was conducted between 2010 and 2015 and only cases with saw-related lower extremity injuries were included in the study. These patients were analyzed according to demographic data, occupational status, procedures performed, hospitalization length of stay, return to work, and complications. Results There were 48 male and 1 female patients; their mean age was 44.06 ± 13.6 (22–77) years. The average referral time after injury was 1.51 ± 0.16 (1–7) hour. The average hospitalization length of stay was 3.76 ± 3.9 (1–22) days. Fractures were also present in 13 (26.5%) patients. Postinjury complications occurred in 18 (36.7%) patients. 4 (8.2%) of the cases did not return to the job after the injury. The average return time to the work was 2.95 ± 1.5 (1–7) months. Conclusion Lower extremity saw-related injuries tend to be overwhelmingly male and most often seen distal to the extremity, especially on the medial side of the extremity. A significant number of patients did not return to the job after the injury.

In view of the challenges of the current coronavirus (COVID-19) pandemic and to protect both patients and ultrasound providers (physicians, sonographers, allied professionals), ISUOG has compiled the following expert-opinion-based guidance for the performance of ultrasound investigations in pregnancy and for gynecological indications.

Tunneled dialysis catheters remain the most common vascular access used to initiate hemodialysis. Unfortunately, their use is associated with higher morbidity and mortality when compared with arteriovenous fistulae or grafts. Different types of catheters with different designs and material properties function differently. Additional devices and medications can be used to decrease the rates of infection and thrombosis. The current available tunneled dialysis catheters remain far from the desired goal and innovation in the field of dialysis vascular access remains in dire need.

Aims and objectives This study aims to explore nurses' perceptions and experiences regarding pressure injuries caused by medical devices and to understand the perceived challenges and barriers nurses face in preventing medical device-related pressure injuries. Background Nurses have a responsibility to prevent pressure injuries and play a major role in their prevention. As there has been a lack of research on medical device-related pressure injuries, not much is known about nurses' perceptions and experiences. This therefore hinders the establishment of effective and efficient interventions in nurses' education and in the practical environment. Design A descriptive qualitative design was adopted, and the COREQ checklist was employed to report on the current study. Methods The study was conducted at an acute care hospital in Singapore. Purposive sampling was used, and a total of 21 enrolled and registered nurses who had recent experiences with medical device-related pressure injuries were recruited between August and December 2018. Face-to-face interviews were conducted using a semi-structured interview guide. A thematic analysis was performed to analyse the qualitative data. Results Five themes emerged regarding pressure injuries: (1) preventable yet unavoidable, (2) everyone's responsibility, (3) harmonising theory with practice reality, (4) pre-existing conditions may limit injury prevention and management; and (5) nurses expressed a need for experiential training. Conclusions The study's findings could be used to develop improvements in nursing practice and policy at acute care hospitals, as well as to improve awareness of medical device-related pressure injuries among healthcare professionals. Moreover, the findings can also inform future research studies to develop effective evidence-based practices and improve patient outcomes. Relevance to the clinical practice This study reveals the unique challenges and dilemmas that nurses face and will help to inform healthcare institutions and management in developing programmes and improving protocols to reduce the incidence rate of pressure injuries caused by medical device.

PURPOSE: The study aims to assess the efficacy and safety of Ahmed glaucoma valve implant in eyes with intractable glaucoma and to evaluate the risk factors for failure. METHODS: A retrospective evaluation of 83 patients (117 eyes) with intractable glaucoma who underwent silicone Ahmed glaucoma valve implant was done in a tertiary care center in Riyadh, Saudi Arabia, between January 2014 and December 2016. Complete success was defined as intraocular pressure (IOP) ≤21 mmHg without medication after a minimum follow-up of 6 months. RESULTS: Eighty-three patients (117 eyes) with intractable glaucoma were evaluated. After a mean follow-up duration of 20.8 ± 3.1 (12–24) months, the overall success rate was achieved in 104 eyes (88.9%). Thirty-six eyes (30.8%) had a complete success rate, whereas 68 eyes (58.1%) had a qualified success rate. Thirteen eyes (11.1%) failed to achieve controlled IOP. The postoperative probability to fail was found to be increasing with time from 0.9% (0.9) in the 1st month to 11.1% (9.9) after 1 year. Complications included a hypertensive phase in 25 eyes (21.4%), encapsulation in 10 eyes (8.5%), hyphema in 7 eyes (6%), hypotony in 2 eyes (1.7%), and blood clots in the implanted tube in 2 eyes (1.7%). The presence of hyphema, scleral patch, and coronary heart diseases was found to increase the risk of failure after Ahmed valve implantation (P = 0.006, 0.040, and 0.014, respectively). CONCLUSIONS: Ahmed glaucoma valve implant was safe and effective in treating cases of intractable glaucoma.

The European Union’s new regulatory framework for medical devices has central implications for the development of new devices, particularly by start-ups.

Pediatric medical device approvals lag behind adult approvals. Historically, medical devices have rarely been designed specifically for children, but use in children has most often borrowed from adult or general use applications. While a variety of social, economic, and clinical factors have contributed to this phenomenon, the regulatory process remains a fundamental aspect of pediatric device development and commercialization. FDA's Center for Devices and Radiological Health (CDRH) has established programmatic and technological areas of advancement to support innovation that serves the public health needs of children and special populations. We highlight four regulatory areas that have the potential to shape the future of pediatric cardiology: the CDRH Early Feasibility Study Program, advancements in 3D printing or additive manufacturing, computational modeling and simulation, and the use of real-world evidence for regulatory applications. These programs have the potential to impact all stages of device development, from early conception, design, and prototyping to clinical evidence generation, regulatory review, and finally commercialization. The success of these programs relies on a collaborative community of stakeholders, including government, regulators, device manufacturers, patients, payers, and the academic and professional community societies.

