Medical Devices-Evidence and Research最新文献

Background: The requirement for medical device manufacturers to label their devices with a unique device identifier (UDI) was formalized by the 2013 US Food and Drug Administration Unique Device Identification System Rule. However, parallel regulatory requirement for US health systems to use UDIs, particularly the electronic documentation of UDIs during patient care is lacking. Despite the lack of regulation, some health systems have implemented and are using UDIs. To assess the current state, we studied representative health system UDI implementation experiences, including barriers and the strategies to overcome them, and identified next steps to advance UDI adoption.

Methods: Semi-structured interviews were performed with health system personnel involved in UDI implementation in their cardiac catheterization labs or operating rooms. Interviews were transcribed and analyzed using the framework methodology of Ritchie and Spencer. An expert panel evaluated findings and informed barriers, strategies, and next steps.

Results: Twenty-four interviews at ten health systems were performed. Identified barriers were internal (lack of organizational support, information technology gaps, clinical resistance) and external (information technology vendor resistance, limitations in manufacturer support, gaps in reference data, lack of an overall UDI system). Identified strategies included relationship building, education, engagement, and communication. Next steps to advance UDI adoption focus on education, research, support, and policy.

Conclusions and implications: Delineation of UDI implementation barriers and strategies provides guidance and support for health systems to adopt the UDI standard and electronically document UDIs during clinical care. Next steps illuminate critical areas for attention to advance UDI adoption and achieve a comprehensive UDI system in health care to strengthen patient care and safety.

Purpose: Cervical cancer is the 4th most common cancer among women, worldwide. Incidence and mortality rates are consistently increasing, especially in developing countries, due to the shortage of screening facilities, limited skilled professionals, and lack of awareness. Cervical cancer is screened using visual inspection after application of acetic acid (VIA), papanicolaou (Pap) test, human papillomavirus (HPV) test and histopathology test. Inter- and intra-observer variability may occur during the manual diagnosis procedure, resulting in misdiagnosis. The purpose of this study was to develop an integrated and robust system for automatic cervix type and cervical cancer classification using deep learning techniques.

Methods: 4005 colposcopy images and 915 histopathology images were collected from different local health facilities and online public datasets. Different pre-trained models were trained and compared for cervix type classification. Prior to classification, the region of interest (ROI) was extracted from cervix images by training and validating a lightweight MobileNetv2-YOLOv3 model to detect the transformation region. The extracted cervix images were then fed to the EffecientNetb0 model for cervix type classification. For cervical cancer classification, an EffecientNetB0 pre-trained model was trained and validated using histogram matched histopathological images.

Results: Mean average precision (mAP) of 99.88% for the region of interest (ROI) extraction, and test accuracies of 96.84% and 94.5% were achieved for the cervix type and cervical cancer classification, respectively.

Conclusion: The experimental results demonstrate that the proposed system can be used as a decision support tool in the diagnosis of cervical cancer, especially in low resources settings, where the expertise and the means are limited.

Erectile dysfunction (ED) is a common problem, and prevalence rates are expected to rise as life expectancy increases worldwide. In more severe cases of ED, penile prosthesis implantation has been an excellent option for patients. Over the past few decades, significant design improvements have been made to the penile prosthesis and modifications to surgical technique to improve clinical outcomes. The purpose of this review is to summarize the safety and efficacy of FDA-approved penile implants in the US market. Design modifications have greatly improved the safety and reliability of the implant. Development of improved surgical techniques has decreased intraoperative injuries and reservoir-related complications. With its high overall satisfaction rates and low risk of complications, the inflatable penile prosthesis remains an excellent option for patients with erectile dysfunction.

Aim: This study aims to compare novice performance of advanced bimanual laparoscopic skills using an articulating laparoscopic device (FlexDex™) compared to a standard rigid needle holder amongst surgical novices in 2-dimension (2D) visualisation.

Methods: In this prospective randomised trial, novices (n = 40) without laparoscopic experience were recruited and randomised into two groups, which used either traditional rigid needle holders or the FlexDex™. Both groups performed 10 repetitions of a validated assessment task. Times taken and error rates were recorded, and results were evaluated based on completion times, error rates, and learning curves.

Results: The intervention group that used the FlexDex™ completed 10 attempts of the standardised laparoscopic task slower than the control group that used traditional rigid needle holder (415 s versus 267 s taken for the first three attempts and 283 s versus 187 s taken for the last three attempts, respectively). The difference in average time for the first three and last three attempts reached statistical significance (P < 0.001). Furthermore, the intervention group demonstrated a higher error rate when compared to the control group (9.3 versus 6.2 errors per individual).

Conclusion: When compared to the FlexDex™, the traditional rigid needle holder was observed to be superior in task performance speed, leading to shorter completion times and quicker learning effect, as well as fewer errors.

Key statement: Traditional rigid needle holder leads to faster task completion times and lower error rates when compared with an articulating laparoscopic needle holder in 2D vision.

Purpose: The purposes of the present research were to assess the accuracy and usability of the inertial navigation system (INS).

Materials and methods: The accuracy of the device navigation subsystem was assessed using benchtop testing. The usability was assessed through simulated use with surgeons. These results were compared to recent cadaveric results for the same system.

