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BACKGROUND: The field of robotic-assisted surgery is rapidly growing as many robotic surgical devices are in development and about to enter the market. Currently, there is no universally accepted language for labeling the different robotic systems. To facilitate this communication, we created what is, to our knowledge, the first classification of surgical robotic technologies that organizes and classifies surgical robots used for endoscopy, laparoscopy and thoracoscopy. METHODS: We compiled a list of surgical robots intended to be used for endoscopy, laparoscopy, and/or thoracoscopy by searching United States, European, Hong Kong, Japan, and Korean databases for approved devices. Devices showcased at the 2023 Annual Meeting for the Society of Robotic Surgery were added. We also systematically reviewed the literature for any existing surgical robotic classifications or categorizations. We then created a multidisciplinary committee of 8 surgeons and 2 engineers to construct a proposed classification of the devices included in our search. RESULTS: We identified 40 robotic surgery systems intended to be used for endoscopy, laparoscopy and/or thoracoscopy. The proposed classification organizes robotic devices with regard to architecture, port design, and configuration (modular carts, multi-arm integrated cart, table-attachable or arm-table integration). CONCLUSION: This 3-level classification of robotic surgical devices used for endoscopy, laparoscopy and/or thoracoscopy describes important characteristics of robotic devices systematically.

Background: Medical devices commonly used for the treatment and care of critically ill patients can cause pressure injuries in intensive care units (ICUs). The endotracheal tube (ETT) is one of the most common medical devices to cause pressure injuries. Aim: This study investigated the incidence of, characteristics of and risk factors for ETT‐related pressure injuries for ICU patients. Study Design: This study adopted a prospective descriptive research design. The sample consisted of 146 endotracheally intubated patients. Data were collected using a patient information form, an Endotracheal Tube‐Related Pressure Injuries Assessment Form, the Braden Risk Assessment Tool and the Nutritional Assessment Test. Results: The study revealed that 80.14% of the patients developed ETT‐related pressure injuries. Over half of the ETT‐related pressure injuries appeared on Day 3 or 4 (56.41%). High body mass index was found to be associated with the development of ETT‐related pressure injuries (OR: 1.15, 95% CI: 1.05–1.26, p =.003). None of the other variables were statistically significant in the development of pressure injuries. Conclusions: The incidence of ETT‐related pressure injuries was quite high in the internal, surgical and anaesthesia ICUs. High body mass index was associated with the development of ETT‐related pressure injuries. Intensive care nurses should implement interventions to prevent ETT‐related pressure injuries in critically ill patients receiving mechanical ventilation support. Relevance to Clinical Practice: ETT‐related pressure injuries are common in ICU patients. High body mass index was associated with the development of ETT‐related pressure injuries in critically ill patients. The skin and mucosa should be assessed for the development of ETT‐related pressure injuries during the daily assessment of the patients receiving mechanical ventilation support. The ETT should be repositioned regularly, and the most suitable ETT fixation method should be used. [ABSTRACT FROM AUTHOR]

Mechanical circulatory support devices have profoundly transformed the management of severe cardiothoracic disorders. While heart transplantation is the gold standard therapy for end-stage heart disease, long-term mechanical support devices are a viable alternative for those ineligible and/or those awaiting organ availability. Major technological advancements were made over first 5 decades of development, resulting in improved durability and survival with reduced adverse events. However, gains have tapered recently for various complications (e.g., internal bleeding, multisystem organ failure), which collectively represent a significant proportion of disability and/or mortality. Further, in light of mature ventricular assist devices failing during clinical trials or even after clinical approval (class I withdrawals), it is timely to consider: Are our preclinical assessment protocols vital in the design and development of mechanical circulatory support devices, providing a realistic and reliable profile of future clinical performance? This commentary explores this question and analyses development pathways through the lens of the various disciplines involved in the preclinical assessment of mechanical circulatory support technologies: Limitations in approaches to benchtop blood testing, computational design and simulation, and animal testing are discussed as likely contributors to some of the common hemocompatibility-related adverse events (HRAEs). While it is acknowledged that some shortcomings are pragmatic in nature, possible solutions are presented that will only be realized through truly transdisciplinary and open approaches that challenge the current nature of medical device development. We suggest that these can and must be overcome to diminish HRAEs and will potentially demarcate the fourth generation of cardiac assist devices. [ABSTRACT FROM AUTHOR]

• New approaches to maternal blood loss quantification should be investigated. • A novel device was more accurate than volumetry and is highly usable. • The device my address limitations of current blood loss quantification practices. • The device may impact PPH related morbidity and needs further testing. To study the accuracy and usability of a novel obstetric blood loss quantifying tool in clinical settings. A mixed-methods study was conducted in an Irish tertiary maternity unit. The accuracy of measuring the blood content (hemoglobin concentration) of elective Caesarean section birth waste with a novel obstetric blood loss quantifying device was compared, using Bland-Altman and correlation analysis, with staff volumetry and a reference hemoglobinometer. Hospital staff (nurses, midwives and doctors) opinion of the usability of the device was studied by an anonymous questionnaire which generated a System Usability Scale (SUS) score. SUS scores range from 0 to 100 with higher scores reflecting greater usability. The device was used by 19 different hospital staff members (nine nurses, four midwives and six doctors) in 19 elective Caesarean deliveries that had varying levels of PPH risk. Bland-Altman analysis produced mean biases of −0.7 ± 1.5 g/dL and 0.2 ± 1.2 g/dL for the device and staff measurements respectively. The width of the limits of agreement was narrower for device measurements than for staff measurements (4.5 g/dL and 5.7 g/dL respectively). The device's measurements of hemoglobin content correlated more strongly with the hemoglobinometer rather than with hospital staff measurements (Spearman correlation coefficients of 0.9 and 0.6 respectively). This suggests that the device is more accurate in determining the blood content of the birth waste than hospital staff volumetric measurements. Hospital staff members assigned the device a mean SUS score of 82 which suggests that the device is highly usable. An early feasibility study in clinical settings suggests that a novel device for quantifying obstetric blood loss was more accurate than volumetry in measuring the hemoglobin content of birth waste. Health professionals also found the device highly usable. This data suggests that there is much potential in transitioning from a "human-made" to a "machine-made" assessment of blood loss. Future studies will entail additional testing of the device to assess its impact on the morbidities associated with postpartum hemorrhage. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to understand the lived experiences of ten (10) product innovation employees in medical device firms' sustainability initiatives, considering leadership, organizational and employee factors within the healthcare industry. Design/methodology/approach: Phenomenology was chosen as it supports an in-depth analysis of the lived experience of several individuals, who are experiencing a similar phenomenon. This methodology permitted the researcher to "view experience and behavior as an integrated and inseparable relationship of the subject and object and of parts and whole." Findings: The intersection of employee, leader and organizational factors should be considered to further organizational citizenship behavior to the environment. Within each theme, cognitive dissonance is present. Understanding and acknowledging the choice required by the individual, leader and/or organization may impact overall environmental organizational citizenship behavior. Practical implications: When implementing sustainable activities, three key areas should be evaluated: leaders, organizations and employees. Social implications: This study provides insight into employee experiences and sustainable activities. Originality/value: This research adds to the literature on organizational citizenship behavior to the environment within medical device firms as it provides insight into how sustainability programs within firms could be approached. Healthcare's climate impact contributes to emissions which are equivalent to having 75 million vehicles on the road, annually. In addition, this study provided an initial understanding of the lived experiences of employees within the medical device industry when themes are analyzed. The results may help organizations understand the experiences of employees to further advance their vision and mission, by understanding the phenomenon of how sustainability initiatives are perceived. [ABSTRACT FROM AUTHOR]