Secondary infusion by large-volume IV smart pump is used extensively in the acute care setting for one-time or intermittent administration of medications such as antibiotics, electrolyte replacements, and some oncology drugs. Consistent and accurate delivery of secondary medications requires a full understanding of the system and setup requirements. Unfortunately, it is not uncommon for nurses to find a secondary medication only partially administered when their programming should have resulted in a complete infusion. This article discusses the technical requirements that every nurse should know when administering secondary medications using an IV smart pump.

International audience; Hip arthroplasty represents a large proportion of orthopaedic activity, constantly increasing. Automating monitoring from clinical data warehouses is an opportunity to dynamically monitor devices and patient outcomes allowing improve clinical practices. Our objective was to assess quantitative and qualitative concordance between claim data and device supply data in order to create an e-cohort of patients undergoing a hip replacement. We performed a single-centre cohort pilot study, from one clinical data warehouse of a French University Hospital, from January 1, 2010 to December 31, 2019. We included all adult patients undergoing a hip arthroplasty, and with at least one hip medical device provided. Patients younger than 18 years or opposed to the reuse of their data were excluded from the analysis. Our primary outcome was the percentage of hospital stays with both hip arthroplasty and hip device provided. The patient and stay characteristics assessed in this study were: age, sex, length of stay, surgery procedure (replacement, repositioning, change, or reconstruction), medical motif for surgery (osteoarthritis, fracture, cancer, infection, or other) and device provided (head, stem, shell, or other). We found 3,380 stays and 2,934 patients, 96.4% of them had both a hip surgery procedure and a hip device provided. These data from different sources are close enough to be integrated in a common clinical data warehouse.

Objective. In this study, we sought to compare the efficacy and safety of the Xience Prime/Xience V/Promus EES and Biomatrix/Biomatrix Flex/Nobori BES with resolute integrity/resolute ZES using the grand drug-eluting stent (Grand-DES) registry. Background. Currently, new-generation drug-eluting stents (DESs) are used as the standard of care in patients undergoing percutaneous coronary intervention. No study has simultaneously compared everolimus-eluting stent (EES), biolimus-eluting stent (BES), and zotarolimus-eluting stent (ZES). Methods. Stent-related composite outcomes (target lesion failure) and patient-related composite outcomes were compared in crude and propensity score-matched analysis. Results. Of the 17,286 patients in the Grand-DES group, 5,137, 2,970, and 4,990 patients in the EES, BES, and ZES groups completed a three-year follow-up. In the propensity score-matched cohort, the stent-related outcome (EES vs. BES vs. ZES; 5.9% vs. 6.7% vs. 7.1%, P=0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P=0.232) were similar among the three groups, at 3 years. The rate of definite or probable stent thrombosis (0.6% vs. 0.8% vs. 0.5%, P=0.549) was similar. In the multivariate analysis, chronic kidney disease was the strongest predictor of stent thrombosis (adjusted hazard ratio 3.178; 95% confidence interval 1.621–6.229; P<0.001). Conclusions. In this robust real-world registry with unrestricted use of EES, BES, and ZES, the three stent groups showed comparable safety and efficacy at the 3-year follow-up.

Objective We examine the relationships between contemporary progress in on‐road vehicle automation and its coherence with an envisioned “autopia” (automobile utopia) whereby the vehicle operation task is removed from all direct human control. Background The progressive automation of on‐road vehicles toward a completely driverless state is determined by the integration of technological advances into the private automobile market; improvements in transportation infrastructure and systems efficiencies; and the vision of future driving as a crash‐free enterprise. While there are many challenges to address with respect to automated vehicles concerning the remaining driver role, a considerable amount of technology is already present in vehicles and is advancing rapidly. Methods A multidisciplinary team of experts met to discuss the most critical challenges in the changing role of the driver, and associated safety issues, during the transitional phase of vehicle automation where human drivers continue to have an important but truncated role in monitoring and supervising vehicle operations. Results The group endorsed that vehicle automation is an important application of information technology, not only because of its impact on transportation efficiency, but also because road transport is a life critical system in which failures result in deaths and injuries. Five critical challenges were identified: driver independence and mobility, driver acceptance and trust, failure management, third-party testing, and political support. Conclusion Vehicle automation is not technical innovation alone, but is a social as much as a technological revolution consisting of both attendant costs and concomitant benefits.

MRI provides diagnostic three-dimensional imaging and remains extremely important in the diagnosis and management of spinal trauma as well as other acute traumatic injuries, including those of the extremities. The American Society for Testing and Materials has created standards against which all implantable medical devices are tested to ensure safety in an MR environment. Most implantable passive orthopaedic devices can undergo MRI without consequence to the patient. However, the American Society for Testing and Materials has recently updated its terminology resulting in confusion among providers and institutions. Primary safety concerns are radiofrequency-induced heating and magnetically induced torque or displacement. These safety concerns have emerged as a recent source of debate, particularly regarding the imaging of patients with external fixation and cervical immobilization devices in place. Surveys have shown a lack of consensus among radiologists regarding this issue. Having an institutional protocol in place for the imaging of these patients streamlines the diagnosis and early stabilization of certain polytraumatized patients. The purpose of this review is to summarize the pertinent literature as well as the current industry recommendations regarding the safety of commonly used external fixation, cervical immobilization, and traction devices in the MR environment.

Study Design: Retrospective cohort study. Objective: We intend to evaluate the accuracy and safety of cervical pedicle screw (CPS) insertion under O-arm-based 3-dimensional (3D) navigation guidance. Methods: This is a retrospective study of patients who underwent CPS insertion under intraoperative O-arm-based 3D navigation during the years 2009 to 2018. The radiological accuracy of CPS placement was evaluated using their intraoperative scans. Results: A total of 297 CPSs were inserted under navigation. According to Gertzbein classification, 229 screws (77.1%) were placed without any pedicle breach (grade 0). Of the screws that did breach the pedicle, 51 screws (17.2%) had a minor breach of less than 2 mm (grade 1), 13 screws (4.4%) had a breach of between 2 and 4 mm (grade 2), and 4 screws (1.3%) had a complete breach of 4 mm or more (grade 3). Six screws were revised intraoperatively. There was no incidence of neurovascular injury in this series of patients. 59 of the 68 breaches (86.8%) were found to perforate laterally, and the remaining 9 (13.2%) medially. It was noted that the C5 cervical level had the highest breach rate of 33.3%. Conclusions: O-arm-based 3D navigation can improve the accuracy and safety of CPS insertion. The overall breach rate in this study was 22.9%. Despite these breaches, there was no incidence of neurovascular injury or need for revision surgery for screw malposition.

