This article introduces the classifications of medical devices by FDA and EU and compares them with the situation in China. Towards the problems found, several reasonable advices are put forward.
China ; Durable Medical Equipment ; classification

Objective:To analyze and evaluate the effect after the PIVAS workflow optimization in our hospital. Methods: One-for-one grouping preparation was carried out by pharmacists and nurses. The checking of medicines, solvents and empty ampoules be-fore and after the preparation was performed by pharmacists, and the preparation of infusions was operated by nurses according to the operation specification. The preparation workload, error number in each link and damage of ampoules and finished goods before the op-timization and in 5 months after the optimization were compared. Results:The working efficiency was obviously improved with less time of about 0. 5 h for the same workload, the error rate was decreased by 40%, and the ampoule damage was reduced by 60% before and during the preparation. Conclusion:The PIVAS workflow optimization improves the working efficiency and management level.

objective: To study the effects of BMP on the growth of osteosarcoma cells. Methods: Human antisense BMP2 retrovirus expression vector was constructed and transfected into human osteosarcoma OS 9901 cells by Lipofect AMINE. Positive cell clones were selected with G 418. The expression of BMP and PCNA were determined by immunohistochemical methods, image analysis and expressed as grey level. The morphology and cell cycle distribution of the cells were studied by electronmicroscope and flowcytometry respectively. Results:The grey levels of BMP and PCNA in the transfected cells were 198.4?8.51 and 197.3?3.22, those of the control were 135.1?12.32 and 142.9?8.47,respectively. G 1, G 2 and S phase cells were 51.9%,18.2% and 22.7% in the cell cycle of transfected cells, while those of the control were 52.8%,11.1% and 36.1%, respectively.Increased lysosome and small pieces of chromatin were observed in the transfected cells under electronmicroscope. Conclusion:Transfection of antisense BMP2 may inhibite the expression of BMP and proliferating activity of osteosarcoma cells.

Objective To evaluate the clinical effects of voice training on the speech ability in patients with oral cancer af. ter free flap reconstruction. Methods Fifty-five patients with oral cancer after free flap reconstruction were assigned to the voice training group(28 cases)and control group(27 cases)from the third week after operation. Their speech function was eval-uated by Chinese Speech Definition Word Table before operation and 2 weeks,3 months and 6 months after the operation. Results The score of speech definition was significantly higher in the voice training group than that of the control group (P< 0.01). Conclusion Postoperative voice training can effectively improve the speech definition for the patients with oral cancer after free flap reconstruction.

Objective To analyze the risk factors for patients with cryptogenic ischemic cerebrovascular disease (CICVD) and patent foramen ovale (PFO), as well as to evaluate the relationship between common risk factors and PFO in cerebral ischemia. Methods Consecutive patients with CICVD aged 15 to 70 years who referred to Department of Neurology, Xuanwu Hospital, Capital Medical University from January 2008 to July 2011 were investigated. Identified by transesophageal echocardiography, they were divided into PFO group and non-PFO group with respect to outcome. The common risk factors of cerebral ischemic between 2 groups were compared. The relationship between these risk factors and PFO was analyzed. Results A total of 102 patients were investigated, including 61 patients (59.80%) with PFO and 41 patients (40.20%) without PFO. Positive family history of ischemic cerebrovascular disease proportion in PFO group (31.1%)was higher than that in non-PFO group (9.8%) (P=0.011). There was no significant difference in other observed indicators (P>0.05). Positive family history of ischemic cerebrovascular disease correlated with PFO among CICVD patients (r=0.251, P=0.011). Conclusion PFO was not only more common in CICVD patients, but also correlated with positive family history of ischemic cerebrovascular disease.

