Measurement of filtration efficiencies of healthcare and consumer materials using modified respirator fit tester setup.

During the current SARS-CoV-2 pandemic there is unprecedented demand for personal protective equipment (PPE), especially N95 respirators and surgical masks. The ability of SARS-CoV-2 to be transmitted via respiratory droplets from asymptomatic individuals has necessitated increased usage of both N95 respirators in the healthcare setting and masks (both surgical and homemade) in public spaces. These precautions rely on two fundamental principles of transmission prevention: particle filtration and droplet containment. The former is the focus of NIOSH N95 testing guidelines, and the latter is an FDA guideline for respirators and surgical masks. While studies have investigated droplet containment to provide guidance for homemade mask production, limited work has been done to characterize the filtration efficiency (FE) of materials used in home mask making. In this work, we demonstrate the low-cost (<$300) conversion of standard equipment used to fit-test respirators in hospital and industrial settings into a setup that measures quantitative FEs of materials based on NIOSH N95 guidelines, and subsequently measure FEs of materials found in healthcare and consumer spaces. These materials demonstrate significant variability in filtration characteristics, even for visually similar materials. We demonstrate a FE of 96.49% and pressure drop of 25.4 mmH20 for a double-layer of sterilization wrap used in surgical suites and a FE of 90.37% for a combination of consumer-grade materials. The excellent filtration characteristics of the former demonstrate potential utility for emergent situations when N95 respirators are not available, while those of the latter demonstrate that a high FE can be achieved using publicly available materials.

Protección del equipo para la realización de ecografías en paciente con COVID-19 / Equipment cover-up for ultrasound use in COVID-19 patients

No disponible

Effectiveness of clinical surface cleaning and disinfection: evaluation methods.

OBJECTIVE: To discuss the methods employed to evaluate the effectiveness of clinical surface cleaning and disinfection (C&D). METHOD: This is a theoretical reflection based on scientific studies and the experience of the authors. Knowledge and current gaps, the need for further studies, and practical application of the methods were approached. RESULTS: There are four main methods used to evaluate the effectiveness of clinical surface C&D: visual inspection, fluorescent markers, microbiological cultures, and adenosine triphosphate (ATP) bioluminescence. The first two are used to evaluate the process and to predict adherence to protocols by the staff, and the last two are employed to evaluate the results, therefore being the most relevant to assess the risk of infection. FINAL CONSIDERATIONS: The ideal method was not found, because all of them showed limitations. There is a need for strategies to optimize the precision of these methods.

ROUTINE USE OF V-LOCK® SUTURE FOR BARIATRIC ANASTOMOSIS IS SAFE: COMPARATIVE RESULTS FROM CONSECUTIVE CASE SERIES.

BACKGROUND: In high-income countries, morbid obesity is a growing health problem that has already reached epidemic proportions. When performing a laparoscopic gastric bypass several operative methods exist. AIM: To describe the institutional experience using a knotless unidirectional barbed suture (V-Loc 180/Covidien, Mansfield, MA) to create a hand-sewn gastrojejunostomy (GJ) and jejunojejunostomy (JJ) during bariatric surgery. METHODS: Evaluation of a case series of 87 morbidly obese patients who underwent laparoscopic gastric bypass with a hand-sewn gastrojejunostomy (GJA) and jejunojejunostomy (JJA) between 01/2015 and 06/2017. The patients were divided into two groups: in group I, GJA und JJA sutures were performed using the knotless unidirectional barbed suture; in group II, GJA and JJA were sutured with resorbable multifilament thread (Vicryl® 3/0 Ethicon, Livingstone, UK). The recorded data on gender, age, BMI, ASA score, operative time, postoperative morbidity, length of hospital stay, and reoperation, were analyzed and compared. RESULTS: All procedures were completed laparoscopically with no mortality. The mean operative time was 123.23 (±30.631) in group I and 127.57 (±42.772) in group II (p<0.05). The postoperative complications did not differ significantly between the two groups. Early complications were observed for two patients (0.9%) in the barbed suture group and for one patient (0.42%) in the multifilament suture group (p<0.05). In group I two patients (0.9%) required reoperation: on the basis of jejunojejunal stenosis in one patient, and local abscess near the gastrojejunostomy, without a leakage, in the other. In group II one patient (0.42%) required reoperation due to stenosis of the GJA. The duration of hospital admission was similar for both groups: 3.36 (±0.743) days in group I vs. 3.38 (±1.058) days in group II (p<0.05). CONCLUSION: The novel anastomotic technique is a safe and effective method and can be applied to gastrojejunal anastomosis and jejunojejunal anastomosis in laparoscopic gastric bypass.

