[Analysis of Field Inspection Issues and Some Suggestions for Software as Medical Device].

With the encouragement of policies and the rapid development of the biopharmaceutical industry, the number of software as medical device (SaMD) registration applications in Shanghai has continued to increase in recent years, and this paper summarizes the GMP nonconformities found in the field inspection of SaMD in Shanghai from 2020 to 2023, and the results show that nearly 70% of the problems were found in the software development process. Through in-depth analysis, this paper proposes the corresponding countermeasures for the problems found in the five most common stages such as software requirements, software design, software testing, software defect management and software configuration management, combined with the characteristics of software development. These suggested measures have certain reference significance for medical device software development and quality control personnel, and technical reviewer and inspectors.

[Production Risk Analysis and Key Points for Field Inspection of Medical Electron Linear Accelerator].

The medical electron linear accelerator（LINAC） has the characteristics of complex system structure, many core components and high precision control requirements, which puts forward higher requirements for product quality control and regulation. This study puts forward the main points of field inspection through the analysis of the technical characteristics and production risk of LINAC, combined with the requirements of the good manufacturing practice of medical devices. It has certain reference significance for quality management personnel and field inspectors.

Ion-imprinted chitosan prepared without cross-linking agent for efficient selective adsorption of Al(III) from rare earth solution.

In the aqueous phase, ion-imprinted materials exhibit excellent selective adsorption properties for specific ions, but their complicated preparation process and large amount of crosslinker consumption limit their application. In this study, ion-imprinted chitosan (IIP-CS) was prepared by a simple one-step hydrothermal method without a cross-linking agent for the efficient adsorption of trace amounts of Al(III) from a rare earth solution. The structures and morphology of IIP-CS were analyzed by FT-IR, SEM, and XRD. The Al(III) adsorption characteristics of IIP-CS were investigated under various preparation processes and adsorption conditions. It was found that the optimum mass ratio of IIP-CS is 3 : 1 and pH is 3 and the adsorption capacity reaches up to 40.36 mg g-1. In addition, three different isothermal models-Temkin, Freundlich, and Langmuir-were used to analyze the equilibrium adsorption of IIP-CS in aqueous solution. The results obtained are consistent with the Langmuir model. The adsorption process of Al(III) on IIP-CS follows a pseudo-secondary kinetic model, suggesting that electron sharing or exchange between IIP-CS and Al(III) is a key factor affecting its adsorption rate. IIP-CS shows high selectivity coefficients for Al(III) in mixtures of La(III), Y(III), and Gd(III), which are 792.50, 163.26, and 55.16, respectively. The mechanism of action is the formation of a complex via amidation between Al(III) and IIP-CS. IIP-CS is an adsorbent with excellent regeneration and selective adsorption performance in aqueous solution.

RUNX1/miR-429 feedback loop promotes growth, metastasis, and epithelial-mesenchymal transition in oral squamous cell carcinoma by targeting ITGB1.

This study aimed to explore the role of miR-429 on the progression of oral squamous cell carcinoma (OSCC). OSCC cell lines were transfected with miR-429 mimic, pcDNA3.1-RUNX1, or pcDNA3.1-ITGB1, and their cell viability, apoptosis, migration, and invasion abilities were analyzed by cell counting, terminal deoxynucleotidyl transferase dUTP nick-end labeling staining, wound healing, and transwell assays, respectively. Furthermore, luciferase reporter assay, RNA pull-down, and ChIP were used to assess the regulation of miR-429, RUNX1, and ITGB1 expression in OSCC. Lastly, the biological role of the RUNX1/miR-429 feedback loop was explored in nude mice. The results revealed that miR-429 level was down-regulated, while RUNX1 and ITGB1 levels were up-regulated in OSCC tissues and that miR-429 was negatively correlated with RUNX1 and ITGB1 in OSCC tissues. Transfection of miR-429 mimic suppressed OSCC cell proliferation, migration, invasion, and epithelial-mesenchymal transition (EMT). Moreover, we found that miR-429 participated in OSCC progression by directly targeting ITGB1. Additionally, we found that RUNX1 negatively regulated miR-429 expression by binding to its promoter. Our results also revealed that the RUNX1/miR-429 feedback loop regulated ITGB1 expression and that RUNX1 overexpression rescued the inhibitory effects of miR-429 mimic on OSCC cells. In addition, miR-429 mimic significantly suppressed tumor growth, inflammatory cell infiltration, EMT, and ITGB1 expression in vivo, which were inhibited by RUNX1 overexpression. Altogether, these results indicate that the RUNX1/miR-429 feedback loop promoted growth, metastasis, and EMT in OSCC by targeting ITGB1.

