Medical Devices-Evidence and Research最新文献

Purpose: The study aimed to assess the safety, tolerability, and acceptability of the IntegriMedical® Needle Free Injection System (IM-NFIS) compared to conventional hypodermic needle injections (CHN) in healthy adult subjects across multiple injection sites.

Patients and methods: Thirty healthy male subjects aged 18-45 years were enrolled in this open-label study. Each subject received both NF and CHN injections at five different sites (forearm, abdomen, thigh, buttocks, and arm). In the study, participants in the forearm cohort received 0.1 mL of saline, whereas, for all other injection sites, 0.5 mL of saline was administered. Both needle-free and hypodermic needle injections were used at the designated sites, with a 5- to 10-minute interval between each injection. Since no active drug was used, saline served as a placebo in both methods. Safety assessments included local and systemic reactions, pain scores using the Visual Analog Scale (VAS), and acceptability questionnaires. The study adhered to ethical guidelines and was approved by the Institutional Ethics Committee.

Results: NF injections demonstrated significantly lower pain scores compared to CHN injections (mean VAS score 0.23 vs 1.07, p < 0.01). Local site reactions were minimal and similar between NF and CHN injections, with no significant differences observed at 20-30 minutes post-injection. Systemic reactions were absent in both groups throughout the study period. The NF injection system was highly acceptable, with a majority of subjects reporting reduced anxiety and pain compared to CHN injections (p < 0.01).

Conclusion: IM-NFIS proved to be safe, well tolerated, and highly acceptable for delivering pharmaceuticals compared to conventional needle and syringe injections. This needle-free technology offers potential advantages in improving patient compliance and reducing injection-related anxieties, suggesting its promising role in future medical practices, including pediatric vaccinations and frequent medication administration.

Background: The number of cardiac implantable electronic devices (CIEDs) implanted has been growing and the population who receive the device is older and has more comorbidities. Long bed rest and immobilisation have always been common after the implant, but a consensus does not exist on the argument.

Purpose: To map and synthesise available literature on the mobilisation approach after the implant of a CIED and which correlated outcomes exist.

Methods: A literature search was conducted in December 2023 on six databases. Screening of articles, data extraction and quality appraisal were performed by more than one author. Articles included were primary articles exploring bed rest or mobilisation after a CIED procedure. Descriptive analysis was conducted to present and synthesise the results.

Results: Of the 113 records identified, eight matched the inclusion criteria. The majority of the articles were randomised controlled trials (n = 6). Other studies were quasi-experimental (n = 1), retrospective (n = 1) and cross-sectional (n = 1). Data descriptive analysis led to the development of three main topics: (1) mobilisation modalities, (2) potential complications and (3) type of device.

Conclusions: Early mobilisation after a CIED procedure appears to be safe and not associated with other complications. A predominant barrier to early mobilisation is the lack of a consensus on the time and type of mobilisation. Early mobilisation could be applied more safely with the use of an arm support. To strengthen the evidence there is a need for more rigorous research analysing the type of device and the leads utilised.

Early detection of neurological deterioration in serious acute brain injury is seen as an important goal to reduce death and disability, but monitoring for neurological deterioration remains challenging. Routine methods, such as neurological examination and brain imaging, often identify brain injuries only after they have progressed to an irreversible stage. Alternate approaches such as invasive brain monitoring, are complex, costly and carry inherent risks. The optical brain pulse monitor (OBPM) is a novel, non-invasive, safe, and continuous monitoring device designed to provide earlier detection of neurological deterioration and address the limitations of traditional approaches. This review presents the development, technical aspects, and clinical results from past and ongoing trials over the last five years.

Background: Patients who have experienced a cryptogenic stroke (CS) may benefit from extended monitoring and possible earlier detection of atrial fibrillation (AF), allowing for the timely initiation of appropriate pharmacotherapy.

Objective: This economic study aimed to evaluate the clinical and cost outcomes of using mid-term cardiac monitors (referred to as "ePatch") versus ILR-only in post-CS patients in the UK, Netherlands (NL) and Sweden.

Methods: An existing cost-minimization model was modified to fit healthcare settings in the UK, Netherlands and Sweden. The model's target population was composed of adult patients who had previously experienced a CS, but had no documented history of AF. The model compares the one-year direct medical costs between two groups: one group receiving wearable ePatch, the other group proceeding directly to ILR.

Results: When applied to a group of 1,000 patients, the ePatch versus ILR approach resulted in cost savings, due to combination of reduced expenses and decreased modelled occurrence of recurrent strokes in all three countries studied. In the base case analysis, the cost savings per patient with detected AF for ePatch ranged from 3.4-6.0 times, depending on the country.

