Safety Devices Research Articles

The electronic artificial urinary sphincter: ongoing innovation of a classic device-a narrative review.

While the modern artificial urinary sphincter (AUS) has benefited from incremental innovation, which has improved both device efficacy and complication rates, the foundational technology in use in Boston Scientific's AMS800 can be traced back to the fundamental hydraulic tenets of the AS721. Research and development in adaptive technology and electronic integration stand to further improve AUS outcomes. The Medline online retrieval system was queried using the MeSH terms "artificial urinary sphincter", "electronic", "complications", "history", and "development" in various combinations. Publications were reviewed if applicable, and their reference lists were used to collect additional articles as needed. Final article inclusion was based on senior author discretion. The AMS800 AUS is the gold standard for male stress incontinence implants. A 2015 consensus conference set out the goals for sphincter device development in the coming decades. A future ideal sphincter would adjust cuff pressure dynamically as well as function with minimal manipulation, or even via electronic control. Multiple new devices are in various states of development. During the next decade, artificial urinary sphincter technology is likely to include multiple Food and Drug Administration (FDA)-approved devices with varying features aimed at satisfying the 2015 consensus conference goal for an "ideal" AUS. The future of stress incontinence therapy lies in both continued innovation for the AUS, as well as advances in regenerative medicine. Electronic and adaptive developments in AUS technology will increase device safety, efficacy, and longevity while improving the user and caregiver experience. For some, regenerative medicine may even make AUS technology obsolete.

Current Application of the Medical Device Single Audit Program (MDSAP) as a Global Regulatory Reliance Framework for the Inspection of Medical Devices.

The globalization and rapid advancements in medical technologies necessitate the harmonization of international regulatory frameworks to ensure the efficient and timely clinical application of medical products, including pharmaceuticals and medical devices. Regulatory reliance, a critical component of this harmonization process, is a powerful tool that provides efficient access for economic entities and regulatory authorities, promoting predictable decision-making and accelerating approvals. The Medical Device Single Audit Program (MDSAP) serves as a regulatory reliance framework for medical device inspections. Implemented by countries including Japan, the United States, Canada, Australia, and Brazil, MDSAP allows third-party certification bodies, recognized by these regulatory authorities, to conduct audits on medical device manufacturers. The outcomes of these audits are shared with the regulatory authorities, who use them for regulatory assessments and decision-making. Since transitioning to its implementation phase in 2017, MDSAP has been widely utilized in various countries. This review provides an overview of the adoption and utilization of MDSAP in major countries, exploring the program's impact on regulatory processes and its potential as a method of regulatory reliance to facilitate timely access to effective and safe medical devices.

Comparison of exsanguination and hemostasis devices for Limb surgery: a multicenter randomized controlled study

BackgroundExcessive intraoperative bleeding remains a challenge in limb surgeries. The exsanguination tourniquet ring has emerged as a potential solution for effective exsanguination and hemostasis. This study aims to evaluate its efficacy and safety compared to the conventional exsanguination and hemostasis approach (pneumatic tourniquet combined with Esmarch bandage).MethodsThis randomized controlled trial evaluates the exsanguination tourniquet ring’s effectiveness and safety versus the conventional approach in 220 participants undergoing various limb surgeries. Allocation included experimental and control groups, assesses through efficacy (including intraoperative and total blood loss, hemoglobin levels, and exsanguination and hemostasis effectiveness) and safety (adverse event occurrence) indicators.ResultsThe experimental group (n = 110) utilizes the exsanguination tourniquet ring, while the control group (n = 110) employs the conventional approach. As for intraoperative blood loss, the experimental group is non-inferior to the control group (p-value < 0.001). While no significant difference is found in total blood loss (for the full analysis set, p-value = 0.442; for the per protocol set, p-value = 0.976) and differences in postoperative and preoperative hemoglobin levels (for the full analysis set, p-value = 0.502; for the per protocol set, p-value = 0.928). Regarding exsanguination and hemostasis effectiveness, the full analysis set reveals significantly superior ratings in the experimental group compared to the control group (p-value = 0.002 < 0.05), while the per protocol set analysis indicates no significant difference between the groups (p-value = 0.504). As for safety indicators, adverse events related to the device are minimal in two groups, with only one severe event unrelated to the device.ConclusionsThe exsanguination tourniquet ring is an effective and safe device for intraoperative blood loss control in various limb surgeries.Trial registrationComparison of Exsanguination and Hemostasis Devices for Limb Surgery A Prospective Multicenter Randomized Controlled Study, ChiCTR2300077998, 11/27/2023.

