Views:9 Author:Site Editor Publish Time: 2021-06-22 Origin:Site
During the monitoring of adverse events of medical devices, Shanghai food and Drug Administration found that some medical institutions violated the instructions when using the buoy type oxygen inhaler, and added high volume oxygen for atomization inhalation treatment without authorization, resulting in serious injuries such as "humidification Cup" burst and burst fragments damaging the eyes of caregivers.
In order to standardize the production and use of buoy oxygen inhalers and strengthen the supervision of such products, the State Food and Drug Administration recently issued an emergency notice on the correct use of buoy oxygen inhalers.
The notice requires the food and Drug Administration (FDA) of all provinces, autonomous regions and municipalities directly under the central government to conduct a comprehensive inspection on the production and use of buoy type oxygen inhalers within their jurisdiction, focusing on the inspection of the product instructions of relevant medical device manufacturers and the use of medical institutions.
The notice requires relevant medical device manufacturers to re-examine the product instructions, add warnings and tips such as "it is forbidden to use buoy type oxygen inhaler for oxygen atomization inhalation treatment", "it is forbidden to disassemble buoy type oxygen inhaler by themselves" and "humidification Cup" disinfection method and reasonable use period.
The notice requires all medical institutions within the jurisdiction to carry out clinical use in strict accordance with the approved scope of use of the buoy type oxygen inhaler. It is forbidden to change the use of the buoy type oxygen inhaler and dismantle the buoy type oxygen inhaler without authorization.