OBJECTIVEProvide the suggestion for MDAEs monitoring and the reference to strengthen the medical device administration by analyzing the 1900 reports of MDAEs.

METHODWith retrospective case study, analyze 1900 MDAE reports in Henan province in 2008. RESULT Orthopedic implants and the intrauterine device (IUD) caused the higher proportion of adverse events with serious degree. The scope that the reports covered needs to be raised.

CONCLUSIONFurther focus monitoring on orthopedic implants and the IUD should be strengthened. The medical device adverse events monitoring should be promoted by improving regulations, training and publicity.

Bone Nails ; adverse effects ; Bone Plates ; adverse effects ; Hip Fractures ; physiopathology ; surgery ; therapy ; Humans ; Prostheses and Implants ; adverse effects

BACKGROUNDDiversity of orthopedic infections with various local environments affects the pattern and prevalence of pathogens. It is not well-characterized whether different pathogens have different propensity to cause different types of orthopedic infections. We aimed to investigate the frequency of different pathogens derived from orthopedic infections, and determine the relationship between the prevalence of clinical isolates and the type of orthopedic implants, especially focusing on staphylococci.

METHODSFrom January 2006 to December 2011, orthopedic infections were identified retrospectively from clinical microbiology laboratory and orthopedic medical records. The sources of orthopedic infections were divided into two main groups: those associated with implants and those not associated with implants. Implants-associated infections were further subdivided into five subgroups: arthroplasty, internal fixation, external fixation, internal and external fixation, and others. We analyzed microbiological spectrum in different groups and subgroups. Antibiotic susceptibility of staphylococci was analyzed.

RESULTSOnly coagulase-negative staphylococci (CoNS) was significantly more likely to be associated with implants-associated infections (P = 0.029). The overall pathogens prevalence of arthroplasty was significantly different from other subgroups (P < 0.05). 65% isolates from external fixation was Gram-negative bacteria. Some percentage (55%) of S. aureus and (83%) CoNS were resistant to methicillin. No resistance to glycopeptide was seen in all of staphylococci.

CONCLUSIONSStaphylococcus aureus was the most frequent isolates in orthopedic infections but was not associated with the presence or absence of implants. Only CoNS was implants-associated, especially for arthroplasty infection. Cefazolin alone is not enough for orthopedic surgery prophylaxis in settings with a high prevalence of methicillin-resistant staphylococci.

OBJECTIVE: The key point of anesthesia management in carotid endarterectomy (CEA) is to maintain adequate cerebral perfusion during carotid artery occlusion. Placement of shunt is one of the common surgical methods. This study analyzed the effects of different shunt strategies on cerebral infarction after carotid endarterectomy. METHODS: A total of 443 patients who underwent CEA under general anesthesia within 2 years were divided into imaging group (based on preoperative imaging data as the basis for shunt) and stump pressure group (based on intraoperative stump pressure as the basis for shunt). The preoperative demographic data, past medical history, degree of cervical vascular stenosis, blood pressure at each time point during the perioperative period, vascular blocking time, whether to place the shunt, postoperative hospital stay, cerebral infarction during hospitalization, and other adverse events were collected and compared between the two groups. On this basis, the preoperative and intraoperative conditions with significant differences were matched with propensity scores, and the influence of different shunt strategies on postoperative cerebral infarction was analyzed. RESULTS: In the study, 268 patients in the imaging group and 175 patients in the stump pressure group underwent CEA under general anesthesia. There were statistically significant differences in basic conditions and blood pressure at each time point between the two groups. After matching the propensity scores, 105 patients in each of the two groups were matched. The basic conditions of the patients before surgery and the difference in blood pressure of the two groups at each time point were not statistically significant. There was no significant diffe-rence in the incidence of postoperative cerebral infarction between the two groups (1.9% vs. 1.0%, P>0.999). The intraoperative shunt rate in the imaging group was lower than that in the stump pressure group (0 vs. 22.9%, P < 0.001). The postoperative hospital stay in the imaging group was 8 (7, 8) days, which was longer than the stump pressure group 5 (4, 6) days (P < 0.001). CONCLUSION The rate of the shunt was lower according to preoperative imaging examination than that according to the residual pressure in our hospital. There is no significant difference in the incidence of cerebral infarction during the postoperative hospital stay. The effect of different shunt strategies on cerebral infarction needs further study.
Anesthesia, General ; Blood Pressure ; Cerebral Infarction/prevention & control* ; Endarterectomy, Carotid/adverse effects* ; Humans ; Prostheses and Implants

