Effects of wearable low-intensity continuous ultrasound on muscle biomechanical properties during delayed onset muscle soreness.

BACKGROUND: Delayed onset muscle soreness (DOMS) is one of the most prevalent musculoskeletal symptoms in individuals engaged in strenuous exercise programs. OBJECTIVE: This study investigated the effects of wearable low-intensity continuous ultrasound on muscle biomechanical properties during DOMS. METHODS: Twenty volunteers were distributed into a wearable ultrasound stimulation group (WUG) (n= 10) and medical ultrasound stimulation group (MUG) (n= 10). All subjects performed wrist extensor muscle strength exercises to induce DOMS. At the site of pain, ultrasound of frequency 3 MHz was applied for 1 h or 5 min in each subject of the WUG or MUG, respectively. Before and after ultrasound stimulation, muscle biomechanical properties (tone, stiffness, elasticity, stress relaxation time, and creep) and body temperature were measured, and pain was evaluated. RESULTS: A significant decrease was found in the tone, stiffness, stress relaxation time, and creep in both groups after ultrasound stimulation (all p< 0.05). A significant decrease in the pain and increases in temperature were observed in both groups (all p< 0.05). No significant differences were observed between the groups in most evaluations. CONCLUSION: The stiffness and pain caused by DOMS were alleviated using a wearable ultrasound stimulator. Furthermore, the effects of the wearable ultrasound stimulator were like those of a medical ultrasound stimulator.

Point-of-care testing preferences 2020-2022: Trends over the years.

Background: The use of point-of-care (POC) tests prior to the COVID-19 pandemic was relatively infrequent outside of the health care context. Little is known about how public opinions regarding POC tests have changed during the pandemic. Methods: We redeployed a validated survey to uncompensated volunteers to assess preferences for point-of-care testing (POCT) benefits and concerns between June and September 2022. We received a total of 292 completed surveys. Linear regression analysis was used to compare differences in survey average response scores (ARSs) from 2020 to 2022. Results: Respondent ARSs indicated agreement for all 16 POCT benefits in 2022. Of 14 POCT concerns, there were only 2 statements that respondents agreed with most frequently, which were that "Insurance might not cover the costs of the POC test" (ARS 0.9, ± 1.0) and "POC tests might not provide a definitive result" (ARS 0.1, ± 1.0). Additionally, when comparing survey responses from 2020 to 2022, we observed 8 significant trends for POCT harms and benefits. Conclusion: The public's opinion on POC tests has become more favorable over time. However, concerns regarding the affordability and reliability of POCT results persist. We suggest that stakeholders address these concerns by developing accurate POC tests that continue to improve care and facilitate access to health care for all.

Nurses' knowledge of medical device-related pressure injuries and risk factors: A descriptive study at a large medical centre from Palestine.

BACKGROUND: Nurses' knowledge of pressure injuries causes and risk factors helps to prevent their occurrences and protect the patient. AIM: To assess the level of knowledge of medical device-related pressure injuries and to identify risk factors that affect the knowledge. METHODS: A cross-sectional design was used in this study considering a convenience sample from critical care nurses. The nurses were invited to complete the Medical Device-Related Pressure Injuries Knowledge Questionnaire. RESULTS: About 71 nurses participated in the study. The mean score of MDRPI_KQ was 23.28 ± 4.14 out of 36. Mann-Whitney Test did not show statistically significant relationships between the MDRPI_KQ mean score and related variables (p > 0.05). The regression results indicated that the three predictors explained 46.4% of the variance (R2 = 0.215, F(3, 6.114) = 3.75, p = 0.001). It was found that the Frequency of encountering a patient with MDRPIs significantly predicted MDRPI_KQ score, job position, and assuming the care responsibility for MDRPIs in the department. CONCLUSIONS: Poor knowledge of pressure injuries can negatively affect patient care so training programs and policies should be developed based on the level of knowledge and practices of the staff to be more effective.

Unveiling, Analyzing the Mechanisms of, and Proposing Solutions for Bribery in Japan's Medical Device Sector.

