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AMDR Bibliography of Peer-Reviewed Articles and Other Scientific Literature on Reprocessing
Author Title Source Date Page, other info.
Vukelich, Daniel J., Esq. Setting the Record Straight: The Debate Over Reprocessing Should Focus on Facts and Science, Not Scare Tactics and Innuendo Journal of Medical Device Regulation May 2011  Vol. 8, Issue 2, pp.23-28
Von Eiff, Wilfried, M.D. Report Confirms: Reprocessing Single-Use Devices Decreases Costs Medical Data Institute March 2011  
Metcalf, Carole L. BS, RN, CNOR, CRNFA Medical Device Reprocessing: A New Way to Go Green OR Nurse March 2011 Vol. 5, Issue 2, pp. 43-46
Kwakye, Gifty; Brat, Gabriel A.; Makary, Martin A. Green Surgical Practices for Health Care Archives of Surgery February 2011 Vol 146, pp.131-6

Tessarolo,Francesco; Caola, Iole; Nollo, Giandomenico

  Critical Issues in Reprocessing Single-Use Medical Devices for Interventional Cardiology Biomedical Engineering, Trends, Research and Technologies  January 2011  pp. 619-644
  The Risks are Controllable European Hospital October 2010  
Kwakye, G. MPH, Pronovost, P J. MD, PhD and Makary, M. A. MD, MPH, Johns Hopkins University A Call to Go Green in Health Care by Reprocessing Medical Equipment   Academic Medicine; The Journal of the Association of American Medical Colleges March 2010 Vol. 85, No. 3, 398-400.
Sloan, T. First, Do No Harm? A Framework for Evaluating New Versus Reprocessed Medical Devices Journal of the Operational Research Society 2010 Vol. 61, 191-201
Lester, Bruce R., Boser, Nicole P., Miller, Keith, Schnapf, Mark, Jacques, Beth A., Sullivan, Brian F., and Marchin, George L. Reprocessing and Sterilization of Single-Use Electrophysiological Catheters: Removal of Organic Carbon and Protein Surface Residues Journal of AOAC International; A Peer-Reviewed Journal Publishing Basic and Applied Research in the Analytical Sciences Related to Foods, Drugs, Agriculture, and the Environment 2009 Vol. 92, No. 4, pp. 1165-73.
Bank, Alan J., Berry, James M., Wilson, Robert F., and Lester, Bruce R. Acceptance Criteria for Reprocessed Acunav Catheters: Comparison Between Functionality Testing and Clinical Image Assessment Ultrasound in Medicine and Biology, Official Journal of the World Federation for Ultrasound in Medicine and Biology March 2009 Vol. 35, No. 3, pp. 507-514.
Kramer, Axel, Assadian, Ojan, Jaekel, Christian and Kraft, Marc. The Safe Processing of Medical Devices in the Interests of Patient Protection GMS Krankenhaushygiene Interdisziplinaer; Deutsche Gesellscheaft fuer Krankenhaushygiene September 3, 2008 Vol. 3(3), Doc 27;  ISSN 186-5245
Kramer, Axel and Assadian, Ojan Ethical and Hygiene Aspects of the Reprocessing of Medical Devices in Germany GMS Krankenhaushygiene Interdisziplinaer; Deutsche Gesellscheaft fuer Krankenhaushygiene September 3, 2008 Vol. 3(3), Doc 25; ISSN 186-5245
Grosskopf, Volker and Jaekel, Christian Legal Framework Conditions for the Reprocessing of Medical Devices GMS Krankenhaushygiene Interdisziplinaer; Deutsche Gesellscheaft fuer Krankenhaushygiene September 3, 2008 Vol. 3(3), Doc 24; ISSN 186-5245
Kraft, Marc Framework Conditions and Requirements to Ensure the Technical Functional Safety of Reprocesed Medical Devices GMS Krankenhaushygiene Interdisziplinaer; Deutsche Gesellscheaft fuer Krankenhaushygiene September 3, 2008 Vol. 3(3), Doc 23; ISSN 186-5245
Klosz, Kerstin Quality Management for the Processing of Medical Devices GMS Krankenhaushygiene Interdisziplinaer; Deutsche Gesellscheaft fuer Krankenhaushygiene September 3, 2008 Vol. 3(3), Doc 22; ISSN 186-5245
Krueger, Colin M. Processing Single-Use Medical Devices for Use in Surgery – Importance, Status Quo and Potential GMS Krankenhaushygiene Interdisziplinaer; Deutsche Gesellscheaft fuer Krankenhaushygiene September 3, 2008 Vol. 3(3), Doc 21; ISSN 186-5245
Gaertner, D., Muenz, K., Hueckelheim, E., and Hesse, U. Ultrasound Scissors: New Single-Use Instruments vs. Resterilized Single-Use Instruments – A Prospective Randomised Study GMS Krankenhaushygiene Interdisziplinaer; Deutsche Gesellscheaft fuer Krankenhaushygiene September 3, 2008 Vol. 3(3), Doc 20; ISSN 186-5245
Vom Woedtke, Thomas and Kramer, Axel The Limits of Sterility Assurance GMS Krankenhaushygiene Interdisziplinaer; Deutsche Gesellscheaft fuer Krankenhaushygiene September 3, 2008 Vol. 3(3), Doc 19; ISSN 186-5245
Sung, Jinsil K., Levin, MD, Rafael, Siegel, MD, Jodi, Einhord, MD, Thomas A., Creevy, MD, Willliam R., and Tornetta, MD, Paul. Reuse of External Fixation Components: A Randomized Trial Journal of Orthpedic Trauma February 2008 Vol. 22, No. 2, pp. 126-131.
