OBJECTIVE: To report guide-wire fragment embolisation of paediatric peripherally inserted central catheter (PICC) devices and explore the safety profile of four commonly used devices. DESIGN, SETTING AND PARTICIPANTS: Clinical incidents involving paediatric PICC devices in Queensland public hospitals were reviewed. A PICC user-experience survey was conducted at five public hospitals with 32 clinicians. A device design evaluation was undertaken, and magnetic resonance imaging (MRI) safety was tested by a simulation study. MAIN OUTCOME MEASURES: Embolisation events; technical mistakes, multiple attempts and breakages during insertion; willingness to use the device; failure modes and risk priority rating; movement and/or temperature change on exposure to MRI. RESULTS: Six clinical incidents of silent guide-wire embolisation, and four near misses were identified; all were associated with one type of device. The survey found that this device had a reported broken-wire embolisation rate of 0.9/100 insertions with no events in other devices; two of the four devices had a higher all-cause embolisation rate (3.3/100 insertions v 0.4/100 insertions) and lower clinician acceptance (68%-71% v 91%-100%). All devices had 6-17 identified failure modes; the two devices that allowed removal of a guide wire through a septum had the highest overall risk rating. Guide-wire exposure to MRI was rated a potential safety risk due to movement. CONCLUSIONS: There is marked variation in the safety profile of 3 Fr PICC devices in clinical use, and safety performance can be linked to design factors. Pre-MRI screening of all children who have previously had a PICC device inserted is recommended. We advocate a decision-making model for evaluation of device safety.
OBJECTIVE: To report guide-wire fragment embolisation of paediatric peripherally inserted central catheter (PICC) devices and explore the safety profile of four commonly used devices. DESIGN, SETTING AND PARTICIPANTS: Clinical incidents involving paediatric PICC devices in Queensland public hospitals were reviewed. A PICC user-experience survey was conducted at five public hospitals with 32 clinicians. A device design evaluation was undertaken, and magnetic resonance imaging (MRI) safety was tested by a simulation study. MAIN OUTCOME MEASURES: Embolisation events; technical mistakes, multiple attempts and breakages during insertion; willingness to use the device; failure modes and risk priority rating; movement and/or temperature change on exposure to MRI. RESULTS: Six clinical incidents of silent guide-wire embolisation, and four near misses were identified; all were associated with one type of device. The survey found that this device had a reported broken-wire embolisation rate of 0.9/100 insertions with no events in other devices; two of the four devices had a higher all-cause embolisation rate (3.3/100 insertions v 0.4/100 insertions) and lower clinician acceptance (68%-71% v 91%-100%). All devices had 6-17 identified failure modes; the two devices that allowed removal of a guide wire through a septum had the highest overall risk rating. Guide-wire exposure to MRI was rated a potential safety risk due to movement. CONCLUSIONS: There is marked variation in the safety profile of 3 Fr PICC devices in clinical use, and safety performance can be linked to design factors. Pre-MRI screening of all children who have previously had a PICC device inserted is recommended. We advocate a decision-making model for evaluation of device safety.