Development of an Apparatus for Digital Measurement of Magnetically Induced Torque on Medical Implants to Facilitate the Application of the ASTM F2213 Standard.

OBJECTIVE: The ASTM F2213 standard describes the measurement of the magnetically induced torques by means of a torsional spring method. As this method is highly complex, it has rarely ever been employed. The purpose was to develop an easy-to-handle measuring setup for the reproducible, fast, and precise measurement of magnetically induced torques, following ASTM F2213, at a static magnetic field (B0) of 1.5 and 3 T. METHODS: An magnetic resonance (MR)-save measuring platform was developed according to the ASTM F2213 standard and combined with a precision balance. The evaluation was performed with ten test objects, e.g., a steel screw (length 60 mm) and a neurostimulator, at 1.5 and 3 T. The torque was measured at 10° increments as the test object was rotated relative to B0. RESULTS: The measurement setup allows fast and reproducible measurements. The maximum magnetically induced torque measured was 397 ± 2 N·mm for the steel screw and 63 ± 1 N·mm for the neurostimulator. The maximum torque on a test object is insensitive to B0 if the magnetization of the object has reached saturation. CONCLUSION: Ferromagnetic implants may exhibit strong magnetically induced torques during MRI examination. For analyzing these magnetically induced torques, we developed a digital measuring device that allows simplified and accelerated application of the ASTM F2213 standard test method. SIGNIFICANCE: In a B0, ferromagnetic implants may exert considerable torques on the surrounding tissue. These forces may affect the functionality of the implant and inflict severe injuries on a patient.

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.

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.

Reporting medical device safety incidents to regulatory authorities: An analysis and classification of technology-induced errors.

The European Union Medical Device Directive 2007/47/EC1 defines software with a medical purpose as a medical device. The implementation of health information technology suffers from patient safety problems that require effective post-market surveillance. The purpose of this study was to review, classify and discuss the incident data submitted to a nationwide database of the Finnish National Competent Authority with other forms of data. We analysed incident reports submitted to the authority database by users of electronic health records from 2010 to 2015. We identified 138 valid reports. Adverse events associated with electronic health record vulnerabilities, clustered around certain error types, cause serious harm and occur in all types of healthcare settings. The low rate of reported incidents raises questions about not only the challenges associated with medical software oversight but also the obstacles for reporting.

Routine use of v-lock® suture for bariatric anastomosis is safe: comparative results from consecutive case series / Uso rotineiro da sutura v-lock® para anastomoses em obesidade é seguro: resultados de estudo clínico comparativo

ABSTRACT Background: In high-income countries, morbid obesity is a growing health problem that has already reached epidemic proportions. When performing a laparoscopic gastric bypass several operative methods exist. Aim: To describe the institutional experience using a knotless unidirectional barbed suture (V-Loc 180/Covidien, Mansfield, MA) to create a hand-sewn gastrojejunostomy (GJ) and jejunojejunostomy (JJ) during bariatric surgery. Methods: Evaluation of a case series of 87 morbidly obese patients who underwent laparoscopic gastric bypass with a hand-sewn gastrojejunostomy (GJA) and jejunojejunostomy (JJA) between 01/2015 and 06/2017. The patients were divided into two groups: in group I, GJA und JJA sutures were performed using the knotless unidirectional barbed suture; in group II, GJA and JJA were sutured with resorbable multifilament thread (Vicryl® 3/0 Ethicon, Livingstone, UK). The recorded data on gender, age, BMI, ASA score, operative time, postoperative morbidity, length of hospital stay, and reoperation, were analyzed and compared. Results: All procedures were completed laparoscopically with no mortality. The mean operative time was 123.23 (±30.631) in group I and 127.57 (±42.772) in group II (p<0.05). The postoperative complications did not differ significantly between the two groups. Early complications were observed for two patients (0.9%) in the barbed suture group and for one patient (0.42%) in the multifilament suture group (p<0.05). In group I two patients (0.9%) required reoperation: on the basis of jejunojejunal stenosis in one patient, and local abscess near the gastrojejunostomy, without a leakage, in the other. In group II one patient (0.42%) required reoperation due to stenosis of the GJA. The duration of hospital admission was similar for both groups: 3.36 (±0.743) days in group I vs. 3.38 (±1.058) days in group II (p<0.05). Conclusion: The novel anastomotic technique is a safe and effective method and can be applied to gastrojejunal anastomosis and jejunojejunal anastomosis in laparoscopic gastric bypass.