Both public and academic scrutiny of the financial relationships between the medical device industry and the healthcare society occur less frequently than those involving the pharmaceutical industry, and Japan is no exception to these shortcomings. This paper examines the ethical and legal challenges inherent in Japan's medical device industry through the lens of bribery scandals, placing these issues within the broader context of global healthcare corruption. It aims to derive lessons and suggest universal strategies for ethical and legal enhancements. The discussion includes two notable cases: one involving inappropriate transactions between a cancer center and a biliary stent manufacturer, and another concerning a corrupt donation scheme between a medical device company and a university's anesthesiology department, which was found guilty. In our analysis, we also acknowledge the industry's efforts toward compliance and reform to maintain a balanced perspective. The analysis not only highlights the unique culture and structure of the Japanese medical device industry, such as the exploitation of flexible pricing and opaque financial practices but also contrasts these issues with the tightly regulated pharmaceutical industry. This approach reveals both sector-specific challenges and common corruption drivers, enhancing our understanding of why such scandals occur and persist. We propose ethical and compliance-focused business measures such as centralizing donation decisions, limiting the financial independence of marketing divisions, and increasing transparency, alongside adopting mandatory disclosure practices based on successful models from the United States and Europe. By emphasizing integrity and presenting diverse perspectives, this study aims to elevate ethical and legal standards in the medical device industry and improve patient health outcomes worldwide.

Systematic review on the implementation of metrological assurance systems for medical devices in Latin America.

Background: Metrology plays a crucial role in small healthcare service businesses to ensure the quality of products and services. While legal metrology in healthcare exists in some regions, it lacks harmonization. In other countries, there is limited presence of metrology in medical and biomedical engineering. We aimed to evaluate the implementation of metrological assurance systems for medical devices in Latin America. Methods: A systematic review was conducted following PRISMA 2020 guidelines and registered with PROSPERO (CRD42022359284). Searches were performed across 13 databases from October 30th to November 3rd, 2022. The search equation was "(((quality assurance) AND (metrology)) AND (medical devices))." A total of 7,789 documents were identified, of which only 16 met the inclusion criteria. Results: The majority of studies (75%) were conducted in Colombia, with a significant portion being undergraduate theses. The primary normative references used in the analyzed studies were ISO 10012 and ISO 17025, with the majority (68.75%) relying on national legislation for their approach. One study in Colombia referenced eight standards, and one in Brazil analyzed user involvement in medical device management. Among the included studies, 56.25% were conducted in healthcare institutions, mainly clinics. Most studies provided implementation guidelines, with ISO 10012 being prominent, alongside ISO 17025, which implicitly addresses ISO 9001 elements. Global bias was low across all studies. Conclusion: Our results underscore the importance of metrological assurance in managing medical devices in Latin America. The utilization of international standards and national legislation illustrates the diverse approaches adopted by different institutions. Future research should focus on optimizing metrological practices to enhance quality and safety in healthcare.

Teaching Medical Devices through Interactive Innovation: Challenges and Rewards.

Medical devices are manmade objects existing at the interface between numerous disciplines. They range from as simple as medical gloves to as complex as artificial limbs. This versatility of medical devices and their inherent interdisciplinary nature means that academic courses on them are attended by cohorts of students from varieties of academic backgrounds, who bring with them similarly broad spectra of interests. To satisfy the learning expectations of each and every student in such diverse classes is a daunting task for the instructor. After many years of teaching medical devices at undergraduate and graduate levels at three different universities in the states of Illinois and California, I have come up with an instructional method that solves this challenge by engaging students in the co-creation of the curriculum via selection of their own medical devices of interest and presentation to the class for collective analysis. The threefold presentations are designed so that they reflect an ascent along the hierarchy of a learning taxonomy extending from foundational concepts to critical assessment of knowledge to creative displays of it. In such a way, the students are acquainted with the ability of critical and creative thinking at the expense of rote memorization or inculcation and are prepared to enter the field of medical devices as innovation-centered individuals. The specifics of this new method of instruction are reported here, with the hope that they will be useful to fellow instructors in any interdisciplinary course that benefits from a balance between the rigorous coverage of the instructional material pertaining to engineering and medicine and the flexible selection of topics that comply with students' individual interests.

AI as a Medical Device Adverse Event Reporting in Regulatory Databases: Protocol for a Systematic Review.

