Safety Devices Research Articles

Water Disinfection Via Zinc Oxide (ZnO) Nanowires Chemically Fabricated on A Modified Polyurethane Substrate

Nowadays, water contamination is a big issue due to concerns about health and water scarcity. Unfortunately, most water for human consumption is contaminated with various pathogenic microorganisms that cause water-related diseases. Most traditional chemical and physical disinfectants are energy- and time-intensive and prone to generating harmful disinfection by-products. The recent controversy about waterborne diseases and the safety of commonly used disinfection methods has renewed interest in other forms of disinfection. Low-cost, high-efficiency, and low-energy devices should be developed for potential water disinfection, enabling safe drinking water access. Recently, many researchers have been working on improving the scalability and economics of nanomaterial-based devices to overcome many of the limitations of using traditional anti-microbial agents. Herein, we develop a safe and efficient new nanomaterial decontamination device targeting bacteria in drinking water. Zinc Oxide (ZnO) Nanowires and polyurethane sponges were utilized as affordable and available materials that would lower the cost of the filtration device. The device is based on an electroporation method that applies a low voltage of ~6 V to inactivated bacteria in water. The performance of our device was optimized using different values of voltages, flow rates, microorganism concentrations, and various operation times. By relying on nanotechnology-enabled electroporation principles, this method aims to address the limitations of traditional techniques and offer a feasible solution, especially in areas grappling with contamination issues that lack water treatment infrastructure.

A Cyber Risk Assessment Approach to Federated Identity Management Framework-Based Digital Healthcare System.

This paper presents a comprehensive and evidence-based cyber-risk assessment approach specifically designed for Medical Cyber Physical Systems (MCPS)- and Internet-of-Medical Devices (IoMT)-based collaborative digital healthcare systems, which leverage Federated Identity Management (FIM) solutions to manage user identities within this complex environment. While these systems offer advantages like easy data collection and improved collaboration, they also introduce new security challenges due to the interconnected nature of devices and data, as well as vulnerabilities within the FIM and the lack of robust security in IoMT devices. To proactively safeguard the digital healthcare system from cyber attacks with potentially life-threatening consequences, a comprehensive and evidence-based cyber-risk assessment is crucial for mitigating these risks. To this end, this paper proposes a novel cyber-risk assessment approach that leverages a three-dimensional attack landscape analysis, encompassing existing IT infrastructure, medical devices, and Federated Identity Management protocols. By considering their interconnected vulnerabilities, the approach recommends tailored security controls to prioritize and mitigate critical risks, ultimately enhancing system resilience. The proposed approach combines established industry standards like Cyber Resilience Review (CRR) asset management and NIST SP 800-30 for a comprehensive assessment. We have validated our approach using threat modeling with attack trees and detailed attack sequence diagrams on a diverse range of IoMT and MCPS devices from various vendors. The resulting evidence-based cyber-risk assessments and corresponding security control recommendations will significantly support healthcare professionals and providers in improving both patient and medical device safety management within the FIM-enabled healthcare ecosystem.

Toward trustworthy medical device in silico clinical trials: a hierarchical framework for establishing credibility and strategies for overcoming key challenges.

Computational models of patients and medical devices can be combined to perform an in silico clinical trial (ISCT) to investigate questions related to device safety and/or effectiveness across the total product life cycle. ISCTs can potentially accelerate product development by more quickly informing device design and testing or they could be used to refine, reduce, or in some cases to completely replace human subjects in a clinical trial. There are numerous potential benefits of ISCTs. An important caveat, however, is that an ISCT is a virtual representation of the real world that has to be shown to be credible before being relied upon to make decisions that have the potential to cause patient harm. There are many challenges to establishing ISCT credibility. ISCTs can integrate many different submodels that potentially use different modeling types (e.g., physics-based, data-driven, rule-based) that necessitate different strategies and approaches for generating credibility evidence. ISCT submodels can include those for the medical device, the patient, the interaction of the device and patient, generating virtual patients, clinical decision making and simulating an intervention (e.g., device implantation), and translating acute physics-based simulation outputs to health-related clinical outcomes (e.g., device safety and/or effectiveness endpoints). Establishing the credibility of each ISCT submodel is challenging, but is nonetheless important because inaccurate output from a single submodel could potentially compromise the credibility of the entire ISCT. The objective of this study is to begin addressing some of these challenges and to identify general strategies for establishing ISCT credibility. Most notably, we propose a hierarchical approach for assessing the credibility of an ISCT that involves systematically gathering credibility evidence for each ISCT submodel in isolation before demonstrating credibility of the full ISCT. Also, following FDA Guidance for assessing computational model credibility, we provide suggestions for ways to clearly describe each of the ISCT submodels and the full ISCT, discuss considerations for performing an ISCT model risk assessment, identify common challenges to demonstrating ISCT credibility, and present strategies for addressing these challenges using our proposed hierarchical approach. Finally, in the Appendix we illustrate the many concepts described here using a hypothetical ISCT example.

