(精选)【医学课件课件】Medical Device Safety教学课件.pptVIP

Medical Device Safety ;The importance of reporting adverse incidents;If an incident occurs, what should I do?;An example of FDA Patient Safety News ; The Vapotherm device uses a nasal cannula(套管) to deliver moisture and warm breathing gases to the patient. When the device was recalled, FDA noted that certain patients, including premature neonates（早产儿） and the immuno-compromised, would be at particularly high risk for infection if they were exposed to breathing gases from a contaminated device. ;If using the re-introduced Vapotherm 2000i, here are the precautionary steps to take:? Be sure that the base unit has been disinfected by Vapotherm under the recall‘s corrective plan. Do not use the unit if this has not been done. Send it back to the company for disinfection（消毒）. ? Discard all used Vapor Transfer Cartridges, all used disinfection kit components, and any disinfection kit that has been opened. ? If you have unopened Vapor Transfer Cartridges with product codes VT01-A and VT01-B, contact the distributor and exchange them for new ones with product codes VT01-AS and VT01-BS.? Get the latest users manual from the company, and closely follow the revised instructions, particularly three important precautions:- Each new Vapor Transfer Cartridge should be used only on a single patient and must be discarded after 30 days of use.- Each disinfection kit is for a single use, and must be discarded after it is used.- Only sterile（消过毒的） water should be used in operating the device. ;其它实例;Risk ;History of GHTF;Risk Management ;Risk-Analysis for Medical Devices According to EN 1441;;;Classification of a Medical Device;;Quality and safety ;Major phases in the life span of a medical device ;.tw/buffetnew/usa.htm;Conception and Development ;Manufacture ;Packaging and labelling ;Advertising ;;Disposal ;;Ideal conditions for ensuring the safety and performance of medical devices;The Public;The Government;FDA根据管理程度把医疗器械分为三类进行上市前管理;FDA行政处罚手段;中国医疗器械召回制度即将启动;T