For successful health technology innovation and implementation it is key to, in an early phase, understand the problem and whether a proposed innovation is the best way to solve the problem. This review performed an initial exploration of published tools that support innovators in academic research and early stage development with awareness and guidance along the end-to-end process of development, evaluation and implementation of health technology innovations. Tools were identified from scientific literature as well as in grey literature by non-systematic searches in public research databases and search engines, and based on expert referral. A total number of 14 tools were included. Tools were classified as either readiness level tool (n = 6), questionnaire/checklist tool (n=5) or guidance tool (n = 3). A qualitative analysis of the tools identified 5 key domains, 5 innovation phases and 3 implementation principles. All tools were mapped for (partially) addressing the identified domains, phases, and principles. The present review provides awareness of available tools and of important aspects of health technology innovation and implementation (vs. nontechnological or non-health related technological innovations). Considerations for tool selection include for example the purpose of use (awareness or guidance) and the type of health technology innovation. Considerations for novel tool development include the specific challenges in academic and early stage development settings, the translation of implementation to early innovation phases, and the importance of multi-disciplinary strategic decisionmaking. A remaining attention point for future studies is the validation and effectiveness of (self-assessment) tools, especially in the context of support preferences and available support alternatives. [ABSTRACT FROM AUTHOR]

Featured Application: The article provides two applications of the Functional Resonance Analysis Method (FRAM) in the healthcare sector. These analyses can be used as a reference by safety managers and practitioners prospectively and retrospectively for the effective risk assessment of interoperable medical device systems. In the recent literature, numerous tools have been found that have been used to evaluate and improve the resilience of socio-technical systems such as hospitals. The Functional Resonance Analysis Method (FRAM) is certainly one of the most diffused, as it can provide information on the system structure and its components through a systemic analysis approach. FRAM has been successfully applied in different contexts. However, in the healthcare sector, only a few studies propose practical analyses that can support practitioners in systematically observing and analyzing events, both when things go right and when they go wrong. To reduce such a research gap, the current study focuses on the application of FRAM to two different case studies: (1) an accident that occurred in a hyperbaric oxygen therapy unit, and (2) the risk assessment of a magnetic resonance imaging unit. The results show the effectiveness of FRAM in detecting discrepancies and vulnerabilities in the practical management of these devices, providing valuable insights not only regarding the analysis of adverse events (i.e., retrospectively) but also concerning the improvement of safety procedures (i.e., prospectively). [ABSTRACT FROM AUTHOR]

Medical devices play a crucial role in human health. These are instruments, machines or even software programs used to diagnose, treat, monitor or prevent health conditions. They are designed to help improve patients' quality of life and range from simple items, such as thermometers, to more advanced technologies, such as pacemakers. In order to guarantee the safety and efficacy of medical devices intended for use on patients, the establishment of appropriate regulatory frameworks is crucial to ascertain whether devices function as intended, comply with safety standards and offer benefits that outweigh the associated risks. Depending on the country, different regulatory agencies are responsible for the evaluation of these products. The regulatory landscape for medical devices varies significantly across major markets, including the European Union, the United States of America and Japan, reflecting diverse approaches aimed at ensuring the safety and efficacy of medical technologies. However, these regulatory differences can contribute to a "medical device lag," where disparities in approval processes and market entry timelines driven by strict regulatory requirements, increasing device complexity and the lack of global harmonization, result in delays in accessing innovative technologies. These delays impact patient access to cutting-edge medical devices and competitiveness in the market. This review aims to address the regulatory framework of medical devices and the approval requirements by the European Commission (EC), the Food and Drug Administration (FDA) and Pharmaceuticals and Medical Device Agency (PMDA). [ABSTRACT FROM AUTHOR]

Distraction Osteogenesis (DO) revolutionizes bone lengthening without donor sites, which is crucial in maxillofacial reconstruction (MRA). Manual DO devices are standard, but continuous DO devices promise faster treatments and better outcomes. Current continuous distractors lack ideal MRA due to size, force generation, and power source limitations. This study introduces a passive distractor system for continuous DO in MRA, aiming to bridge existing gaps and provide an ideal solution for human MRA use. It utilizes a miniaturized mechanism powered by a passive energy source, eliminating the need for active power. Advanced manufacturing methods enable the reduction of device size while hydraulic systems ensure controlled and smooth movement. The system includes a proximal bone fixture, movable distractor components, and passive drive means for distraction force application. Results show promising potential to address existing limitations. By utilizing passive energy for continuous force generation, the device size is reduced, and the need for force transition mechanisms is minimized. This innovative system and method offer an ideal treatment environment for MRA in humans. Further research and clinical evaluation are essential to validate its efficacy and safety in clinical practice. [ABSTRACT FROM AUTHOR]

Background: Fall risk and incidence increase with age, creating significant physical and mental burden for the individual and their care provider. Lift assistive devices are used in multiple healthcare facilities, but are generally not portable nor self-operational, limiting their use outside of medical supervision. The RaymexTM lift is a novel lift assistance device within a rollator to address these limitations. We aim to gather user-centered feedback on the RaymexTM lift, set up instructions, safety protocols to improve feasibility and usability, and explore the potential usability as a fall recovery or prevention device. Methods: Four older adults, two informal caregivers and 16 formal caregivers (clinicians and continuing care assistants) participated in a focus group. Participants provided feedback on the RaymexTM lift after viewing a demonstration and using the device. Qualitative and quantitative data were analysized using thematic and descriptive analysis respectively. Results: Participants highlighted three major themes: (1) Design features requiring improvement, (2) Positive feedback and suggestions to optimize the RaymexTM lift and (3) Pricing vs. social utility. Participants suggested widening the seat, changing the braking button layout, and lowering the device weight to improve usability. Participants believed the main device feature was fall recovery and had implications for social utility by reducing the need for ambulance visits to the home. Price point led to a concern on affordability for older adults. Conclusion: The feedback gained will advance the development of the RaymexTM lift and may highlight cost-effective design choices for other developers creating related aging assistive technologies. [ABSTRACT FROM AUTHOR]

Hemorrhage remains a major complication of anticoagulants, with bleeding leading to serious and even life-threatening outcomes in rare settings. Currently available anticoagulants target either multiple coagulation factors or specifically coagulation factor (F) Xa or thrombin; however, inhibiting these pathways universally impairs hemostasis. Bleeding complications are especially salient in the medically complex population who benefit from medical devices. Extracorporeal devices—such as extracorporeal membrane oxygenation, hemodialysis, and cardiac bypass—require anticoagulation for optimal use. Nonetheless, bleeding complications are common, and with certain devices, highly morbid. Likewise, pharmacologic prophylaxis to prevent thrombosis is not commonly used with many medical devices like central venous catheters due to high rates of bleeding. The contact pathway members FXI, FXII, and prekallikrein serve as a nexus, connecting biomaterial surface-mediated thrombin generation and inflammation, and may represent safe, druggable targets to improve medical device hemocompatibility and thrombogenicity. Recent in vivo and clinical data suggest that selectively targeting the contact pathway of coagulation through the inhibition of FXI and FXII can reduce the incidence of medical device-associated thrombotic events, and potentially systemic inflammation, without impairing hemostasis. In the following review, we will outline the current in vivo and clinical data encompassing the mechanism of action of drugs targeting the contact pathway. This new class of inhibitors has the potential to herald a new era of effective and low-risk anticoagulation for the management of patients requiring the use of medical devices. [ABSTRACT FROM AUTHOR]