We are writing in response to the editorial “ROPS Are Not Homemade” by W. E. Field, R. Tormoehlen, S. Ehlers, C. Cheng, A. Talbert, G. Deboy, D. Haberlin, and C. V. Schwab, which was published in the July 2019 issue of the Journal of Agricultural Safety and Health (Field et al., 2019). The editorial warns secondary school teachers and FFA advisors about the potential liability of fabricating and installing low-cost rollover protective structures (ROPS) as service learning projects for agricultural education students. The apparent intent of the editorial is to discourage teachers and advisors from carrying out such projects. We wish to present arguments as to why these are actually highly beneficial projects to undertake, and perhaps one of our best hopes for significantly reducing the number of tractor overturn injuries and fatalities by directly involving our nation’s youth. Keywords: Homemade ROPS, ROPS, Tractor overturns.

The primary purpose of an avalanche airbag is to prevent burial during an avalanche. Approximately twenty percent of avalanche victims deploying airbags become critically buried, however. One avalanche airbag actively deflates three minutes after deployment, potentially creating an air pocket. Our objective was to evaluate this air pocket and its potential to prevent asphyxiation.Twelve participants were fitted with an airbag and placed prone on the snow. Participants deployed the airbag and were buried in 1.5 m of snow for 60 min with vital signs including oxygen saturation (SpO2) and end-tidal CO2 (ETCO2) measured every minute. Participants completed a post-burial survey to determine head movement within the air pocket.Eleven of the 12 participants (92%) completed 60 min of burial. Preburial baseline SpO2 measurements did not change significantly over burial time (P 0.05). Preburial baseline ETCO2 measurements increased over the burial time (P 0.02); only one ETCO2 value was outside of the normal ETCO2 range (35-45 mmHg). Participants reported they could move their head forward 11.2 cm (SD 4.8 cm) and backward 6.6 cm (SD 5.1 cm) with the majority of participants stated that they had enough head movement to separate the oral cavity from opposing snow if necessary. Visual examination during extrication revealed a well-defined air pocket in all burials.The avalanche airbag under study creates an air pocket that appears to delay asphyxia, which could allow extra time for rescue and improve overall survival of avalanche victims.

© 2019, Springer Nature Switzerland AG. We propose the following definition of a medical device: “A contrivance designed and manufactured for use in healthcare, and not solely medicinal or nutritional.” Current regulatory classifications of medical devices are complex and designed primarily for regulators. We propose a simpler classification, based on (1) the site of application of the device, (2) the time scale of its use, and (3) whether it has an external power source. The regulation of medical devices is less well developed than the regulation of medicinal products, which it could follow more closely. In particular, devices that incorporate medicines should be required to meet the same regulatory standards as medicinal products. This would remove the anomaly that some delivery systems that incorporate medicines are classified as devices while other similar systems that deliver the same medicines are classified as medicinal products. Some improvements might also result from more widespread use of registries, such as those used for prosthetic joint replacements. Registries would allow both a prospective examination of the performance of high-risk devices and a retrospective analysis when signals from other sources of information suggest problems. Those who apply for a marketing authorization for a new device should have to assure regulators of its quality of manufacture, safety, and efficacy before licensing. Even the most straightforward device should be shown to be useable in practice. Trials on patients, or at least simulations of use in the real world, should be practicable for most devices.

The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre- and post-authorization controls. Combining Quality with Risk Management processes and implementing them as early as possible in the design of MDs has proven to be an effective strategy to minimize residual risk. This article aims to discuss how the design of MDs interacts with their safety profile and how this dipole of intended performance and safety may be supported by Human Factors Engineering (HFE) throughout the Total Product Life-Cycle (TPLC) of an MD in order to capitalize on medical technologies without exposing users and patients to unnecessary risks.

This article describes the concept of Medical Device Interface Data Sheets (MDIDSs) to document and characterize medical device interface data requirements, the processes for creating MDIDSs, and its role in supporting patient safety and cybersecurity of current systems while enabling innovation in the area of next-generation medical Internet of Things (IoT) platforms for integrating sensors, actuators, and applications (apps).