How to remove the well fixed cement or cementless prosthesis and get a completely distal cement removal in the rTHR are critical to the outcome of revision. Because of higher rate of union, excellent intraoperative exposure, and adjustment of abductor tension, ETO has been widely applied to rTHR and complicated primary THR by foreign scholars. Furthermore, this technology has wide indications, very few contraindications, high cure rates,and low complications rate. ETO turns out to be a safe and effective revision technology. In the article, the indication, contraindication, complications and advantages of this technique were reviewed.
Arthroplasty, Replacement, Hip ; methods ; Humans ; Osteotomy ; adverse effects ; methods

BACKGROUND:With the development of genetic engineering and tumor molecular biology, gene therapy for tumors has become a new treatment modality.
OBJECTIVE:To explore the effect of the KDR gene silencing on the proliferation and invasion capacity of breast cancer MCF-7 cel s.
METHODS:Interfering RNA (siRNA) sequences for smal molecule KDR gene was designed and transferred into human breast cancer MCF-7 cel s. Then, RT-PCR and western blot assay were used to detect the KDR mRNA and protein expression. Flow cytometry, cel counting kit-8 test and Transwel test were employed to detect the cel cycle, proliferative capacity and invasion capacity of breast cancer MCF-7 cel s after the KDR gene silencing.
RESULTS AND CONCLUSION:After 48 hours of KDR silencing, the mRNA and protein expressions of KDR in MCF-7 cel s were decreased obviously;MCF-7 cel s arrested at G0/G1 stage and the number of cel s at S stage was reduced. Cel proliferation was inhibited significantly. The amount of cel s passing through the filtering membrane became less. After KDR gene silencing, the proliferation and invasion of breast cancer MCF-7 cancer stem cel s were inhibited remarkably, indicating that KDR gene silencing may be a new target for the effective treatment of breast cancer.

Objective:To explore the application effect of action learning for nursing ethic teaching in operating room.Methods:Total 94 nursing students were divided into two groups to compare the testing scores and the inci-dence of hidden security events .The control group underwent the traditional teaching method , and the experimental group taken Action learning .Results:The testing scores and the accurate rates of case analysis problem of the ex-perimental group were higher than those in the control group (P<0.05).While the rate of hidden danger events of the experimental group was significantly lower than that in the control group ( P <0 .05 ) .Conclusion: Action learning can stimulate students′learning potential , improve the effect of learning , and reduce the incidence of secu-rity events.

Objective To evaluate the relationship between recurrence of cryptogenic ischemic cerebrovascular disease (CICVD) and patent foramen ovale (PFO),as well as to access the clinical significance of PFO in ischemic cerebrovascular disease.Methods Consecutive patients with CICVD aged 15 to 70 years who were hospitalized in Department of Neurology,Xuanwu Hospital Capital Medical University from January 2008 to March 2011 were prospectively investigated.Identified by transesophageal echocardiography,patients were divided into two groups with respect to outcome:PFO group and non-PFO group.The recurrence of cerebral ischemic events was compared between the two groups after neurological follow-up.Results A total of 91 patients were recruited,including 57 patients with PFO and 34 patients without PFO.The follow-up period of two groups was 695 (506,1142) d.The recurrence rate at 15 months in patients with PFO (24.5％ (12/49)) was higher than those without PFO (6.9％ (2/29),x2 =4.391,P =0.036).Cum hazard curve indicated that recurrence risk of cerebral ischemic events in patients with CICVD in PFO group was higher than that of patients in non-PFO group during the follow-up period (P =0.044).Cox model used for multivariate survival analysis indicated that PFO was a risk factor for cerebral ischemic event recurrence among patients with CICVD (OR =4.159,95％ CI 1.178-14.689,P =0.027).Conclusions PFO is associated with increased recurrence risk of cerebral ischemia in CICVD patients.In addition,PFO may be a significant factor for ischemic cerebrovascular disease.

OBJECTIVE:To provide suggestions for the government decision of payment price of medicare drugs. METHODS:Investigation was conducted for the beginning of payment price policy of medicare drugs,effect of the implementation of policy in other countries and the encountered problems. The payment pricing mechanism was explored based on the combination of new medi-cal reform with theoretical analysis and empirical research. RESULTS:The reform of payment pricing mechanism of medicare drugs will have effect on current drug price,especially for R&D oriented pharmaceutical industries. The policy can decrease drug expendi-ture in medicare expenditure,and it is not sure whether it can decrease total medicare expenditure. CONCLUSIONS:It is suggest-ed to notice the related measures and government should keep balance between drug availability and encouraging R&D innovation.