title: Development of a program model to evaluate the potential for reuse of single-use medical devices: results of a pilot test study.
abstract: Single-use medical devices (SUDs, or disposables) have become a major expense in hospital budgets. The need for cost reduction and the availability of sterilization technologies other than the autoclave have prompted hospitals worldwide to begin reusing disposables, in many cases without proper assessment of the true costs (time, personnel, etc) and ease/difficulty of implementation of an institutional reuse program. Our group has developed a rigorous program model to evaluate SUDs for reuse. The program comprises 3 sequential protocols: (1) device audit, (2) laboratory evaluation, and (3) clinical evaluation. Use of this model can produce scientific and financial data sufficient for any institution interested in reuse to reach an initial decision about its feasibility. In addition to the testing outcomes, regulatory requirements, the position of manufacturers and third-party reprocessors, and legal and ethical concerns must be considered. A successful reuse program must include ongoing evaluations to ensure that the safety levels and cost savings established during the initial audit and evaluation phases continue. Herein, we give the rationale and details of our program model and discuss results of our pilot application of the "ideal" protocol in a real-world context.
authors.affiliation: Department of Biomedical Engineering/ND20, Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195, USA. abreu@bme.ri.ccf.org
authors.forename: Eduardo L
authors.initials: EL
authors.lastname: Abreu
authors.forename: Donna M
authors.initials: DM
authors.lastname: Haire
authors.forename: Paul S
authors.initials: PS
authors.lastname: Malchesky
authors.forename: David F
authors.initials: DF
authors.lastname: Wolf-Bloom
authors.forename: J Fredrick
authors.initials: JF
authors.lastname: Cornhill
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation; D002408:Catheters, Indwelling; D003661:Decision Support Techniques; D003663:Decision Trees; D004203:Disinfection / Q000379:methods; D004209:Disposable Equipment; D004866:Equipment Contamination / Q000517:prevention & control; D019544:Equipment Failure Analysis / Q000379:methods*; D017743:Equipment Reuse; D010477:Perfusion / Q000295:instrumentation; D010865:Pilot Projects; D016730:Program Development / Q000379:methods*; D014481:United States