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Remanufactured circular mapping catheters: safety, effectiveness and cost.

Authors
  • Leung, Lisa Wm1
  • Evranos, Banu2
  • Grimster, Alexander2
  • Li, Anthony2
  • Norman, Mark2
  • Bajpai, Abhay2
  • Zuberi, Zia2
  • Sohal, Manav2
  • Gallagher, Mark M2
  • 1 Cardiology Clinical Academic Group, St. George's University Hospitals NHS Foundation Trust, St. George's, University of London, St George's Hospital, Blackshaw Road, London, SW17 0QT, UK. [email protected]
  • 2 Cardiology Clinical Academic Group, St. George's University Hospitals NHS Foundation Trust, St. George's, University of London, St George's Hospital, Blackshaw Road, London, SW17 0QT, UK.
Type
Published Article
Journal
Journal of Interventional Cardiac Electrophysiology
Publisher
Springer-Verlag
Publication Date
Nov 01, 2019
Volume
56
Issue
2
Pages
205–211
Identifiers
DOI: 10.1007/s10840-018-0497-x
PMID: 30588568
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

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. 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. 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. The use of remanufactured circular mapping catheters is safe, efficient and reliable. Widespread use of remanufactured SUDs offers the possibility of significant economic benefit.

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