Conclusion: Utilizing ePatch extended wear Holter for mid-term ECG monitoring in CS patients represents a cost-saving alternative to monitoring with ILR. The cost savings were achieved by reducing device expenses and by prevention of recurrent strokes via earlier anticoagulation initiation. Preventing recurrent strokes in this population is highly significant, as it can lead to improved long-term health outcomes and reduced overall healthcare costs.

The NOL-Nociception Level Index^® is a multiparameter index, based on artificial intelligence for the monitoring of nociception (physiological pain response) during anesthesia that has recently been authorized by the FDA. The monitor utilizes continuous streams of information from a finger probe comprising four sensors, including photoplethysmography, to provide a personalized nociception score on a scale of 0-100. Recent studies have suggested racial bias in pulse oximeter measurements due to the effect of melanin levels on photoplethysmography measurements. Therefore, there is a need to clinically validate new monitoring technologies in patients of all skin tones. The performance of the NOL scale in 8 patients that self-identified as Black or multiracial was compared to a database of 447 consented patients, assessing the response to surgical events at different levels of intensity. The descriptive, pilot data suggest that NOL performance in Black and multiracial patients is not different from the performance shown for the large database. Larger studies utilizing recognized skin tone scales to ensure accurate assessment of skin pigmentation are planned for the future.

Purpose: Press-through packages (PTPs) are frequently used for the packaging of prescription drugs in Japan. However, tablets or capsules packaged in PTPs may become unstable and difficult to store. Therefore, aluminum pouches (pillow packages) are applied as an additional packaging option. Especially for 10-sheet tablet (capsule) PTPs, there are many opportunities for health-care professionals (mainly pharmacists) to open pillow packages during the dispensing process. However, aluminum pouches (pillow packages) that are easy to open and store appropriately by not only pharmacists, but also patients, are needed.

Methods: A 100-unit PTP (pillow package) with conventional specifications ① and two other products (②: open vertically by a wavy processed half-cut and ③: pinch the backlining open) were developed with the aim of improving the ease of opening. The study participants, consisting of pharmacists and patients, performed tasks such as opening and taking drugs out of the PTP for each sample, and evaluated the differences in usability.

Results: The results of a sensory test revealed that pharmacists rated products ② and ③ higher than product ①. On the other hand, patients, including those with weak grip and pinching strengths, rated ③ highly, confirming the superiority of usability in the order of ③, ②, and ①. In addition, item ③ was successfully opened by all patients.

Conclusion: The present results indicated the superiority of the developed pillow packaging, which enables pharmacists to save time in the dispensing process. In addition, product ③ was evaluated highly by patients, especially those with disabilities, for its ease of use not only in terms of opening, but also storage. Sensory testing by actual users applying ergonomic methods enabled a multifaceted evaluation of the products and provided insights into the actual status of pharmacists' dispensing work (product issues) and patients' daily medication use.

Purpose: To explore the effect of fine management combined with man-machine fixation mode in reducing the attrition rate of laparoscopic instruments.

Methods: This is a non-randomized, concurrent controlled study, from December 1, 2023, to May 1, 2024, the use of 4 laparoscopic instruments in the operating room which belongs to shanghai first maternity and infant hospital was analyzed. The instruments were divided into two groups, and the control group was managed by conventional methods. The observation group implemented with fine management combined with man-machine fixed mode. We used instrument attrition rate and physician satisfaction as outcome indicators.

Results: In this study, four laparoscopic instruments were investigated, and a total of 858 cases were used, including 429 cases in the control group (machine 1, machine 2) and 429 cases in the observation group (machine 3, machine 4). After the implementation of refined management combined with man-machine fixed mode, the observation group had significantly lower attrition rate and failure rate of laparoscopic instruments than the control group, including insufficient instrument preparation (p = 0.000), unstable light source (p = 0.012), air leakage (p = 0.000), screen color distortion (p = 0.040), and blurred visual field (p = 0.000). The satisfaction of doctors in the observation group was significantly higher than that in the control group, including preoperative preparation, process cooperation, operation proficiency, trouble solving ability, instrument debugging ability, communication and service attitude (p < 0.01).

Conclusion: The use of fine management combined with man-machine fixed mode in the management of laparoscopic instruments in the operating room can effectively reduce the incidence of instrument attrition rate, improve the efficiency of surgery, and the economic benefit of the hospital, which is worthy of popularization and application.

Purpose: Adherence to growth hormone treatment is known to affect growth outcomes. Both device preference and ease of use have been shown to affect treatment adherence. In this study, we assessed device preference and ease of use with two long-acting growth hormones, somapacitan (Sogroya^®, Novo Nordisk A/S) and somatrogon (Ngenla^®, Pfizer).

