Abstract
BackgroundThe use of remanufactured single-use devices (SUDs), including cardiac electrophysiology catheters, has become established in the USA and other health care systems but without much published scientific evaluation on the relative safety or efficacy of these devices. In the United Kingdom (UK), the use of remanufactured SUDs has not been routine. We performed a structured evaluation of the safety and efficacy of a remanufactured circular mapping catheter (Stryker® remanufactured Lasso NAV 2515) during its introduction in our centre.MethodsWe prospectively evaluated the performance of a remanufactured circular mapping catheter in 100 consecutive patients undergoing an AF ablation. Operator feedback was obtained, assessing the device appearance, ease of use and function. As an indirect measurement of efficacy, acute procedure metrics were compared to those in 100 propensity-matched cases performed by the same operators using a new device. Cost savings were calculated.ResultsNo complication occurred in association with the remanufactured device. There was one reported failure of device malfunction—the flexion-extension mechanism of a remanufactured catheter and none in the matched-control group. There was satisfactory communication with the electro-anatomic mapping system. Ease of use of the remanufactured catheter was reported to be similar to a newly manufactured device. Procedural duration was similar with remanufactured devices and matched controls. With 100 cases using the remanufactured device, cost savings amounted to £30,444.ConclusionsThe use of remanufactured circular mapping catheters is safe, efficient and reliable. Widespread use of remanufactured SUDs offers the possibility of significant economic benefit.
Highlights
The use of remanufactured single-use devices (SUDs), including cardiac electrophysiology catheters, has become established in the USA and other health care systems but without much published scientific evaluation on the relative safety or efficacy of these devices
We prospectively studied 100 consecutive patients undergoing elective AF ablation using a remanufactured circular mapping catheter (Stryker®, Michigan, USA), a remanufactured version of the 22-pole model of the Lasso® 2515 eco Variable Catheter (Biosense-Webster®), with an electro-anatomic system (Carto®, Biosense-Webster®)
All of the Stryker® remanufactured catheters used were at the first reuse cycle
Summary
The use of remanufactured single-use devices (SUDs), including cardiac electrophysiology catheters, has become established in the USA and other health care systems but without much published scientific evaluation on the relative safety or efficacy of these devices. In the United Kingdom (UK), the use of remanufactured SUDs has not been routine. The use of remanufactured single-use devices (SUDs), including electrophysiology (EP) catheters, has been established for decades in the USA. The financial burden on healthcare systems is ever increasing and the cost of running a cardiac EP laboratory is high. The incentive for investigating the integration of remanufactured cardiac EP catheters as part of routine use is to provide a sustainable approach to cost reduction in the cardiac EP laboratory
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