ObjectiveTo analyze standards of alginate-based medical devices at home and abroad, and to emphasize key issues of quality control that should be concerned about.MethodsBased on investigation of alginate application in medical devices and alginate-related medical standards, alginate-related technical indicators and quality control points were comprehensively analyzed.ResultsWith the rapid development of alginate-based medical materials and medical devices, the relevant standards at home and abroad have been elaborated on the basic technical indicators and detection methods. In addition to Chinese Pharmacopoeia, China has issued one alginate standard for tissue engineering and three alginate related product standards.ConclusionConsidering the special physical and chemical properties of alginate, researchers also need to focus on the sterilization method, expiry date, molecular weight, and ratio of α-L-guluronic acid to β-D-mannuronic acid of alginate, and impurity content.
ObjectiveTo investigate whether continuous quality improvement (CQI) measures can reduce the episodes of peritonitis.
MethodsWe analyzed the data of 114 cases of peritoneal dialysis related peritonitis from January to December 2011 before applying CQI measures and 72 cases from January and December 2012 after applying CQI measures in West China Hospital. Then we studied the episodes, cause and pathogenic bacteria species of peritonitis in peritoneal dialysis patients. We implemented the process of reducing the episodes of peritonitis by applying PDCA four-step design: plan-do-check-act.
ResultsThe episodes of peritonitis were reduced from per 60.8 patient-months (0.197/patient-years) to per 66.6 patient-months (0.180/patient-years) after applying CQI measures. The positive rate of pathogenic bacteria culture was both 50.0% before and after applying CQI measures, in which 66.7% were gram-positive cocci. The curing rate of peritonitis was increased from 57 case/times (76.3%) to 87 case/times (79.2%). Switching to hemodialysis rate was reduced from 17 cases/times (14.9%) to 10 cases/times (13.9%). Death cases was reduced from 9 cases/times (7.9%) to 5 cases/times (6.9%).
ConclusionThese results show that the incidence of peritoneal dialysis related peritonitis decreases and the curing rate increases through CQI measures.
Objective
To investigate the change of pathogenic distribution and drug resistance in peritoneal dialysis associated peritonitis (PDAP).
Methods
The clinical data of all the patients undergoing continuous ambulatory peritoneal dialysis and suffered from PDAP between January and December in 2014 was retrospectively collected, and the pathogens, drug resistance, outcomes and underlying causes were analyzed.
Results
A total of 64 patients had 72 cases of PDAP. Only 36 strains (50.0%) had positive culture results, among which 24 strains (66.7%) were Gram-positive bacteria strains, 7 strains (19.4%) were Gram-negative bacteria strains, and 5 strains (13.9%) were fungi. For Gram-positive bacteria strains, the resistance rates to vancomycin, linezolid and rifampicin were all 0%; the resistance rate to levofloxacin, gentamycin and cefazolin was 14.3%, 26.3% and 50.0%, respectively. For Gram-negative bacteria strains, the resistance rates to amikacin and imipenem were both 0%; the resistant rate to gentamycin, ceftazidime, levofloxacin and ampicillin was 28.6%, 28.6%, 42.9% and 100.0%, respectively.
Conclusions
The pathogenic spectrum and drug resistance in PDAP have been markedly changed. Selection of antibiotics should be chosen according to the characteristic of the pathogenic spectrum and drug resistance of each center. Great effort is still needed to improve the culture positive rate of the effluent dialysate and to improve the recovery rate of peritonitis.