AcuNav Reprocessing: An Evaluation of Safety, Clinical Effectiveness and Cost Savings

Classical Reprocessing Paradigm.
AcuNav Reprocessing: An Evaluation of Safety, Clinical Effectiveness and Cost Savings
AcuNav Reprocessing: An Evaluation of Safety, Clinical Effectiveness and Cost Savings
AcuNav Reprocessing: An Evaluation of Safety, Clinical Effectiveness and Cost Savings
AcuNav Reprocessing: An Evaluation of Safety, Clinical Effectiveness and Cost Savings
AcuNav Reprocessing: An Evaluation of Safety, Clinical Effectiveness and Cost Savings
Author(s): 

Rafal Chudzik, Product Development Engineer, Research & Development, Alliance Medical Corporation, Phoenix, Arizona; Michael Howell, BSN, RN, Supervisor Cardiac Cath Lab, Paradise Valley Hospital, Paradise Valley, Arizona; Atul Mahajan, Manufacturing Engineer, Operations, Alliance Medical Corporation, Phoenix, Arizona

References: 

1. Hynes BJ, Mart C, Artman S, et al. Role of intracardiac ultrasound in interventional electrophysiology. Curr Op Cardiol 2004;19:52-57.

2. Weigang B, Moore W, Gessert J, et al. The Methods and Effects of Transducer Degradation on Image Quality and the Clinical Efficacy of Diagnostic Sonography. J Diagn Med Sonography 2003;19:3-13.

3. Eisner L, Brown MR, Modi D. Leakage Current Standards Simplified. MD&DI July 2004.

4. QuadTech. Electrical Safety Testing Reference Guide. 1998.5. Shafer M. Sonic Tech, Inc. Analysis Report on Alliance Medical Reprocessing of AcuNav Transducers: Analysis of FirstCallâ„¢ 2000 repeatability with AcuNav transducers, 2004.

6. IEC 60601-1, -Medical Electrical Equipment - Part 1: General Requirements for Safety and Essential Performance- (Geneva: International Electrotechnical Commission, 1995).

7. UL 2601-1, -Medical Electrical Equipment, Part 1: General Requirements for Safety- (Northbrook, IL: Underwriters Laboratories, 2003).

8. ANSI/AAMI ES1:1993, -Safe Current Limits for Electromedical Apparatus- (Arlington, VA: AAMI, 1993).

9. Report on acoustical measurements conducted for Alliance Medical, Inc., Sonora Medical Systems, Report number 561, pg14.

10. AAMI TIR 30, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable devices, 2004.

11. ANSI/AAMI ST35-1991. Good Hospital Practice: Handling and Biological Decontamination of Reusable Medical Devices. ANSI/AAMI.

12. Food and Drug Administration. 1996. Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance, Office of Device Evaluation.

13. Avitall B, Khan M, Krum D, et al. Repeated use of ablation catheters: A prospective study. J Am Coll Cardiol 1993;22:1367-1372.


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