MXene grafted porous carbon cloth with alumina for high thermal conductivity and EMI shielding effect

Thermal interface material (TIM) has a great potential for efficient heat management and safety of electronic devices. However, achieving high performance polymer-based TIM is still challenging because of its intrinsic thermal conductivity and weak mechanical properties. In particular, electromagnetic interference shielding effect (EMI SE) of polymer-based composites has a great attraction according to electronic devices have become ubiquitous, playing integral roles in everyday life in our increasingly interconnected world. Herein, a porous carbon cloth (CC) for use as a continuous thermally and electrically conductive template is prepared via a freeze-casting method, after which mxene (MX) is chemically grafted onto the CC surface. Then, the as-prepared MX-CC is used along with alumina (AO) to fill a poly vinyl alcohol (PVA) matrix in order to fabricate a thermally conductive film with electromagnetic interference (EMI) shielding properties. The resultant composite demonstrates remarkable characteristics, including an excellent EMI shielding effect of 28 dB, substantial tensile strength of 19 MPa, and impressive out of plane thermal conductivity (3.98 W/mK). When applied to a light-emitting diode (LED), the PVA/MX-CC/AO composite effectively manages heat, thereby resulting in a 49 °C reduction in the operating temperature. Therefore, the composites developed herein hold great promise for improving thermal management in electronic devices.

Safety and efficacy of endovenous microwave ablation for treatment of varicose veins of the lower limbs in China: A prospective registered clinical trial.

This study aimed to investigate the safety and efficacy of a new Chinese device using microwave ablation for treating symptomatic great saphenous vein (GSV) varicose veins (VVs). This prospective, single-arm, single-center, cohort study investigated the safety and efficacy of endovenous microwave ablation for the treatment of symptomatic VVs. A total of 50 patients with lower limb varicose veins were enrolled from the Hospital of Chengdu University of Traditional Chinese Medicine. The clinical outcomes and complications were assessed at 1, 6, and 12 months after the procedure. The primary outcome was the occlusion rate of GSV immediately and at 1, 6, and 12 months after the treatment. The secondary outcomes included the venous clinical severity score (VCSS), the chronic venous insufficiency questionnaire 14 items (CIVIQ-14) score, the Aberdeen varicose vein questionnaire (AVVQ) score, and the pain visual analog scale (VAS) score. This study protocol was registered at ClinicalTrials.gov (ID: NCT04645771). In total, 50 limbs from 50 patients (26 female; mean age: 53.45 ± 9.78 years) were treated. A technical success rate of 100% was achieved and no serious adverse events were recorded. During the follow-up period, the occlusion rate of the major/minor saphenous vein trunk remained 100% at 1, 6, and 12 months after surgery except one patient fell off. The median 24-h VAS value was 2 (2,3). The VCSS score, CIVIQ-14 score, and AVVQ score (p < .05) at 1, 6, and 12 months improved significantly compared with the value preoperative (p < .05). EMA was safe and effective for treating varicose veins in the lower limbs, with a high rate of venous trunk occlusion and few complications, thus improving patients' postoperative quality of life.

Evaluating the Safety and Efficacy of a Novel Glaucoma Drainage Device in High-Risk Adult Glaucoma Patients: A One-Year Pilot Study.

