Guide-wire fragment embolisation in paediatric peripherally inserted central catheters

被引:5
作者
Dulhunty, Joel M. [1 ,2 ]
Suhrbier, Andreas [4 ]
Macaulay, Graeme A. [5 ]
Brett, Jennifer C. [5 ]
van Straaten, Alexa V. A. [1 ]
Brereton, Ian M. [3 ]
Farmer, Jillann F. [1 ]
机构
[1] Queensland Hlth, Patient Safety & Qual Improvement Serv, Brisbane, Qld, Australia
[2] Univ Queensland, Burns Trauma & Crit Care Res Ctr, Brisbane, Qld, Australia
[3] Univ Queensland, Ctr Adv Imaging, Brisbane, Qld, Australia
[4] Queensland Inst Med Res, NHMRC, Brisbane, Qld 4006, Australia
[5] Queensland Hlth, Biomed Technol Serv, Brisbane, Qld, Australia
关键词
D O I
10.5694/mja12.10097
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 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.
引用
收藏
页码:250 / 255
页数:6
相关论文
共 11 条
[1]  
*FOOD DRUG ADM, 1997, PRIM MED DEV INT MAG
[2]  
Institute for Healthcare Improvement, 2011, FAIL MOD EFF AN TOOL
[3]   Peripherally Inserted Central Catheters in Children A Survey of Practice Patterns [J].
Knue, Marianne ;
Doellman, Darcy ;
Jacobs, Brian R. .
JOURNAL OF INFUSION NURSING, 2006, 29 (01) :28-33
[4]  
Norman D., 2013, DESIGN EVERYDAY THIN
[5]  
Pettit Janet, 2002, Adv Neonatal Care, V2, P304, DOI 10.1053/adnc.2002.36826
[6]  
Pettit Janet, 2003, Adv Neonatal Care, V3, P14, DOI 10.1053/adnc.2003.50011
[7]  
Ragg P, 2007, UNRAVELLING EMBOLISA
[8]  
Shellock FG, 2010, LIST INFORM TERMINOL
[9]   MR Labeling Information for Implants and Devices: Explanation of Terminology [J].
Shellock, Frank G. ;
Woods, Terry O. ;
Crues, John V., III .
RADIOLOGY, 2009, 253 (01) :26-30
[10]  
Therapeutics Goods Administration, 2009, MED DEV INC REP 01 0