Objective We sought to identify clinical and demographic factors associated with gastrostomy tube (g-tube) placement in periviable infants. Study Design We conducted a single-center retrospective cohort study of live-born infants between 22 and 25 weeks' gestation. Infants not actively resuscitated and those with congenital anomalies were excluded from analysis. Results Of the 243 infants included, 158 survived until discharge. Of those that survived to discharge, 35 required g-tube prior to discharge. Maternal race/ethnicity (p = 0.006), intraventricular hemorrhage (p = 0.013), periventricular leukomalacia (p = 0.003), bronchopulmonary dysplasia (BPD; p ≤ 0.001), and singleton gestation (p = 0.009) were associated with need for gastrostomy. In a multivariable logistic regression, maternal Black race (Odds Ratio [OR] = 2.88; 95% confidence interval [CI]: 1.11–7.47; p = 0.029), singleton gestation (OR = 3.99; 95% CI: 1.28–12.4; p = 0.017) and BPD (zero g-tube placement in the no BPD arm; p ≤ 0.001) were associated with need for g-tube. Conclusion A high percentage of periviable infants surviving until discharge require g-tube at our institution. In this single-center retrospective study, we noted that maternal Black race, singleton gestation, and BPD were associated with increased risk for g-tube placement in infants born between 22 and 25 weeks' gestation. The finding of increased risk with maternal Black race is consistent with previous reports of racial/ethnic disparities in preterm morbidities. Additional studies examining factors associated with successful achievement of oral feedings in preterm infants are necessary and will inform future efforts to advance equity in newborn health. Key Points BPD, singleton birth, and Black race are associated with need for g-tube in periviable infants. Severe intraventricular hemorrhage is associated with increased mortality or g-tube placement in periviable infants. Further investigation into the relationship between maternal race and g-tube placement is warranted. [ABSTRACT FROM AUTHOR]

Electrical discharge machining (EDM), widely used to fabricate medical devices, is applicable for antibacterial surface protection. Silver, transferred from tool electrode or powder suspended in the dielectric to the modified layer during the EDM process, significantly enhanced antibacterial properties of the modified surface. However, bacterial resistance to silver, which was widespread in clinical, still posed challenges for the modified surfaces containing silver. Zinc, owing to its strong antibacterial effects and no challenge related to Zn-resistant bacteria hitherto reported in clinical, was therefore used as tool electrode material to modify Ti6Al4V surfaces during the EDM process. Discharge energies up to 170 µJ with different polarities were applied in the EDM milling process using deionized water-based dielectric fluid. Results show that discharge energy and polarity play a vital role in chemical composition and roughness of the modified surfaces as well as material removal rate and tool wear rate. The surfaces containing zinc contents up to 28 % can be generated. The use of a low energy generates zinc-rich surfaces with less micro-cracks. The EDM process using zinc tool electrode shows a promising potential for antibacterial surface modification of medical devices. [ABSTRACT FROM AUTHOR]

An adaptive medical device is a piece of equipment designed to adjust or respond to changes in a patient's condition or environment. The use of 3D printing technology for the development of adaptive medical devices has opened up new possibilities for customization, efficiency, and accessibility in healthcare. Sagittal craniosynostosis is a birth defect that arises due to a premature fusion of the sagittal suture in infants. This disease causes a misshapen skull and a rise of intracranial pressure that can lead to cognitive impairments. At six months of age, the preferred technique for craniosynostosis is an open vault remodeling surgery, an extremely invasive procedure with severe blood loss for the patient and significant postoperative pain. In this context, growth adaptive cranial plates, that can be tuned depending on the patient to achieve the desired skull shape through the deformation of the structure, can be a valid alternative. Cellular and lattice structures offer tailorable mechanical properties in relation to the designed geometry. Specifically, the geometry of cellular materials can be modified in relation to the final mechanical requirements. In this study, the predictability of the deformation of a PLA structure composed by honeycomb unit cells was studied performing compression simulations. The geometry was then modified, simulations and compression tests were then repeated in order to find an equation that could describe the relation between the internal angle of the honeycomb and the relative Poisson ratio. This relation can be further exploited for the production of customized adaptive devices for the treatment of sagittal craniosynostosis. [ABSTRACT FROM AUTHOR]

Introduction: The Medical Device Regulation (EU)745/2017, increased the regulatory requirements and thus the time and the cost associated with marketing medical devices. For a majority of medical device manufacturers, this has lead to reconsiderations of their product portfolio. The risk of important or essential devices being withdrawn is particularly relevant for pediatric patients and other rare disease patients where limited numbers of devices can be sold and hence the investment needed may not be recovered. This generates critical challenges and opportunities from a regulatory and public health perspective. Areas covered: This paper is based upon the experience of the authors who contributed to working groups, guidance development and research related to orphan and pediatric devices. We examine the use of medical devices in orphan and pediatric conditions, the relevant aspects of regulations and associated guidance, and we suggest possible policy and practice interventions to ensure the continued availability of essential devices for children and people with rare diseases. Expert opinion: We recommend a more proactive approach to identifying devices at risk and essential devices, increasing the use of exceptional market approvals, expanding the role of expert panels, engaging with the rare disease communities and supporting registries and standards. [ABSTRACT FROM AUTHOR]

The main goal of the article is to familiarize specialists working in the field of medical devices (MDs) with existing approaches to the study of their biocompatibility, set out in the standards of the GOST (State Standard) ISO 10993 series. The concept of the GOST (State Standard) ISO 10993 series of standards lies in establishing the biological safety and functional effectiveness of MDs in the terms of biological risk, as necessary and sufficient conditions for biocompatibility of MDs in clinical application. The main attention in the general scheme of assessing the biological safety of MD is paid to the program of toxicological studies (tests), consisting of a set of methods that take into account the category, purpose, and duration of MD functioning. [ABSTRACT FROM AUTHOR]

Trismus commonly arises after surgery for head and neck cancer (HNC) and its severity is potentiated by postoperative radiotherapy. While the benefit of trismus rehabilitation after surgery and radiotherapy is well established, the evidence during radiotherapy is less clear. This may be due to poor adherence to trismus exercises secondary to acute mucositis. This study assessed the feasibility of using a novel trismus device during adjuvant radiotherapy for HNC in patients with acute postoperative trismus. Prospective single-arm cohort feasibility study. Eligible patients had undergone surgery with curative intent for HNC, planned for adjuvant radiotherapy, and were suitable for trismus rehabilitation. Participants completed a 10-week exercise program using a novel jaw stretching device. Study outcomes were adherence, maximal incisal opening (MIO), and trismus-related function and quality of life scores, assessed at baseline, 10 weeks, and 6 months after commencing exercises. Nine patients diagnosed with trismus after primary surgery were recruited. The mean increase in MIO at 10 weeks was 7.8 mm (range −4 to 15 mm, p = 0.03), and at 6 months was 10.6 mm (range 1–26 mm, p = 0.03). Significant improvements were observed in trismus-related quality of life (Gothenburg Trismus Questionnaire; p = 0.04). Adherence to the exercises was 100% in week 1–2, 67% in weeks 3–6, and 100% at 10 weeks (1 month post radiation). This study demonstrates the feasibility of using a novel jaw stretching device during adjuvant radiotherapy. Further evaluation is warranted to assess the effectiveness of early intervention and prevention of trismus during HNC radiotherapy. Level of Evidence: IV [ABSTRACT FROM AUTHOR]