Sanhuang decoction inhibits autophagy of periodontal ligament fibroblasts during orthodontic tooth movement by activating PI3K-Akt-mTOR pathway.

BACKGROUND: Orthodontic tooth movement (OTM) is a typical treatment that corrects malaligned teeth by applying mechanical forces. However, mechanical overload often leads to damage of PDL fibroblasts. Sanhuang decoction (SHD) is commonly used to inhibit inflammation and oxidative stress. However, the mechanism of SHD for OTM treatment is still unclear. Therefore, this study attempts to explore the underlying mechanism through relevant experiments. METHODS: In the present paper, we established a OTM rat model and further explored the effects of SHD on the PDL of OTM rats. The OTM model and effects of SHD were determined by micro-CT, and the PDL pathological changes, PDL width and capillaries in PDL were observed by H&E staining. Subsequently, the ROS levels in PDL was determined using flow cytometry analysis with DCFH-DA staining, MDA contents and antioxidative enzymes activities were also measured using commercial kits. Furthermore, the autophagy of PDL fibroblasts and proteins in the PI3K/Akt/mTOR pathway were detected using immunoluminescence, qPCR and western blotting assays. RESULTS: The results showed SHD treatment can alleviate the decrease of PDL cells and capillaries induced by OTM, and improve the MDA and ROS levels in PDL, as well as enhance the activities of SOD and GSH-Px. Further experiments indicated SHD decreased the autophagy levels of PDL fibroblasts via promoting the phosphorylation levels of mTOR, PI3K and Akt proteins. CONCLUSION: SHD inhibited autophagy of periodontal ligament fibroblasts during orthodontic tooth movement by inhibiting oxidative stress via activating PI3K-Akt-mTOR pathway. Our present findings suggested SHD treatment would be useful for management of the possible disorders occurs in orthodontic tooth movement therapy.

[Analysis of Risk in Production of MRI and Some Suggestions for Field Inspection].

In recent years, with the wide application of magnetic resonance imaging (MRI) equipment in clinical practice, the quality of the equipment causes adverse events, which put pressure on manufacturers, at the same time, it puts forward higher requirements for medical device supervisors. In order to help the medical device supervisors to clarify the key points of verification, this paper analyzes the main risk points in the production process of the product according to the medical device good manufacturing practice(GMP), and puts forward the suggestions for field verification, which has practical significance for the submission of verification efficiency.

[Analysis of Risk in Production for PET/MR and Suggestions for Field Inspection].

PET/MR is a high-end medical imaging equipment with integrating PET and MR equipment into the highly sophisticated one and has rich clinical and molecular diagnosis functions, can obtain comprehensive information about the human body structure, function and metabolism, is of great value for the diagnosis and treatment of disease improvement. In this paper, through the analysis of existing production risk points on one of the primary stages of the whole product life cycle, combining with the medical device good manufacture practice, some suggestions have been put forward exploratively to field inspection for PET/MR manufacturers. It has certain significance for regulators of medical devices to clear the production risk point and improve verification efficiency during field inspection.

[Analysis of Risk Prevention and Control in Production for Medical X-ray CT System and Some Suggestions for Field Inspection].

