Risk Analysis of Automated Peritoneal Dialysis Machines
The Manufacturer and User Facility Device Experience(MAUDE)database of the US FDA was searched for AE reports of APD machines from 2016 to 2023,and 757 retrieved AE reports were statistically analyzed.In addition,10 medical institutions using APD machines in Shandong Province were selected as key monitoring sentinel sites for APD machines during the 13th Five-Year Plan period,and a multicenter active monitoring study was conducted to comprehensively monitor the use of APD machines.And then some suggestions were proposed to regulatory agencies,medical institutions and manufacturing enterprises.References were provided for the safe use and regulation of APD machines.
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