RESUMO Racional : Em países de alta renda, a obesidade mórbida é um problema crescente de saúde que já atingiu proporções epidêmicas. Ao realizar um bypass gástrico laparoscópico, existem vários métodos operatórios. Objetivo: Descrever a experiência institucional utilizando uma sutura farpada unidirecional sem nós (V-Loc 180/Covidien, Mansfield, MA) para criar gastrojejunostomia (JJ) e jejunojejunostomia (JJ) costuradas à mão durante a cirurgia bariátrica. Métodos: Avaliação de uma série de casos com 87 pacientes obesos mórbidos submetidos ao bypass gástrico por videolaparoscopia com gastrojejunostomia (JJA) e jejunojejunostomia (JJA) suturados à mão entre 01/2015 e 06/2017. Os pacientes foram divididos em dois grupos; no grupo I, GJA e JJA as suturas foram realizadas com a sutura farpada unidirecional sem nós e, no grupo II, com sutura multifilamentar reabsorvível (Vicryl® 3/0 Ethicon, Livingstone, UK). Foram analisados ​​e comparados os dados registrados sobre gênero, idade, IMC, escore ASA, tempo operatório, morbidade pós-operatória, tempo de internação hospitalar e reoperação. Resultados: Todos os procedimentos foram concluídos por laparoscopia sem mortalidade. O tempo cirúrgico médio foi 123,23 (±30,631) no grupo I e 127,57 (±42,772) no grupo II (p<0,05). As complicações pós-operatórias não diferiram significativamente entre os dois grupos. Complicações precoces foram observadas em dois pacientes (0,9%) no grupo de sutura farpada e um (0,42%) no de sutura multifilamentar (p<0,05). No grupo I, dois pacientes (0,9%) necessitaram de reoperação; um devido à estenose jejunojejunal e abscesso local próximo à gastrojejunostomia, sem vazamento, no outro. No grupo II, um paciente (0,42%) necessitou de reoperação por estenose da GJA. O tempo de internação hospitalar foi semelhante nos dois grupos: 3,36 (±0,743) dias no grupo I vs. 3,38 (±1,058) dias no grupo II (p<0,05). Conclusão: A nova técnica de anastomose é método seguro e eficaz e pode ser aplicado nas anastomoses gastrojejunal e jejunojejunal no bypass gástrico laparoscópico.

Power-system protection device with IoT-based support for integration in smart environments.

This paper proposes a power-system protection device designed to be integrated in smart environments based on Internet-of-Things technologies. The proposed system enhances electrical safety by fast disconnection of the power supply in case of fault events like leakage current, electrical arc, overcurrent or overvoltage and has been designed with the goal to be integrated in smart environments like smart homes or smart cities for protecting the electrical equipment. The system also enables real-time monitoring and notification events through an advanced communication interface using a data concentrator architecture. This paper provides an extended description of the proposed system's design and implementation, as well as the experimental validation results.

Medical devices must be carefully validated.

The safety and performance of medical devices should be validated in the conditions and the environment that would most benefit patients.

Radiation Exposure During Uterine Fibroid Embolization (UFE): A Confounder-Controlled Comparison Between a State-of-the-Art Angiography Unit and a Conventional Angiography unit.

PURPOSE: To compare radiation exposure of a state-of-the-art and a conventional angiography unit in patients undergoing uterine fibroid embolization (UFE). MATERIALS AND METHODS: Between January 2009 and December 2016, 286 patients underwent UFE in our Interdisciplinary Fibroid Center. The inclusion criteria for this retrospective analysis were first-time transarterial embolization for symptomatic fibroids, bilateral embolization, procedures applying a state-of-the-art (Group 1) or a conventional angiography unit (Group 2), and bilateral technical success with an adequate embolization endpoint after the injection of microspheres. Study endpoints included radiation exposure, major complications, morphological success (MRI), and clinical success (questionnaire on quality-of-life). Propensity score matching controlled for confounders. RESULTS: The inclusion criteria were met by 58 (Group 1) and 177 (Group 2) patients. After propensity score matching, there was no significant difference between Group 1 (n = 46) and Group 2 (n = 92) regarding age, body-mass index, volume of the dominant fibroid and the uterus, fluoroscopy time, and amount of embolic agent (p ≥ 0.10 each). The dose-area product was significantly lower in Group 1 than in Group 2 (1159.0 cGycm2 vs. 3123.5 cGycm2; p < 0.001), while major complication rates (both groups 0 %) and dominant fibroid devascularization (both groups 100 %) were equal (p > 0.99). There were no significant differences between both groups regarding shrinkage of the dominant fibroid and the uterus and no relevant differences regarding patient-reported quality-of-life. CONCLUSION: A state-of-the-art angiography unit has the potential to reduce radiation exposure in patients undergoing UFE without increasing the risk of major complications and with comparably high morphological and clinical success. KEY POINTS: · A state-of-the-art angiography unit potentially reduces radiation exposure in patients undergoing UFE.. · Reduced radiation exposure does not seem to negatively influence the rate of major complications.. · Reduced exposure does not seem to negatively affect morphological and clinical success.. CITATION FORMAT: · Sommer C, Voigt W, Oliger MK et al. Radiation Exposure During Uterine Fibroid Embolization (UFE): A Confounder-Controlled Comparison Between a State-of-the-Art Angiography Unit and a Conventional Angiography unit. Fortschr Röntgenstr 2018; 190: 250 - 258.