Rapid growth in the use of medical devices has drawn attention to gaps in the systematic monitoring of medical device-associated adverse events in India.Implementation of national regulations on medical devices started in January 2018. Supported by a nationwide network of monitoring centres, the Indian Pharmacopoeia Commission coordinates adverse event reports from manufacturers, legal representatives and patients or users. The commission follows-up and reviews reports with subject expert groups and sends recommendations on necessary action to the national regulatory authority.Before 2015, no systematic structure was in place to collate adverse events associated with medical devices. Several reports of deaths and hospitalization due to faulty hip implants, cardiac stents and poor-quality devices prompted the health ministry to launch the materiovigilance programme.From July 2015 to October 2019, the commission received 1931 adverse event reports, mostly from marketing authorization holders; 1277 were serious events. Reporting increased markedly after 2017. Cardiac stents were the most reported device (926 events; 47.95%). To encourage a culture of reporting, the commission has raised awareness about the programme among stakeholders, developed user-friendly reporting tools and guidelines, and conducted training for hospital personnel on medical device adverse event reporting.Regular training to stakeholders develops a sense of responsibility towards reporting medical device adverse events and ensures quality data reporting. Reporters must be assured that reporting adverse events does not have any legal implications for them and given acknowledgement of their role in high-quality device associated adverse event reporting.La croissance rapide de l’utilisation des dispositifs médicaux a attiré l’attention sur les lacunes dans le suivi systématique des évènements indésirables associés aux dispositifs médicaux en Inde.Une réglementation nationale sur les dispositifs médicaux a été mise en place en janvier 2018. Soutenue par un réseau national de centres de surveillance, la Commission de la Pharmacopée indienne coordonne les signalements d’évènements indésirables effectués par les fabricants, les représentants légaux et les patients ou les utilisateurs. La Commission assure un suivi et une évaluation des signalements avec des groupes d’experts et adresse à l’autorité réglementaire nationale des recommandations sur les mesures nécessaires.Avant 2015, il n’existait aucune structure systématique pour compiler les évènements indésirables associés aux dispositifs médicaux. Plusieurs signalements de décès et d'hospitalisation causés par des prothèses de hanche défectueuses, des stents cardiaques et des dispositifs de mauvaise qualité ont poussé le ministère de la Santé à lancer le programme de matériovigilance.Entre juillet 2015 et octobre 2019, la Commission a reçu 1931 signalements d’évènements indésirables, principalement de la part de titulaires d’autorisation de mise sur le marché; 1277 étaient des évènements graves. Le nombre de signalements a nettement augmenté à partir de 2017. Les stents cardiaques étaient le dispositif faisant l’objet du plus grand nombre de signalements (926 évènements; 47,95%). Pour encourager une culture du signalement, la Commission a mené des actions de sensibilisation sur le programme auprès des parties prenantes, a élaboré des outils conviviaux et des directives de déclaration et a formé le personnel hospitalier au signalement des évènements indésirables associés aux dispositifs médicaux.La formation régulière des parties prenantes développe un sens des responsabilités vis-à-vis du signalement des évènements indésirables associés aux dispositifs médicaux et garantit la déclaration de données de qualité. Les déclarants doivent avoir l’assurance que le signalement d’évènements indésirables n’a aucune répercussion juridique pour eux et leur rôle dans la qualité des signalements des évènements indésirables associés aux dispositifs médicaux doit être reconnu.El crecimiento acelerado en el uso de dispositivos médicos ha llamado la atención sobre los vacíos en el seguimiento sistemático de los eventos adversos asociados a los dispositivos médicos en la India.La implementación de la normativa nacional sobre los dispositivos médicos comenzó en enero de 2018. Con el apoyo de una red nacional de centros de seguimiento, la Comisión de Farmacopea de la India coordina las notificaciones de los eventos adversos presentadas por los fabricantes, los representantes legales y los pacientes o usuarios. La Comisión realiza el seguimiento y la revisión de las notificaciones con los grupos de expertos y envía recomendaciones sobre las medidas necesarias a la autoridad reguladora nacional.Antes de 2015, no existía una estructura sistemática para recopilar los eventos adversos asociados con los dispositivos médicos. Varias notificaciones de muertes y hospitalizaciones por implantes de cadera defectuosos, stents cardíacos y dispositivos de mala calidad llevaron al Ministerio de Salud a poner en marcha el programa de tecnovigilancia (materiovigilance programme).Entre julio de 2015 y octubre de 2019, la Comisión recibió 1931 notificaciones de eventos adversos, la mayoría de ellas de titulares de la autorización de comercialización; 1277 fueron eventos graves. Las notificaciones aumentaron notablemente después de 2017. El dispositivo más notificado fue el stent cardíaco (926 eventos; 47,95 %). Para fomentar una cultura de notificación, la Comisión ha sensibilizado a las partes interesadas sobre el programa, ha desarrollado herramientas y directrices de fácil uso para la notificación y ha impartido formación al personal hospitalario sobre la notificación de los eventos adversos de los dispositivos médicos.La formación regular a las partes interesadas desarrolla un sentido de responsabilidad hacia la notificación de eventos adversos de los dispositivos médicos y garantiza la calidad de la notificación de los datos. Quienes notifiquen eventos adversos deben saber que la notificación de los mismos no tiene implicaciones legales para ellos y que se les reconoce su participación en la notificación de eventos adversos asociados a los dispositivos de alta calidad.أدى النمو السريع في استخدام الأجهزة الطبية إلى جذب الانتباه إلى الثغرات الموجودة في المراقبة المنهجية للأحداث السلبية المرتبطة بالأجهزة الطبية في الهند.بدأ تنفيذ اللوائح الوطنية الخاصة بالأجهزة الطبية في يناير/كانون ثاني 2018. وفي ظل الدعم من شبكة وطنية لمراكز المراقبة، تقوم لجنة دستور الأدوية الهندية بتنسيق تقارير الأحداث السلبية من جهات التصنيع، والممثلين القانونيين، والمرضى أو المستخدمين. تقوم اللجنة بمتابعة التقارير ومراجعتها مع مجموعات من الخبراء ذوي الصلة، وترسل توصيات حول الإجراءات اللازمة إلى السلطة التنظيمية الوطنية.قبل عام 2015، لم يكن هناك أية بنية منهجية قيد الاستخدام لتصنيف الأحداث السلبية المرتبطة بالأجهزة الطبية. العديد من بلاغات الوفيات وتقارير العلاج بالمستشفيات، الناتجة عن أخطاء في زراعات الورك، ودعامات القلب، والأجهزة منخفضة الجودة، دفعت وزارة الصحة إلى إطلاق برنامج الاحتراز المادي.من يوليو/تموز 2015 إلى أكتوبر/تشرين أول 2019، استقبلت اللجنة 1931 تقريراً بخصوص أحداث سلبية، معظمها من حاملي تراخيص التسويق؛ 1277 منها كانت أحداثاً خطيرة. زادت وتيرة الإبلاغ بشكل ملحوظ بعد عام 2017. وكانت أغلب البلاغات بخصوص دعامات القلب (926 حدثاً؛ بنسبة 47.95%). لتشجيع ثقافة الإبلاغ، قامت اللجنة برفع الوعي حول البرنامج بين أصحاب المصلحة، وقامت بتطوير أدوات وإرشادات الإبلاغ سهلة الاستخدام، ونفذت تدريباً لفريق العاملين في المستشفى على الإبلاغ عن الأحداث السلبية للأجهزة الطبية.يؤدي التدريب الدوري لأصحاب المصلحة إلى توليد شعور بالمسؤولية تجاه الإبلاغ عن الأحداث السلبية للأجهزة الطبية، وضمان جودة الإبلاغ عن البيانات. يجب أن يضمن أصحاب البلاغات أن الإبلاغ عن الأحداث السلبية لا يترتب عليه أية آثار قانونية بالنسبة لهم، ويجب أن يحصلوا على التقدير لدورهم في الإبلاغ بجودة عالية عن الأحداث السلبية المرتبطة بالجهاز.医疗器械使用的快速增长引起了人们对印度医疗器械相关不良事件系统监测方面差距的关注。.2018 年 1 月开始实施印度《医疗器械法规 2018》。在全国监测中心网络的支持下，印度药典委员会协调来自制造商、法定代理人和患者或用户的不良事件报告。印度药典委员会与项目专家组一起跟踪和审查报告，并向国家监管机构提出必要的行动建议。.2015 年之前，缺乏系统性结构来整理与医疗器械相关的不良事件。几份有关髋关节植入失误、心脏支架和劣质设备导致死亡和住院的报告促使卫生部启动了物资警戒计划。.从 2015 年 7 月至 2019 年 10 月，委员会收到了 1931 份不良事件报告，大部分报告来自销售许可持有人；其中，1277 份为严重事件。2017 年后，报告数量显著增加。心脏支架是被报告次数最多的器械（926 起事件；47.95%）。为了鼓励形成报告文化，委员会提高了利益相关者对该方案的认识，开发方便用户的报告工具和准则，并就医疗器械不良事件报告对医院工作人员进行培训。.对利益相关者的定期培训提高了报告医疗器械不良事件的责任感，并确保了高质量的数据报告。必须向报告者保证，报告不良事件对他们没有任何法律影响，并认可他们在高质量器械相关不良事件报告方面的积极作用。.Стремительный рост использования медицинских устройств в Индии привлек внимание к пробелам в систематическом мониторинге нежелательных явлений, связанных с использованием медицинских устройств.Внедрение государственных норм в отношении применения медицинских устройств началось в январе 2018 года. Индийская фармакопейная комиссия, поддерживаемая общегосударственной сетью центров мониторинга, координирует сбор информации о нежелательных явлениях, связанных с использованием медицинских устройств, от производителей, юридических представителей и пациентов или пользователей. Комиссия отслеживает и рассматривает отчеты с участием групп экспертов в данной области и направляет рекомендации относительно необходимых действий в национальный регулирующий орган.Структурированная система для сопоставления нежелательных явлений, связанных с использованием медицинских устройств, отсутствовала вплоть до 2015 года. Несколько случаев смерти и госпитализации по причине неисправности имплантатов бедра, сердечных стентов и некачественных устройств побудили Министерство здравоохранения внедрить программу контроля за инцидентами, связанными с использованием медицинских изделий.С июля 2015 года по октябрь 2019 года комиссия получила 1931 отчет о нежелательных явлениях, в основном от держателей регистрационных удостоверений; 1277 из них были серьезными нежелательными явлениями. Количество отчетов заметно возросло после 2017 года. Наибольшее количество отчетов было зарегистрировано для сердечных стентов (926 случаев; 47,95%). В целях стимулирования системы информирования о нежелательных явлениях комиссия активно привлекает внимание заинтересованных сторон к программе, разрабатывает удобные в использовании инструменты и руководящие принципы информирования, а также проводит обучение персонала больниц методам отчетности о нежелательных явлениях, связанных с использованием медицинских устройств.Регулярное обучение заинтересованных сторон прививает чувство ответственности в отношении информирования о нежелательных явлениях, связанных с использованием медицинских устройств, и обеспечивает качественную отчетность. Сообщающие о нежелательных явлениях лица должны быть уверены в том, что информирование о таких явлениях не влечет за собой никаких правовых последствий, и получать благодарность за их вклад в поддержание системы качественного информирования о нежелательных явлениях, связанных с применением устройств.

