Radiofrequency Ablation on Heart-equivalent Phantom. Functionality Testing of Percutaneous Single-use Catheter.

Tessarolo, Francesco; Ferrari, P.; Antolini, R.; Nollo, Giandomenico

doi:10.1016/b978-008044648-6.50037-9

Cited by 3 publications

References 9 publications

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Health Technology Assessment on Reprocessing Single-use Catheters for Cardiac Electrophysiology: Results of a Three-years Study

Tessarolo

Disertori

Caola

et al. 2007

2007 29th Annual International Conference of the IEEE Engineering in Medicine and Biology Society

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The study aims to define the technical, ethical, juridical and economic issues involved in the assessment of a reprocessing policy for single-use interventional cardiac devices (SUDs). The feasibility of reprocessing was evaluated for cardiac electrophysiology catheters by comparing the chemical, physical and functional properties of new and reprocessed devices. The issue of hygiene was addressed by developing microbiological tests for the quantification of bioburden, sterility and pyrogenic load. The results of more than 1500 tests, conducted on 531 catheters, suggested a precautionary number of regenerations of five cycles. The ethical aspects were reviewed and the European juridical framework was assessed, revealing a need for harmonization. Applying a specific economic model, potential savings were calculated for a representative cardiology department and estimated at national and European level. Potential savings of 41.2% and 32.9% were calculated for diagnostic and ablation catheters, respectively. Safe and effective reprocessing of SUDs could be pursued if quality control processes and certified procedures are met. A reprocessing policy in EP laboratory could lead to savings of about 27,250 euros per 100,000 population, but the economic benefits are strongly dependent on the maximum number of regenerations and the regeneration rate.

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Health Technology Assessment on Reprocessing Single-use Catheters for Cardiac Electrophysiology: Results of a Three-years Study

Tessarolo

Disertori

Caola

et al. 2007

2007 29th Annual International Conference of the IEEE Engineering in Medicine and Biology Society

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Reprocessing single-use cardiac catheters for interventional cardiology. A cost-minimization model for estimating potential saving at departmental scale and national level

Tessarolo

Disertori²,

Guarrera³

et al. 2009

ijph

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Background: The utilization of single-use percutaneous catheters (SUDs) is a common practice in interventional cardiology, but the increasing of cardiac interventions and the consequent economic load demand for assessing SUDs’ reuse. The study aimed at estimating the potential saving for Italian cardiology departments in the hypothesis that reprocessing and reuse of SUD is performed by guaranteeing safety and efficiency of the reconditioned device as high as the new marketed one. Methods: A cost-minimization model was applied from the perspective of the health national service. Input parameters for the model were settled by reviewing published data on technical, hygiene and functional properties of reprocessed electrophysiology (EP) and percutaneous transluminal coronary angioplasty (PTCA) catheters. Potential saving at department level was calculated as percentage of the actual expenditure for purchasing single-use devices. Two-ways sensitivity analysis was conducted on main cost drivers. Finally, saving at national level was estimated. Results: The revision of technical and safety data showed the feasibility of reprocessing and reuse of EP and PTCA catheters under determined constrains. Potential savings of 39%, and 12% were calculated at department level for EP and PTCA catheters, respectively. Sensitivity analysis showed saving was dependent primarily on departmental workload. Major variations in saving occurred in the range between one and 200 catheters per year. The cut-off between benefit and charges was also related to regeneration rate and maximum number of uses. The estimate of potential saving at national level ranged in the interval from €19.85M to €24.24M. Conclusions:When safety and efficiency is assured by certified reuse processing, substantial saving could be achieved both at departmental and national level contributing to optimize budget allocation for the healthcare system.

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Critical Issues in Reprocessing Single-Use Medical Devices for Interventional Cardiology

Tessarolo¹,

Caola²,

Nollo³

2011

Biomedical Engineering, Trends, Research and Technologies

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Radiofrequency Ablation on Heart-equivalent Phantom. Functionality Testing of Percutaneous Single-use Catheter.

Cited by 3 publications

References 9 publications

Health Technology Assessment on Reprocessing Single-use Catheters for Cardiac Electrophysiology: Results of a Three-years Study

Health Technology Assessment on Reprocessing Single-use Catheters for Cardiac Electrophysiology: Results of a Three-years Study

Reprocessing single-use cardiac catheters for interventional cardiology. A cost-minimization model for estimating potential saving at departmental scale and national level

Critical Issues in Reprocessing Single-Use Medical Devices for Interventional Cardiology

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