[Objective]In order to explore the regulatory requirements for clinical evaluation about peripheral and pulmonary thrombus removal apparatus,the marketing status of these apparatuses in the Food and Drug Administration(FDA)of United States was searched,and the pre-marketing research contents of relevant documents were summarized and organized.Based on the current public information on their official website,the clinical trial designs of FDA's three main categories of peripheral and pulmonary thrombus removal apparatuses(aspiration catheter,thrombectomy stent and mechanical thrombus removal system)in 510(k)pre-marketing notice were sorted out,and the regulatory requirements of FDA clinical evaluation about this kind of apparatus were analyzed,which could provide references for researchers and developers of relevant products,and clinical researchers about the pre-marketing clinical evaluation of peripheral blood thrombolysis apparatus.

[Objective]In order to explore the regulatory requirements for clinical evaluation about peripheral and pulmonary thrombus removal apparatus,the marketing status of these apparatuses in the Food and Drug Administration(FDA)of United States was searched,and the pre-marketing research contents of relevant documents were summarized and organized.Based on the current public information on their official website,the clinical trial designs of FDA's three main categories of peripheral and pulmonary thrombus removal apparatuses(aspiration catheter,thrombectomy stent and mechanical thrombus removal system)in 510(k)pre-marketing notice were sorted out,and the regulatory requirements of FDA clinical evaluation about this kind of apparatus were analyzed,which could provide references for researchers and developers of relevant products,and clinical researchers about the pre-marketing clinical evaluation of peripheral blood thrombolysis apparatus.

A variety of facial injection filler materials have been approved for market at home and abroad.The marketing approvals,clinical application literature,expert consensus or clinical application guidelines of facial injection filler products at home and abroad were collected and it was found that facial injection filler materials may cause a number of adverse reactions.The clinical application and adverse reactions of facial injection filler materials were summarized,the pre-market adverse reaction evaluation requirements of such products in the United States and China were analyzed and summarized,aiming to provide reference for relevant product developers and clinical researchers to evaluate the pre-market adverse reactions of facial injection filler materials.

Objective To investigate noise management-associated behavioural intentions of ICU nurses and identify the factors that influence the intentions under the framework of the Theory of Planned Behaviour so as to provide references for proposing a noise management programme for ICU. Methods Objective sampling method was used to conduct semi-structured interviews with 17 ICU nurses in our hospital. The interview data were analysed with the method of Colaizzi seven-step analysis to extract themes. Results A total of 3 themes and 9 sub-themes were extracted. The themes together with the sub-themes included:the different behaviours and attitudes of ICU nurses (actively controlling noise sources,negatively responding to noise management);being influenced by multifaceted subjective norms (engaging in active management after noise event,responding to patient requests and team reminders and supervision);and limited perceptual behavioural control (require improvement in noise management,lack of knowledge in noise management,complex work scenarios lead to the neglect of noise management,and lack of training in noise management). Conclusion It is found that while ICU nurses generally hold a positive attitude towards noise management,there are still many challenges in the implementation process. ICU nursing staff are recommended to improve the awareness of the importance of noise management,establish the noise management system,conduct relevant training,and to develop a systematic,comprehensive and sustainable noise management strategy,therefore to reduce ICU noise levels and improve the hospital experience of the patients.

Objective To investigate noise management-associated behavioural intentions of ICU nurses and identify the factors that influence the intentions under the framework of the Theory of Planned Behaviour so as to provide references for proposing a noise management programme for ICU. Methods Objective sampling method was used to conduct semi-structured interviews with 17 ICU nurses in our hospital. The interview data were analysed with the method of Colaizzi seven-step analysis to extract themes. Results A total of 3 themes and 9 sub-themes were extracted. The themes together with the sub-themes included:the different behaviours and attitudes of ICU nurses (actively controlling noise sources,negatively responding to noise management);being influenced by multifaceted subjective norms (engaging in active management after noise event,responding to patient requests and team reminders and supervision);and limited perceptual behavioural control (require improvement in noise management,lack of knowledge in noise management,complex work scenarios lead to the neglect of noise management,and lack of training in noise management). Conclusion It is found that while ICU nurses generally hold a positive attitude towards noise management,there are still many challenges in the implementation process. ICU nursing staff are recommended to improve the awareness of the importance of noise management,establish the noise management system,conduct relevant training,and to develop a systematic,comprehensive and sustainable noise management strategy,therefore to reduce ICU noise levels and improve the hospital experience of the patients.

OBJECTIVE: To investigate the effect of orthodontic traction on the microstructure of dental enamel. METHODS: Forty-eight isolated premolars were randomly divided into 6 groups (=8), including Group A (blank control group), in which the teeth were bonded with the orthodontic brackets without any loading force; Groups B1, B2, and B3 where the teeth were bonded with the orthodontic brackets using clinical adhesives and loaded with 50 g force for 6 months, 200 g force for 6 months, and 200 g force for 1 month, respectively; and Groups C1 and C2, where the teeth were bonded with straight wire brackets using light curing bonding and chemical curing bonding techniques, respectively. All the teeth were embedded with non-decalcified epoxy resin. Scanning electron microscope (SEM), atomic force microscope (AFM), and energy spectrometer (EDS) were used to analyze interface morphology and elemental composition of the teeth sliced with a hard tissue microtome. RESULTS: Compared with those in Group A, the teeth in the other 5 groups showed increased adhesive residue index with microcracks and void structures on the enamel surface under SEM; AFM revealed microcracks on the enamel surface with angles to the grinding direction. A larger loading force on the bracket resulted in more microcracks on the enamel interface. The interface roughness differed significantly between Groups A and C2, and the peak-to-valley distance differed significantly between Groups A, C, and C2. CONCLUSIONS Orthodontic traction can cause changes in the microstructure of normal dental enamel.
Dental Enamel ; Materials Testing ; Orthodontic Brackets ; Resin Cements ; Surface Properties ; Traction