Outstanding user reported satisfaction for light emitting diodes under-eye rejuvenation.

The under-eye region is an area of significant cosmetic concern. Photobiomodulation (PBM) has emerged as an effective, safe, inexpensive, and convenient treatment for skin rejuvenation. Herein, we aim to evaluate the safety and efficacy of a LED under-eye device for under-eye rejuvenation, as measured by objective and patient reported outcomes. Eleven participants self-administered treatment using a commercially available LED device emitting red (633nm) and near infrared (830nm) light for six weeks. Standardized photographs and questionnaires were administered at baseline and six weeks. Photographic digital analysis indicated an improvement in under-eye wrinkles at six weeks compared to baseline, with a reduction in wrinkle score from 20.05 to 19.72. However, this finding was not statistically significant. Participants self-reported consistent improvements in under-eye wrinkles, texture, dark circles, bags, pigmentation, and erythema. All participants reported a high degree of comfortability, ease of use, and satisfaction with the eye device. The participants noted no moderate or severe adverse events and few reports of transient expected outcomes such as mild erythema. The participants' self-reported improvementsand high user satisfaction, and the device'sfavorable safety profile, highlights the benefits of at-home LED devices for under-eye rejuvenation. Future randomized controlled trials with larger sample sizes could further establish the safety and efficacy of at-home LED under-eye treatments.

Efficient Zn-Ion Pouch Cell Assembling Based on Aramid Nanofiber Hydrogel

With the fast advancement of portable and wearable electronics, it is urgent to develop safe, stable and flexible power supply devices. Safe and environmentally friendly aqueous zinc-ion batteries (AZIBs) have a low-cost and are perfect candidates for energy storage device in such applications [1-4]. Giving the general challenges, such as the formation of the dendrites on the Zn anodes and hydrogen evolution and side reactions, extensive and wide research has focused on building stable AZIBs with high performance, but less attention was paid to making Zn ion pouch cells which are flexible and with high capacity In this presentation, we developed an efficient method to assemble Zn-ion pouch cells based on the process of formation of the aramid nanofiber hydrogel. The method involves the dipping precursor solution, solvent exchanging, and in-situ electrodeposition of MnO2. The assembled Zn-ion pouch cells exhibit excellent mechanical performance, flexibility and electrochemical performance, which are ideal for portable and wearable electronics. Based on this method, we successfully assembled 3-layer (cathode/anode/cathode, A/C/A) and 5 layer (A/C/A/C/A) pouch cells with over 100 times higher capacity compared with coin cell. In addition, the pouch cell with aramid nanofiber hydrogel and in-situ electrodeposited MnO2 cathode on carbon nanotube mat demonstrates superior cycling stability [5,6]. More details about our assembling method for flexible and stable pouch cells for AZIBs and experimental measurements related to the cycling and stability characteristics, will be presented at the meeting.[1] Yu, Peng, et al. "Flexible Zn‐ion batteries: recent progresses and challenges." Small 15.7 (2019): 1804760.[2] Li, Yingbo, et al. "Recent advances in flexible zinc‐based rechargeable batteries." Advanced Energy Materials 9.1 (2019): 1802605.[3] Li, Chunyang, et al. "High-rate and high-voltage aqueous rechargeable zinc ammonium hybrid battery from selective cation intercalation cathode." ACS Applied Energy Materials 2.10 (2019): 6984-6989.[4] Yu, Feng, et al. "Aqueous alkaline–acid hybrid electrolyte for zinc-bromine battery with 3V voltage window." Energy Storage Materials 19 (2019): 56-61.[5] Wang, Peng, and Petru Andrei. "High Performance Separator and Hydrogel Based on Aramid Fibers for Zn Ion Batteries." Electrochemical Society Meeting s 242. No. 4. The Electrochemical Society, Inc., 2022.[6] Xu, Lizhi, et al. "Water‐rich biomimetic composites with abiotic self‐organizing nanofiber network." Advanced Materials 30.1 (2018): 1703343.