BACKGROUND: The reporting of adverse events (AEs) relating to medical devices is a long-standing area of concern, with suboptimal reporting due to a range of factors including a failure to recognize the association of AEs with medical devices, lack of knowledge of how to report AEs, and a general culture of nonreporting. The introduction of artificial intelligence as a medical device (AIaMD) requires a robust safety monitoring environment that recognizes both generic risks of a medical device and some of the increasingly recognized risks of AIaMD (such as algorithmic bias). There is an urgent need to understand the limitations of current AE reporting systems and explore potential mechanisms for how AEs could be detected, attributed, and reported with a view to improving the early detection of safety signals. OBJECTIVE: The systematic review outlined in this protocol aims to yield insights into the frequency and severity of AEs while characterizing the events using existing regulatory guidance. METHODS: Publicly accessible AE databases will be searched to identify AE reports for AIaMD. Scoping searches have identified 3 regulatory territories for which public access to AE reports is provided: the United States, the United Kingdom, and Australia. AEs will be included for analysis if an artificial intelligence (AI) medical device is involved. Software as a medical device without AI is not within the scope of this review. Data extraction will be conducted using a data extraction tool designed for this review and will be done independently by AUK and a second reviewer. Descriptive analysis will be conducted to identify the types of AEs being reported, and their frequency, for different types of AIaMD. AEs will be analyzed and characterized according to existing regulatory guidance. RESULTS: Scoping searches are being conducted with screening to begin in April 2024. Data extraction and synthesis will commence in May 2024, with planned completion by August 2024. The review will highlight the types of AEs being reported for different types of AI medical devices and where the gaps are. It is anticipated that there will be particularly low rates of reporting for indirect harms associated with AIaMD. CONCLUSIONS: To our knowledge, this will be the first systematic review of 3 different regulatory sources reporting AEs associated with AIaMD. The review will focus on real-world evidence, which brings certain limitations, compounded by the opacity of regulatory databases generally. The review will outline the characteristics and frequency of AEs reported for AIaMD and help regulators and policy makers to continue developing robust safety monitoring processes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48156.

Targeting Macrophage Polarization for Reinstating Homeostasis following Tissue Damage.

Tissue regeneration and remodeling involve many complex stages. Macrophages are critical in maintaining micro-environmental homeostasis by regulating inflammation and orchestrating wound healing. They display high plasticity in response to various stimuli, showing a spectrum of functional phenotypes that vary from M1 (pro-inflammatory) to M2 (anti-inflammatory) macrophages. While transient inflammation is an essential trigger for tissue healing following an injury, sustained inflammation (e.g., in foreign body response to implants, diabetes or inflammatory diseases) can hinder tissue healing and cause tissue damage. Modulating macrophage polarization has emerged as an effective strategy for enhancing immune-mediated tissue regeneration and promoting better integration of implantable materials in the host. This article provides an overview of macrophages' functional properties followed by discussing different strategies for modulating macrophage polarization. Advances in the use of synthetic and natural biomaterials to fabricate immune-modulatory materials are highlighted. This reveals that the development and clinical application of more effective immunomodulatory systems targeting macrophage polarization under pathological conditions will be driven by a detailed understanding of the factors that regulate macrophage polarization and biological function in order to optimize existing methods and generate novel strategies to control cell phenotype.

[Design and Development of a Heat Sealing System for Rapid Reuse of Ultrasonic Probes]. / è¶ å£°æŽ¢å¤´å¿«é€Ÿå¤ç”¨çƒ­å°ç³»ç»Ÿçš„è®¾è®¡ä¸Žç ”å‘.

