ObjectiveTo review the registration and technical data for sodium hyaluronate facial derma fillers. MethodsRecent literature concerning registration for sodium hyaluronate facial derma fillers was reviewed and analyzed. ResultsThe aspects on registration for sodium hyaluronate facial derma fillers include nominating the product, dividing registration unit, filling in a registration application form, preparing the technical data, developing the standard, and developing a registration specification. ConclusionThe main difficulty in registration is how to prepare the research data of that product, so the manufacturers need to enhance their basic research ability and work out a scientific technique routing which could ensure the safety and effectiveness of the product, also help to set up the supportive documents to medical device registration.
ObjectiveTo review the registration and technical data for breast implants. MethodsRecent literature concerning registration for breast implants was reviewed and analyzed. ResultsThe aspects on registration for breast implants are complicated. The major aspects include providing technical data, establishing develop standard, progress type test, and developing the registration specification. ConclusionThe manufacturers need to be well aware of the risk of this kind of product and have the full ability to conduct the researching and developing. Only the strict risk controlling can ensure the safety and effectiveness of the product.
Objective To analyze and compare the domestic quality standard and foreign quality standard of sodium hyaluronate (HA), and to expatiate on the critical process monitoring parameters. Methods Different quality standards of HA were compared by translating and sorting, and some experimental data were analyzed as well as the manufacturing practice was elaborated. Results Differences exist in raw materials standard or specifications of products between domestic and foreign, but the basic control points are concordant. Conclusion The company should set up reasonable and controllable quality standard based on quality requirements and related process characteristics so as to assure the safety and effectiveness of the clinical application.
Objective To investigate and compare the demands of dosage forms and specifications of essential medicine for children in different levels of medical institutions, so as to provide references for selection of essential medicines for children by levels of medical institutions. Methods In 13 provinces or municipalities, 104 medical institutions, including tertiary, secondary and primacy medical institutions, were investigated by questionnaires. Kinds of drugs, dosage forms, requirement types and requirement levels of drugs were analyzed and compared in different levels of medical institutions. Results Tertiary medical institutions had higher demands than other levels of medical institutions for the number of drugs types, dosage forms and level of demand on each drug (P < 0.05), secondary medical institutions were higher than primacy medical institutions (P < 0.05), but community health service centers were the same as township health centers. Conclusion The demands of dosage forms and specifications of essential medicine for children in different levels of medical institutions are different. So future studies should develop the essential medicines list for children depend on different levels of care.
ObjectiveTo build the list of appropriate dosage forms and specifications of essential medicines for children which is subsistent abroad and absent in China. MethodsBased on the authoritative data and expert consultation, we established the selection methodology which included the standard of essential medicine for children, the standard of appropriate dosage for children, the standard of appropriate specifications for children, the standard of urgent classification, the standard of urgent level. ResultsThe list of appropriate dosage forms and specifications included 61 medicines which included 20 dosage forms and 112 specifications. 112 specifications included 27 specifications which belong to level Ⅱ, and 85 specifications which belong to level Ⅲ. ConclusionThe established list can be included by the green channel.
In recent years, day surgery has developed rapidly in China. It is very important to ensure the medical quality and safety of day surgery patients post-discharge. However, there are no regulations, guidelines or policy on the quality and safety of medical care post-discharge in China yet. As one of the medical institutions which are the earliest to carry out day surgery in a standardized way in China, West China Hospital of Sichuan University has summarized the nearly 10 years’ experiences in day surgery, and formulated management norms after discharge of day surgery, including discharge evaluation, discharge guidance, follow-up after discharge, and emergency plan. This paper introduces the management norms for day surgery post-discharge from West China Hospital ofSichuan University, in order to provide reference for the management of the day surgery patients post-discharge medical care in China.
Day surgery can shorten the average hospital stay and enhance the recovery of patients, and has great social and economic benefits. In order to provide reference for the establishment of standardized operating room management, West China Hospital of Sichuan University summed up the experience of past years to develop this management specification for day surgery operating room. The main contents of this specification include: the principles of scheduling day surgery; the resource allocation of operating room; operating room nursing care, nursing points, and precautions. The release of this specification is conducive to the improvement of the nursing management for day surgery operating room, and the promotion of day surgery.
ObjectiveTo explore the practical effect of standardized management path for inpatients with chronic and difficult-to-heal wounds.MethodsThe inpatients with chronic and difficult-to-heal wounds in People’s Hospital of Deyang City from July 2015 to June 2019 were collected. According to the random number table, the patients were divided into control group and intervention group. The control group were given routine management and the intervention group were given standardized management. Skin symptoms, Visual Analogue Scale (VAS), wound healing time, length of hospital stay, efficacy, complications, satisfaction and scar hyperplasia were recorded and compared.ResultsA total of 605 patients were included. There were 314 cases in the control group and 291 cases in the intervention group. Before treatment, there was no significant difference in skin symptom score or VAS score between the two groups (P>0.05); after treatment, the skin symptom scores and VAS scores of the two groups decreased (P<0.05), and the scores in the intervention group were lower than those in the control group (P<0.05). The wound healing time [(24.21±1.42) vs. (18.59±1.63) d; t=45.301, P<0.001] and length of hospital stay [(26.97±1.54) vs. (20.03±1.42) d; t=57.492, P<0.001] in the intervention group were shorter than those in the control group. All patients were followed up. The total effective rate (χ2=3.911, P=0.048) and satisfaction (χ2=4.340, P=0.037) of the intervention group were higher than those of the control group. The degree of scar hyperplasia (Z=4.913, P<0.001) and the incidence of complications (P=0.039) of the intervention group were also lower than those of the control group.ConclusionsThe standardized management of hospitalized patients can significantly shorten the chronic and difficult-to-heal wounds healing time, reduce the occurrence of complications, improve the patient’s satisfaction and prognosis. It is worthy of clinical application.