Aqueous Lithium-Ion Battery with Dual Electrolytes at Equilibrium across Cation-Exchange Membrane Separator

Aqueous lithium-ion batteries (ALIBs) have been investigated as a promising safe and low-cost storage device for sustainable energy. For the stability of ALIBs, it is important to expand the electrochemical stability window of aqueous electrolytes. Although “Water-in-salt” electrolytes [1] containing significant amounts of lithium salts have been reported as an effective approach, cost reduction of the aqueous electrolyte remains a major challenge for the industrialization of such ALIBs.Controlling the pH of the aqueous electrolyte is another approach to widen the electrochemical window with a smaller use of lithium salts. The 2 V-class ALIB of Zn-coated Li4Ti5O12/LiMn2O4 was demonstrated using dual aqueous electrolytes having different pH separated by a lithium-ion conductive inorganic solid electrolyte.[2] However, lithium-ion conductive inorganic solid electrolytes may often be unstable in alkaline solutions. A perfluorinated sulfonic acid cation-exchange membrane (CEM) is one of the possible alternatives for separating two different aqueous electrolytes. In principle, the concentration of the entire electrolyte does not change during lithium-ion battery operation where lithium ions shuttle between the cathode and anode. Therefore, the specific compositions of the cathode and anode electrolytes are selected to achieve the Donnan equilibrium across the CEM, and stable battery operation is expected as long as the electrolyte equilibrium is maintained. In this study, the feasibility of this concept was investigated using ALIB cell of the anatase-TiO2/spinel-LiMn2O4.A stable combination of cathode and anode electrolytes was investigated experimentally. Several compositions of cathode and anode electrolytes were prepared, and equal volumes of the cathode and anode electrolytes were faced across the CEM, stored for 10 days at room temperature, and the composition of each electrolyte were determined using inductively coupled plasma atomic emission spectroscopy (ICP-AES). After repeating this procedure, a stable combination of cathode and anode electrolytes was found as 27 g/L of Li and 8 g/L of K for an anode electrolyte, and 24 g/L of Li, 36 g/L of K, 41 g/L of P, and 68 g/L of S for a cathode electrolyte prepared using LiOH, KOH, Li2SO4, and KH2PO4. The pH was 4 and 11 for the cathode and anode electrolytes, respectively.The battery test was demonstrated for the TiO2/LiMn2O4 cells assembled with the cathode/anode electrolyte and the same 2 mol/kg Li2SO4 electrolyte in both sides for comparison. The initial charge/discharge profiles are shown in Fig. 1. The profiles were obtained by constant current of 15 mA/g regarding the weight of the cathode active material with the cutoff voltage of 2.8 V and 1.5 V in charge and discharge processes, respectively. The Coulombic efficiency was reached to 96% in the cells with electrolytes having the pH difference, whereas it was 69% in the cell with the 2 mol/kg Li2SO4. The alkaline anode electrolyte suppressed hydrogen generation sufficiently for the lithiation/delithiation of anatase TiO2, which leads to an excellent reversibility over 2 V operation with an improvement in the Coulombic efficiency of the cell with dual aqueous electrolytes.To further investigate the stability of the aqueous battery, a cycle test was conducted on the cell with the dual electrolytes. Figure 1(b) shows the discharge capacity during 100 charge-discharge cycles obtained by the constant current of 75 mA/g-cathode. The Coulombic efficiency reached >99%, and the capacity retention was calculated to be 75% at 100 cycles, which indicates that the suitable pH of the cathode and anode electrolyte was maintained during repeated charge/discharge cycles.In the presentation, we will discuss the details of the battery operation, including a role of perfluorosulfonated CEM and issues to improve the battery performance.

