ABSTRACT
The registration system of medical device Master Files is established to solve the problem that the outsourcing suppliers are not willing to cooperate with the device applicants in the process of providing medical device application documents. After a brief introduction of Master Files systems established by foreign regulatory agencies, this article focuses on the research of establishing a medical device Master Files registration system in China. The results show that the establishment of Chinese Master Files registration system can both improve the standardization and convenience of outsourcing activities of medical devices, and satisfy the needs of the development of medical device industry and regulatory system. At the same time, the probability of additional risk caused by the implementation of the system is low. Therefore, it is expected that the benefits of the system to promote public health outweigh the potential risks, which demonstrates that establishment of the system has important application values.
Subject(s)
China , Industry , Reference StandardsABSTRACT
Objective To explore the value of protective lung ventilation mode in patients undergoing single lung ventilation in thoracic surgery operation.Methods 59 patients undergoing surgical treatment in Ankang Central Hospital from January 2012 to January 2015 were analyzed.According to the ventilation mode adopted in the operation,the patients were divided into the protective group (30 cases) and conventional group (29 cases).The protective group took tidal volume 8 ml/kg.According to the patient's circulatory function,we gradually increase the end expiratory positive pressure ventilation,until 10 cmH2O.The conventional group took tidal volume 8 ml/kg and was maintained positive end expiratory pressure at 3 cmH2O.Results There was no statistically significant difference in operation time,blood volume,infusion volume,and single lung ventilation time between the protective group and the conventional group (P ＞ 0.05).There was also no statistically significant difference in T1,T2,T3,T4,inhalation of oxygen partial pressure (FiO2),mean arterial pressure (MAP) level between the two groups (P ＞ 0.05).The T2 and T3 moment of arterial oxygen partial pressure (PaO2) oxygenation index (OI) level in protective group was significantly higher than that in conventional group (P ＜ 0.05).The preoperative serum tumor necrosis factor-α (TNF-α),interleukin-8 (IL-8),superoxide dismutase (SOD),macrophage inflammatory protein Ⅰ (MIP-Ⅰ),malondialdehyde (MDA) level between the two group showed no significant difference (P ＞0.05).While after the operation,the serum TNF-alpha,MIP-Ⅰ,IL-8 and the level of MDA in protective group was significantly lower than that of conventional group (P ＜ 0.05),the SOD level showed the opposite (P ＜ 0.05).Conclusions The protective lung ventilation mode is beneficial to maintain the blood gas indexes,at the same time reduce the inflammatory response and protect the lung function of the patients.