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For the purpose of this document, Society of Gastroenterology Nurses and Associates, Inc. (SGNA) adopted the following definitions:


Critical Medical Devices refer to instruments that may be introduced directly into the bloodstream or into other normally sterile areas of the body (American Society for Testing and Materials [ASTM], 2000). These devices break the mucus membrane and/or come into contact with sterile tissue or the vascular system.


Reusable Device refers to an instrument designed and validated by the manufacturer to be used more than once, provided that after each use, an appropriate reprocessing protocol and functionality check is performed (ASTM, 2000).


Reuse refers to the repeated use or multiple use of any medical device including devices intended for reuse or single use, with reprocessing (cleaning, disinfection, or sterilization) between uses (United States Food and Drug Administration [FDA], 2001).


Reprocessed is defined as follows:


The term "reprocessed," with respect to a single-use device, means an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. The subsequent processing and manufacture of a reprocessed single-use device shall result in a device that is reprocessed within the meaning of this definition. (FDA, 2002, p. 116)


Single-Use Device (SUD) refers to an instrument designed for one-time use only, on one patient, during a single procedure. SUDs are not designed by their manufacturers to be reprocessed and/or used on another patient. The manufacturer's label on these devices does not include reprocessing instructions and may or may not identify the device as an SUD (FDA, 2000). SUDs are also referred to as disposable devices (FDA, 2000).



Cost-containment concerns led healthcare facilities to consider reuse of single-use medical devices (Alfa, 2000; Association of periOperative Registered Nurses, 2006; Hambrick, 2001; Wilcox, 2000). This statement is intended to address the reuse of critical medical devices manufactured and labeled for single use.


Original equipment manufacturers (OEMs) are required to conduct stringent testing processes for reusable products. In order for a device to be labeled "reusable," the OEM must meet FDA criteria to validate that a device can be cleaned and, if necessary, resterilized.


In 2002, the FDA established new statutory requirements for SUD reprocessors and hospitals engaging in reprocessing of SUDs (FDA, 2002). The FDA requires that reprocessors also submit data ensuring that the reprocessed device is "substantially equivalent to newly manufactured devices" (Emergency Care Research Institute, 2006).


SGNA believes that patients deserve the same standard of care regardless of practice setting. The reuse of SUDs is a complex issue that must be balanced with the assurance of patient safety and the delivery of quality healthcare. These concerns cannot be overlooked when evaluating the legal, ethical, financial, and technical aspects of reusing SUDs.



In the absence of substantial scientific evidence to prove the safety and effectiveness of reprocessed critical medical devices in the endoscopy setting, SGNA maintains the position that critical medical devices originally manufactured and labeled for single use should not be reused.




Alfa, M. J. (2000). Medical-device reprocessing. Infection Control and Hospital Epidemiology, 21, 496-498. [Context Link]


American Society for Testing and Materials. (2000). Standard practice for reprocessing of reusable, heat-stable endoscopic accessory instruments (EAI) used with flexible endoscopes [Standard]. West Consohocken, PA: Author. [Context Link]


Association of periOperative Registered Nurses. (2006). Reuse of single-use devices [Guidance Statement]. AORN Journal, 84(5), 876-884. [Context Link]


Emergency Care Research Institute. (2006). FDA issues statement on reuse of single-use devices [Normal Priority Medical Device Alert]. Retrieved May 12, 2008, from[Context Link]


Hambrick, D. (2001). Reprocessing of single-use endoscopic biopsy forceps and snares. Gastroenterology Nursing, 24(3), 112-115. [Context Link]


United States Food and Drug Administration. (2000). Guidance for industry and for FDA staff: Enforcement priorities for single-use devices reprocessed by third parties and hospitals [Guidance]. Rockville, MD: Author. [Context Link]


United States Food and Drug Administration. (2001). Labeling recommendations for single-use devices reprocessed by third parties and hospitals: Final guidance for industry and FDA [Guidance]. Rockville, MD: Author. [Context Link]


United States Food and Drug Administration. (2002). Medical Device User Fee and Modernization Act of 2002, Public Law 107-250 [Title III Additional Amendments, Section 301 Identification of manufacturer of medical devices]. Retrieved August 23, 2008, from[Context Link]


Wilcox, C. M. (2000). Methodology of reprocessing one-time use accessories. Gastrointestinal Endoscopy Clinics of North America, 2(10), 379-385. [Context Link]

Suggested Readings


Alfa, M. J., & Castillo, J. (2004, October). Impact of FDA policy change on the reuse of single-use medical devices in Michigan hospitals. American Journal of Infection Control, 32(6), 337-341.


Alfa, M. J., & Nemes, R. (2003, June). Inadequacy of manual cleaning for reprocessing single-use, triple-lumen sphinctertomes: Simulated-use testing comparing manual with automated cleaning methods. American Journal of Infection Control, 31(4), 193-207.


American Health Consultants. (1998). The dilemma: Should you tell patients when you reuse single-use devices? Same-Day Surgery, 22(8), 1-4.


American Society for Testing and Materials. (2001). Standard practice for cleaning and disinfection of flexible fiberoptic and video endoscopes used in the examination of the hollow viscera [Standard]. West Consohocken, PA: Author.


Cahoon, B. D. (2002, March). Reprocessing single-use medical devices. AORN Journal, 75(3), 557-567.


Carey, D. (2001). Reprocessing and reusing single-use only medical devices: Safe medical practice or risky business? Journal of Contemporary Health Law Policy, 17(2), 657-685.


Dunn, D. (2002a, May). Reprocessing single-use devices: The ethical dilemma. AORN Journal, 75(5), 987-1004.


Dunn, D. (2002b, June). Reprocessing single-use devices: The equipment connection. AORN Journal, 75(6), 1140-1164.


Dunn, D. (2002c, July). Reprocessing single-use devices: Regulatory roles. AORN Journal, 76(1), 98-132.


Sachs, M. (2002, May). Reprocessing single use devices. AORN Journal, 75(5), 919.


Smith, J. J., Henderson, J. A., & Baim, D. S. (2002). The Food and Drug Administration and reprocessing of single-use medical devices. Journal of Vascular and Interventional Radiology, 13(12), 1179-1182.


United States General Accounting Office. (2000). Single use medical devices: Little available evidence of harm from reuse, but oversight warranted [Report to Congressional Requesters]. Retrieved October 1, 2005, from


Wang, E. P. (2001). Regulatory and legal implications of reprocessing and reuse of single-use medical devices. Food and Drug Law Journal, 56(1), 77-98.

Practice Committee Members 2008-2009


LeaRae Herron-Rice, MSM, BSN, RN, CGRN, Chair


LaVonne E. Albertson, BS, RN, CGRN


Phea Anderson, MS, RN, CGRN


Michelle Day, ADN, RN, CGRN


Cynthia M. Friis, MEd, RN-BC


Donna Girard, BSN, RN, CGRN


Mary Anne Malone, RN, CGRN


Tina Schaeublin, BSN, RN, CGRN


Michelle R. Symms, MSN, RN, CGRN


Laura Strohmeyer, RN, CGRN