The growing integration of software in healthcare, particularly the rise of standalone software as a medical device (SaMD), is transforming digestive medicine, a field heavily reliant on medical imaging for both diagnosis and therapeutic interventions. This narrative review aims to explore the impact of SaMD on digestive healthcare, focusing on the evolution of these tools and their regulatory and ethical challenges. Our analysis highlights the exponential growth of SaMD in digestive healthcare, driven by the need for precise diagnostic tools and personalized treatment strategies. This rapid advancement, however, necessitates the parallel development of a robust regulatory framework to ensure SaMDs are transparent and deliver universal clinical benefits without the introduction of bias or harm. In addition, the discussion highlights the importance of adherence to the FAIR principles for data management—findability, accessibility, interoperability, and reusability. However, enhanced accessibility and interoperability require rigorous protocols to ensure compliance with data protection guidelines and adequate data security, both of which are crucial for effective integration of SaMDs into clinical workflows. In conclusion, while SaMDs hold significant promise for improving patients' outcomes in digestive medicine, their successful integration into clinical workflow depends on rigorous data protection protocols and clinical validation. Future directions include the need for adequate clinical and real-world studies to demonstrate that these devices are safe and well-suited to healthcare settings. [ABSTRACT FROM AUTHOR]

Bioimpedance imaging aims to generate a 3D map of the resistivity and permittivity of biological tissue from multiple impedance channels measured with electrodes applied to the skin. When the electrodes are distributed around the body (for example, by delineating a cross section of the chest or a limb), bioimpedance imaging is called electrical impedance tomography (EIT) and results in functional 2D images. Conventional EIT systems rely on individually cabling each electrode to master electronics in a star configuration. This approach works well for rack-mounted equipment; however, the bulkiness of the cabling is unsuitable for a wearable system. Previously presented cooperative sensors solve this cabling problem using active (dry) electrodes connected via a two-wire parallel bus. The bus can be implemented with two unshielded wires or even two conductive textile layers, thus replacing the cumbersome wiring of the conventional star arrangement. Prior research demonstrated cooperative sensors for measuring bioimpedances, successfully realizing a measurement reference signal, sensor synchronization, and data transfer though still relying on individual batteries to power the sensors. Subsequent research using cooperative sensors for biopotential measurements proposed a method to remove batteries from the sensors and have the central unit supply power over the two-wire bus. Building from our previous research, this paper presents the application of this method to the measurement of bioimpedances. Two different approaches are discussed, one using discrete, commercially available components, and the other with an application-specific integrated circuit (ASIC). The initial experimental results reveal that both approaches are feasible, but the ASIC approach offers advantages for medical safety, as well as lower power consumption and a smaller size. [ABSTRACT FROM AUTHOR]

Background: The field of digital mental health has followed an exponential growth trajectory in recent years. While the evidence base has increased significantly, its adoption within health and care services has been slowed by several challenges, including a lack of knowledge from researchers regarding how to navigate the pathway for mandatory regulatory approval. This paper details the steps that a team must take to achieve the required approvals to carry out a research study using a novel digital mental health intervention. We used a randomised controlled trial of a digital mental health intervention called STOP (Successful Treatment of Paranoia) as a worked example. Methods: The methods section explains the two main objectives that are required to achieve regulatory approval (MHRA Notification of No Objection) and the detailed steps involved within each, as carried out for the STOP trial. First, the existing safety of digital mental health interventions must be demonstrated. This can refer to literature reviews, any feasibility/pilot safety data, and requires a risk management plan. Second, a detailed plan to further evaluate the safety of the digital mental health intervention is needed. As part of this we describe the STOP study's development of a framework for categorising adverse events and based on this framework, a tool to collect adverse event data. Results: We present literature review results, safety-related feasibility study findings and the full risk management plan for STOP, which addressed 26 possible hazards, and included the 6-point scales developed to quantify the probability and severity of typical risks involved when a psychiatric population receives a digital intervention without the direct support of a therapist. We also present an Adverse Event Category Framework for Digital Therapeutic Devices and the Adverse Events Checklist—which assesses 15 different categories of adverse events—that was constructed from this and used in the STOP trial. Conclusions: The example shared in this paper serves as a guide for academics and professionals working in the field of digital mental health. It provides insights into the safety assessment requirements of regulatory bodies when a clinical investigation of a digital mental health intervention is proposed. Methods, scales and tools that could easily be adapted for use in other similar research are presented, with the expectation that these will assist other researchers in the field seeking regulatory approval for digital mental health products. [ABSTRACT FROM AUTHOR]

The Organ-on-a-Chip is a microfluidic device designed to replicate human organ and tissue conditions. Temperature regulation is crucial for mimicking physiological processes and ensuring cellular viability in Organ-on-a-Chip platforms. This article focuses on employing system identification to mathematically model thermal regulation in a new Organ-on-a-Chip. A controlled environment box was constructed for testing, using infrared and negative temperature coeficient sensors for intrim temperature analysis. Data collected from the cell culture chamber were processed and analyzed in MATLAB®. System identification led to the selection of a transfer function, and a descriptive equation for Organ-on-a-Chip temperature was obtained. The study revealed temperature differences between ambient and culture chamber temperatures, emphasizing the importance of real-time analysis. Mathematical modeling and in silico tests play a crucial role in predicting physiological behavior, allowing complex interactions to be simulated. The obtained temperature equation can be refined and applied in various 3D models. indicating innovation in the integration of Organ-on-a-Chip in medicine and biomedical engineering. [ABSTRACT FROM AUTHOR]

Chronic wounds result from the body's inability to heal, causing pain, pathogen entry, limited treatment options, and societal burden. Diabetic foot ulcers are particularly challenging, often leading to severe complications like leg amputation. A clinical study tested AMNIODERM+®, a new device with a lyophilized human amniotic membrane (HAM), on chronic diabetic foot ulcers. Participants had diabetic neuropathic or neuroischemic leg wounds (2–16 cm2) unhealed by 20% after six weeks of standard care. This study showed significant wound healing improvements with AMNIODERM+®. The median wound size reduction after 12 weeks was 95.5%, far exceeding the null hypothesis of 20% change. Additionally, 65% of patients achieved complete ulceration healing, surpassing the 50% efficacy requirement. The median time to full closure was 11.4 weeks, with the proportion of completely healed patients rising progressively, reaching 55% by week 11. These findings, from the clinical trial "Freeze-dried amniotic membrane in the treatment of nonhealing wounds", suggest AMNIODERM+® as a promising future treatment for chronic diabetic foot ulcers. The published results were obtained as part of a clinical trial entitled "Freeze-dried amniotic membrane in the treatment of nonhealing wounds: a single-arm, retrospectively-perspective clinical trial", EUDAMED Nr. CIV-SK-22-10-041146. [ABSTRACT FROM AUTHOR]

BACKGROUND: Unicompartmental knee arthroplasty (UKA) is a viable alternative to total knee arthroplasty (TKA) for osteoarthritis patients with single-compartment involvement, with advantages including accelerated recovery, reduced pain, and improved function. Robotic-assisted UKA (rUKA) is a promising development that ensures precise implant positioning and limb alignment. However, concerns about complications remain. OBJECTIVE: This study looks at patient satisfaction as a key metric for determining the efficacy of rUKA versus manual UKA (mUKA). METHODS: The search strategy for this study followed PRISMA. Using precise keywords, PubMed, Scopus, Web of Science, and the Cochrane library were searched. English articles were searched until August 2, 2023. Selection criteria included mUKA and rUKA patient satisfaction studies. The NOS scale evaluated study quality. Meta-analysis was done with R and heterogeneity analysis. RESULTS: This systematic review examined 5 studies with 1060 UKAs (532 robotic-assisted and 528 manual). Variable satisfaction assessment methods were used. Three studies found no difference in patient satisfaction after robotic-assisted UKA, but two found a higher satisfaction. Meta-analysis showed robotic-assisted UKA improved patient satisfaction (OR = 1.72 [1.25–2.37]). Overall, most studies showed low risk of bias, except one with higher bias. CONCLUSION: This review suggests that robotic assistance may enhance patient satisfaction in UKA procedures. [ABSTRACT FROM AUTHOR]

