医疗器械的安全性及认证法则.pptVIP

Medical Device Safety The importance of reporting adverse incidents What is an adverse incident? A device-related adverse incident is an event which can produce, or have the potential to produce, unwanted effects involving the safety of patients, users or other people. An adverse incident can arise from shortcomings in the device, its accessories, its operating instructions, user practice, servicing and maintenance and conditions of use. However, many adverse incidents are the result of user error. If an incident occurs, what should I do? Check and take steps necessary for the well-being of the patient. Take device(s) involved out of action and label, together with other material evidence, e.g. packaging if available. If this is not possible the state of the device at the time of incident should be recorded. Record: date and time of the incident device settings if relevant details of incident (how it happened and any outcomes for the person affected) details of device affected and any others (type, make, model and serial numbers) details of any error message or failures. Report incident to relevant manager and to the incident centre in your country. An example of FDA Patient Safety News The Vapotherm 2000i Respiratory Gas Humidifier, which had previously been recalled because of potential bacterial contamination, has now been re-introduced to the market. The company has taken steps to correct the problem, but FDA is cautioning healthcare facilities to take certain precautions before using the re-introduced device. 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 t