Patients and methods: In a randomized, crossover study conducted between September 20 and November 2, 2023, we recruited 33 adolescents with a growth-related disorder, and 37 caregivers, at six locations in the United States. Each participant was trained in the use of both devices and asked to perform a simulated injection. Device training time, preparation and injection time, and injection completeness were recorded. Participants also completed the Device Handling and Preference Questionnaire (DHPAQ) to indicate their device preference and ease of use opinions. Following conclusion of the "standard" visit, 10 adolescents and 10 caregivers were randomly selected to participate in a sub-study to validate the relevance, comprehensiveness, and comprehension of the DHPAQ.

Results: The majority of participants (84.3%; 95% confidence interval [CI]: 74;92) preferred the somapacitan device to the somatrogon device (p < 0.0001). Almost all (98.6%; 95% CI: 92;100) participants answered that the somapacitan device was easy or very easy to use, while three-quarters (74.3%; 95% CI: 62;84) answered the same for the somatrogon device. Average training and injection times were lower for the somapacitan device than for the somatrogon device. Also, more patients successfully completed the injection with the somapacitan device than with the somatrogon device (97.1% vs 92.9%). Cognitive debriefing interviews indicated the DHPAQ was relevant, comprehensive, and fully comprehended.

Conclusion: The somapacitan device was preferred to the somatrogon device by a majority of participants. More participants considered the somapacitan device to be easy or very easy to use than the somatrogon device.

Background: The cerebral fluid-dynamic system plays a critical role in maintaining brain health and function. Recent studies identify the glymphatic system as primarily responsible for removing waste products and toxins from brain tissue. In recent years, we have achieved beneficial improvements in MS patients' symptoms and lifestyle using a specific Fluid Dynamic Intensive MAM (FD-MAM) protocol.

Methods: We treated 40 outpatients with progressive MS, aged 45-55 years and with EDSS scores from 6 to 9. We applied FD-MAM in 10 daily sessions over two weeks. Before and after glymphatic drainage by FD-MAM, we assessed each patient's clinical status and quality of life using six validated questionnaires.

Results: Data from the six validated questionnaires administered to the 40 MS patients show an improvement in 83% of the scores. At the same time, we observed a shift from pathological to physiological values in 50% of the pathological scores after 10 sessions of FD-MAM protocol.

Conclusion: This study confirms the positive improvements on life quality in outpatients with progressive multiple sclerosis after one cycle of Fluid Dynamic Intensive MAM (FD-MAM) protocol. Initial follow-up on few patients treated with the FD-MAM protocol suggests that the results persist for six to ten months post-treatment. Future detailed studies, on MS outpatients' larger cohort, are essential to assess the duration of results and its effect on glymphatic system.

Introduction: The aim of the article is to determine the appropriate concentration of desflurane to effectively counteract the increase in blood pressure resulting from surgical stress. In medical practice, this increase is often limited by using additional doses of opioid drugs. Additional medications or higher doses of those already used may adversely affect your health. During anesthesia, physician must note the use of drugs and remember them, especially those that he has recently administered, which affect his concentration. For this purpose, the authors decided to propose support for the selection of desflurane concentration so that frequent use of opioid drugs is not necessary. The authors used a system based on AI issues to accomplish this task. The learned system supports the anesthesiologist's work by imitating him.

Patients and methods: The proposed method for selecting the desflurane concentration is based on a fuzzy controller. This system includes a learning mechanism that allows for minimizing the operating error. The main advantage of this system is the ability to build a function allowing the selection of anesthesia parameters without knowledge of the mathematical description of the process. To accomplish this task, you need an expert who will provide information in the construction of logical if-then sentences (points in space). The fuzzy controller connects the points in the consideration space appropriately, generating a hypersurface. The algorithm test was performed only by computer without the participation of patients.

Results: The operation of the proposed algorithm was verified by computer simulation. The authors of the article analyzed the compliance of the obtained results with the table provided by the expert. The desflurane concentration values obtained by computer simulation are similar to those given in the table Minimal driver error does not affect the patient's clinical response. This error results from the functions used in the fuzzy system and its settings. The results of the performance test of the proposed algorithm are presented in a time course, and it has the shape of a step function. The work proposes a function that allows you to enter the time needed for the body's reaction to reach the desired E_tdes level.

Conclusion: In this study, a controller was created to support the selection of the concentration of desflurane allowing for a reduction in blood pressure (resulting from surgical stress). The results obtained by computer simulation provide valuable insights for optimizing anesthesia. This system can also be used as an important simulation program for teaching purposes.