Analysis on Re-classifcation Management Procedure of Medical Devices in the United States / 中国医疗器械杂志

A detailed analysis on re-classification procedure of medical devices from Food and Drug Administration.The experience on classification procedures,the work-flow of risk reanalysis and regulatory categories reassessment of listed products,as well as launching a comprehensive evaluation and downgrading of listed high-risk products were explored in recent years.Based on the analysis on classification procedures and supervision of medical device products in the USA,and combined with the current situation of classification of medical devices in China,some suggestions were put forward on the current classification mode of medical devices so as to improve the quality and efficiency of classified management of medical devices in China.

The several problems to be paid attention to the classification of medical devices / 中国医疗器械杂志

By analysis on existing problems of the classification, the suggestions were put forward to provide a reference for improving the classification of medical devices.

Reconstruction of the anterior cruciate ligament with bone-patellar tendon-bone transplantation and absorbable screws fixation under knee arthroscopy / 中华骨科杂志

Objective To evaluate the clinical results of the anterior cruciate ligament (ACL) reconstruction by bone-patellar tendon-bone(BPB) transplantation and fixation with absorbable interface screws under arthroscopy. Methods From December 1999 to June 2003, 32 patients with ACL injuries underwent BPB transplantation. There were 22 males and 10 females, and the average age was 32.5 years (ranged from 20-45 years). The lesions were left knees in 18 and right knees in 14, including 8 acute and 24 chronic injuries. The BPB for reconstructing the ACL was harvested from the anterior approach mini-invasively; the implants were fixed with the absorbable interface screws under arthroscopy. The associated injuries were treated simultaneously. All the patients were encouraged to rehabilitate with the continuous passive motion (CPM) and other physical therapies earlier after operation. Results All the patients were available at follow-up; the average duration of follow-up was 32 months (ranged from 6-40 months). Before operation, anterior drawer test positive in 32, Lachman test positive in 20 and pivot shift test positive in 16, were changed into negative. The patients were evaluated according to Lysholm knee scoring scale and the modified Lysholm knee score, the functional results of knee joint were classified as excellent in 24, good in 7 and fair in 1, and the average knee score was 52.1?5.6 and 98.7?3.6 before and after operation respectively, the difference was of statistical significance(P

Treatment of frozen shoulder by hydraulic distension and manipulation under dynamic arthrography of shoul-der joint / 中华骨科杂志

Objective The investigation was to evaluate the efficiency of the frozen shoulder treated by hydraulic distention and manipulation under dynamic arthrography of shoulder joint ,and analyze the in-fluencing factors on the outcome.Methods One hundred patients with frozen shoulders were enrolled the prospective and controlled study,who were divided into two groups randomly.Fifty patients were treated by the hydraulic distention and manipulation under dynamic arthrography of shoulder joint (GroupⅠ),and fifty patients were treated by NSAIDs administration(GroupⅡ).The relationship of clinical results with the amounts of injected fluid during hydraulic distention and manipulation,the range of motion,the visualized rate of the vagina synovialis of long head of biceps brachii tendon and subacromial bursa,and releasing de-gree of joint adherence were observed.The patients consisting of forty-two males and58females aging from42to74years were assessed at two time-intervals.The short term follow-up period ranged from3to6months,and final follow-up from10to21months.Results The clinical results was significantly difference between GroupⅠand GroupⅡdepending on daily activity and range of motion(P

The implantation of suspension of Schwann cell modified by nerve growth factor and brain-derived neurtrophic factor and fetal spinal cord cells for the promotion of repairing spinal cord injuries in rats / 中华骨科杂志

Objective An investigation of the effectiveness of treatment of spinal cord injuries(SCI) from the point of view of the transforming factor. Methods Animal model of SCI was made by modified Allens method. Mixed grafts of Schwann cells(SCs) modified with nerve growth factor(NGF) and brain derived neurotrophic factor(BDNF) genes along with fetal spinal cord cell suspension(FSCS) were transplanted into SCI site after 1 month and 3 months. Immunocytochemical staining was conducted for neurofilament(NF), glial fibrillary acidic protein(GFAP), myelin basic protein(MBP), 5 hydroxytryptamine/serotonin(5 HT), NGF, BDNF and the results analyzed with image pattern analysis. Pathological changes of spinal cord tissues were observed with light and electronic microscopy. Results These findings demonstrate the advantages of using mixed grafts of NGF and BDNF genetically modified SCs with FSCS in SCI in the rat: 1) They can be well integrated with the host and survive, 2) FSCS plays the role of bridging and mesomerism, 3) SCs can act as canal tubes and guides for the axons, 4)NGF and BDNF may stimulate the growth of axons and salvage the injuried neruron. Conclusion Mixed grafts of SCs genetically modified with NGF and BDNF genes along with FSCS may be effective measures for the treatment of SCI.