Horwitz, Daniel S. MD, Schabel, Kathryn L.S. MD, Higgins, Thomas F. MD The Economic Impact of Reprocessing External Fixation Components Journal of Bone and Joint Surgery October 2007 89: 2132-36
Tessarolo, F., Disertori, M., Caola, I., Guarrera, G.M., Favaretti, C., and Nollo, G. Health Technology Assessment on Reprocessing Single-Use Catheters for Cardiac Electrophysiology: Results of a Three-Years Study Conf Proc IEEE Eng Med Biol Soc. August 23-26, 2007 pp. 1758-1761
Tessarolo, F., Caola, I., Fedel, M., Stacchiotti, A., Caciagli, P., Guarrera, G.M., Motta, A., and Nollo, G. Different Experimental Protocols for Decontamination Affect the Cleaning of Medical Devices Journal of Hospital Infection 2007 Vol. 65, pp. 326-333
Lester, Bruce R., Alexander, Alan A., Miller, Keith, Boser, Nicole P., Sullivan, Brian F., and Brucker, Gregory Comparison of Performance Characteristics Between New and Reprocessed Electrophysiology Catheters Journal of Interventional Cardiac Electrophysiology 2006 Vol. 17, pp. 77-83
Chudzik, Rafal, Howell, Michael, BSN, RN, Mahajan, Atul AcuNav Reprocessing: An Evaluation of Safety, Clinical Effectiveness and Cost Savings EP Lab Digest February 2006 Vol. 6, No. 2
Dirschl, Douglas R., MD (Department of Orthopaedics, University of North Carolina, Chapel Hill) Reuse of Selected External Fixator Components is Safe and Should be Supported Journal of Orthopaedic Trauma January 2006 Vol. 20, No. 1, pp. 43-46.
Tessarolo, F., Caola, I., Nollo, G., Antolini, R., Guarrera, G.M., and Caciagli, P. Efficiency in Endotoxin Removal by a Reprocessing Protocol for Electrophysiology Catheters Based on Hydrogen Peroxide Plasma Sterilization Int J Hyg Environ Health November 2006 Vol. 209, pp. 557-565
Tessarolo, F., Caola, I., Caciagli, P., Guarrera, G.M., and Nollo G. Sterility and Microbiological Assessment of Reused Single Use Cardiac Electrophysiology Catheters Infection Control and Hospital Epidemiology 2006 Vol. 27, No. 12
Druce, JD, Russell, JS, Birch, CJ, Vickery, K., Harper, RW, and Smolich, JJ. Cleaning and Sterilization Protocol for Reused Cardiac Electrophysiology Catheters Inactivates Hepatitis and Coxsackie Viruses Infect Control Hosp Epidemiol. August 2005 Vol. 26, No. 8, pp. 720-725.
Sikka, Robby S., Fischer, David A., and Swiontkowski, Marc F.  (Department of Orthopaedic Surgery, University of Minnesota) Reprocessing Single-Use Devices: An Orthopaedic Perspective The Journal of Bone & Joint Surgery February 2005 Vol. 87-A, No. 2, pp. 450-57.