(Invited) Diverse Strategies for Pseudocapacitance in 2D Materials and Beyond

As electronic technology advances, the need in safe and long-lasting energy storage devices that occupy minimum volume arises. Short charging times of several seconds to minutes, with energy densities comparable to those of batteries, can be achieved in pseudocapacitors. These are sub-class of supercapacitors, where capacitance is mediated by fast redox reactions and can enable at least an order of magnitude more energy to be stored than in typical electrical double layer capacitors. Transition metal oxides (e.g. RuO2, MnO2) and conducting polymers (e.g. polyaniline) serve as typical examples. However, these materials are often high in cost and/or suffer from low cycling stability. As a result, the search for new pseudocapacitive materials constitutes an important direction today.In my talk, I will discuss various strategies to improve the performance metrics of pseudocapacitors, specifically focusing on enhancing capacitance and charging rates. I will primarily discuss the electrochemical behavior of layered materials, such as 2D transition metal carbides (MXenes) and 2D pi-conjugated conductive metal-organic frameworks, with a strong emphasis on understanding the mechanisms of charge storage and the various factors influencing electrochemical performance. Additionally, I will explore the role of cation intercalation in layered MXenes as a means to finely tune their electrochemical responses.

Radiographic Anatomy of the Common Carotid Artery for Direct Carotid Puncture

Direct common carotid puncture (DCP) is conventionally used as a bailout technique in stroke patients. However, little is known about the relevant anatomy. Our objective was to examine the relationship of the common carotid artery (CCA) to surrounding structures based on different DCP trajectories passing through the artery's center. Fifty randomly selected head/neck CTAs were analyzed. The trajectory of DCP and relationship to the internal jugular vein (IJV) and thyroid were analyzed at 1cm intervals above the clavicle on 7 axial sections. Using the trans-carotid sagittal plane as the 0° trajectory, we plotted 3 additional trajectories at 30° intervals and the relationship with the IJV and thyroid proximity was graded as following: 0=absent, 1=adjacent, and 2=crossing. The CCA tortuosity index was also analyzed for each vessel. Analysis of 2800 trajectories across 100 CCAs showed that the IJV and thyroid were least encountered on the axial sections 2cm above the clavicle, at 0° on the right (9 thyroids and 6 IJV), and at 90° on the left (0 Thyroids and 14 IJVs). The tortuosity index of the CCA was significantly lower above the clavicle than its entire length (P < 0.001). DCP performed 2cm above the clavicle at 0° on the right, and 90° on the left appears to minimize encounters with the IJV and thyroid gland, reducing potential complications. However, despite these findings, ultrasound guidance remains vital for DCP safety. Further focus on endovascular device safety in DCP is needed.

Comparing adaptations from blood flow restriction exercise training using regulated or unregulated pressure systems: A systematic review and meta-analysis.

No study has examined outcomes derived from blood flow restriction exercise training interventions using regulated compared with unregulated blood flow restriction pressure systems. Therefore, we used a systematic review and meta-analyses to compare the chronic adaptations to blood flow restriction exercise training achieved with regulated and unregulated blood flow restriction pressure systems. The electronic database search included using the tool EBSCOhost and other online database search engines. The search included Medline, SPORTDiscus, CINAHL, Embase and SpringerLink. Included studies utilised chronic blood flow restriction exercise training interventions greater than two weeks duration, where blood flow restriction was applied using a regulated or unregulated blood flow restriction pressure system, and where outcome measures such as muscle strength, muscle size or physical function were measured both pre- and post-training. Studies included in the meta-analyses used an equivalent non-blood flow restriction exercise comparison group. Eighty-one studies were included in the systematic review. Data showed that regulated (n = 47) and unregulated (n = 34) blood flow restriction pressure systems yield similar training adaptations for all outcome measures post-intervention. For muscle strength and muscle size, this was reaffirmed in the included meta-analyses. This review indicates that practitioners may achieve comparable training adaptations with blood flow restriction exercise training using either regulated or unregulated blood flow restriction pressure systems. Therefore, additional factors such as device quality, participant comfort and safety, cost and convenience are important factors to consider when deciding on appropriate equipment to use when prescribing blood flow restriction exercise training.