Harms from medical devices are important, but have been much less well studied than adverse drug reactions. Information provided to device users is of variable quality. Our aim was to define “medical device fault” and “adverse effect of a medical device”; to establish whether medical device faults arise in design, manufacture, or use; and to consider ways of mitigating the adverse effects of medical devices. We analysed 100 consecutive faults reported by the US Food and Drug Administration (FDA) and 50 faults reported by the UK Medicines and Healthcare products Regulatory Agency (MHRA), and classified faults according to the point at which they occurred. Nearly 70% of reported faults related to devices that entered the body. Over 70% arose at the design stage, a quarter of the faults were associated with manufacture, and less than 5% were primarily caused by faulty use. We defined a medical device fault as an unintended failure in the design, manufacture, or use of a medical device that leads to, or has the potential to lead to, harm to the patient, and an adverse effect of a medical device as an unintended and appreciably harmful effect, caused by a medical device, which demonstrates a hazard of the device and may warrant preventive measures, or a change in the mode of use, or withdrawal of the device. Most faults that generate warnings arise from problems at the design stage, some arise at the manufacturing stage, and a few in usage. Careful assessment of the design of safety-critical devices in the light of previous problems may help to prevent repetition of errors. It would be helpful if, in addition to user manuals, manufacturers were required to produce Summaries of Device Characteristics (SDCs, “labels”) that contained a systematically presented set of information about a product.