In recent years, the R&D and production level for Computed Tomography(short for CT) have been greatly improved and developed in China. In fact, it leads to higher requirements for medical device regulators. In order to clear key points in field inspection for regulators, this article analyzes the risk prevention and control points in the production process of CT based on the 5M1E analysis, and combined with medical device good manufacturing practice (short for GMP), presents exploratively some suggestions on the field inspection of CT manufacturers. This article also has important sense for regulators to clear the pertinence and improve the efficiency during the field inspection.

Sword-like CuO/CeO2 composites derived from a Ce-BTC metal-organic framework with superior CO oxidation performance.

Porous shape-controllable metal oxide composites derived from a metal-organic framework have gained more and more attention due to their extensive applications. In this paper, sword-like CuO/CeO2 composites were successfully synthesized by calcination of a strawsheave-like Ce-based metal-organic framework (Ce-BTC) containing suitable Cu loading as self-sacrificial templates at 500 °C. Moreover, sword-like CuO/CeO2 composites displayed superior catalytic performance for CO oxidation, which was ascribed to a good interfacial contact, easily reducible surface copper species at low temperature and abundant surface lattice oxygen species, more Cu+ and oxygen vacancies.

[Comparison between one-step and two-step space closing methods of sliding mechanics using three-dimensional finite element].

UNLABELLED: To construct a three-dimensional finite element model comparing between one-step and two-step methods in torque control of anterior teeth during space closure. METHODS: Dicom image data including maxilla and upper teeth were obtained though cone-beam CT. A three-dimensional model was set up and the maxilla, upper teeth and periodontium were separated using Mimics software. The models were instantiated using Pro/Engineer software, and Abaqus finite element analysis software was used to simulate the sliding mechanics by loading 1.47 Nforce on traction hooks with different heights (2, 4, 6, 8, 10, 12 and 14 mm, respectively) in order to compare the initial displacement between six maxillary anterior teeth (one-step method) and four maxillary anterior teeth (two-step method). RESULTS: When moving anterior teeth bodily, initial displacements of central incisors in two-step method and in one-step method were 29.26 × 10⁻6 mm and 15.75 × 10⁻6 mm, respectively. The initial displacements of lateral incisors in two-step method and in one-step method were 46.76 × 10(-6) mm and 23.18 × 10(-6) mm, respectively. Under the same amount of light force, the initial displacement of anterior teeth in two-step method was doubled compared with that in one-step method. The root and crown of the canine couldn't obtain the same amount of displacement in one-step method. CONCLUSIONS: Two-step method could produce more initial displacement than one-step method. Therefore, two-step method was easier to achieve torque control of the anterior teeth during space closure.

Simultaneous determination of biotoxins DSP and AZAs in bivalve molluscs and fish by liquid chromatography/tandem mass spectrometry.

RATIONALE: A method has been developed for simultaneous determination of the toxins OA, DTX-1, AZA-1, AZA-2 and AZA-3 in various aquatic products as these can cause diarrhoetic shellfish poisoning (DSP) in humans, an intoxication characterized by vomiting and diarrhea. METHODS: Separation of the toxins was achieved on a C18 column (150 mm × 2.1 mm, 3.5 µm) using an acetonitrile/water gradient with formic acid as an eluent modifier. Electrospray ionisation (ESI) in negative mode was used to generate the molecule related ion [M-H](-), for OA and DTX-1, while ESI in positive mode was used to generate the molecule related ion [M+H](+) for AZAs. Samples were extracted with 80% methanol, followed by partitioning with ethyl acetate, purified on a Poly-Sery MAX cartridge and finally analyzed by LC/ESI-MS/MS in the multiple reaction monitoring (MRM) mode. RESULTS: The limit of detection (LOD) and limit of qualification (LOQ) of the method were in the range of 0.02-0.79 µg/kg and 0.07-2.64 µg/kg in Scomberomorus niphonius, blood clam and oyster, respectively, recoveries of the toxins at three fortification levels ranged from 71.3% to 104.8% with relative standard deviation from 1.0% to 12.5%. The calibration curves were well linear between the LC peak area of the selected ion pair and the concentration of the toxins, with the correlation coefficient over 0.99. CONCLUSIONS: The method was sufficiently sensitive to permit the determination of the toxins DSP and AZA in sea food.