Safety and efficacy of flow redirection endoluminal device (FRED) for treatment of intracranial aneurysm; A systematic review and meta-analysis.

Previous research has shown promising results for treating intracranial aneurysms (IAs) with a flow redirection endoluminal device (FRED). In this systematic review and meta-analysis, we aimed to assess the safety and efficacy of this device by providing pooled estimates using the data from previous studies. A systematic literature search of Web of Sciences, PubMed, Scopus, and Embase was performed until October 8th, 2023. After selecting the final articles, relevant data were extracted. Parameters relating to safety and efficacy were pooled using STATA software. Heterogeneity was assessed using I-squared and Cochran's Q. Funnel plots and Egger's regression methods were used to evaluate publication bias. Sensitivity analysis was also performed using the leave-one-out method. The data of 37 studies were used for meta-analysis. The rates of immediate adequate occlusion and complete occlusion were 0.51 (95% CI: 0.31-0.71) and 0.34 (95% CI: 0.16-0.53), respectively, while the rates of the adequate and complete occlusion at the latest follow-up were 0.90 (95% CI: 0.84-0.94) and 0.75 (95% CI: 0.65-0.84), respectively. The periprocedural complications rate was 0.04 (95% CI: 0.03-0.06), and the overall complications rate was 0.12 (95% CI: 0.09-0.15). The rate of good functional outcome was 0.99 (95% CI: 0.99-1.00) and the successful implantation rate was 1.00 (95% CI: 1.00-1.00). There was substantial heterogeneity among the reports for most of the evaluated parameters. FRED had high safety and efficacy in treating IAs, as evidenced by its high occlusion and low complication rates.

Child Home Safety in Hispanic and Rural Communities Along the Texas–Mexico Border: A Community Health Worker Intervention

Low-income children are among the most affected by unintentional injuries. Although these injuries are preventable, outreach to low-income families in Hispanic and rural communities can be challenging. Community Health Workers (CHWs) are effective partners in reaching these populations. This study sought to determine whether a CHW-led intervention would reduce common hazards that increase the risk of unintentional injuries in low-income rural Hispanic homes along the Texas–Mexico border. CHWs conducted home visits to assess for injury hazards and distribute safety devices to 47 families with children ages 0 to 5 in five low-income rural border communities. CHWs provided follow-up assessments and support 30 days later. Analyses examined changes in the proportion of hazards from visits 1 to 2, with relative risks estimating the impact of safety devices on hazard reduction. Findings showed a 26.2% reduction in the total number of common hazards present in homes from visit 1 to visit 2 ( p &lt; .001). There was a 70% reduction in the overall risk of a hazard being present at visit 2, relative to visit 1 ( relative risk = 0.30, 95% CI [0.28, 0.33], p &lt; .001). This study suggests that tailored CHW interventions can reduce home safety hazards. CHWs are well suited to inform hard-to-reach Hispanic and rural populations, addressing feelings of distrust and promoting acceptance of recommended environmental changes. More rigorous evaluations of this intervention strategy are needed.

Feasibility, safety, and efficacy of a novel external compression vascular closure device: The LockeT® study.