[Handling and reprocessing of semicritical medical devices in the ENT - a prospective study]. / Umgang und Aufbereitung semikritischer Medizinprodukte in der HNO ­ eine prospektive Studie.

Numerous laws, guidelines and recommendations govern the handling and reprocessing of semi-critical medical devices in the field of ENT. Although mechanically reprocessing is characterized as a preferential, manual reprocessing is still conducted in most ENT clinics and medical practices for reasons of cost and practicability. In the presented study, we developed an optimized hygienic concept for reprocessing of medical products in the field of ENT.A demand analysis of rigid endoscopes and of ENT equipment was carried out based on hypothesis that only mechanical reprocessing was performed for the entire instrumentation. Additionally, patient-free activities like preparing instrumentation for examination were investigated. As a result, we could demonstrate that such patient-free activities represent a considerable time factor and as a consequence a cost factor in daily patient care. Necessary investments for only mechanical reprocessing of instrumentation including rigid endoscopes are considerably high, since number of endoscopes have to be kept very high.

The influence of landing mat composition on ankle injury risk during a gymnastic landing: a biomechanical quantification.

PURPOSE: About 70% injury of gymnasts happened during landing - an interaction between gymnast and landing mat. The most injured joint is the ankle. The current study examined the effect of mechanical properties of landing mat on ankle loading with aims to identify means of decreasing the risk of ankle injury. METHOD: Gymnastic skill - salto backward stretched with 3/2 twist was captured by two high-speed camcorders and digitized by using SIMI-Motion software. A subject-specific, 14-segment rigid-body model and a mechanical landing-mat model were built using BRG.LifeMODTM. The landings were simulated with varied landing-mat mechanical properties (i.e., stiffness, dampness and friction coefficients). RESULT: Real landing performance could be accurately reproduced by the model. The simulations revealed that the ankle angle was relatively sensitive to stiffness and dampness of the landing mat, the ankle loading rate increased 26% when the stiffness was increased by 30%, and the changing of dampness had notable effect on horizontal ground reaction force and foot velocity. Further, the peak joint-reaction force and joint torque were more sensitive to friction than to stiffness and dampness of landing mat. Finally, ankle muscles would dissipate about twice energy (189%) when the friction was increased by 30%. CONCLUSION: Loads to ankles during landing would increase as the stiffness and dampness of the landing mat increase. Yet, increasing friction would cause a substantial rise of the ankle internal loads. As such, the friction should be a key factor influencing the risk of injury. Unfortunately, this key factor has rarely attracted attention in practice.

Efficacy and safety of a NiTi CAR 27 compression ring for end-to-end anastomosis compared with conventional staplers: A real-world analysis in Chinese colorectal cancer patients.

OBJECTIVES: This study aimed to evaluate the safety and efficacy of a new nickel-titanium shape memory alloy compression anastomosis ring, NiTi CAR 27, in constructing an anastomosis for colorectal cancer resection compared with conventional staples. METHODS: In total, 234 consecutive patients diagnosed with colorectal cancer receiving sigmoidectomy and anterior resection for end-to-end anastomosis from May 2010 to June 2012 were retrospectively analyzed. The postoperative clinical parameters, postoperative complications and 3-year overall survival in 77 patients using a NiTi CAR 27 compression ring (CAR group) and 157 patients with conventional circular staplers (STA group) were compared. RESULTS: There were no statistically significant differences between the patients in the two groups in terms of general demographics and tumor features. A clinically apparent anastomotic leak occurred in 2 patients (2.6%) in the CAR group and in 5 patients (3.2%) in the STA group (p=0.804). These eight patients received a temporary diverting ileostomy. One patient (1.3%) in the CAR group was diagnosed with anastomotic stricture through an electronic colonoscopy after 3 months postoperatively. The incidence of postoperative intestinal obstruction was comparable between the two groups (p=0.192). With a median follow-up duration of 39.6 months, the 3-year overall survival rate was 83.1% in the CAR group and 89.0% in the STA group (p=0.152). CONCLUSIONS: NiTi CAR 27 is safe and effective for colorectal end-to-end anastomosis. Its use is equivalent to that of the conventional circular staplers. This study suggests that NiTi CAR 27 may be a beneficial alternative in colorectal anastomosis in Chinese colorectal cancer patients.