Objective: Ultrasound diagnosis and treatment is easy to perform and takes little time. It is widely used in clinical practice thanks to its non-invasive, real-time, and dynamic characteristics. In the process of ultrasound diagnosis and treatment, the probe may come into contact with the skin, the mucous membranes, and even the sterile parts of the body. However, it is difficult to achieve effective real-time disinfection of the probes after use and the probes are often reused, leading to the possibility of the probes carrying multiple pathogenic bacteria. At present, the processing methods for probes at home and abroad mainly include probe cleaning, probe disinfection, and physical isolation (using probe covers or sheaths). Yet, each approach has its limitations and cannot completely prevent probe contamination and infections caused by ultrasound diagnosis and treatment. For example, when condoms are used as the probe sheath, the rate of condom breakage is relatively high. The cutting and fixing of cling film or freezer bags involves complicated procedures and is difficult to perform. Disposable plastic gloves are prone to falling off and causing contamination and are hence not in compliance with the principles of sterility. Furthermore, the imaging effect of disposable plastic gloves is poor. Therefore, there is an urgent need to explore new materials to make probe covers that can not only wrap tightly around the ultrasound probe, but also help achieve effective protection and rapid reuse. Based on the concept of physical barriers, we developed in this study a heat sealing system for the rapid reuse of ultrasound probes. The system uses a heat sealing device to shrink the protective film so that it wraps tightly against the surface of the ultrasound probe, allowing for the rapid reuse of the probe while reducing the risk of nosocomial infections. The purpose of this study is to design a heat sealing system for the rapid reuse of ultrasound probes and to verify its application effect on the rapid reuse of ultrasound probes. Methods: 1) The heat sealing system for the rapid reuse of ultrasound probes was designed and tested by integrating medical and engineering methods. The system included a protective film (a multilayer co-extruded polyolefin thermal shrinkable film) and a heat sealing device, which included heating wire components, a blower, a photoelectric switch, temperature sensors, a control and drive circuit board, etc. According to the principle of thermal shrinkage, the ultrasound probe equipped with thermal shrinkable film was rapidly heated and the film would wrap closely around the ultrasound probe placed on the top of the heat sealing machine. The ultrasound probe was ready for use after the thermal shrinkage process finished. Temperature sensors were installed on the surface of the probe to test the thermal insulation performance of the system. The operation procedures of the system are as follows: placing the ultrasound probe covered with the protective film in a certain space above the protective air vent, which is detected by the photoelectric switch; the heating device heats the thermal shrinkable film with a constant flow of hot air at a set temperature value. Then, the probe is rotated so that the thermal shrinkable film will quickly wrap around the ultrasound probe. After the heat shrinking is completed, the probe can be used directly. 2) Using the convenience sampling method, 90 patients from the Department of Anesthesiology and Perioperative Medicine, the First Affiliated Hospital of Xi'an Jiaotong University were included as the research subjects. All patients were going to undergo arterial puncture under ultrasound guidance. The subjects were divided into 3 groups, with 30 patients in each group. Three measures commonly applied in clinical practice were used to process the probes in the three groups and water-soluble fluorescent labeling was applied around the puncture site before use. In the experimental group, the probes were processed with the heat sealing system. The standard operating procedures of the heat sealing system for rapid reuse of ultrasonic probes were performed to cover the ultrasonic probe and form a physical barrier to prevent probe contamination. There were two control groups. In control group 1, disinfection wipes containing double-chain quaternary ammonium salt were used to repeatedly wipe the surface of the probe for 10-15 times, and then the probe was ready for use once it dried up. In the control group 2, a disposable protective sheath was used to cover the front end of the probe and the handle end of the sheath was tied up with threads. Comparison of the water-soluble fluorescent labeling on the surface of the probe (which reflected the colony residues on the surface of the probe) before and after use and the reuse time (i.e., the lapse of time from the end of the first use to the beginning of the second use) were made between the experimental group and the two control groups. Results: 1) The temperature inside the ultrasound probe was below 40 ℃ and the heat sealing system for rapid reuse did not affect the performance of the ultrasound probe. 2) The reuse time in the heat sealing system group, as represented by (median [P25, P75]), was (8.00 [7.00, 10.00]) s, which was significantly lower than those of the disinfection wipe group at (95.50 [8.00, 214.00]) s and the protective sleeve group at (25.00 [8.00, 51.00]) s, with the differences being statistically significant (P<0.05). No fluorescence residue was found on the probe in either the heat sealing system group or the protective sheath group after use. The fluorescence residue in the heat sealing system group was significantly lower than that in the disinfection wipes group, showing statistically significant differences (χ 2=45.882, P<0.05). Conclusion: The thermal shrinkable film designed and developed in this study can be cut and trimmed according to the size of the equipment. When the film is heated, it shrinks and wraps tightly around the equipment, forming a sturdy protective layer. With the heat sealing system for rapid reuse of ultrasonic probes, we have realized the semi-automatic connection between the thermal shrinkable film and the heating device, reducing the amount of time-consuming and complicated manual operation. Furthermore, the average reuse time is shortened and the system is easy to use, which contributes to improvements in the reuse and operation efficiency of ultrasound probes. The heat sealing system reduces colony residues on the surface of the probe and forms an effective physical barrier on the probe. No probes were damaged in the study. The heat sealing system for rapid reuse of ultrasonic probes can be used as a new method to process the ultrasonic probes.