Colonoscopy has a limited field of view because it relies solely on a small camera attached to the end of the scope and a screen displayed on a monitor. Consequently, the quality and safety of diagnosis and treatment depend on the experience and skills of the gastroenterologist. When a novice attempts to insert the colonoscope during the procedure, excessive pressure can sometimes be applied to the colon wall. This pressure can cause a medical accident known as colonic perforation, which the physician should prevent. We propose an assisting device that senses the pressure applied to the colon wall, analyzes the risk of perforation, and warns the physician in real time. Flexible pressure sensors are attached to the surface of the colonoscope shaft. These sensors measure pressure signals during a colonoscopy procedure. A simple signal processor is used to collect and process the pressure signals. In the experiment, a colonoscope equipped with the proposed device was inserted into a simulated colon made from a colon extracted from a pig. The processed data were visually communicated to the gastroenterologist via displays and light-emitting diodes (LEDs). The device helps the physician continuously monitor and prevent excessive pressure on the colon wall. In this experiment, the device appropriately generated and delivered warnings to help the physicians prevent colonic perforation. In the future, the device is to be improved, and more experiments will be performed in live swine models or humans to confirm its efficacy and safety. [ABSTRACT FROM AUTHOR]

Wound healing, a complex physiological process orchestrating intricate cellular and molecular events, seeks to restore tissue integrity. The burgeoning interest in leveraging the therapeutic potential of natural substances for advanced wound dressings is a recent phenomenon. Notably, Sericin, a silk-derived protein, and Chelidonium majus L. (C. majus), a botanical agent, have emerged as compelling candidates, providing a unique combination of natural elements that may revolutionize conventional wound care approaches. Sericin, renowned for its diverse properties, displays unique properties that accelerate the wound healing process. Simultaneously, C. majus, with its diverse pharmacological compounds, shows promise in reducing inflammation and promoting tissue regeneration. As the demand for innovative wound care solutions increases, understanding the therapeutic potential of natural products becomes imperative. This review synthesizes current knowledge on Sericin and C. majus, envisioning their future roles in advancing wound management strategies. The exploration of these natural substances as constituents of wound dressings provides a promising avenue for developing sustainable, effective, and biocompatible materials that could significantly impact the field of wound healing. [ABSTRACT FROM AUTHOR]

Background: The new EU Medical Device Regulation (MDR) places greater importance on the role of clinical evidence to establish safety and performance. Article 54 of the MDR calls for expert committees to independently review the scientific, technical, and clinical evidence supporting the market authorization of certain novel devices independently from the established process of Notified Body reviews. These experts provide a review and opinion that ultimately is taken into consideration alongside the information reviewed by the Notified Body during the review process. Four expert committees (General and Plastic Surgery and Dentistry; Orthopaedics, Traumatology, Rehabilitation, Rheumatology; Circulatory System; and Neurology) have published at least one Scientific Opinion (SO) under the Clinical Evaluation Consultation Procedure (CECP) in 2021–2022. Methods: The four expert committees with published CECP opinions were reviewed to assess the academic backgrounds and professional expertise of each member with respect to clinical, technical, and biological domains on a 0–2 scale for each domain. A content review was conducted on the 10 CECP opinions published by these committees to assess their consistency with the goals and outcome expectations set by the MDR. The extent of content related to each of the clinical, technical, and biological domains was also assessed on a 0–2 scale. Results: All committees were composed primarily by members with strong clinical expertise, but only a few had strong technical and biological expertise. Across committees, the average scores of members related to academic background and professional expertise both ranged from 1.64 to 2.00 in the clinical domain, but only 0–0.15 and 0.15–0.69, respectively, in the biological domain, and 0.12–0.55 and 0.23–0.73, respectively, in the technical domain. A content review for the 10 SOs showed that all opinions focused exclusively or primarily on the clinical evidence. Three contained a modest amount of additional text directed at technical/engineering issues and five at biological issues. Conclusion: Expert committees are composed predominantly of expert clinical reviewers but have many fewer members with significant technical or biological expertise. This may limit the ability of the committees to evaluate the significant technical and biological risks that are often best understood by preclinical testing. Broadening the expertise across the committees may improve the depth of their benefit/risk critiques. [ABSTRACT FROM AUTHOR]

Copyright of Chinese Medical Equipment Journal is the property of Chinese Medical Equipment Journal Editorial Office and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: This study aims to facilitate the identification of similar devices for both, the European Medical Device Regulation (MDR) and the US 510(k) equivalence pathway by leveraging existing data. Both are related to the regulatory pathway of read across for chemicals, where toxicological data from a known substance is transferred to one under investigation, as they aim to streamline the accreditation process for new devices and chemicals. Research design and methods: This study employs latent semantic analysis to generate similarity values, harnessing the US Food and Drug Administration 510k-database, utilizing their 'Device Descriptions' and 'Intended Use' statements. Results: For the representative inhaler cluster, similarity values up to 0.999 were generated for devices within a 510(k)-predicate tree, whereas values up to 0.124 were gathered for devices outside this group. Conclusion: Traditionally, MDR equivalence involves manual review of many devices, which is laborious. However, our results suggest that the automated calculation of similarity coefficients streamlines this process, thus reducing regulatory effort, which can be beneficial for patients needing medical devices. Although this study is focused on the European perspective, it can find application within 510(k) equivalence regulation. The conceptual approach is reminiscent of chemical fingerprint similarity analysis employed in read-across. Plain Language Summary: This study addresses improvement of the registration process for medical devices by using automated methods to determine how similar they are to existing devices. Such a process is already used in chemistry for analysis of related substances. In the context of Medical Device Regulation (MDR), which sets standards for these devices, this process might be applicable in device equivalence evaluation. Traditionally, proving equivalence involves manually finding devices that are similar, but this is time-consuming, repetitive and labor-intensive. This study proposes a new approach, using advanced computer methods and a database from the US Food and Drug Administration (FDA) to automatically identify similar devices. This could make the process much quicker and more accurate and furthermore reduce bias. The study suggests that by applying these automated methods, the impact of recent regulatory changes could be reduced. This means that proving equivalence, a critical step to facilitate device accreditation, could be done more efficiently. The study shows potential for a significant transformation in compliance processes within the medical device industry, making them more streamlined and automated. [ABSTRACT FROM AUTHOR]

Background: Patients with ileostomies may develop intestinal failure and high stoma output. Chyme reinfusion (CR) was considered an alternative to parenteral nutrition. The Insides System, a closed system for CR, was introduced to allow complete patient control and management. In this paper the authors used the system for 3 years and aimed to describe its use in clinical practice. Methods: A cohort of patients considered for the system was included in the study. They were followed from screening until discontinuation of the system. Data on health-related quality of life were collected, and journal audits were performed. Results: A total of 14 patients were included in the results. Two did not receive the system, four answered the questionnaires one time or less and four had the system discontinued before discharge. Answers from the remaining four patients were inconclusive. The audit revealed that evaluating patient compliance and motivation was key before introducing the system. With the system in place, pain and discomfort levels were found to be important for the patients. Conclusion: The Insides System was feasible in a clinical practice setting. However, comprehensive screening was necessary, with specialised nurses playing a key role. [ABSTRACT FROM AUTHOR]

This abstract supplement includes findings presented through oral or poster presentations at the 50th annual Scientific Day event held on May 22, 2024. Scientific Day provides both an in-person and virtual forum for sharing of research, quality improvement, and case studies conducted by faculty, fellows, residents, and other health professionals associated with Illinois-based Advocate Health Care and Wisconsin-based Aurora Health Care.