Results: The navigation subsystem had an overall mean absolute error of 1.21° and a maximum absolute error across all devices of 4.79°. The device was found to be usable and to add an estimated 7 minutes to surgery time.

Conclusion: The INS uses a novel approach to provide the surgeon with accurate and fast acetabular cup inclination and anteversion angles during THA.

The pulse wave velocity (PWV) threshold for hypertensive target organ damage is presently set at 10 meters per second. New 24-hour monitors (eg, BPLab® and Vasotens®) provide several PWV measurements over a period of 24-72 hours. A new parameter, ie, the Pulse Time Index of Norm (PTIN), can be calculated from these data. The PTIN is defined as the percentage of a 24-hour period during which the PWV does not exceed 10 meters per second. The aim of the present study was to test the new PTIN for clinical feasibility using day-to-day repeatability analysis. Oscillometrically generated waveform files (n=85), which were previously used for research studies, were reanalyzed using the new 2013 version software of the Vasotens technology program, which enables calculation of PTIN. The intraclass correlation coefficient was 0.98 and Cronbach's alpha was 0.97, indicating that the PTIN has excellent day-to-day repeatability and internal consistency. The present results show adequate repeatability, and PTIN assessment using the Vasotens technology appears to be feasible.

First-generation drug-eluting stents have raised concerns regarding the risk of late and very late stent thrombosis compared with bare metal stents and require prolonged dual antiplatelet therapy. Despite extensive investigations, the physiopathology of these late events remains incompletely understood. Aside from patient- and lesion-related risk factors, stent polymer has been cited as one of the potential causes. In fact, the persistence of durable polymer after complete drug release has been shown to be responsible for local hypersensitivity and inflammatory reactions. Third-generation drug-eluting stents with more biocompatible or biodegradable polymers have subsequently been developed to address this problem. In this article, we evaluate and discuss the concept and clinical results (safety and efficacy) of a third-generation drug-eluting stent with biodegradable polymer: the Nobori® stent.

Background: Even though acupuncture has long been used for alleviating symptoms related to vascular insufficiency, the clinical effect of acupuncture on peripheral circulation has not been fully confirmed. In this study, we investigated whether a near-infrared optical imaging-based method can be used to evaluate the efficacy of the acupuncture procedure to induce changes in peripheral tissue perfusion.

Methods: Two normal, healthy controls were treated with acupuncture on two acupoints (LI-4 and SI-3) three times within 1 week. At the first and third visits, participants were examined using indocyanine green (ICG) perfusion imaging before and 10 minutes after the acupuncture procedure. Blood perfusion of the hands was determined after intravenous bolus injection of ICG and dynamic analysis of the fluorescence signals by near-infrared imaging system.

Results: The blood perfusion rates of the hands were markedly increased immediately after acupuncture at the first trial in both cases. The baseline perfusion rates of the hands measured at the third visit were higher compared to the original basal level in one case; there was no difference in baseline perfusion rates of both hands in another case. In both cases, there was no acute effect of acupuncture on hand perfusion at the third trial.

Conclusions: These results collectively suggest a potential of the ICG perfusion imaging as an effective evaluation tool to validate the vasoactive effect of acupuncture.

This review describes issues for the estimation of pulse wave velocity (PWV) under ambulatory conditions using oscillometric systems. The difference between the principles of measuring the PWV by the standard method and by oscillometry is shown, and information on device validation studies is summarized. It was concluded that currently oscillometry is a method that is very convenient to use in the 24-hour monitoring of the PWV, is relatively accurate, and is reasonably comfortable for the patient. Several indices with the same principles as those in the analysis of blood pressure in ambulatory monitoring of blood pressure, namely the assessment of load, variability, and circadian rhythm, are proposed.

Even if the performance of a given ventilator has been evaluated in the laboratory under very well controlled conditions, inappropriate maintenance and lack of long-term stability and accuracy of the ventilator sensors may lead to ventilation errors in actual clinical practice. The aim of this study was to evaluate the actual performances of ventilators during clinical routines. A resistance (7.69 cmH(2)O/L/s) - elastance (100 mL/cmH(2)O) test lung equipped with pressure, flow, and oxygen concentration sensors was connected to the Y-piece of all the mechanical ventilators available for patients in four intensive care units (ICUs; n = 66). Ventilators were set to volume-controlled ventilation with tidal volume = 600 mL, respiratory rate = 20 breaths/minute, positive end-expiratory pressure (PEEP) = 8 cmH(2)O, and oxygen fraction = 0.5. The signals from the sensors were recorded to compute the ventilation parameters. The average ± standard deviation and range (min-max) of the ventilatory parameters were the following: inspired tidal volume = 607 ± 36 (530-723) mL, expired tidal volume = 608 ± 36 (530-728) mL, peak pressure = 20.8 ± 2.3 (17.2-25.9) cmH(2)O, respiratory rate = 20.09 ± 0.35 (19.5-21.6) breaths/minute, PEEP = 8.43 ± 0.57 (7.26-10.8) cmH(2)O, oxygen fraction = 0.49 ± 0.014 (0.41-0.53). The more error-prone parameters were the ones related to the measure of flow. In several cases, the actual delivered mechanical ventilation was considerably different from the set one, suggesting the need for improving quality control procedures for these machines.