Leveraging User-Friendly Mobile Medical Devices to Facilitate Early Hospital Discharges in a Pediatric Setting: A Randomized Trial Study Protocol.

BACKGROUND: Mobile technology is increasingly prevalent in healthcare, serving various purposes, including remote health monitoring and patient self-management, which could prove beneficial to early hospital discharges. AIMS: This study investigates the transitional care program experience facilitating early discharges in a pediatric setting through the use of an easy-to-use mobile medical device (TytoCare™, TytoCare Ltd., Natanya, Israel). OUTCOMES: This study aims to assess the effectiveness of telehomecare in achieving complete resolution of diseases without readmission, compare the length of stay between intervention and standard care groups, and gather user and professional experiences. METHODS: A randomized open-label, controlled pilot study enrolled 102 children, randomly assigned to the telehomecare (TELE) group (n = 51, adopting early hospital discharge with continued home monitoring) or the standard-of-care (STAND) group (n = 51). Primary outcomes include complete disease resolution without readmission. Secondary objectives include recording a shorter length of stay in the intervention group. Surveys on user and professional experiences were conducted. A group of 51 children declining telemedicine services (NO-TELE) was also included. RESULTS: In the TELE group, 100% of children achieved complete disease resolution without readmission, with a median duration of stay of 4 days, significantly shorter than the 7 days in the STAND group (p = 0.01). The telemedicine system demonstrated efficient performance and high satisfaction levels. The NO-TELE group showed no significant differences in demographics or digital technology competence. Perceived benefits of telemedicine included time and cost savings, reduced hospital stays, and technology utility and usability. CONCLUSIONS: This study demonstrates that user-friendly mobile medical devices effectively facilitate early hospital discharges in a pediatric setting. These devices serve as a bridge between home and hospital, optimizing care pathways.

Transdermal gene delivery.

Gene delivery has revolutionized conventional medical approaches to vaccination, cancer, and autoimmune diseases. However, current gene delivery methods are limited to either intravenous administration or direct local injections, failing to achieve well biosafety, tissue targeting, drug retention, and transfection efficiency for desired therapeutic outcomes. Transdermal drug delivery based on various delivery strategies can offer improved therapeutic potential and superior patient experiences. Recently, there has been increased foundational and clinical research focusing on the role of the transdermal route in gene delivery and exploring its impact on the efficiency of gene delivery. This review introduces the recent advances in transdermal gene delivery approaches facilitated by drug formulations and medical devices, as well as discusses their prospects.

Gastrointestinal devices: common and uncommon foreign bodies.

Devices for the gastrointestinal tract are widely available and constantly advancing with less invasive techniques. They play a crucial role in diagnostic and therapeutic interventions and are commonly placed by interventional radiologists, gastroenterologists, and surgeons. These devices frequently appear in imaging studies, which verify their proper placement, identify any complications, or may be incidentally detected. Radiologists must be able to identify these devices at imaging and understand their intended purpose to assess their efficacy, detect complications such as incorrect positioning, and avoid misinterpreting them as abnormalities. Furthermore, many patients with these devices may require MRI, making assessing compatibility essential for safe patient care. This review seeks to provide a succinct and practical handbook for radiologists regarding both common and uncommon gastrointestinal devices. In addition to textual descriptions of clinical indications, imaging findings, complications, and MRI compatibility, the review incorporates a summary table as a quick reference point for key information and illustrative images for each device.

A comparative study of medical device regulation between countries based on their economies.

INTRODUCTION: Medical devices play a crucial role in healthcare, addressing the diagnosis, treatment, and monitoring of various medical conditions. This study conducts a comprehensive analysis of medical device regulations across nations, considering the economic contexts of diverse countries. AREAS COVERED: The research involves a comparative examination of medical device regulations, dissecting unique frameworks in countries like the United States (US), European Union (EU), India, and Africa. These nations were chosen based on economic significance, market influence, and regulatory structures. The study aims to achieve a nuanced understanding of global medical device regulation, develop strategies to enhance guidelines, especially in developing nations, and provide recommendations for improvements in relevant regions. EXPERT OPINION: Through this study, valuable insights are gained into the diverse regulatory frameworks governing medical devices globally. The analysis identifies areas within these frameworks that require improvement, as well as strategies to enhance regulatory guidelines, particularly addressing the specific needs of developing economies. Ultimately, the research provides significant recommendations for policymakers and industry stakeholders. By offering a deeper understanding of regulatory intricacies, this study establishes pragmatic approaches to address challenges within the medical device industry and improve the regulatory landscape on a global scale.