Purpose To determine the thermal energy damage potential by heat sources, such as endoscopes and fiber optic light cables, in contact with materials commonly placed around an operating room (OR) table. Materials and method Injury by xenon and halogen light sources were tested by direct and indirect contact using fiber optic light bundle cables and scopes at light intensities between ranging from Standby to 100%. The scopes had diameters ranging from 2.7 mm to 10 mm and were set at varying angles. The materials tested were surgical drapes, cotton towels, child shirts, child pants, lap sponges, X-ray detectable sponges, and Mayo covers. The damage potential was determined qualitatively by presence of smoking or smell of burning. Results Permutations involving direct contact were able to cause thermal injury, while permutations involving indirect contact, endoscopes, or halogen lamp were not. The xenon light source with the fiber optic light cable created thermal injury at light intensities of 50%, 75%, and 100%. Time to injury increased as light intensity was decreased. Only the surgical drape, child shorts, and cotton towel showed evidence of burn injury. Conclusions This report supports the potential for thermal injury to the patient secondary to fiber optic light sources, although this potential may be limited in extent. The injury risk can be reduced by avoiding direct contact to materials overlying the patient, confirming standby mode or 25% light intensity, and maintaining the endoscope connected to the fiber optic cable at all times.

Low-field magnetic resonance imaging (MRI), i.e. MRI with a static magnetic field strength0.5 T, has been reported to be safe in patients with pacemakers, however there are no data about the safety of low-field MRI in patients with implantable cardioverter defibrillators (ICD) and/or cardiac resynchronization therapy (CRT). We aimed to investigate the safety and diagnostic efficiency of routine low-field MRI in patients with different devices for cardiac rhythm management (i.e. pacemakers and ICD, including devices with CRT).MRI scans of 446 regions of interest were evaluated with field strength of 0.2 T in 338 patients (62% male; age at MRI scan 76.1 ± 9.2 years; time since device implantation 4.1 ± 3.2 years) with cardiac rhythm management devices (298 pacemakers, 25 ICD, 8 CRT-ICD, and 7 CRT pacemakers). This analysis included 62 pacemaker-dependent patients (18.3%), 52 patients with 1.5-Tesla-MR conditional pacemakers (15.4%) and 13 patients with abandoned leads (3.9%).Except for one examination, which was interrupted because of recurrent severe nausea, all MRI scans could be analyzed efficiently. No induction of arrhythmia or inhibition of pacemaker function occurred. Compared to the device interrogation before MRI, there were no significant changes in battery voltage, pacing capture threshold, sensing of intrinsic ECG, lead impedance, as well as shock impedance in ICD devices after completed examination.Low-field MRI examinations (0.2 T) were efficient and safe regarding clinical and technical complications in patients with devices for cardiac rhythm management, even in case of pacemaker-dependency or the presence of abandoned leads.

Objective This study aims to develop user acceptance models for two concepts of full driving automation: personally owned and shared use. Background Many manufacturers have been investing considerably in and actively developing full driving automation. However, factors influencing user acceptance of full driving automation are not yet fully understood. Method This study consisted of two parts: focus group discussions and online surveys. A total of 30 potential users participated in focus groups to discuss their perception of full driving automation acceptance. Based on the findings from focus group discussions, theoretical foundations, and empirical evidence, we hypothesized the acceptance models for both personally owned and shared-use concepts. We tested the models with 310 and 250 participants, respectively, online. Results The results of focus groups indicated that users’ concerns are centered around safety, usefulness, compatibility, trust, and ease of use. The survey results revealed the important roles of perceived usefulness and perceived safety in both models, whereas the direct impact of perceived ease of use was found to be insignificant. The indirect impact of perceived ease of use was less significant in the personally owned than in the shared-use model, whereas usefulness, trust, and compatibility played more important roles in the personally owned when compared with the shared-use model. Conclusion The findings uncovered a chain of constructs that affect behavioral intention to use for both full driving automation concepts. Application The framework and outcome of this study provide valuable guidelines that allow better understanding for government agencies, manufacturers, and automation designers regarding users’ acceptance of full driving automation.

Percutaneous needle puncture operation is widely used in the image-guided interventions, including biopsy and ablation. MRI guidance has the advantages of high-resolution soft tissue imaging and thermal monitoring during energy-based ablation. This paper proposes the design of a 5-DOF pneumatic needle puncture robot, with all the cylinders, sensors and structure material MRI-compatible. Also, a hybrid fuzzy-PID controller is designed for the pneumatic driven system to adjust the PID parameters adaptively. The experiment validation result shows that, compared with the traditional fix-parameter PID control, the proposed hybrid fuzzy-PID control has no overshoot, and the settle time/steady state error remains low even with increasing load. This proves that the hybrid fuzzy-PID control strategy can increases the positioning accuracy and robustness of the pneumatic driven needle puncture robot, which is significant for the safety of percutaneous needle puncture operation.

Almost all electrophysiology (EP) devices need to obtain premarket approval before they can be commercially sold and available for use in the community. The US Food and Drug Administration (FDA) has different paths to market approval depending on the intended use and the associated risks of the device. The European Union and Japan have device approval processes that have many similarities as well as differences to the US regulatory system. This paper describes some of the history and background of the US device approval process with an emphasis on EP devices. It provides an overview of the different regulatory pathways in the USA that are currently being utilized and contrasts them to the procedures often used in the European Union and in Japan. It also touches on the impact of the twenty-first Century Cures Act and how the balance between premarket and postmarket regulatory oversight is continually being examined and refined.

Aims There have been no published studies on the safety of magnetic resonance imaging (MRI) at 3 Tesla (3 T) in patients with MRI-conditional implantable cardioverter-defibrillators (ICDs). The aim of this study was to assess clinical safety of the Biotronik ProMRI ICD system during non-diagnostic head and lower lumbar scans under 3 T MRI conditions. Methods and results The study enrolled 129 patients at 12 sites in Australia, Singapore, and Europe. Predefined head and lower lumbar MR scans (total duration ≈30 min) were performed in 112 patients. Three primary endpoints were evaluated from the pre-MRI to the 1-month post-MRI visit: (i) freedom from serious adverse device effects (SADEs) related to MRI (hypothesized to be >90%); (ii) pacing threshold invariance for all leads (geometric mean of the patient-wise ratios for 1 month vs. pre-MRI was hypothesized to be 0.993). No MRI-related SADE occurred (SADE-free rate 100%, 95% confidence interval 95.98–100%). Pacing threshold and sensing amplitudes fulfilled the invariance hypotheses with high statistical significance (P 0.5 V or sensing amplitude decrease by >50% was observed (secondary endpoints). Lead impedances, battery capacity, and detection and treatment of arrhythmias by ICDs were not affected by MRI scans. Conclusion The head and lower lumbar scans under specific 3 T MRI conditions were safe in the investigated MR-conditional ICD systems. There was no evidence of harm to the patients or any negative influence of the MRI scan on the implanted systems.

