Extract:
“Non-electrical infusion pumps (neIPs) are used to infuse smaller volumes over a defined period of time. There are two types of neIPs: elastomeric pumps and mechanical pumps with a spring mechanism. NeIPs are used to infuse antibiotics, analgesics or cytostatics in both outpatient and inpatient settings. Serious incidents (SIs) occurring with the use of medical devices, such as neIPs, must be reported to the German Federal Institute for Drugs and Medical Devices (BfArM) where they are recorded and evaluated on a centralized basis. The legal basis is the European Medical Device Regulation (EU) 2017/745 (MDR) (1) and Medical Devices User Reporting and Notification Ordinance (MPAMIV) (2). By reporting such cases, rare risks and any necessary measures can be identified. The aim of this study is to provide a summary of the reported incidents which occurred with the use of neIPs and to highlight potential risks relevant to clinical practice.”
Reference:Munzert E, Jacobshagen A. Malfunctions of Non-Electrical Infusion Pumps. Dtsch Arztebl Int. 2024 Aug 9;121(16):541-542. doi: 10.3238/arztebl.m2024.0082. PMID: 39411899.