Blomström-Lundqvist C
Department of Cardiology, University Hospital, Uppsala, Sweden.
Pacing Clin Electrophysiol. 1998 Dec;21(12):2563-70. doi: 10.1111/j.1540-8159.1998.tb00032.x.
The objective of this study was to evaluate the safety of reusing ablation catheters with temperature control, which has not previously been reported. A review of previously conducted studies on the feasibility of reusing electrode catheters is also presented. From September 1994 to December 1997, 74 deflectable ablation catheters with temperature control (Cordis-Websters and Osypkas) were used during mean 7.6 +/- 8.0 ablation sessions. The catheter tests included visual inspection for surface defects using a magnification glass, impedance measurements, evaluation of the catheter deflection capability, and the integrity of the thermistor and thermocouple. The catheters were sterilized by Sterrad after each use. A total of 41 catheters were rejected after an average 9.1 +/- 8.8 uses (range 1-31). The main reasons for rejection were inaccurate temperature measurements by the thermistor or thermocouple (19%), breakage of or defect in the internal pulling wire (12%), loss or disturbance of electrogram (9%), and loss of deflection capability (8%). The reuse of the catheters has not resulted in any major catheter failures or any major adverse clinical complications. There were no local or systemic infections. It can be concluded that these types of ablation catheters will sustain repeated uses and resterilizations without untoward harm to the patient provided that a thorough validation protocol and guidelines for quality control and rejection of catheters are used. There seems to be no rational for setting a limit for the number of reuses, since most failures occurred at any time of reuse.
本研究的目的是评估重复使用带温度控制的消融导管的安全性，此前尚无相关报道。本文还综述了先前关于重复使用电极导管可行性的研究。1994年9月至1997年12月期间，平均在7.6±8.0次消融手术中使用了74根带温度控制的可弯式消融导管（Cordis-Websters和Osypkas）。导管测试包括用放大镜目视检查表面缺陷、测量阻抗、评估导管的可弯性以及热敏电阻和热电偶的完整性。每次使用后，导管采用Sterrad消毒。平均使用9.1±8.8次（范围1 - 31次）后，共有41根导管被拒收。拒收的主要原因是热敏电阻或热电偶温度测量不准确（19%）、内部牵引线断裂或有缺陷（12%）、电信号图丢失或干扰（9%）以及可弯性丧失（8%）。导管的重复使用未导致任何重大导管故障或任何重大不良临床并发症。无局部或全身感染。可以得出结论，只要使用完善的验证方案以及质量控制和导管拒收指南，这些类型的消融导管在反复使用和再消毒后不会对患者造成不良伤害。似乎没有理由为重复使用次数设限，因为大多数故障在任何一次重复使用时都可能发生。