Tessarolo, F., Ferrari, P., Bortoluzzi, S., Motta, A., Migliaresi, C., Zennaro, L., Rigo, A., Guarrera, G.A., and Nollo, G. Evaluation and Quantification of Reprocessing Modification in Single-Use Devices in Interventional Cardiology Applied Surface Science 2004 pp. 341.346
Association for Healthcare Resource & Materials Management AHRMM Reprocessing Advisory Hospitalconnect.com (American Hospital Association) January 2004  
Warburton, David Regaining Control: How OEMs Can Participate in the Medical Device Aftermarket in the Wake of MDUFMA: TAs Reprocessed Medical Devices Gain Legitimacy, Manufacturers Prepare for a Changing Market Medical Device & Diagnostic Industry July 2003  
Druce, JD, Russell, JS, Birch CJ, Yates, LA, Harper, RW, and Smolich, JJ. A Decontamination and Sterilization Protocol Employed During Reuse of Cardiac Electrophysiology Catheters Inactivates Human Immunodeficiency Virus Infect Control Hosp Epidemiol. March 2003 Vol 24, No. 3, pp. 184-190.
Matsuura, Maiko, MS, Lounici, Smain, MS, Inoue, Nozomu, MD, PhD, Walulik, Stephen, BS, and Chao, Edmund Y.S., PhD (Johns Hopkins University: Orthopaedic Biomechanics Laboratory) Assessment of External Fixator Reusability Using Load- and Cycle-Dependent Tests Clinical Orthopaedics and Related Research January 2003 No. 406, pp. 275-81.
Ma, Nan., Petit, Alain, Huk, Olga L., Yahia L’Hocine, and Tabrizian Maryam. Safety Issue of Re-Sterilization of Polyurethane Electrophysiology Catheters: a Cytotoxicity Study Journal of Biomaterials Science, Polymer Edition 2003 Vol. 14, No. 3, pp. 213-226
Haley, Deborah RN, CNOR, MBA Implementing a Reprocessing Program: Success Hinges on Planning Infection Control Today December 2002  
Ischinger, T.A., Neubauer, G., Ujlaky, R., Schatzl, H., and Bock, M. Reuse of ‘Single Use’ Medical Devices After Quality Assured Reprocessing: Hygenic, Legal and Economic Aspects. Potential for Cost Savings in Interventional Cardiology Zeitschrift Fur Kardiologie November, 2002 Vol. 92, No. 11, pp. 889-98
Stante, Doug Medical Device Reprocessing – An Alternative AORN (Association of peri-Operative Registered Nurses) Journal September 2002 Vol. 76, No. 3, pp. 406, 409-411
Kinney, Timothy P. MD, Kozarek, Richard A.MD, Raltz, Shirley RN, and Attia, Fouad MBBCh Contamination of Single-Use Biopsy Forceps: a Prospective in Vitro Analysis Gastrointestinal Endoscopy August 2002 Vol. 56, No. 2, pp. 209-12
Dunn, Debra RN, MBA, CNOR Reprocessing Single-Use Devices – Regulatory Roles AORN Journal July 2002 Vol. 76, No. 1, pp. 98-132
Dunn, Debra RN, MBA, CNOR Reprocessing Single-Use Devices – the Equipment Connection AORN Journal June 2002 Vol. 75 No. 6, pp. 1140-1164
Ayzman, Igor, Dibs, Samer R., Goldberger, Jeffrey, Passman, Rod, and Kadish, Alan In Vitro Performance Characteristics of Reused Ablation Catheters Journal of Interventional Cardiac Electrophysiology May 2002 No. 7, pp. 53-59
Sachs, Marion Reprocessing Single Use Devices AORN Journal May 2002 Vol. 75, No. 5, pp. 919
Grabsch, E.A., Grayson, M.L., Johnson, P.D., Yates, L.A., Harper, R.W., and Smolich, J.J. Bactericidal Efficacy of Sterilizing Protocol for Reused Cardiac Electrophysiology Catheters American Journal of Cardiology March 2002 Vol. 89, pp. 770-772
Campbell, Steve The Reuse of Single-Use Devices: The Story Continues Biomedical Instrumentation and Technology (Association for the Advancement of Medical Instrumentation) September/October 2001 Vol. 35, No. 5, pp. 307-311
Furman, Pamela J. Esq. New Regulations Clear the Way for Third-Party Reprocessors Infection Control Today October 2001 pp. 36-38
Lindsay, Bruce D., Kutalek, Steven P., Cannom, David S, Hammill, Stephen C., and Naccarelli, Gerald V. Reprocessing of Electrophysiology Catheters: Clinical Studies, Regulations, and Recommendations Journal of Pacing and Clinical Electrophysiology August 2001 Vol. 24, pp. 1297-1305