Hemostasis following large-bore femoral vein access remains a challenge. Manual compression has been the standard of care but requires bedside staff, prolonged bed rest, and longer length of stay. The LockeT is an external compression device that attempts to address these issues while achieving venous hemostasis. We evaluate postprocedural hemostasis and vascular closure outcomes after using LockeT following cardiac electrophysiologic procedures. We performed a single-center, observational study of patients who underwent vascular closure for electrophysiology procedures using LockeT. Postprocedural outcomes were subsequently analyzed. We studied 102 patients (N) for whom LockeT was used to close 182 separate vascular access sites (n). Common procedures were atrial fibrillation ablation (56.9%, N = 58) and left atrial appendage occlusion (28.4%, N = 29). Most often, 8-Fr [48.3% (n = 126)], 11-Fr [27.2% (n = 71)], and 8.5-Fr [16.9% (n = 44)] sheaths were used, with an average procedure time of 82.1 ± 29.4 min. Hemostasis was achieved in 97.8% (n = 187) of all LockeT cases. Time to ambulation and discharge were 3.93 ± 1.10 hand 8.1 ± 4.4 h, respectively. No major complications were noted. Postprocedurally, 52% (N = 53) of patients were discharged on the same day. There were no differences in hemostasis (p = .859) or ambulation times (p = .202) between procedure types. The LockeT can effectively close venous access sites with no major complications.

Enhanced specific surface area and mechanical property of silk nanofibers aerogel for potential hemostasis applications

Biopolymer aerogel is a new type of material with potential applications in the biomedical field. Silk fibroin is of particular interest as a raw material with good biocompatibility and degradable. However, the low mechanical strength and small specific surface area of silk fibroin aerogels limit its further development. Herein, a fast water absorption, highly specific surface area and mechanically strong of aerogels were prepared using low crystal silk fibroin nanofibers (SNF), sol-gel process, solvent exchange and supercritical carbon dioxide (CO2) drying method. The resulting Aero-Sc displayed highly specific surface area (251 m2/g), porosity (97.6 %) and water absorption capacity (1200 %). Furthermore, with rapid water absorption and stronger erythrocyte adhesion, the Aero-Sc showed highly effective hemostasis in vitro. In vivo, animal experiments on rat liver hemorrhage model confirmed that SNF aerogels have a less blood loss (312 ± 29 mg) and faster hemostatic time (92 ± 13 s) than commercially gelatin sponge (p < 0.05). The unique properties of silk fibroin nanofibers aerogel developed in this study has great potential to be a safe and effective hemostatic medical device.

Superconductive and flexible antenna based on a tri-nanocomposite of graphene nanoplatelets, silver, and copper for wearable electronic devices

Printed electronics, fueled by graphene's conductivity and flexibility, are revolutionizing wearable technology, surpassing copper's limitations in cost, signal quality, size, and environmental impact. Graphene-based inks are positioned to lead in this domain, offering cost-effective solutions directly applicable to materials such as textiles and paper. However, graphene encounters a primary drawback due to its lack of an energy band gap, constraining its potential applications in various electronic devices. In this study, we present a novel formulation of a superconductive, flexible leather graphene antenna utilizing a tri-nanocomposite structure of Graphene Nanoplatelet/Silver/Copper (GNP/Ag/Cu), covering a wideband bandwidth from 5.2 GHz to 8.5 GHz. The electrical conductivity of the GNP/Ag/Cu sample was assessed using the four-point probe method. With each additional layer, conductivity increased from 10.473 × 107 S/m to 40.218 × 107 S/m, demonstrating a direct correlation between conductivity and antenna gain. The study evaluates the efficacy of various thicknesses of conductive Graphene (GNP/Ag/Cu) ink on drill fabric. Safety assurance is provided through specific absorption rate (SAR) testing, indicating 0.84 W/kg per 10 g of tissue for an input power of 0.5 W, in compliance with ICNIRP standards for wearable device safety. Additionally, a morphological analysis of the antenna was conducted, showcasing its potential for efficient signal transmission in wearable electronic devices.

Pilot Safety Study of a Microfabricated Device for Anterior Stromal Puncture to Treat Corneal Epithelial Disease in the Optical Axis.