A cross-sectional, web-based survey was conducted to assess the health-care professionals (HCPs)’ perception toward existing medical device postmarket surveillance (PMS) practices in India. A total of 1756 responses (medical practitioners [19.8%], nurses [22.5%], pharmacists [21.4%], and biomedical engineers [13.8%]) were recorded and analyzed. About 71.2% of participants were aware about the ongoing PMS program, 87.5% were aware that medical devices are under regulation in India, and 83.3% were aware about who can report medical device adverse event (MDAE). About 56.3% of participants agreed that they take regular feedback from patients after using high-risk medical device. Majority of participants (69.4%) were aware about tools for reporting MDAE and the online reporting form is the most preferable tool among users. About 76.2% of participants were agreeing that reporting of MDAE is their professional/ethical responsibility. This study reveals that Indian HCPs show a good understanding of PMS practices and a positive perception toward MDAE reporting. However, underreporting still remains a challenge in India.

The medical industry is strategically important for the national economy and healthcare. The COVID-19 pandemic has shown the importance of local MedTech capacity and production facilities to meet the needs of the healthcare market. The purpose of the study is to conduct the analysis of the Russian market of artificial lung ventilation devices (ventilators). Materials and methods. The analysis of customs statistics data was carried out by the Ministry of Foreign Economic Activity of the Russian Federation (RF), the Federal Customs Service of Russia (FCS Russia), Federal Tax Service of Russia (FTS Russia), Federal State Statistics Service (Rosstat), the Ministry of Economic Development of the Russian Federation, the Ministry of Health of the Russian Federation, Federal Service for Supervision in the Sphere of Health Care (Roszdravnadzor) as well as the Commodity Nomenclature of Foreign Economic Activity (FEACN RF). During the study, statistical methods were used, as well as analysis and synthesis. The author determined the number of ventilator models present on the Russian market, the dynamics of their import and export volumes (during and after the COVID-19 pandemic) in the country context. Results. Up to 200 ventilator models from 87 vendors are represented on the RF market. The volume of imports of ventilators in 2022 amounted to $ 32.0 million (2.2 billion rubles). After a jump in imports during the COVID-19 pandemic in 2021, the volume of deliveries fell to 43 million (-23% by 2019), and in 2022 the decline was 25% (-44% by 2019). In 2020, the imports volume of value of ventilators increased 6.5 times. In 2021, the volume of imports and exports immediately fell below the indicators of the pre-crisis period. Deliveries from Germany decreased by 52%, the USA — by 86%, Korea — by 98%, France — by 29%, Slovakia — by 36%, and from Sweden stopped altogether. China has increased the volume of imports, adding 81% by 2021, and Switzerland to 41%. The volume of exports amounted to $ 383 thousand (410 million rubles), including exports to the EAEU countries amounted to $ 88 thousand, exports to non-CIS countries decreased by 95% (from $ 6.7 million to $ 0.3 million in 2021-2022). Conclusion. The results of this study can be applied by Russian ventilator manufacturers to assess the growth potential, as well as by government authorities to set priorities for strategic development by segments of the medical devices market.

Abstract Background Our case report provides the first clinical evaluation of autopsy practices for a patient death that occurs on the cloud. We question how autopsy practices may require adaptation for a death that presents via the ‘Internet of Things’, examining how existing guidelines capture data related to death which is no longer confined to the patient's body. Case presentation The patient was a British man in his 50s, who came to the attention of the medical team via an alert on the cloud-based platform that monitored his implanted cardioverter defibrillator (ICD). The patient had a background of congenital heart disease, with previous ventricular fibrillation cardiac arrest, for which the ICD had been implanted two years earlier. Retrospective analysis of the cloud data demonstrated a gradually decreasing nocturnal heart rate over the previous three months, falling to a final transmission of 24 beats per minute (bpm). In the patient post-mortem the ICD was treated as medical waste, structural tissue changes precluded the effective evaluation of device hardware, potential issues related to device software were not investigated and the cause of death was assigned to underlying heart failure. The documentation from the attending law enforcement officials did not consider possible digital causes of harm and relevant technology was not collected from the scene of death. Conclusion Through this patient case we explore novel challenges associated with digital deaths including; (1) device hardware issues (difficult extraction processes, impact of pathological tissue changes), (2) software and data limitations (impact of negative body temperatures and mortuary radio-imaging on devices, lack of retrospective cloud data analysis), (3) guideline limitations (missing digital components in autopsy instruction and death certification), and (4) changes to clinical management (emotional impact of communicating deaths occurring over the internet to members of family). We consider the implications of our findings for public health services, the security and intelligence community, and patients and their families. In sharing this report we seek to raise awareness of digital medical cases, to draw attention to how the nature of dying is changing through technology, and to motivate the development of digitally appropriate clinical practice.

Artificial intelligence (AI) technology is actively being applied for the interpretation of medical imaging, such as chest X-rays. AI-based software medical devices, which automatically detect various types of abnormal findings in chest X-ray images to assist physicians in their interpretation, are actively being commercialized and clinically implemented in Korea. Several important issues need to be considered for AI-based detection assistant tools to be applied in clinical practice: the evaluation of performance and efficacy prior to implementation; the determination of the target application, range, and method of delivering results; and monitoring after implementation and legal liability issues. Appropriate decision making regarding these devices based on the situation in each institution is necessary. Radiologists must be engaged as medical assessment experts using the software for these devices as well as in medical image interpretation to ensure the safe and efficient implementation and operation of AIbased detection assistant tools.

The osteotome was a hand-cranked medical chainsaw designed in 1830 by the German surgeon Bernhard Heine. Before Heine, surgeons used crude, manual tools, such as hammers, chisels, and handsaws. The osteotome was among the first mechanical tools used in orthopedic surgery, and it preceded the later use of the motorized chainsaw for woodcutting. Due to the small number of units manufactured, questions remain about the osteotome’s usage. To facilitate conservation and assist with investigation, Heine’s osteotome was digitally reconstructed. As with other digital reconstruction attempts in cultural heritage, assumptions were made to facilitate reproduction. To highlight the functional similarities and contrasts between early and contemporary tools, its parts were compared with contemporary chainsaws and surgical tools. Contemporary orthopedic surgeons have largely shifted away from medical chainsaws, such as the osteotome, in favor of reciprocating saws. Due to its small size and medical purpose, the osteotome was designed for greater precision than a modern industrial chainsaw. Based on the reproduction and comparative analysis, the device was likely used in a manner more similar to modern medical reciprocating saws than to its direct descendant, the industrial chainsaw. The Heine osteotome mechanized surgery and its descendants are still used in medicine and the industry. The osteotome model enabled an analysis of its function and use.

The digital positron emission tomography (PET) innovation technology system, which gradually evolved from the Multi-Voltage Threshold (MVT) sampling method, has driven the development of many fields, including key materials, core devices, electronics, intelligent algorithms, and industry standards, forming a new PET industry ecology characterized by modular hardware and intelligent software. In 2010, the world's first All-Digital PET scientific instrument, based on the MVT method, was successfully developed and showed an obvious spatial resolution advantage. With the modular characteristics of the All-Digital PET’s detector, it has successively developed digital PET scientific instruments with different apertures, different fields of view (FOV), and different geometric structures for small animals, large animals, primates, and plants, and has been put into various scientific research applications. In 2015, the world's first All-Digital PET medical device prototype for human scanning was successfully developed. In the following 7 years, several clinical All-Digital PET products have been developed and put into the market. These All-Digital PET products break the fixed architecture of conventional whole body scanning in the past and use modular digital detectors to build various medical devices, such as site-dedicated PET systems, PET-insert system, wearable PET, and proton PET. It has helped promote the rapid expansion of PET applications from tumor diagnosis to new application fields such as nervous system diseases, unexplained fever, and proton precision treatment. The vigorous development of All-Digital PET ecology has also brought innovation to the industrial division of labor. The new scintillation crystal materials, the new silicon photomultiplier (SiPM), and the modular PET detector are developing independently and rapidly, forming their own standardized component or interface. The synchronous progress of upstream and downstream technologies has promoted the development of the entire PET industry chain and innovation chain. With the rapid development of All-Digital PET, the proposal of a variety of PET digital technology routes has also put forward new challenges to industry technical standards and regulatory systems, such as technical requirements for the digitization of PET medical devices and the registration guidelines that have been updated and developed simultaneously. This paper reviewed the dynamic progress of All-Digital PET in scientific instruments, medical devices, the industrial chain, and regulatory science in the past 20 years and looked forward to the future ecological development of All-Digital PET.