Background: We report on the 12-month safety and efficacy outcomes of a new non-valved glaucoma drainage device, the eyePlate-300 (Rheon Medical, Lausanne, Switzerland), in managing refractory glaucoma. Methods: A retrospective review was conducted on consecutive patients over 18 who underwent glaucoma drainage device (GDD) surgery with the eyePlate-300 after a single glaucoma consultation between February 2020 and April 2021, with at least 12 months of documented post-op follow-up. Results: A total of 16 eyes from 15 patients were included. Complete success was observed in 47% of patients and overall success in 83%. The mean IOP decreased from 31.5 mm Hg to 10.7 mm Hg (67% reduction from baseline), and the number of IOP-lowering drops was reduced from 3.1 to 0.7 at one year. The mean BCVA remained stable. No additional IOP-lowering surgeries were required, and no severe sight-threatening complications were noted. Conclusions: The initial one-year results suggest that the eyePlate could be a safe and effective device for reducing IOP in an ethnically diverse refractory glaucoma population. Further follow-up is necessary to determine the long-term safety and efficacy.

Knowledge, attitudes, and practices of anaesthesia personnel towards needle stick injuries in a tertiary care hospital.

The cross-sectional, prospective study was conducted at the Aga Khan University Hospital, Karachi. A questionnaire was distributed amongst anaesthesia personnel, including faculty, residents, medical officers, technicians, recovery room nurses and pain nurses working in the Department of Anaesthesiology for >3 months. Knowledge, attitudes and practices were assessed according to the operational definitions. Of the 162 respondents, 106(65.4%) were males and 56(34.6%) were females. The overall mean age was 31±6.2 years. Adequate knowledge was found in 41(25%) subjects. Overall, 56(35%) respondents reported having had a needle-stick injury, and, among them, 49(87.5%) had a positive attitude. Also, 156(96.3%) participants followed good practices. Although entirely preventable, needle stick injuries were found to be common, indicating the need for proper implementation or revision of existing policies and attainment of safe needle devices.

Advanced overpressure protection: A concept for smart controlled safety pressure relief systems

Safety devices such as safety valves and rupture discs are crucial components in protecting chemical reactors from exothermic runaway reactions and overpressure scenarios. While traditional safety valves operate autonomously, controlled safety devices offer the potential for dynamic adjustments to optimize system performance. However, existing safety valves and controlled safety pressure relief systems (CSPRS) lack flexibility in a fixed relief pressure and stroke positions. This article introduces a new smart overpressure protection device (SmOP) with an adaptable safety device controlled through a combination of model predictive control and PID-control. Tested extensively in a high-pressure loop, the SmOP demonstrates rapid and precise control behavior, ensuring reactor safety as well increasing the efficiency. The control concept, based on model prediction followed by PID-correction, is validated through endurance tests and various opening conditions. Results indicate the SmOP's robustness against external disturbances and its potential for industrial applications. Future work includes developing a failsafe concept and laboratory tests with chemical reactions to further validate the SmOP's performance.

Integrating firearm storage and safety devices into health care.

Millions of US children and adolescents live in homes with loaded firearms, with only half of these homes securing their guns. Firearm-related deaths among youth have doubled over the past decade, making firearms the leading cause of death for children and adolescents in the United States. The recent advisory by the US Surgeon General, identifying firearm violence as a public health crisis, underscores the urgent need for responsible firearm ownership, including safe firearm storage. However, the healthcare community currently lacks durable medical equipment (DME) codes for firearm storage devices, limiting the ability of healthcare providers to support responsible gun ownership. We propose the establishment of DME codes for firearm storage and safety devices, which would facilitate insurance coverage of these vital prevention measures. Durable medical equipment codes would empower physicians and other healthcare providers to integrate anticipatory guidance and lethal means counseling of firearm safety into routine care and support hospital- and community-based efforts to prevent firearm-related injuries and deaths among children and adolescents.

Update on Retinal Drug Safety: Proceedings of the ASRS ReST Committee Webinar Part 1.

