Recently, the reporter learned from the Inspection and Quarantine Bureau of Qinghai Province, Qinghai Inspection and Quarantine Bureau recently passed Spot checks found that 36 medical institutions in Qinghai Province since 2012 from Japan, Spain, South Korea, the United States and Germany and other countries purchasing 397 batches of imported medical devices, including medical monitors, hematology reagents commonly used equipment such as hospital, there are security risks of 69 batches of imported medical equipment, valued at $ 7,310,000, substandard rate of 17.38%.
According to reports, the sampling of imported medical equipment, mainly the following security risks: First, the power distribution cabinet without warning labels and protective isolation facilities, equipment operators and patients will be the safety of some kind of threat; Second, the power plug structure is not comply with Chinese technical specifications. Forcibly insert the jack cause damage as a result of poor contact and heat, there is the risk of accidents caused; Third, the electrical equipment grounding protection security risk. Once the device any electrical components or wiring insulation insulation failure resulting in equipment damage live shell, ground protection does not work, it will give the operator, the patient and the surrounding personal safety threat.
Electrical Inspection and Quarantine, according to the Qinghai Department Textile Inspection sampling results, the main reason contributing to this problem: First, the foreign enterprises to China's laws and regulations, technical standards and mandatory safety regulations not pay enough attention, there is no requirement for China to make the electrical safety technical changes. Second, foreign enterprises in obtaining permission to enter the Chinese medical device market, after, in the absence of any technological innovation in the case, will not meet the technical requirements for China's security products directly sold to the Chinese market. Third, when the signing of procurement contracts generally do not occur on the electrical safety of technical issues to make clearly defined.
If you have any questions, please feel free to contact us.
|