A.S.P.E.N. Supports Major Medical Device Changes for Improved Patient Safety

October 22, 2013

Washington, DC – The American Society of Parenteral and Enteral Nutrition (ASPEN) joined today with the Food and Drug Administration (FDA), The Joint Commission, Centers for Medicare & Medicaid Services (CMS), Association for the Advancement of Medical Instrumentation (AAMI), Premier Safety Institute, and the newly formed Global Enteral Device Supplier Association (GEDSA) for a panel discussion on new standards for patient safety that address tubing misconnections at the Healthcare Supply Chain Association Conference.  

Representatives from each organization teamed up to introduce “Stay Connected,” a comprehensive educational campaign developed to inform and prepare the healthcare community for impending changes to medical device small-bore connectors.    

Misconnections in tubing that delivers medication, oxygen, and fluids are rare—many clinicians go their entire career without experiencing an incident—but when misconnections do occur, they can be harmful and even fatal.  To address this issue, an international group of clinicians, manufacturers and regulators, including the FDA, are collaborating with the International Standard Organization (ISO), and AAMI to develop ISO 80369 small-bore connector standards.  

“Having advocated for solutions to this problem for more than a decade, ASPEN is very pleased that the healthcare community will soon have international standards for small-bore connectors that will greatly improve patient safety,” said Peggi Guenter, PhD, RN, Senior Director of Clinical Practice, Advocacy, and Research Affairs for A.S.P.E.N..  

Standards for a newly designed connector will provide greater ability for different manufacturers’ devices to integrate, while making it difficult, if not impossible, for unrelated delivery systems to be connected. A phased approach will start with enteral devices as early as 4th Quarter 2014.    

“The better this initiative is understood, the easier it will be to prepare for the adoption of these new connectors,” said Guenter.  

Additional information on the developing small-bore connector standards is available at www.nutritioncare.org.  

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The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) is dedicated to improving patient care by advancing the science and practice of nutrition support therapy and metabolism. Founded in 1976, A.S.P.E.N. is an interdisciplinary organization whose members are involved in the provision of clinical nutrition therapies, including parenteral and enteral nutrition. With more than 5,500 members from around the world, A.S.P.E.N. is a community of dietitians, nurses, nurse practitioners, pharmacists, physicians, scientists, students and other health professionals from every facet of nutrition support clinical practice, research and education. For more information about A.S.P.E.N., please visit www.nutritioncare.org.