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Remanufactured circular mapping catheters: safety, effectiveness and cost.

Leung, LW; Evranos, B; Grimster, A; Li, A; Norman, M; Bajpai, A; Zuberi, Z; Sohal, M; Gallagher, MM (2019) Remanufactured circular mapping catheters: safety, effectiveness and cost. J Interv Card Electrophysiol, 56 (2). pp. 205-211. ISSN 1572-8595 https://doi.org/10.1007/s10840-018-0497-x
SGUL Authors: Leung, Lisa

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Abstract

BACKGROUND: 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. 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. METHODS: We 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. RESULTS: No 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. CONCLUSIONS: The use of remanufactured circular mapping catheters is safe, efficient and reliable. Widespread use of remanufactured SUDs offers the possibility of significant economic benefit.

Item Type: Article
Additional Information: © The Author(s) 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
Keywords: Cardiac electrophysiology catheters, Circular mapping catheters, Cost-effectiveness, Infection risk, Remanufacturing, Safety, Sterilisation, 1102 Cardiovascular Medicine And Haematology, Cardiovascular System & Hematology
SGUL Research Institute / Research Centre: Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Journal or Publication Title: J Interv Card Electrophysiol
ISSN: 1572-8595
Language: eng
Dates:
DateEvent
November 2019Published
26 December 2018Published Online
10 December 2018Accepted
Publisher License: Creative Commons: Attribution 4.0
PubMed ID: 30588568
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/110517
Publisher's version: https://doi.org/10.1007/s10840-018-0497-x

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