| Technical and economic feasibility of reusing disposable perfusion cannulae. | |
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MedLine Citation:
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PMID: 9181243 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Journal Article |
Journal Detail:
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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:
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Created Date: 1997-08-14 Completed Date: 1997-08-14 Revised Date: 2008-11-21 |
Medline Journal Info:
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Nlm Unique ID: 8905560 Medline TA: Biomed Instrum Technol Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 248-9 Citation Subset: IM |
Affiliation:
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Department of Biomedical Engineering, Cleveland Clinic Foundation, OH, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Animals 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 Elasticity Equipment Design Equipment Reuse / economics Equipment Safety Feasibility Studies Hospital Costs Hot Temperature Humans Peracetic Acid / therapeutic use Perfusion / economics, instrumentation* Plasma Sheep Spores, Bacterial / drug effects Sterilization / methods Surface Properties United States United States Food and Drug Administration |
| Chemical | |
Reg. No./Substance:
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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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