Validation techniques for fluid delivery systems

Abstract

A fluid delivery system may include a container that houses a medical fluid, a fluid pressurizing unit, and a fluid transfer set that transfers the medical fluid from the container to the fluid pressurizing unit. To validate the integrity and sterility of the fluid delivery system, the system may undergo testing protocols to evaluate the susceptibility of the system to pathogenic ingress, chemical degradation, and/or fluid cross-contamination between patient fluid delivery procedures. The testing protocols may help ensure that delivery system components used during multiple different fluid delivery procedures perform as well as if the components were replaced after each fluid delivery procedure.

1 . A method comprising:
 challenging a connection between a medical fluid container and a fluid transfer component with one or more pathogens and subsequently evaluating whether the one or more pathogens enter a medical fluid in either the medical fluid container or fluid transfer component; and   contacting the fluid transfer component with the medical fluid for a period of time longer than the fluid transfer component would be contacted with the medical fluid during a single patient injection and subsequently determining if the fluid transfer component chemically degrades into the medical fluid.   
     
     
         2 . The method of  claim 1 , wherein the fluid transfer component comprises at least one of a fluid transfer line, a connector, and a fluid pressurizing unit. 
     
     
         3 . The method of  claim 1 , wherein the fluid transfer component comprises a fluid pressurizing unit having an inlet line connected to the medical fluid container and a discharge line, and further comprising:
 filling the discharge line with a tracking agent not present in the inlet line;   pressurizing the tracking agent in the discharge line; and   determining if the tracking agent enters the inlet line.   
     
     
         4 . The method of  claim 1 , wherein the fluid transfer component comprises a fluid transfer set and the medical fluid container contains one of saline and contrast agent. 
     
     
         5 . The method of  claim 4 , wherein fluid transfer set comprises a polymeric tube that extends from a proximal end to a distal end and includes a bottle spike positioned on the proximal end of the polymeric tube and a mechanical connector positioned on the distal end of the polymeric tube. 
     
     
         6 . The method of  claim 5 , wherein the medical fluid container has an opening sealed by a septum that is pierced by the bottle spike, thereby providing the connection between the medical fluid container and the fluid transfer component. 
     
     
         7 . A method comprising:
 validating a fluid transfer set configured to connect a medical fluid container to a fluid pressurizing unit for at least one of pathogen ingress at a connection between the fluid transfer set and the medical fluid container, chemical compatibility with medical fluid contained in the medical fluid container, and cross-contamination of fluid flowing back through the fluid pressurizing unit into the fluid transfer set.   
     
     
         8 . The method of  claim 7 , wherein validating the fluid transfer set comprises validating the fluid transfer set for each of pathogen ingress, chemical compatibility, and cross-contamination. 
     
     
         9 . The method of  claim 7 , wherein the medical fluid container is sized to hold enough medical fluid for multiple patient injection procedures. 
     
     
         10 . The method of  claim 9 , wherein the fluid transfer set is a patient-specific fluid transfer set. 
     
     
         11 . The method of  claim 9 , wherein the medical fluid container is sized to hold greater than approximately 100 milliliters of medical fluid. 
     
     
         12 . The method of  claim 9 , wherein the medical fluid container holds contrast agent. 
     
     
         13 . A product comprising:
 a fluid transfer set validated for at least one of pathogen ingress, chemical compatibility, and cross-contamination.   
     
     
         14 . The product of  claim 13 , wherein the fluid transfer set is validated for each of pathogen ingress, chemical compatibility, and cross-contamination.