This study briefly introduces the basic theory of sterilization, the characteristics of ethylene oxide sterilization for medical devices and the key factors about sterilization effectiveness, analyzes and compares three methods used in the product release of medical devices sterilized by ethylene oxide: test for sterility, traditional release and parametric release, and focuses on the theoretical basis, feasibility, validation requirements, advantages and disadvantages of parametric release.
Ethylene Oxide ; Sterilization/methods*

Objective To study the correlation between liver fibroindex and prognosis of hepatocellular carcinoma after hepatectomy.Methods The clinical data of 77 patients with hepatocellular carcinoma who underwent hepatectomy at the 5th Hospital Affiliated to Sun Yat-sen University from 2009 October to 2014 December were analyzed retrospectively.Using data from preoperative Fibroindex,these patients were divided into 2 groups,Group 1:Fibroindex ≤5.4,and Group 2:Fibroindex ＞5.4.The clinical pathological parameters and postoperative disease free survival rates in these groups were analyzed.The Cox ratio risk pattern analysis was used for factors correlating recurrence.Results The parameters in the 2 groups which included sex (35/0 vs 29/13),type of cirrhosis (23/12 vs 14/28),numbers of tumor (35/0 vs 26/16),maximal diameter of tumor (31/4 vs 23/19),vascular invasion status (32/3 vs 26/16),resection margin status (35/0 vs 36/6),hepatic vein/portal vein tumor thrombus status (35/0 vs 29/13),perioperative change of HBV DNA levels (23/12 vs 15/27)were correlated with postoperative recurrence,and they all showed significant differences (P ＜ 0.05).Disease free survival rate in Group 2 was lower than Group 1 (71.4％,33.7％,22.4％ vs 94.3％,46.2％,46.2％,P ＜ 0.05).The Cox regression analysis showed Fibroindex ＞ 5.4,AFP-L3％ ≥ 10％,and number of tumor ＞ 3 to be independent predictors of poor disease-free survival after hepatectomy for hepatocellular carcinoma (P ＜ 0.05).Conclusions Preoperative Fibroindex ＞ 5.4 was an independent adverse predictor of poor disease-free survival.It was valuable to predict postoperative recurrence in hepatocellular carcinoma patients.

Objective To investigate the mouse liver blood vessel images using phase contrast X-ray imaging with synchrotron radiation. Methods 6 female C57BL/6 mice were randomly divided into two groups, 3 mice in each group. In one group, livers excised after hgated arteries, veins and common bile duct. In another group, iodine infused via the portal vein and drained from inferior vena cave until all the blood in the portal veins and hepatic veins was displaced. After infusion, arteries, veins and common bile duct were ligated and livers were excised. Results Blood vessel images were clearly produced by diffraction enhanced imaging. This method can discriminate vessels down to about 40 μm in diameter without contrast agent. Using a contrasting agent more details could be produced. In one liver lobe, the entire branch of the portal vein could be clearly produced by one by one phase contrast image from the main axial blood vessels of liver lobe to the nine generation of branching. Conclusions Phase contrast imaging has the advantage of good contrast and high spatial resolution. [Key wnrds] Synchrotron radiation; Phase contrast imaging; Diffraction enhanced imaging; Blood vessel; X-rays