Assessing friction and damage of cell monolayers on soft substrates in vitro.

In the area of surgical applications, understanding the interaction between medical device materials and tissue is important since this interaction may cause complications. The interaction often consists of a cell monolayer touching the medical device that can be mimicked in vitro. Prominent examples of this are contact lenses, where epithelial cells interact with the contact lens, or stents and catheters, which are in contact with endothelial cells. To investigate those interactions, in previous studies, expensive microtribometers were used to avoid pressures in the contact area far beyond physiologically relevant levels. Here, we aim to present a new methodology that is cost- and time-efficient, more accessible than those used previously and allows for the application of more realistic pressures, while permitting a quantification of the damage caused to the monolayer. For this, a soft polydimethylsiloxane is employed that better mimics the mechanical properties of blood vessels than materials used in other studies. Furthermore, a technique to account for misalignments within the experiment set-up is presented. This is carried out using the raw spatial and force data recorded by the tribometer and adjusting for misalignments. The methodology is demonstrated using an endothelial cell (human umbilical vein endothelial cells) monolayer.

Study on the impact of sensitization on materiovigilance programme among pharmacy and dental postgraduate students.

BACKGROUND: Medical devices play a crucial role in patient care but entail inherent risks, necessitating the presence of materiovigilance to monitor and prevent medical device adverse events (MDAEs). The primary objective of our study is to evaluate the impact of an awareness and sensitization program regarding medical devices among participants. METHODS: A self-administered, validated knowledge, attitude, and practice (KAP) questionnaire consisting of 15 questions was distributed to study participants, and their responses were collected. The data were analyzed using SPSS software version 18. RESULTS: Out of the 182 responses received, 56% were from the Pharmacy, while 44% were from the Dental field. 64.8% of the participants were unaware of the Materiovigilance Programme of India (MvPI). However, an overwhelming 97.5% displayed a positive attitude towards reporting MDAEs. Only 5% of the participants had received training on how to report MDAEs. Furthermore, 85.71% of participants had not seen the MDAE reporting form. CONCLUSION: To improve the reporting of MDAEs, it is essential to implement educational interventions and provide training to Pharmacy and Dental postgraduate students. These measures will increase awareness and promote better understanding and implementation of materiovigilance practices.

[Research Progress of 3D-Printed Polyetheretherketone in Implantable Medical Devices].

Polyetheretherketone (PEEK) has emerged as a thermoplastic material of choice in the realm of implantable medical devices, owing to its high biocompatibility and exceptional mechanical strength. Despite its promise for custom-made medical devices, 3D-printed PEEK in orthopedics, trauma, and spinal implants has not yet achieved widespread application. This study outlines the properties of PEEK, 3D-printed PEEK-based composites, and their utilization in implantable medical devices, thereby fostering the development and regulation of next-generation medical devices.

[Application of NGO-BP Neural Network in Battery Life Prediction of Portable Medical Devices].

The development of portable medical devices cannot be separated from safe and efficient batteries. Accurately predicting the remaining life of batteries can greatly improve the reliability of batteries, which is of great significance for portable medical devices. This article focuses on the high dependence of the BP neural network algorithm on initial weights and thresholds, as well as its tendency to fall into local minima. The Northern Goshawk Optimization (NGO) algorithm is used to optimize the BP neural network and to test the 18650 lithium battery data under different ambient temperatures (4, 24, 43°C) typical of medical equipment. The experimental results show that the NGO algorithm can significantly improve the prediction accuracy of the BP neural network under various temperature conditions, achieving accurate and effective prediction of the remaining battery life.

Innovative solution or cause for concern? The use of continuous glucose monitors in people not living with diabetes: A narrative review.