The safety and security of medical devices driven by software, the software-development processes, and the need for data collection and privacy, all offer challenges and opportunities for device regulation and clinical care.

Background The 2013 UK sharps safety regulations require healthcare facilities to use safety-engineered devices (SEDs) to protect staff. The recent increase in UK-reported occupational exposures could indicate increased reporting or increased exposures from suboptimal SED use. Aims To ascertain SED use through examination of sharps container contents in a sample of UK hospitals. Methods Reusable sharps containers (RSCs) were selected from seven UK hospitals in 2013 and seven different hospitals in 2016. At licensed processing facilities, the operator, wearing protective apparel, decanted RSCs, separated hollow-bore needles (HBNs) from other sharps and enumerated HBNs into capped/uncapped non-SEDs, activated/non-activated/tampered SEDs, and blunt draw-up SEDs. Probability, risk ratios (RRs) and 95% confidence limits (95% CLs) were calculated using WinPepi v2.78. Results In 2013 and 2016, respectively, 2545 HBNs were categorized from 22 RSCs versus 2959 HBNs from 33 RSCs; 70% of HBNs were SEDs versus 93% (P < 0.001; RR 1.33; CL 1.30–1.37); 32% of activatable HBNs were not activated versus 22% ( 0.05); and 1% of SEDs were tampered with in both years (P > 0.05). Hospital practices varied widely. Conclusions SED use and activation have increased significantly since 2013. Of concern is that in 2016, 22% of SEDs were non-activated and 20% of sharps were discarded ‘sharp’. Increased training in SED handling, assiduous adherence to safe sharps work practices and a higher level of individual safety-ownership are indicated.

INTRODUCTION: During a hyperbaric oxygen therapy (HBOT) session, every medical device that is used within the hyperbaric chamber is exposed to several hazards, including an increased ambient pressure and partial pressure of oxygen. In Europe, all medical devices marketed and/or sold for use in hyperbaric conditions must be tested by the manufacturer and marked ‘CE’ if approved. At the moment, no left ventricular assist device (LVAD) has been formally approved and CE-marked for HBOT. CASE: A 65-year-old male was referred to our Hyperbaric Centre for HBOT due to a persistent life-threating soft tissue infection of the non-removable wire connecting the external controller with the pump implanted into the left ventricle of the heart (Heartware LVAD). The aim of the intervention reported here was to safely conduct HBOT sessions with this non-CE marked medical device. After risk analysis, the decision was made to isolate the external part of the LVAD (controller and batteries) from the ambient conditions in the hyperbaric chamber by placing it in a pressure-resistant housing that was vented to the external atmosphere. The housing, a 'Hyperbaric Protective Tube' was built and tested, and the resulting operating procedures were practiced by personnel involved in the patient’s care. Thirty uneventful HBOT standard sessions were conducted with subsequent clinical improvement of the soft tissue infection, resulting in an extended timeframe for awaiting heart transplantation. CONCLUSIONS: An isolation housing that vents into the dumping system of the hyperbaric chamber allows for the safe use of critical medical devices without prior testing for their compatibility with the hyperbaric environment.

Reprocessing a flexible endoscope is a complex multistep process. Attention to detail is essential for patient safety. Physicians need to empower their staff to function as guardians and advocates for best practices in endoscope reprocessing. Current best practice standards and guidelines for flexible endoscope reprocessing in the United States have been led by the Society of Gastroenterology Nurses and Associates, the Association for the Advancement of Medical Instrumentation, the Association of periOperative Registered Nurses, American Society for Gastrointestinal Endoscopy, and Multisociety Guideline. This article focuses on important aspects and current best practices for flexible endoscope cleaning and high-level disinfection.

Background Maintenance of thermal homeostasis is of crucial importance in the anesthetized pediatric patient. Gold-standard methods for central core temperature measurement are however inappropriately invasive and impractical in daily practice. The SpotOn sensor uses zero-heat-flux thermometry technology and claims to bypass the invasiveness of classical methods and still accurately display central core temperatures. Up to date no formal analysis of this method in children has taken place. Aims The primary objective was to assess the accuracy in comparison with esophageal temperature; the secondary objective concerned the safety of the SpotOn sensor in the pediatric patients. Methods Fifty-four children aged 1-12 years with an American Society of Anesthesiology classification I or II scheduled to undergo elective surgical procedures under general anesthesia for a minimum of 30 minutes were included. Exclusion criteria included: fragile forehead skin, procedures impeding proper SpotOn placement, thoracoscopic or gastroesophageal procedures, coagulopathy, hemodynamic instability, or vasoactive medication use. After sevoflurane induction, an esophageal temperature probe was placed in the lower third of the esophagus, and a SpotOn sensor on the lateral forehead. Temperatures were recorded in pairs per 1 minute intervals. Temperatures were subjected to bias analysis with 0.5°C as the a priori established clinical significance cutoff. Results Bland-Altman analysis revealed the two methods differed on average 0.14°C (95% limits of agreement: -0.39 to 0.66), with 89.5% of the differences being under 0.5°C. No significant differences could be found between the two methods for the established 0.5°C cutoff. Linear regression analysis determined the following linear regression equation: 0.837x + 5.86 (R2 = 0.738). Lin's concordance correlation coefficient of 0.83 (95% CI: 0.81-0.84). No complications were observed with the use of the SpotOn sensor. Conclusion SpotOn revealed itself as accurate as an esophageal temperature probe when estimating central core temperatures under ideal conditions and over a narrow range of temperatures. No adverse effects were observed with the use of the SpotOn sensor.