Abstract Background A pressure injury refers to localized damage to the skin and/or tissue due to prolonged pressure, and it has recently been defined to include pressure injuries related to medical devices. Medical device-related pressure injuries occur in various sites and are difficult to detect. Even if it is detected, medical devices are essential to life for critically ill patients. Thus, it is difficult to remove or change the position of the medical device; therefore, prevention is essential. This study aims to integrate the literature on medical device-related pressure injury prevention protocols among critically ill patients. Methods The literature inclusion criteria were (1) critically ill patients, (2) device-related pressure injury interventions, (3) randomized controlled trials and quasi-experimental designs, and (4) written in Korean or English. The literature search and selection were performed following the Cochrane Handbook for Systematic Reviews of Interventions with the support of the PRISMA Guidelines. Results Twelve articles were finally selected. The incidence of medical device-related pressure injury decreased from 8.1–96.7% before intervention to 0.3–53.3% after intervention, respectively. Medical device-related pressure injury prevention was effective in reducing medical device-related pressure injury incidence when applied to patients of all ages, from neonates to adults, in a variety of intensive care units. Medical device-related pressure injury prevention strategies include nurse education, assessment, documentation, and interventions (hygiene, repositioning, emergent therapy such as protective dressing or designed equipment reducing pressure) of pressure injury. Pressure injury dressings primarily included hydrocolloid foam dressings, but transparent hydrocolloid formulations also effectively reduced medical device-related pressure injury incidence rates. Conclusions In the future, it is necessary to increase the level of evidence by applying specialized medical device-related pressure injury prevention methods for different medical devices and areas of pressure injuries, and verifying their effectiveness. Trial registration The review protocol was registered (PROSPERO registration number: CRD42022346450).

This article focuses on researching and developing a medical support device with functions to monitor various health parameters of patients directly or remotely, such as body temperature, heart rate, and blood oxygen saturation. The implementation method includes designing algorithm diagrams, hardware circuit design, component selection, and building a display application on smartphones or a website interface that allows monitoring the parameters quickly and accurately. Actual testing initially showed that, the device essentially operates quite accurately according to the design and programming with many advantages such as: The system operates stably, meeting design requirements; Results can be monitored visually in a variety of ways and conveniently on LCD screen, App, Web; Each measurement data is saved with data security assurance; The system is evaluated to have minimal errors, low power consumption, and is cost-effective, along with the convenience of result monitoring, making it suitable for various user groups. Furthermore, the research results can serve as a practical model for students in the Biomedical Engineering field at educational institutions where there is currently a shortage of devices catering to learning needs.

This document pays tribute to Dr. Gregory Campbell, a highly respected biostatistician known for his leadership and innovations in the field. It discusses his education, career, and contributions, particularly his work at the FDA and his use of Bayesian statistics in medical device regulatory evaluation. The document also highlights his leadership style, mentorship of junior staff, and the culture of collaboration and diversity he fostered within the FDA. Dr. Campbell's impact on the field of biostatistics and the lives of those he mentored is celebrated throughout the document. [Extracted from the article]

Vascular hemostasis after venous and arterial access in cardiovascular procedures remains a challenge. As sheath size gets larger for structural heart and vascular procedures, no dedicated closure devices exist that can overcome all the challenges of achieving vascular hemostasis, in particular on the venous side. Efficiently and reliably ensuring hemostasis at the access point is crucial for enhancing the safety of a procedure. Historically, hemostasis relied on manually compressing venous access sites. However, the shift towards larger sheaths and the more frequent use of continuous anticoagulation has strained this approach. Achieving hemostasis solely through compression in these scenarios demands heightened vigilance and prolonged application, resulting in increased patient discomfort and extended immobility. Consequently, manual compression may consume more time for healthcare providers and contribute to bed occupancy in hospitals. This review article summarizes the development of the SiteSeal® Vascular Closure Device, a novel leave-nothing-behind approach to achieve hemostasis. The introduction of this technology has provided clinicians with a safer and more effective way to achieve immediate hemostasis, facilitate early ambulation, and enable earlier discharges with fewer access site complications compared with traditional manual compression. [ABSTRACT FROM AUTHOR]

Background: Our case report provides the first clinical evaluation of autopsy practices for a patient death that occurs on the cloud. We question how autopsy practices may require adaptation for a death that presents via the 'Internet of Things', examining how existing guidelines capture data related to death which is no longer confined to the patient's body. Case presentation: The patient was a British man in his 50s, who came to the attention of the medical team via an alert on the cloud-based platform that monitored his implanted cardioverter defibrillator (ICD). The patient had a background of congenital heart disease, with previous ventricular fibrillation cardiac arrest, for which the ICD had been implanted two years earlier. Retrospective analysis of the cloud data demonstrated a gradually decreasing nocturnal heart rate over the previous three months, falling to a final transmission of 24 beats per minute (bpm). In the patient post-mortem the ICD was treated as medical waste, structural tissue changes precluded the effective evaluation of device hardware, potential issues related to device software were not investigated and the cause of death was assigned to underlying heart failure. The documentation from the attending law enforcement officials did not consider possible digital causes of harm and relevant technology was not collected from the scene of death. Conclusion: Through this patient case we explore novel challenges associated with digital deaths including; (1) device hardware issues (difficult extraction processes, impact of pathological tissue changes), (2) software and data limitations (impact of negative body temperatures and mortuary radio-imaging on devices, lack of retrospective cloud data analysis), (3) guideline limitations (missing digital components in autopsy instruction and death certification), and (4) changes to clinical management (emotional impact of communicating deaths occurring over the internet to members of family). We consider the implications of our findings for public health services, the security and intelligence community, and patients and their families. In sharing this report we seek to raise awareness of digital medical cases, to draw attention to how the nature of dying is changing through technology, and to motivate the development of digitally appropriate clinical practice. [ABSTRACT FROM AUTHOR]

Any tool, apparatus, machine, appliance, implant, reagent for in vitro usage, software, material, or other like or related item that the producer intends to be used, either alone or in combination, for medical purposes is considered a medical device. A thorough review was conducted for the purpose of revealing the medical device data and medical device industry in the current paper. Some of the data incorporated in this paper has been taken from Government Websites, Press Releases, Media Reports, Deloitte Report, Union Budget 2022-23 and dully citation was mentioned. [ABSTRACT FROM AUTHOR]