Study on the simultaneous determination of seven benzoylurea pesticides in Oolong tea and their leaching characteristics during infusing process by HPLC-MS/MS.

A method for the simultaneous determination of 7 benzoylurea pesticides (chlorfluazuron, diflubenzuron, fluazuron, flufenoxuron, hexaflumuron, teflubenzuron and triflumuron) in the manufactured Oolong tea leaves and its infusion was described. The method has a LOD of 0.03-1.00ng/mL, a recovery of 90.4-103% for made tea and 90.3-102% for tea-infused liquid, respectively. By using the proposed method, the leaching characteristics of above 7 pesticides during infusing process were investigated. The experimental results revealed that: (1) diflubenzuron can be most easily extracted out during infusing process, followed by triflumuron, teflubenzuron, hexaflumuron, chlorfluazuron, flufenoxuron and fluazuron. (2) The leaching of flufenoxuron and chlorfluazuron during infusing process seems to be controlled by only their solubility, whereas, the leaching of other 5 benzoylurea insecticides was primarily controlled by their partitioning coefficient between made tea and hot water. The results of this study are helpful for the accurate evaluation of the safety of Oolong tea.

Determination of paralytic shellfish poisoning toxins by HILIC-MS/MS coupled with dispersive solid phase extraction.

This paper describes the use of QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) for the extraction, cleanup and detection of 10 paralytic shellfish toxins (PSP) in sea food by HILIC-MS/MS with positive ESI. Matrix matched calibration standards were used to compensate for matrix effects. The toxins were extracted with acetonitrile/water (90:10, v/v) containing 0.1% formic acid and cleaned by HLB and GCB sorbents. Qualitative and quantitative detection for the analytes were carried out under the multiple reaction monitoring (MRM) in positive ionization mode after chromatography separation on a TSK-gel Amide-80® column (150 mm×2.0 mm×3 µm). Studies at three fortification levels for the toxins in the range of 8.1-225.5 µg/kg gave mean recoveries from 71.3% to 104.6% with relative standard deviation (RSD) ≤ 15.8%. The limit of detection (LOD) was below the recommended regulatory limit of 170 µgSTX(equ.)/kg and the proposed method fully meets the needs of daily monitoring.

[Comparison between the tooth length measured by cone-beam CT and the tooth length measured with vernier caliper].

OBJECTIVE: To evaluate the accuracy of cone-bean CT (CBCT) on the measurement of the tooth length. METHODS: One hundred and sixty single root premolars extracted for orthodontic purposes were selected. The tooth length was measured with vernier caliper. The premolars were divided into 10 groups randomly, 16 premolars in each group.In each group, the teeth were lined in molar area, premolar area, canine area and anterior tooth area in maxilla and mandible. Then CBCT was taken, and the tooth length was measured using the software supplied by the manufacturer in coronal and sagittal plane. Accuracy was compared between vernier caliper measurement and CBCT measurement. RESULTS: The tooth length measured by CBCT was smaller than that measured with the vernier caliper. Significant differences were found in six areas, except the maxillary and mandibular premolar areas. With the increase of mesial-distal inclination or buccolingual torque angle, the difference between tooth length measured by CBCT and that measured with vernier caliper increased. The correlation between buccolingual torque angle (∠X1) and the coronal view of CBCT radiology tooth length (Spearmen index was 7.00, P < 0.001), and the correlation between mesial-distal inclination and the coronal view of CBCT radiology tooth length (Spearmen index was 0.624, P < 0.001) were found. CONCLUSIONS: The tooth length measured by CBCT was smaller than that measured with vernier caliper.