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.

Vascular hemostasis after venous access in cardiovascular procedures remains a challenge. Figure-of-eight (FoE) emerged as an alternative technique to manual pressure. However, its feasibility and safety is unknown. A comprehensive search in clinicalTrials.gov, PubMed, Web of Science, EBSCO Services, Cochrane Central Register of Controlled Trials, Google Scholar, and various scientific conference sessions from inception to December 1, 2018, was performed. A meta-analysis was performed using random effects model to calculate risk ratio (RR) and mean difference (MD) with 95% confidence interval (CI). Seven studies were eligible and included 1978 patients, of whom 982 patients received the FoE suture, while 996 received manual pressure. There was no difference in the risk of access site pseudoaneurysm (RR 0.48, 95%CI 0.13 to 1.73, p = 0.26) and fistula (RR 0.90, 95%CI 0.22 to 3.75, p = 0.89) between the two techniques. Compared with manual pressure, FoE was associated with lower risk of access site complications (RR 0.37, 95%CI 0.24 to 0.58, 0.65, p

Background Symptoms remain a poor prompt for acute coronary syndromes (ACS). Timely restoration of perfusion in ST-segment elevation myocardial infarction is associated with improved left ventricular function and survival. Objectives This report details the results of ALERTS (AngelMed for Early Recognition and Treatment of STEMI), a multicenter, randomized trial of an implantable cardiac monitor that alerts patients with rapidly progressive ST-segment deviation. Methods High-risk ACS subjects (N = 907) were randomized to a control (alarms deactivated) or treatment group for 6 months, after which alarms were activated in all subjects. The primary safety endpoint was absence of system-related complications (>90%). The composite primary efficacy endpoint was cardiac/unexplained death, new Q-wave myocardial infarction, or detection to presentation time >2 h. Results Safety was met with 96.7% freedom from system-related complications (n = 30). The efficacy endpoint for a confirmed occlusive event within 7 days was not significantly reduced in the treatment compared with control group (16 of 423 [3.8%] vs. 21 of 428 [4.9%], posterior probability = 0.786). Within a 90-day window, alarms significantly decreased detection to arrival time at a medical facility (51 min vs. 30.6 h; Pr [pt 0.999). In an expanded analysis using data after the randomized period, positive predictive value was higher (25.8% vs. 18.2%) and false positive rate significantly lower in the ALARMS ON group (0.164 vs. 0.678 false positives per patient-year; p Conclusions The implantable cardiac system detects early ST-segment deviation and alerts patients of a potential occlusive event. Although the trial did not meet its pre-specified primary efficacy endpoint, results suggest that the device may be beneficial among high-risk subjects in potentially identifying asymptomatic events. (AngelMed for Early Recognition and Treatment of STEMI [ALERTS]; NCT00781118)

The purpose of this study is to report the patient safety and image quality of 1.5-T multiparametric MRI of the prostate in patients with cardiac implantable electronic devices (CIEDs).In this retrospective study, a database was searched to identify prostate multiparametric 1.5-T MRI examinations performed with endorectal coils for patients with CIEDs from 2012 to 2016 (study group) and matched patients without CIEDs (control group). Clinical safety in the study group was reviewed. The specific absorption rate (SAR) and signal-to-noise ratio (SNR) were measured in both groups. Imaging quality and artifact on T2-weighted images, DW images, and dynamic contrast-enhanced images were rated on a 5-point scale by two independent readers.The study group consisted of total 28 multiparametric MRI examinations in 25 patients. There were no serious device-related adverse effects observed (0/28; 0%), and the estimated whole-body SAR in the study group was never greater than 1.5 W/kg. The SNR values tended to be lower in the study group than in the control group. However, overall perceived image preferences and influences of artifacts on image quality for the study group were not significantly different from those for the control group (p0.05), which were rated above average (rating 3) by both readers 1 and 2.Multiparametric 1.5-T MRI examination of the prostate can be safely performed in selected patients with CIEDs under controlled conditions with applicable image quality while maintaining a SAR less than 1.5 W/kg.

Pathologic evaluation is crucial to the study of medical devices and integral to the Food and Drug Administration and other regulatory entities’ assessment of device safety and efficacy. While pathologic analysis is tailored to the type of device, it generally involves at a minimum gross and microscopic evaluation of the medical device and associated tissues. Due to the complex nature of some implanted devices and specific questions posed by sponsors, pathologic evaluation inherently presents many challenges in accurately assessing medical device safety and efficacy. This laboratory’s experience in numerous collaborative projects involving veterinary pathologists, biomedical engineers, physicians, and other scientists has led to a set of interrelated assessments to determine pathologic end points as a means to address these challenges and achieve study outcomes. Thorough device evaluation is often accomplished by utilizing traditional paraffin histology, plastic embedding and microground sections, and advanced imaging modalities. Combining these advanced techniques provides an integrative, comprehensive approach to medical device pathology and enhances medical device safety and efficacy assessment.

Highlights This study uses a new tractor driving simulator to examine the impact of age on perception response time in an emergency braking situation. The results demonstrate increased risk for crash among older farm equipment operators. Abstract. Transportation-related incidents are the leading cause of occupational fatalities for all industries in the U.S. In the agriculture industry, where tractor-related incidents are the leading cause of occupational fatality, fatal crashes occur more frequently among senior farm equipment operators (FEOs) than younger FEOs. This study examined the association between age and driving performance among FEOs using a simulated driving environment. We demonstrated that older FEOs have longer perception response times when encountering an incurring semi-truck during a simulated drive than younger FEOs. These results persisted when adjusted for selected medical diagnoses and medications, tractor generation, and tractor horsepower. However, due to the small sample size and limitations of the tractor driving simulator, its use for event perception response time research is questionable. The tractor driving simulator used in this study may be better suited for distracted driving studies and studies comparing the ways in which FEOs drive passenger vehicles compared to tractors. Keywords: Driving simulation, Perception response time, Senior drivers, Tractor.