Document Detail

Technical and economic feasibility of reusing disposable perfusion cannulae.
MedLine Citation:
PMID:  9181243     Owner:  NLM     Status:  MEDLINE    
The reuse of disposable devices is a potential source of significant cost savings to hospitals. Venous and arterial perfusion cannulae 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. Single- and dual-stage venous and arterial cannulae 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 the connectors, and by two 1-hour soaks in plasma at 4 degrees C and 40 degrees C, respectively. Cannulae were decontaminated and then sterilized by a peracetic acid based liquid chemical sterilization system following each use/reuse. Sterilization was validated by eliminating Bacillus subtilis spores from the cannulae on each of five consecutive cycles. Cannulae were tested for physical changes, functional integrity, biocompatibility, and in vivo performance in sheep. A cost minimization analysis was also performed. No clinically important differences were found between new and reused cannulae, even after nine simulated reuses. Mechanical changes were less than 20% on all variables studied and were undetectable by experienced cardiac surgeons in selective evaluation. Sterilization was successfully achieved. Reusing cannulae for times would reduce the cost per procedure from $53 to $19 (64%). Perfusion cannulae tested can be safely and efficaciously used five times. This study suggests that reuse would result in a small incremental savings; however, with more expensive devices and higher-volume sterilization procedures, the savings could be exponentially greater. Although this study demonstrates that it may be technically feasible and cost-effective to reuse disposable cannulae, the U.S. Food and Drug Administration does not sanction the reuse of disposable cannulae.
D F Bloom; J F Cornhill; P S Malchesky; D M Richardson; K A Bolsen; D M Haire; F D Loop; D M Cosgrove
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Biomedical instrumentation & technology / Association for the Advancement of Medical Instrumentation     Volume:  31     ISSN:  0899-8205     ISO Abbreviation:  Biomed Instrum Technol     Publication Date:    1997 May-Jun
Date Detail:
Created Date:  1997-08-14     Completed Date:  1997-08-14     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  8905560     Medline TA:  Biomed Instrum Technol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  248-9     Citation Subset:  IM    
Department of Biomedical Engineering, Cleveland Clinic Foundation, OH, USA.
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MeSH Terms
Bacillus subtilis / drug effects
Biocompatible Materials
Cardiac Surgical Procedures / instrumentation
Catheterization / economics,  instrumentation*
Cold Temperature
Cost Savings
Cost-Benefit Analysis
Disinfectants / therapeutic use
Disposable Equipment* / economics
Equipment Design
Equipment Reuse / economics
Equipment Safety
Feasibility Studies
Hospital Costs
Hot Temperature
Peracetic Acid / therapeutic use
Perfusion / economics,  instrumentation*
Spores, Bacterial / drug effects
Sterilization / methods
Surface Properties
United States
United States Food and Drug Administration
Reg. No./Substance:
0/Biocompatible Materials; 0/Disinfectants; 79-21-0/Peracetic Acid

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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