Purpose: To review the first Research and Safety in Therapeutics (ReST) Committee webinar and summarize the most current recommendations regarding diagnosis and management. Methods: The ReST Committee is comprised of members of the American Society of Retina Surgeons (ASRS). At regular internal meetings, safety issue reports from the website are reviewed. A webinar series was started in 2021 to update members on multiple relevant potential safety events. Results: Topics reviewed in the webinar included pentosan polysulfate sodium (Elmiron) maculopathy, intraocular pressure elevation reported with the aflibercept prefilled syringe (PFS), and brolucizumab-associated inflammation with occlusive retinal vasculitis. Retinal toxicity related to intraoperative medications was reviewed, including hemorrhagic occlusive retinal vasculitis after intraocular vancomycin, dilution errors with intravitreal aminoglycosides, inadvertent overdoses of cefuroxime after cataract surgery, and toxic posterior segment syndrome after dropless cataract surgery using compounded triamcinolone-moxifloxacin. Indocyanine green toxicity has been reported after its use as an adjuvant during macular hole surgery. Conclusions: The past decade has seen advances in retinal pharmaceuticals and drug-delivery devices. The ASRS ReST Committee collects data from its website reporting system to inform members about up-to-date pharmaceutical and device safety concerns. Recently, a webinar was used to inform members of pigmentary maculopathy associated with pentosan polysulfate sodium, safety regarding the aflibercept PFS, intraocular inflammation and occlusive retinal vasculitis secondary to brolucizumab, and retinal toxicity from intraoperative ocular medications.

Endovascular Embolization of Intracranial Aneurysms Using Target Tetra Detachable Coils: Angiographic and Clinical Results from a Single Center.

Background/Objectives: Target tetra detachable coils (TTDCs) aid in achieving effective framing during the coil embolization of small intracranial aneurysms by maintaining a tetrahedral conformation within the aneurysm sac. We aimed to report the initial experience of patients treated for intracranial aneurysms using TTDCs, with a specific focus on efficacy and safety. Methods: We retrospectively reviewed the medical records of 41 patients who underwent the coil embolization of intracranial aneurysms sized ≤10 mm with TTDCs between April and May 2023. Post-procedural angiographic and clinical results were reviewed. Results: Of the 46 aneurysms (45 unruptured and 1 ruptured), 33 (71.7%) were treated with the stent-assisted technique and 13 (28.3%) using the simple coil embolization technique. Post-procedural angiography showed complete occlusion in 41 aneurysms (89.1%), neck remnants in 1 (2.2%), and residual aneurysms in 4 (8.7%). The mean packing density was 34.7% (19.3-46.8%), with TTDC coil length comprising a mean of 88.5% of the total coil length. No major device- or procedure-related complications were observed. During the follow-up, 40 aneurysms (93.0%) demonstrated complete occlusion, while neck remnants were observed in 1 (2.3%), and residual aneurysms in 2 (4.7%). No cases of recanalization were observed. Conclusions: The TTDC is a safe and effective device for the endovascular treatment of intracranial aneurysms. Follow-up studies are required to establish long-term results.

Percutaneous Extraction of Transvenous Permanent Pacemaker/Defibrillator Leads-A Single-Center Experience.

Background and Objectives: The number of cardiac pacemakers being used has increased in recent decades, and this increase has led to a rise in device-related complications, requiring percutaneous device extraction. Our aim was to present our single-center clinical experience in percutaneous lead extractions. Materials and Methods: We analyzed an observational retrospective cohort study of 93 patients for the transvenous removal of a total of 163 endocardial leads. We evaluated the device details, indications, lead characteristics, extraction methods, complications, reimplantation procedure, follow-up data, effectiveness, and safety. Results: Patients' mean age was 68.6 ± 11.6 years. Lead extraction indications were pocket infection in 33 (35.5%), lead dysfunction in 33 (35.5%), and system upgrade in 21 (23%) cases, and lead endocarditis in 6 (6%) cases. The duration from implantation to extraction time was a detected median of 43 (24-87) months. The most common retracted lead type was the RV defibrillator lead (62%), and the lead fixation type was active for one hundred (61%) patients. A new device was inserted in 74 (80%) patients, and the device type was most commonly a CRT-D (61%). Patients were followed up at a median of 17 (8-36) months, and 18 patients (19%) died at follow-up. Complete procedural success was obtained in 78 (84%) patients, and clinical procedural success was obtained in 83 (89%) patients. Procedural failure was detected in 15 (16%) patients. Major and minor complications were detected in 10 (11%) and 6 (6.5%) patients, respectively. The most common minor complication was pocket hematoma. Conclusions: Our experience suggests that transvenous lead extraction has a high success rate with an acceptable risk of procedural complications. The simple manual traction method has a high rate of procedural success, despite a high dwell time of the lead.