Anterior stromal puncture is an inexpensive and widely used technique at the slit lamp to treat recurrent corneal erosions (RCE), common sequelae of corneal abrasions, trauma, and epithelial basement membrane dystrophies (EBMDs). The purpose of this study was to determine safety of a novel anterior stromal micropuncture device (termed a "plexitome") for use in the optical axis of the cornea. We performed an IRB-approved clinical pilot study on 45 patients with diverse corneal pathologies to determine the safety of the plexitome device and examined corneal healing responses clinically for a minimum of 30 days after treatment. Follow on efficacy data was collected for treated patients with RCE.Micropuncture treatment was performed either through loose epithelial tissue or after debridement using a cotton tip at the slit lamp. After "imprinting," patients were treated with topical medications including antibiotics, hypertonic saline/ointment, bandage contact lenses, and/or patching according to the treating physician's routine care for the condition. Micropuncture using the "plexitome" device did not create visible scars in the corneal stroma of the 45 patients treated and followed for at least 30 days. Photographic evidence of imprinting was seen at in 1 patient at 30 days. There were no significant adverse events associated with treatment. Micropuncture of the cornea using the "plexitome" device does not create optically evident anterior stromal scarring after treatment. Micropuncture using the device may be an effective way of treating RCE and other corneal manifestations of EBMD in the optical axis, which is not currently possible using standard anterior stromal puncture methods.

A Comprehensive Analysis of Class I Medical Device Recalls: Unveiling Patterns, Causes and Global Impacts.

In the landscape of medical device regulation, Class I recalls serve as pivotal indicators of potential risks, necessitating comprehensive analysis to unveil underlying patterns and causal factors. This research offers a detailed examination of Class 1 recalls, focusing on the critical aspects of device classification, review panel involvement, and the geographic distribution of recalling companies. Utilizing a robust dataset spanning multiple jurisdictions and device categories, this study reveals recurring trends in recall occurrences, providing insights into the regulatory mechanisms governing device safety assessments. Furthermore, it investigates the role of review panels in evaluating device safety and effectiveness, shedding light on their significance in the recall process. Moreover, the analysis explores the countries of origin of companies initiating recalls, offering insights into the global impact of regulatory actions on medical device manufacturers. By understanding the drivers behind recall decisions and their implications on a regional scale, regulatory authorities, and healthcare stakeholders can implement targeted measures to enhance patient safety and strengthen post-market surveillance practices.

Impact-resistant supercapacitor by hydrogel-infused lattice

The safety of energy storage devices is increasingly crucial due to the growing requirements for application under harsh conditions. Effective methods for enhancing robustness without compromising functionality are necessary. Here we present an impact-resistant, ready-to-use supercapacitor constructed from self-healable hydrogel electrolyte-infused lattice electrodes. Three-dimensional-printed carbon-coated silicon oxycarbide current collectors provide mechanical protection, with compressive stress, Young’s modulus, and energy absorption up to 70.61 MPa, 2.75 GPa, and 92.15 kJ/m3, respectively. Commercially viable polyaniline and self-healable polyvinyl alcohol hydrogel are used as active coatings and electrolytes. I-wrapped package structured supercapacitor electrode exhibits a static specific capacitance of 585.51 mF/cm3 at 3 mA/cm3, with an energy density of 97.63 μWh/cm3 at a power density of 0.5 mW/cm3. It maintains operational integrity under extreme conditions, including post-impact with energy of 0.3 J/cm3, dynamic loading ranging from 0 to 18.83 MPa, and self-healing after electrolyte damage, demonstrating its promise for applications in extreme environments.

Suture closure AFtEr large bore vein access (SAFE-VEIN): A randomized, prospective study of the efficacy and safety of venous closure device.

Perclose ProGlide (PPG) Suture-Mediated Closure System™ is safe and can reduce time to hemostasis following procedures requiring arterial access. We aimed to compare PPG to figure of 8 suture in patients who underwent interventional catheter procedures requiring large bore venous access (LBVA) (≥13 French). In this physician-initiated, randomized, single-center study [clinicaltrials.gov ID: NCT04632641], single-stick venous access was obtained under ultrasound guidance. Eligible patients were randomized 1:1, and 100 subjects received allocated treatment to either PPG (n = 47) or figure of 8 suture (n = 53). No femoral arterial access was used in any patient. Primary outcomes were time to achieve hemostasis (TTH) and time to ambulation (TTA). Secondary outcomes were time to discharge (TTD) and vascular-related complications and mortality. Wilcoxon rank-sum test was used to compare TTH, TTA, and TTD. TTH (minutes) was significantly lower in PPG versus figure of 8 suture [median, (Q1, Q3)] [7 (2,10) vs. 11 (10,15) respectively, p < 0.001]. TTA (minutes) was significantly lower in PPG compared to figure of 8 suture [322 (246,452) vs. 403 (353, 633) respectively, p = 0.005]. TTD (minutes) was not significantly different between the PPG and figure of 8 suture arms [1257 (1081, 1544) vs. 1338 (1171,1435), p = 0.650]. There was no difference in minor bleeding or access site hematomas between both arms. No other vascular complications or mortality were reported. PPG use had lower TTH and TTA than figure of 8 suture in a population of patients receiving LBVA procedures. This may encourage same-day discharge in these patients.