The aim of this integrative review was to explore the effect of care bundles in the prevention of Medical Device Related Pressure Ulcers (MDRPU). An MDRPU is a wound that occurs on the skin or mucosal membranes because of pressure or pressure in combination with shear. Like other types of pressure ulcers, they will have negative consequences for patients and healthcare organisations alike. Many MDRPU's are preventable. A literature search was undertaken from computerised databases using key search terms, Pressure Ulcer* Pressure Injur* and Medical Device*. Databases included CINAHL; Medline and SocIndex. A total of seven studies were found that met the criteria for inclusion in this review. When compared to the widely recognised and trusted international guidelines there was variation found between the individual interventions selected within each study for inclusion within the bundle. Skin assessment and device repositioning were the most frequently included interventions in the bundles, followed by use of prophylactic dressings, appropriate device selection and fitting. The least common intervention was monitoring the tension of the device and/or its securements. All studies reported a reduction in the number of MDRPU's when care bundles were used in clinical practice. However, there is variation in bundle designs and study methodologies employed. This review has demonstrated the potential benefit of care bundles in reducing MDRPU. However, due to heterogeneity in the study methods employed and the interventions within the care bundles, further, more robust research is required to establish which interventions show the most clinical and patient benefit. • Medical Device related pressure ulcers will have a negative impact on patients and healthcare organisations. • Medical Device related pressure ulcers can be prevented. • Multi intervention care bundles can reduce rates of MDRPU's. • Variation exists between the recommended guidelines and prevention strategies used in clinical practice. [ABSTRACT FROM AUTHOR]

A chronic wound is one that fails to progress through a normal timely sequence of repair, or in which the repair process fails to restore anatomic and functional integrity after 3 months. The most common chronic wounds include venous, ischaemic and mixed leg ulcers, diabetic foot ulcers and pressure injuries. Chronic wounds place immense physical and psychosocial burden on patients and exact heavy costs for healthcare systems, with many patients continuing to live with chronic wounds even after all management options have been exhausted. The muscle pump activator (MPA) device can be used to bridge this therapeutic gap. By stimulating the common peroneal nerve to activate venous muscle pump of the leg and foot, the MPA device increases blood flow to the lower leg and foot to improve conditions for healing. Currently, evidence in the literature exist to show that the MPA device improves wound outcomes over standard compression therapy, decreases edema and increases wound healing rates. In this review, we also present a series of chronic wound patients treated with the MPA device in multicentre clinics to demonstrate the ability of the MPA device to improve wound outcomes, reduce pain and edema and improve patient quality of life. [ABSTRACT FROM AUTHOR]

Objective: Combining clinical investigations with usability studies provides valuable information for medical devices evaluation. But both types of study are very different in terms of objectives and methodologies. How are usability studies integrated into clinical investigations in practice? Methods: We searched the ClinicalTrials.gov database for clinical investigation protocols that included usability outcome(s) and analyzed them. Results: 77 study protocols were identified for the analysis, including 102 outcomes related to usability in total. The most frequently assessed outcomes were satisfaction (53/102) and ease of use (33/102). The questionnaire was the most frequently planned technique (85/102) followed by interviews (24/102). Other methods were used, such as observation (9/102), mostly when the end users was a healthcare professional, and diary (6/102), mostly with patients. Conclusion: Our study results showed that the collection of usability data can be included in a clinical investigation, with various levels of investment. Resource-light, rapid integration via a questionnaire will enable the collection of subjective data on the users' perceptions. When more resources are available, observation in accessible environments can be set up (especially during use by healthcare professionals in hospital) or interviews and/or diaries for home-based environments (especially by patients). [ABSTRACT FROM AUTHOR]

The osteotome was a hand-cranked medical chainsaw designed in 1830 by the German surgeon Bernhard Heine. Before Heine, surgeons used crude, manual tools, such as hammers, chisels, and handsaws. The osteotome was among the first mechanical tools used in orthopedic surgery, and it preceded the later use of the motorized chainsaw for woodcutting. Due to the small number of units manufactured, questions remain about the osteotome's usage. To facilitate conservation and assist with investigation, Heine's osteotome was digitally reconstructed. As with other digital reconstruction attempts in cultural heritage, assumptions were made to facilitate reproduction. To highlight the functional similarities and contrasts between early and contemporary tools, its parts were compared with contemporary chainsaws and surgical tools. Contemporary orthopedic surgeons have largely shifted away from medical chainsaws, such as the osteotome, in favor of reciprocating saws. Due to its small size and medical purpose, the osteotome was designed for greater precision than a modern industrial chainsaw. Based on the reproduction and comparative analysis, the device was likely used in a manner more similar to modern medical reciprocating saws than to its direct descendant, the industrial chainsaw. The Heine osteotome mechanized surgery and its descendants are still used in medicine and the industry. The osteotome model enabled an analysis of its function and use. [ABSTRACT FROM AUTHOR]

Background/Aims: Motility disorders are prevalent, often leading to disrupted regional or whole gut transit times. In this study, we conducted a comparative analysis between the wireless motility capsule and an innovative gas-sensing capsule to evaluate regional and whole gut transit times in individuals with diagnosed motility disorders. Methods: We prospectively enrolled 48 patients (34 women) diagnosed with functional dyspepsia and/or functional constipation according to Rome IV criteria. Patients ingested the capsules in tandem. We assessed the agreement between transit times recorded by both devices using Spearman correlation and Bland-Altman analysis. Additionally, diagnostic concordance between the capsules were evaluated using confusion matrices. Results: We observed a significant correlation between the wireless motility capsule and the gas-sensing capsule for gastric emptying time (r = 0.79, P < 0.001) and colonic transit time (r = 0.66, P < 0.001). The gas-sensing capsule exhibited a sensitivity of 0.83, specificity of 0.96, and accuracy of 0.94 when using the standard cutoff for delayed gastric emptying (5 hours). Similarly, when applying the cutoff value for delayed colonic transit (> 59 hours), the gas-sensing capsule demonstrated a sensitivity of 0.79, specificity of 0.84, and accuracy of 0.82. Importantly, the gas-sensing capsule was well-tolerated, and no serious adverse events were reported during the study. Conclusions: Our findings underscore the gas-sensing capsule's suitability as a dependable tool for assessing regional and whole gut transit times. It represents a promising alternative to the wireless motility capsule for evaluating patients with suspected motility disorders. [ABSTRACT FROM AUTHOR]

Poly(lactic acid) (PLA) is widely used in the field of medicine due to its biocompatibility, versatility, and cost-effectiveness. Three-dimensional (3D) printing or the systematic deposition of PLA in layers has enabled the fabrication of customized scaffolds for various biomedical and clinical applications. In tissue engineering and regenerative medicine, 3D-printed PLA has been mostly used to generate bone tissue scaffolds, typically in combination with different polymers and ceramics. PLA's versatility has also allowed the development of drug-eluting constructs for the controlled release of various agents, such as antibiotics, antivirals, anti-hypertensives, chemotherapeutics, hormones, and vitamins. Additionally, 3D-printed PLA has recently been used to develop diagnostic electrodes, prostheses, orthoses, surgical instruments, and radiotherapy devices. PLA has provided a cost-effective, accessible, and safer means of improving patient care through surgical and dosimetry guides, as well as enhancing medical education through training models and simulators. Overall, the widespread use of 3D-printed PLA in biomedical and clinical settings is expected to persistently stimulate biomedical innovation and revolutionize patient care and healthcare delivery. [ABSTRACT FROM AUTHOR]

Artificial intelligence (AI) technology is actively being applied for the interpretation of medical imaging, such as chest X-rays. AI-based software medical devices, which automatically detect various types of abnormal findings in chest X-ray images to assist physicians in their interpretation, are actively being commercialized and clinically implemented in Korea. Several important issues need to be considered for AI-based detection assistant tools to be applied in clinical practice: the evaluation of performance and efficacy prior to implementation; the determination of the target application, range, and method of delivering results; and monitoring after implementation and legal liability issues. Appropriate decision making regarding these devices based on the situation in each institution is necessary. Radiologists must be engaged as medical assessment experts using the software for these devices as well as in medical image interpretation to ensure the safe and efficient implementation and operation of AIbased detection assistant tools. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Health Academics / Sağlık Akademisyenleri Dergisi is the property of Journal of Health Academics and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)