Brainjacking: Implant Security Issues in Invasive Neuromodulation.

The security of medical devices is critical to good patient care, especially when the devices are implanted. In light of recent developments in information security, there is reason to be concerned that medical implants are vulnerable to attack. The ability of attackers to exert malicious control over brain implants ("brainjacking") has unique challenges that we address in this review, with particular focus on deep brain stimulation implants. To illustrate the potential severity of this risk, we identify several mechanisms through which attackers could manipulate patients if unauthorized access to an implant can be achieved. These include blind attacks in which the attacker requires no patient-specific knowledge and targeted attacks that require patient-specific information. Blind attacks include cessation of stimulation, draining implant batteries, inducing tissue damage, and information theft. Targeted attacks include impairment of motor function, alteration of impulse control, modification of emotions or affect, induction of pain, and modulation of the reward system. We also discuss the limitations inherent in designing implants and the trade-offs that must be made to balance device security with battery life and practicality. We conclude that researchers, clinicians, manufacturers, and regulatory bodies should cooperate to minimize the risk posed by brainjacking.

Efficacy and safety of a NiTi CAR 27 compression ring for end-to-end anastomosis compared with conventional staplers: A real-world analysis in Chinese colorectal cancer patients

OBJECTIVES: This study aimed to evaluate the safety and efficacy of a new nickel-titanium shape memory alloy compression anastomosis ring, NiTi CAR 27, in constructing an anastomosis for colorectal cancer resection compared with conventional staples. METHODS: In total, 234 consecutive patients diagnosed with colorectal cancer receiving sigmoidectomy and anterior resection for end-to-end anastomosis from May 2010 to June 2012 were retrospectively analyzed. The postoperative clinical parameters, postoperative complications and 3-year overall survival in 77 patients using a NiTi CAR 27 compression ring (CAR group) and 157 patients with conventional circular staplers (STA group) were compared. RESULTS: There were no statistically significant differences between the patients in the two groups in terms of general demographics and tumor features. A clinically apparent anastomotic leak occurred in 2 patients (2.6%) in the CAR group and in 5 patients (3.2%) in the STA group (p=0.804). These eight patients received a temporary diverting ileostomy. One patient (1.3%) in the CAR group was diagnosed with anastomotic stricture through an electronic colonoscopy after 3 months postoperatively. The incidence of postoperative intestinal obstruction was comparable between the two groups (p=0.192). With a median follow-up duration of 39.6 months, the 3-year overall survival rate was 83.1% in the CAR group and 89.0% in the STA group (p=0.152). CONCLUSIONS: NiTi CAR 27 is safe and effective for colorectal end-to-end anastomosis. Its use is equivalent to that of the conventional circular staplers. This study suggests that NiTi CAR 27 may be a beneficial alternative in colorectal anastomosis in Chinese colorectal cancer patients.

Evaluation of a Commercial Tractor Safety Monitoring System Using a Reverse Engineering Procedure.

There is a high rate of work-related deaths in agriculture. In Italy, despite the obligato-ry installation of ROPS, fatal accidents involving tractors represent more than 40% of work-related deaths in agriculture. As death is often due to an overturn that the driver is incapable of predicting, driver assistance devices that can signal critical stability conditions have been studied and marketed to prevent accidents. These devices measure the working parameters of the tractor through sensors and elaborate the values using an algorithm that, taking into account the geometric characteristics of the tractor, pro-vides a risk index based on models elaborated on a theoretical basis. This research aimed to verify one of these stability indexes in the field, using a commercial driver as-sistance device to monitor five tractors on the University of Bologna experimental farm. The setup of the device involved determining the coordinates of the center of gravity of the tractor and the implement mounted on the tractor. The analysis of the stability in-dex, limited to events with a significant risk level, revealed a clear separation into two groups: events with high values of roll or pitch and low speeds, typical of a tractor when working, and events with low values of roll and pitch and high steering angle and forward speed, typical of travel on the road. The equation for calculating the critical speed when turning provided a significant contribution only for events that were typi-cal of travel rather than field work, suggesting a diversified calculation approach ac-cording to the work phase.