Emergency Care Research Institute (ECRI) Single-Use Device Reprocessing Companies; How to Choose Health Devices March 2001 Vol. 30, pp.65-71
Mickelsen, Steven, Mickelsen, Cara, MacIndoe, Chamisa, Jaramillo, Joe, Bass, Sam MD, West, Gail RN, and Kusumoto, Fred MD Trends and Patterns in Electrophysiologic and Ablation Catheter Reuse in the United States American Journal of Cardiology, The February 1, 2001 Vol. 87, pp. 351-353
Buchwalsky, R., Grove, R., and Feldkamp, E. 25 Year’s Experience with Reusable Heart Catheters Zeitschrift Fur Kardiologie February 2001 pp. 542-549
Selvey, Don Medical Device Reprocessing Infection Control Today January 2001 Vol. 5, No. 1
Furman, Pamela J. Esq. Single-Use Device Reprocessing FDA Consumer November/December 2001 Vol. 34, No. 6, pp. 3
Clough, John. D., Maurer, Walter, and Nickelson, Dan E. If it Ain’t Broke, What are we Trying to Fix? Reprocessing Devices Labeled ‘for Single Use Only’ Cleveland Clinic Journal of Medicine September 2000 Vol. 67, No. 9, pp. 682-4
Spera, Gabriel GAO Looks Favorably on Device Reprocessing Medical Device & Diagnostic Industry August 22, 2000  
Dickinson, James G. Justify Device Reuse Curbs on Your Labels, FDA Says Medical Device & Diagnostic Industry August 2000  
Wilcox, C.M. Methodology of Reprocessing One-Time Use Accessories Gastrointestal Endoscopy Clinics of North America April 2000 Vol. 10, No. 2, pp. 379-84
Furman, Pamela J. Esq. Third-Party Reprocessing of Endoscopic Accessories Gastrointestinal Endoscopy Clinics of North America April 2000 Vol. 10, No. 2, pp. 385-392
Lerouge, S., Guignot, C., Tabrizian, M., Ferrier, D., Yagoubi, N., and Yahia, L. Plasma-Based Sterilization: Effect on Surface and Bulk Properties and J Hydrolytic Stability of Reprocessed Polyurethane Electrophysiology Catheters J Biomed Mater Rs. 2000 pp. 1430-1343
  FDA Deals Setback to Device Reprocessing Foes Medical Device & Diagnostic Industry October 22, 1999  
Stoermer, William B., Jr. Reprocessing Single-Use Devices: Why Does the Debate Continue? Medical Device & Diagnostic Industry October 1999  
Kozarek, R.A. MD, Raltz, S.L. RN, MSN, Ball, T.J. MD, Patterson, D.J. MD, and Brandaour, J.J. MD Reuse of Disposable Sphincterotomes for Diagnostic and Therapeutic ERCP: A One-Year Prospective Study Gastrointestinal Endoscopy January 1999 Vol. 49, No. 1, pp. 39-42
Roach, S.K., Kozarek, R.A. MD, Raltz S.L. RN, MSN, and Sumida, S.E. Ph.D In Vitro Evaluation of Integrity and Sterilization of Single-Use Argon Beam Plasma Coagulation Probes American Journal of Gastroenterology, The January 1999 Vol. 94, No. 1, pp. 139-143
Blomstrom- Lundqvist, Carina The Safety of Reusing Ablation Catheters with Temperature Control and the Need for a Validation Protocol and Guidelines for Reprocessing Pacing and Clinical Eletrophysiology (PACE) December 1998 Vol. 21, pp. 2563-70
Bathina, Murali N. MD, Mickelsen, Steve, Brooks, Conni RN, Jaramillo, Joe, Hepton, Trish. Kusumoto, Fred M. MD FACC Safety and Efficacy of Hydrogen Peroxide Plasma Sterilization for Repeated Use of Electrophysiology Catheters Journal of the American College of Cardiology November 1, 1998 Vol. 32, No. 5, pp. 1384-1388
Furman, Pamela J. Esq. Third-Party Reprocessing: Conserving HealthCare Resources Medical Device & Diagnostic Industry October 1998  
Dirschl, Douglas R. MD, Smith, Ilyse, J. RN  (Department of Orthopaedics, University of North Carolina School of Medicine, Wake Medical Education Institute, and the Wake Medical Center, Raleigh, NC) Reuse of External Skeletal Fixator Components: Effects on Costs and Complications The Journal of Trauma: Injury, Infection, and Critical Care May 1998 Vol. 44(5), pp. 855-858.