More than pacemakers and defibrillators: perioperative management of implantable devices for patient safety.

The use of implantable medical devices (IMDs) continues to increase with estimates that 10% of the American population will have an IMD in their lifetime. IMDs require special considerations for management in the perioperative period to ensure optimal patient care and patient safety. This review summarizes the current perioperative considerations for IMDs. This review summarizes perioperative recommendations for spinal cord stimulators, deep brain stimulators, peripheral nerve stimulators, vagus nerve stimulators, muscle stimulators, intrathecal drug delivery systems, implantable infusion pumps, artificial pancreas devices, continuous glucose monitors, and cochlear implants. There are multiple publications and guidelines regarding the perioperative considerations of cardiac implantable electronic devices; thus, this review excludes those devices. This review includes recommendations on management of the device perioperatively, the potential complications, and postoperative care of the device. There are very few guidelines regarding the perioperative management of IMDs. Given the significant impact that these devices have on patient care and safety, evidence-based guidelines should be established.

The Registration of Medical Device in FDA, EU and CDSCO: Overview

This comprehensive summary provides a detailed look into the regulatory processes for registering medical devices in three major jurisdictions: the US Food and Drug Administration (FDA), the European Union (EU), and India's Central Drugs Standard Control Organization (CDSCO). Each regulatory agency plays a crucial role in ensuring the safety, effectiveness, and quality standards of medical devices in their respective markets. The FDA, as the regulatory authority in the United States, has a stringent registration system in place to evaluate and approve medical devices before they can be marketed and sold. Manufacturers must adhere to specific procedures and programs to comply with FDA regulations, which are designed to safeguard patient health and promote innovation in the medical device industry. In the European Union, medical device registration is regulated by the EU's Medicinal Products for Human Use Directive, which sets forth stringent requirements for safety and quality standards. Manufacturers must undergo a thorough review process and obtain a CE Mark certification before their devices can be introduced to the European market. The EU's regulatory framework aims to harmonize standards across member states and ensure consistency in device registration procedures. In India, the CDSCO oversees the registration of medical devices and plays a key role in evaluating the safety and efficacy of products before they can be launched in the Indian market. Manufacturers must comply with CDSCO regulations and submit detailed documentation to demonstrate the safety and performance of their devices.

Strength and Electrostatic Discharge Resistance Analysis of Additively Manufactured Polyethylene Terephthalate Glycol (PET-G) Parts for Potential Electronic Application.

Optoelectronic components are crucial across various industries. They benefit greatly from advancements in 3D printing techniques that enable the fabrication of intricate parts. Among these techniques, Material Extrusion (MEX) stands out for its simplicity and cost-effectiveness. Integrating 3D printing into production processes offers the potential to create components with enhanced electrostatic discharge (ESD) resistance, a critical factor for ensuring the reliability and safety of optoelectronic devices. Polyethylene terephthalate glycol-modified (PET-G) is an amorphous copolymer renowned for its high transparency, excellent mechanical properties, and chemical resistance, which make it particularly suitable for 3D printing applications. This study focuses on analyzing the mechanical, structural, and electrostatic properties of pure PET-G as well as PET-G doped with additives to evaluate the effects of doping on its final properties. The findings highlight that pure PET-G exhibits superior mechanical strength compared to doped variants. Conversely, doped PET-G demonstrates enhanced resistance to electrostatic discharge, which is advantageous for applications requiring ESD mitigation. This research underscores the importance of material selection and optimization in 3D printing processes to achieve desired mechanical and electrical properties in optoelectronic components. By leveraging 3D printing technologies like MEX and exploring material modifications, industries can further innovate and enhance the production of optoelectronic devices, fostering their widespread adoption in specialized fields.

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.