SGNA Issues Position Statement on Reuse of Single-Use Critical Medical Devices

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The Society of Gastroenterology Nurses and Associates, Inc. (SGNA) has issued a position paper on Reuse of Single-Use Critical Medical Devices.
 
In order to save costs and reduce medical waste, the FDA (2002) established statutory requirements in 2002 for reprocessing of specific single use devices by approved reprocessors. 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

SGNA supports further research to define risk and document benefits of reprocessing single-use devices.

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.

This position statement was originally adopted by the SGNA board of directors in February 1998. Since then it has been revised in May 2002, October 2005, August 2008, March, 2012, and May 2013.

References
American Society for Testing and Materials. (2007). Standard practice for reprocessing of reusable, heat-stable endoscopic accessory instruments (EAI) used with flexible endoscopes. West Conshohocken, PA: Author.

Rutala, W. A., Weber, D. J., & the Healthcare Infection Control Practices Advisory Committee(HICPAC). (2008). Guideline for disinfection and sterilization in healthcare facilities. Retrieved from http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf

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 from
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm109133.htm

United States Food and Drug Administration. (2009). Definitions. Retrieved from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Reprocessingof Single-UseDevices/ucm121090.htm
United States Food and Drug Administration. (2011). What are reusable medical devices? Retrieved from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Reprocessingof Reusable Medical Devices/ucm252909.htm

Recommended Reading
Alfa, M. J., & Castillo, J. (2004). 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.

American Society for Gastrointestinal Endoscopy Quality Assurance in Endoscopy Committee, Petersen, B. T., Chennat, J., Cohen, J., Cotton, P. B., Greenwald, D. A., Kowalski, T. E., Krinsky, M. L., Park, W. G., Pike, I. M., Romagnuolo, J., & Society for Healthcare Epidemiology of America, Rutala, W. A. (2011). Multisociety guideline on reprocessing flexible gastrointestinal endoscopes. Gastrointestinal Endoscopy, 73(6), 1075-1084.

Jacobs, P., Polisena, J., Hailey, D., & Lafferty, S. (2008). Economic analysis of reprocessing single-use medical devices: A systematic literature review. Infection Control Hospital Epidemiology, 29(4), 297-301.

Shuman, E. K., & Chenoweth, C. E. (2012). Reuse of medical devices: Implications for infection control. Infectious Disease Clinics of North America, 26(1), 165-172.

Sloan, T.W. (2007). Safety-cost trade-offs in medical device reuse: A Markov decision process model. Health Care Management Science, 10(1), 81–93.

Tinkham, M. R. (2010). Reprocessing of single use devices: Do the benefits outweigh the potential dangers? Perioperative Nursing Clinics, 5(3), 377-381.

 

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