Kleinbeck, Susan V.M., English, Nancy L., and Hueschen, H. Jody Surgical Services Management January 1998 Vol. IV, No. 1
Browne, Kevin.F. MD, FACC, Maldonado, Rey PhD, Telatnik, Mary RN, Vlietstra, Ronald E. MB, ChB, FACC and Brenner, Alan S. MD, FACC Initial Experience With Reuse of Coronary Angioplasty Catheters in the United States Journal of the American College of Cardiology December 1997 Vol. 30, No. 7, pp. 1735-1740
Stewart, Ian “Single Use Only” Labelling of Medical Devices: Always Essential or Sometimes Spurious? Medical Journal of Australia November 17, 1997 Vol. 167, pp. 538-539
Whitby, R.Michael ‘Single Use Only’: Obfuscation or the Necessary Attainment of Zero Risk? Medical Journal of Australia November 17, 1997 Vol. 167, pp.519-520
Bloom, David F. MS, Cornhill J. Fredrick Dphil, Malchesky, Paul S. DEng, Richardson, Donna M. MS, Bolsen, Kathryn A., BS, Haire, Donna M., BS, Loop, Floyd D. MD, and Cosgrove III, Delos M. MD TECHNICAL AND ECONOMIC FEASIBILITY OF REUSING DISPOSABLE PERFUSION CANNULAS Journal of Thoracic Cardiovascular Surgery, The September 1997 Vol. 114, No. 3, pp. 448-460
Sites, Rick Policies for the Reuse of Disposables; Reprocessing Road Map OHA (the Association for Hospitals and Health Systems) News May 16, 1997  
Kozarek, Richard A. MD, Sumida, StanleyE. PhD, Raltz, Shirley L. RN, MSN, Merriam, Linda D. and Irizarry, David C. In vitro evaluation of wire integrity and ability to reprocess single-use sphincterotomes Gastrointestinal Endoscopy February 1997 Vol. 45, No. 2, pp. 117-121
English, N. Australian and New Zealand Journal of Medicine 1996 Vol. 26, pp. 632-635
English, Nancy RN, BA, CNOR Reprocessing Disposables: One Strategy to Balance Cost Reduction and Quality Patient Care Today’s Surgical Nurse July/August 1996 pp.23-26
Turi, Zoltan G. MD Reuse of Single-Use Items Catheterization and Cardiovascular Diagnosis June 1996 Vol. 38, No. 2, pp. 133-134
  Reuse of Disposable Laparoscopic Instruments: A Study of Related Surgical Complications Infection Control & Sterilization Technology May 1996 pp. 78-80
DesCôteaux, Jean G. MD, MA, FRCSC, Poulin, Eric C. MD, MSc, FRCSC, Lortie, Micheline RN, BSc, Murray, Gilles MD, FRCPC, and Gingras, Suzanne RT Reposables – A Matter of Financial Survival Canadian Journal of Surgery December 1995 Vol. 38, No. 6, pp. 497-500
Becker, G.Edward Put Those Nagging Sterilization Worries to Rest, Once and for All Infection Control & Sterilization Technology October 1995 pp. 38-40
Aton, Elizabeth A. MS, Murray, Patrick PhD, Fraser, Victoria MD, Conaway, Larry AA, and Cain, Michael E. MD  

      

 American Journal of Cardiology, The December 1, 1994 Vol. 74, pp. 1173-1175
Bourassa, Martial G. MD, FACC Is reuse of coronary angioplasty catheters safe and effective? Journal of the American College of Cardiology November 15, 1994 Vo. 24, No. 6, pp. 1482-1483
Jacob, Roger and Bentolila, Patricia The Re- Use of Single-Use Cardiac Catheters: Safety, Economical, Ethical, and Legal Issues Canadian Journal of Cardiology, The May 1994 Vol. 10, No. 4, pp. 413-421
Avitall, Boaz MD, PhD, FACC, Khan, Miqdad MD, Krum, David MSEE, Jazayeri, Mohammad MD, FACC and Hare, John BS  

      

 Journal of American College of Cardiology November 1, 1993 Vol. 22, No. 5, pp. 1367-1372
Bentolila, P. Jacob, R., and Roberge, F. Effects of re-use on the physical characteristics of angiographic catheters Journal of Medical Engineering and Technology November/December 1990 Vol. 14, No. 6, pp. 254-259
O’ Donoghue, Susan and Platia, Edward V. Reuse of Pacing Catheters: A Survey of Safety and Efficacy Pacing and Clinical Eletrophysiology (PACE) September 1988 Vol. 11, pp. 1279-1280
Dunnigan, Ann MD, Roberts, Connie RN, McNamara, Mary RN, Bensen, D. Woodrow Jr. MD, PhD and Benditt, David G. MD American Journal of Cardiology, The October 1, 1987 Vol. 60, pp. 807-810