AIMS: Continuous glucose monitors (CGMs) have expanded their scope beyond indicated uses for diabetes management and are gaining traction among people not living with diabetes (PNLD). CGMs track in time glucose levels and are proposed as tools for the early detection of abnormal glucose and a potential solution for its normalisation through behavioural change, particularly, diet personalisation and motivation of physical activity. This becomes relevance given the growing incidence of metabolic conditions, such as type 2 diabetes mellitus (T2DM). Clinical guidelines, however, do not recommend CGMs in contexts outside type 1 diabetes (T1DM) or insulin-treated T2DM. Therefore, there is a visible disconnect between the indicated and real-world usage of these medical devices. While the commercial market for CGMs in PNLD is expanding rapidly, a comprehensive and evidence-based evaluation of the devices' utility in this population has not been done. Therefore, this review aims to formulate a working model for CGM utility in PNLD as proposed by the 'health and wellness' market that advertises and distributes it to these individuals. METHODS: We aim to critically analyse the available research addressing components of the working model, that is (1) detection of abnormal glucose; (2) behavioural change, and (3) metabolic health improvement. RESULTS: We find a lack of consistent and high-quality evidence to support the utility of CGMs for these purposes. We identify significantly under-reserved areas including clinical benchmarks and scoring procedures for CGM measures, device acceptability, and potential adverse effects of CGMs on eating habits in PNLD. We also raise concerns about the robustness of available CGM research. CONCLUSION: In the face of these research gaps, we urge for the commercial claims suggesting the utility of the device in PNLD to be labelled as misleading. We argue that there is a regulatory inadequacy that fuels 'off-label' CGM distribution and calls for the strengthening of post-market clinical follow-up oversight for CGMs. We hope this will help to avert the continued misinformation risk to PNLD and 'off-label' exacerbation of health disparities.

A Lumped-Parameter Model of the Cardiovascular System Response for Evaluating Automated Fluid Resuscitation Systems.

Physiological closed-loop controlled (PCLC) medical devices, such as those designed for blood pressure regulation, can be tested for safety and efficacy in real-world clinical settings. However, relying solely on limited animal and clinical studies may not capture the diverse range of physiological conditions. Credible mathematical models can complement these studies by allowing the testing of the device against simulated patient scenarios. This research involves the development and validation of a low-order lumped-parameter mathematical model of the cardiovascular system's response to fluid perturbation. The model takes rates of hemorrhage and fluid infusion as inputs and provides hematocrit and blood volume, heart rate, stroke volume, cardiac output and mean arterial blood pressure as outputs. The model was calibrated using data from 27 sheep subjects, and its predictive capability was evaluated through a leave-one-out cross-validation procedure, followed by independent validation using 12 swine subjects. Our findings showed small model calibration error against the training dataset, with the normalized root-mean-square error (NRMSE) less than 10% across all variables. The mathematical model and virtual patient cohort generation tool demonstrated a high level of predictive capability and successfully generated a sufficient number of subjects that closely resembled the test dataset. The average NRMSE for the best virtual subject, across two distinct samples of virtual subjects, was below 12.7% and 11.9% for the leave-one-out cross-validation and independent validation dataset. These findings suggest that the model and virtual cohort generator are suitable for simulating patient populations under fluid perturbation, indicating their potential value in PCLC medical device evaluation.

Lysine grafted poly(lactic acid): An intrinsically antimicrobial polymer.

Nosocomial infections or healthcare-associated infections, normally develops after the healthcare treatment in the hospital. Most of them are caused by infected medical devices. Plastics are the most common materials for manufacturing these devices because of their good processability, sterilization efficacy, ease of handling and harmlessness, however, it usually do not display antimicrobial properties. Here, in order to infer antimicrobial activity to poly(lactic acid), it was modified by maleation, followed by l-lysine grafting to its structure. The chemical modifications were confirmed by FTIR and 1H NMR analysis, indicating the success of the reactions. The antimicrobial activity was tested using Escherichia coli and Staphylococcus aureus and the results showed that the sample was capable of inhibiting about 99 % of the S. aureus growth by contact. The samples cytotoxicity was also tested using the L929 mouse cells and the results indicated no cytotoxic effect. These results indicated the sample antimicrobial potential, without affect the normal eukaryotic cells. In addition, the processability of the modified PLA (PLA-g-Lys) was improved without compromising its mechanical properties, as shown by thermal analysis and tensile tests. Thus, this novel PLA derivative can be seen as a promising material for future applications in the manufacturing of biomedical devices.