Medical infusion pumps deliver medicine (e.g. drugs, food nutrients, chemicals) to patients in various physical conditions. These types of devices are ubiquitous in health care settings from hospitals, to nursing homes, to private residences. Researchers in FDA/CDRH/ Office of Science and Engineering Laboratories (OSEL) developed the notion of a Generic Infusion Pump (GIP) safety “reference” model in response to extensive evidence of safety problems in this class of medical device.
The GIP safety model project serves to identify hazards, their causes, and control measures common to all types of medical infusion pumps at a design level that is independent of any hardware or feature set.
Two safety models have been established to date – the Generic Patient Controlled Analgesic (GPCA) infusion pump and the Generic Insulin Infusion pump (GIIP). These two models are “open / public” designs, intended to be used by academia as a realistic workbench for demonstrating tools and techniques that can improve the safety, security and usability of these and other medical devices. The ultimate goal is to (a) establish safety/security/usability reference models that can be used by manufacturers early in their design process to verify safety/security/usability properties which, in turn, (b) can be used to establish safety/security/usability assurance case arguments for regulatory review processes, and (c) serve as examples demonstrating the use of state-of-the-art safety-critical design and development engineering techniques.
This website provides direct links to tools, techniques, and examples developed to date by various international research groups in collaborations with the US Food and Drug Administration. Device manufacturers may find this information helpful for the analysis of aspects of their pump design before submitting their product for regulatory review. Manufacturers are particularly encouraged to contribute their knowledge to this effort.
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