Good anticoagulant biomaterials need good surface chemical properties, good mechanics performances and particularly good characteristics of biocompatibility, including tissue compatibility and hemocompatibility. In order to understand with greater clearness the anticoagulant biomaterial, we have to characterize them by different methods. In this paper, the approaches to assessing and displaying the characteristics of anticoagulant biomaterial are reviewed in three aspects, namely the surface chemical properties and structure, the mechanics performances the and the biocompatibility of anticoagulant biomaterial.
Anticoagulants ; Biocompatible Materials ; chemistry ; Blood Coagulation ; drug effects ; Humans ; Materials Testing ; Prostheses and Implants ; adverse effects ; Prosthesis Design ; Surface Properties

We conducted studies to confirm the hypothesis that the cellular damage occurring around implanted biphasic bioceramics could be related to a micro-particles release because of an insufficient sintering. An in vitro cytotoxicity study was performed on four biphasic ceramic (BCP) samples. Without the treatment of extraction medium, a cytotoxicity was observed, although after centrifugation this cytotoxicity disappeared in all samples. (2) Micro-particles of HA, beta-TCP and 40%beta-TCP/60%HA mixture were used for a cell inhibition study. A decrease of cell viability was observed with the increase in particles concentration. At 10000 particles/ cell, the viability and proliferation were completely inhibited. (3) HA, beta-TCP and BCP ceramic granules were implanted in rabbit femoral cavities for 12 weeks. No degradation of HA granules was observed. The degradation was higher for beta-TCP (40%) than for BCP (5%). On the other hand, new bone formation was significantly higher for beta-TCP (21%) and HA (18%) than for BCP (12%). Much more micro-particles were formed around BCP granules than around beta-TCP, and were phagocytosed by macrophages. The release of ceramic micro-particles could be related to the sintering process. BCP ceramics have to be sintered at only 1160 degrees C. Consequently, HA microparticles of BCP ceramic are incompletely sintered and easily released after immersion or implantation. The microparticles could be at the origin of local inflammation and cell damage and could perhaps modify osteogenesis. Particular attention must be paid to this problem with regard to BCP ceramics because of the sintering difficulties of this bioceramic.
Biocompatible Materials ; adverse effects ; chemistry ; Calcium Phosphates ; adverse effects ; chemistry ; Cells, Cultured ; Ceramics ; adverse effects ; chemistry ; Fibroblasts ; cytology ; drug effects ; Hydroxyapatites ; adverse effects ; chemistry ; Materials Testing ; Particle Size ; Prostheses and Implants ; adverse effects

Female ; Humans ; Consensus ; East Asian People ; Pelvic Floor/surgery* ; Prostheses and Implants ; Registries ; Plastic Surgery Procedures/adverse effects* ; Prosthesis Implantation

There has been increasing attention over the past few years on the potential for the medical devices to cause changes in the immune systems, and it was necessary to provide guidance on how to address the adverse effects of medical devices on the immune system. Here we introduce the principles and methods for immunotoxicology testing of medical devices.
Biocompatible Materials ; Equipment and Supplies ; adverse effects ; standards ; Humans ; Immune System Diseases ; etiology ; Materials Testing ; methods ; standards ; Prostheses and Implants ; adverse effects ; Toxicity Tests ; methods

Female ; Hemorrhage ; etiology ; Humans ; Middle Aged ; Orbital Diseases ; etiology ; Orbital Fractures ; surgery ; Prostheses and Implants ; adverse effects ; Silicones ; adverse effects ; Staphylococcal Infections ; etiology

Arthroplasty ; adverse effects ; Cervical Vertebrae ; surgery ; Female ; Humans ; Intervertebral Disc ; surgery ; Middle Aged ; Postoperative Complications ; Prostheses and Implants ; adverse effects ; Treatment Outcome