Safety and behavior of implantable electronic devices during cremation

BackgroundThe current standard of practice for cremating patients with cardiac implantable electronic devices (CIEDs) is surgical explantation before cremation to mitigate the risk of device explosion. This surgery may conflict with patient or family beliefs, whereas cremation of CIEDs may create occupational hazards. ObjectiveThis study sought to establish an ex vivo model for screening CIED behavior during cremation. MethodsSeven CIEDs underwent testing including projectile/sound testing, impact testing, and gas analysis. In the projectile test, devices were heated until thermal failure (explosion) and filmed with a high-speed camera and microphone. For impact testing, brick structures were built to assess damage after explosion. Gas chromatography–mass spectrometry identified released gases. Findings were compared with occupational health standards, where available. ResultsThe implantable loop recorder and leadless pacemaker produced minimal kinetic energy and impact risk with thermal failure. The remaining devices demonstrated explosive disintegration at thermal temperatures <500°C. The pacemakers and implantable cardiac defibrillators produced sound levels >120 dB and resulted in damage to brick structures. Small quantities of benzene and hydrogen fluoride were produced but at quantities within acceptable occupational exposure limits in a cremation chamber. ConclusionAll tested CIEDs experienced explosion at temperatures below crematorium standards. The smallest devices produced minimal risk of damage or injury, suggesting that they may safely remain in situ during cremation, whereas the larger devices produced more kinetic energy, testing chamber damage, and louder explosions, suggesting potential risk with cremation. Cadaveric testing in full-sized cremation chambers is required to determine real-world risk.

Micron-scale topographies affect phagocytosis of bacterial cells on polydimethylsiloxane surfaces

Many medical devices implanted in patients to mitigate diseases and medical conditions have different types of topographic features. While appropriate textures can promote the integration of host cells and reduce scar tissue formation, some textured implants with inappropriate topographies have been associated with inflammation, bacterial colonization, or even malignant complications. To better understand how surface topography affects host immune response to colonizing bacteria, a protocol was developed to investigate phagocytosis of bacterial cells attached on polydimethylsiloxane (PDMS) surfaces with different square-shaped recessive patterns. The interaction between activated RAW 264.7 macrophages and Escherichia coli in recessive wells was visualized in 3D using multiple fluorescent markers. The results revealed that there is a threshold dimension of topography, below which phagocytosis of attached bacterial cells is significantly impeded. Specifically, under our experimental condition, up to 100-fold reduction in phagocytosis was observed in square-shaped patterns with 5 µm side length and 10 µm depth compared to the flat control and patterns with 10 µm or longer side length. The spacing between wells also showed significant effects; e.g., phagocytosis in the wells further decreased when spacing increased to 50 µm. These results are helpful for understanding how undesired topographies may contribute to bacterial colonization and thus infection and other associated complications. Statement of significanceSurface topography plays an important role in bacteria-material infections and thus the safety of implantable medical devices. Undesired topographic features can cause biofilm formation and related complications. However, how surface topography affects the capability of host immune cells to clear colonizing bacteria is not well understood. In this study, the interaction between macrophage RAW264.7 and colonizing E. coli cells on polydimethylsiloxane (PDMS) with recessive features is investigated. It was discovered that the size of recessive features and the spacing between these features have significant effects on phagocytosis of bacteria by macrophages. These new results are helpful for understanding the complex interaction among host cells, bacteria, and implanted biomaterials, which will help guide the rational design of safer medical devices.