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J Thorac Cardiovasc Surg 1997;114:448-460
© 1997 Mosby, Inc.

CARDIOPULMONARY BYPASS, MYOCARDIAL MANAGEMENT, AND SUPPORT TECHNIQUES

TECHNICAL AND ECONOMIC FEASIBILITY OF REUSING DISPOSABLE PERFUSION CANNULAS

This study was presented in part at the AAMI/FDA conference entitled "Designing, Testing, and Labcling Reusable Medical Devices for Reprocessing in Health Care Facilities," November 13-15, 1996, Los Angeles, and a poster appears in Biomedical Instrumentation and Technology. May/June 1997.

Received for publication Nov. 13, 1996; accepted for publication Feb. 21, 1997. Address for reprints: J. Fredrick Cornhill, DPhil, Chairman, Department of Biomedical Engineering, The Cleveland Clinic Foundation, 9500 Euclid Ave., Cleveland, OH 44195.

Abstract

Objective(s): The reuse of disposable devices is a potential source of significant cost savings to hospitals. Venous and arterial perfusion cannulas under new and reused conditions were selected to identify the clinical, safety, technical, logistic, and economic issues that must be addressed to realize these savings. Methods: Single- and dual-stage venous and arterial cannulas from two manufacturers were tested when new, after initial clinical use, and after a single clinical use plus up to nine simulated reuses. Reuse was simulated by end-to-end bending, coupling and uncoupling of the connectors, and by two 1-hour soaks in plasma at 4° and 40° C, respectively. Cannulas were decontaminated and then processed by a peracetic acid-based liquid chemical sterilization system after each use/reuse. Sterilization was validated by eliminating Bacillus subtilis spores from the cannulas on each of five consecutive cycles. Cannulas were tested for physical changes, functional integrity, biocompatibility, and in vivo performance in sheep. A cost analysis was also performed. Results: Sterilization was successfully achieved. Mechanical changes were less than 20% on all variables studied and were undetectable by experienced cardiac surgeons in selective evaluation. No clinically important differences were found between new and reused cannulas, even after nine simulated reuses. Reusing cannulas four times would reduce the cost per procedure from $53 to $19 (64%). Conclusions: Preliminary data suggest that the perfusion cannulas tested can be safely and efficaciously used five times. Limited reuse of these disposable cannulas is technically feasible and cost-effective. Cannula reuse would result in a small incremental savings; however, with more expensive devices and higher-volume sterilization procedures, the savings could be considerably greater. This program provides a model for evaluation of other single-use medical devices for reuse.