This paper introduced the medical device classification in China and USA. Through the comparison between the two systems, several problems in Chinese classification system were exposed. To the end, some suggestions were proposed referred to the classification system of USA.
China ; Device Approval ; standards ; Equipment and Supplies ; classification ; United States

Environmental Monitoring ; Humans ; Occupational Health

Equipment Safety ; Nanostructures ; adverse effects

For the preparation of implementing IEC 60601-1 Ed. 3.1 in advance, this paper analyzes the main difference between IEC 60601-1 Ed. 3.1 and GB 9706.1-2007, and discusses the possible influence to medical device designing and testing.
Equipment Design ; standards ; Equipment and Supplies ; standards

Animals ; Apoptosis ; Hypoxia-Inducible Factor 1, alpha Subunit ; Hypoxia-Ischemia, Brain ; genetics ; pathology ; Neurons ; cytology ; metabolism ; RNA, Messenger ; analysis ; Rats ; Rats, Sprague-Dawley ; Transcription Factors ; genetics

Objective To test using musculoskeletal ultrasound (MSUS) to observe uncovertebral joints (UJs) and to explain the ultrasound images of UJs and their adjacent tissues,especially the vertebral artery (VA).Methods MSUS was used first with human skeletons and cadavers to localize the UJs and VA on the MSUS images with the aid of implanted needles.MSUS was then used with a patient clinically diagnosed with cervical spondylosis of the vertebral artery type (CSA) to detail the image of a normal UJ and its relationship with the adjacent tissues,especially the VA.Whether there was a lateral spur from the uncinate process (UP) was assessed to try to establish a method for measuring osteophytes.Results During the examination the patient was in supine,the neck was elevated 15cm with a pillow and was at 45 degrees of rotation to the contralateral side.The probe was placed at the medial border of the sternocleidomastoid muscle.When the longitudinal section of the common carotid artery was shown,the probe was slowly moved laterally until the VA first appeared,and then was moved up along the VA.Once the VA entered the transverse foramen,moving the probe slightly allowed the UJ behind the VA to be seen between two transverse processes.The UJ thus lies between two transverse processes,that is,between the lateral margins of two vertebral bodies and outside the intervertebral disc.The echo of the lateral border of the UP is on a straight line with the echo of the lateral margin of the vertebral body,with the VA in front of the line.It was noticed that the image of a UP with lateral osteophyte formation crossed the line and reached closer to the VA.The transverse diameter of the UJ was measured as the distance from a line cutting the lateral cortical margin of the cervical vertebra to the outer cortical margin of the lateral UP.Conclusion MSUS can clearly show the UJ and its adjacent tissues,especially the VA.It can be used to assess and measure UJs with lateral osteophyte formation.

Objective To explore the clinical efficacy of one-stage cannulated screw fixation in treatment of tibial avulsion fracture at the insertion of posterior cruciate ligament(PCL) under posterior direction version and in treatment of tibial avulsion fracture at the anterior cruciate ligament (ACL)under arthroscopy.Methods From January 2010 to June 2015,25 patients with tibial avulsion fractures of the posterior cruciate ligament combined with the anterior cruciate ligament in our hospital were retrospectively analyzed.Firstly,arthroscopic exploration was conducted in all patients in their horizontal position,aiming to observe whether combined injures existed or not and to confirm fracture fragments and the degree of tibial avulsion fractures of the cruciate ligaments.All patients recieved arthroscopic fragment fixation by using cannulated screws,then,were treated with a minimally posteromedial incision in the prone position by cannulated screw fixation.All knee joints were protected by adjustable orthopedic brace for 4-6 weeks.The clinical knee joint function of patients were measured by using International Knee Documentation Committee (IKDC) scoring scale and Lysholm scoring scale.The X-ray or CT image were used to evaluate healing process of the fractures.Results All patients were followed up for 6-24 months,the median follow-up time was 15 months.All fractures healed in one stage,time of fracture healing ranged from 9 to 24 weeks,and the median time was 12 weeks.The average IKDC scores at the finial follow-up were as follows:claudication (4.88±0.29)points,support (4.65±0.36)points,pain (4.78±0.49)points,swelling (4.88±0.52)points,squat (4.85±0.35)points,all were higher than those before operation,there were statistically significant differences when compared with those assessed before operation (P<0.05).The average Lysholm score at the finial follow-up was (93.4±2.8)points,the rate of excellent and fine was 96.0%,no statistically significant difference was found compared with that at the healthy side (P>0.05).Conclusion The one-stage cannulated screw fixation in treatment of tibial avulsion fracture at the insertion of PCL under posterior direction version and in treatment of tibial avulsion fractures at the ACL under arthroscopy is easy and convenient to operate,which has the advantages of reliable fixation and satisfactory recent curative efficacy.

AIM: To study the effects of intrathymic inoculation of liver specific antigen (LSA) on hepatocyte apoptosis after liver allotransplantation. METHODS: Orthotopic liver transplantation was used in this study. Group Ⅰ: syngenic control (Wistar-to-Wistar); Group Ⅱ: acute rejection (SD-to-Wistar); Group Ⅲ: thymus inoculation of SD rat LSA day 7 before transplantation. The observation of general situation and survival time, hepatocyte apoptosis and LAT expression in liver transplants were used to analyze immune state of animals in different groups. RESULTS: The general situation of group Ⅰ was very well after transplantation. Recipients of groupⅡ lost body weight progressively and all died within day 9 to day 13 post transplantation. As for group Ⅲ, the general situation of recipients was remarkably better than that in group Ⅱ. The positive cells of apoptosis in group Ⅲ detected by TUNEL were not significantly different from that in group Ⅰ, but was significantly lower than that in group Ⅱ. LAT was detected at any time in group Ⅱ with peak expression at day 5 and day 7 post transplantation. In contrast, LAT was not detected in any other groups. CONCLUSION: Intrathymic inoculation of LSA protects hepatocytes from apoptosis after liver allotransplantation.

OBJECTIVE:To investigate the effects of hydrophilic polymers on the stability of self-microemulsifying drug deliv-ery systems (SMEDDS). METHODS:Taking felodipine (FDP) as model drug,the content of FDP was determined by HPLC method. The effects of pure water,0.5% Kollidon VA64,HPMC E5,HPMC K100LV,HPMC K4M,PVP K30 solution,while 0.1%,0.5% and 1.0% HPMC E5 and Kollidon VA64 on residual content of dissolved FDP were determined in SMEDDS. RE-SULTS:The residual contents of dissolved FDP in SMEDDS placed in Kollidon VA64,HPMC E5,HPMC K100LV,PVP K30, HPMC K4M and pure water for 1 h were 92.7%,63.6%,50.2%,46.2%,36.0%and 24.0%,respectively. The order of maintain-ing the supersaturation state was Kollidon VA64>HPMC E5>HPMC K100LV>PVP K30>HPMC K4M>pure water. The residu-al contents of dissolved FDP in SMEDDS placed in 0.1%,0.5%,1% Kollidon VA64 and HPMC E5 and pure water for 1 h were 93.2%,95.1%,96.0% and 48.4%,62.1%,75.1%. CONCLUSIONS:Kollidon VA64 and HPMC E5 can significantly inhibit drug release in SMEDDS and be used as stabilizer of SMEDDS,wherein Kollidon VA64 was better.

Humans ; Male ; Splenectomy ; Stem Cell Transplantation ; adverse effects ; Thrombocytopenia ; etiology ; surgery ; Thrombotic Microangiopathies ; complications ; surgery ; Young Adult