Staying Connected: An Opportunity for Patient Advocacy
Neil Ead MSN, CPNP
Since the late 1970s there has been increasing reports of misconnections between medical devices. Some of these misconnections have resulted in serious consequences including patient deaths (Guenter, Hicks, 2008). Misconnections between unrelated devices are almost unheard of among other industries; which begs the question: How has this been possible or allowable within the health care industry? This has become a global concern. The International Organization for Standardization (ISO) established ISO standard 80369-1 as a framework for all small bore connections to reduce medical tubing misconnections. Most recently an international group of clinicians, manufacturers, suppliers, and the U.S. Food and Drug Administration (FDA) have partnered with the ISO and the Association for the Advancement of Medical Instrumentation (AAMI) to create an ISO standard specifically for enteral connectors (80369-3). The enteral connector for the new ISO standard has been given the name ENFit. The Global Enteral Device Supplier Association (GEDSA) was formed to help introduce these standards and to enhance communication that raises awareness and encourages adoption of these standards. The American Society for Parenteral and Enteral Nutrition (ASPEN) established a task force and has published Enteral Nutrition Practice Recommendations that address this issue (ENPR Task Force, 2009). The Joint Commission (2014) has published a Sentinel Event Alert and posted requirements relevant to misconnections.
Consumer groups have also been influential in this process. The Oley Foundation was founded to inform and advocate for home parenteral and enteral nutrition consumers. They have made a commitment to facilitating an open dialogue between consumers, members of industry, the FDA, and the clinical community and are working toward seeing these issues resolved. On December 11, 2015 they coordinated a Global ENFit Summit in Atlanta, Georgia to bring consumers together with manufacturers, the FDA, and members of the home enteral nutrition clinical community to showcase the issues and concerns of end-users and to brainstorm possible solutions. The ENFit summit was available live and continues to be available on demand on the Oley Foundation website at www.oley.org. Consumers expressed concerns surrounding ISO Standard 80369-1, 80369-3, and ENFit. Specifically issues related to reimbursement, clogging of connections, cost, portability, and dexterity were discussed. Health care providers have mirrored these concerns and added that the implementation of ENFit would render the off label use of devices such as urologic catheters no longer possible. Adapters for these devices have already been designed and implemented as institutions transition to ENFit, but in time, these adapters will no longer be available.
Additional concerns have been expressed by clinicians regarding syringes used for the administration of enteral feedings and medications. Although oral syringes have been available and many hospitals have introduced them they are not ENFit compatible. The prototypes for smaller ENFit compatible syringes (1-3 mL) were found to have issues with “dead space” resulting in inaccurate dosing. This is of particular concern for the pediatric population. It was suggested that clinicians concentrate medications into larger volumes and administer medications using larger ENFit compatible syringes thereby minimizing the problem with dead space. A clear message was sent to industry that this is not an appropriate solution. Manufacturers are beginning to address the issue of “dead space” in their design, but these syringes have not yet met FDA approval.
The ISO had planned a vote in December of 2015 aimed at adopting ISO standards 80369-1 and 80369-3 and implementing those standards for all medical device connections globally. Medical device connections have posed an even greater challenge among the international community. Timelines for hospital implementation of these standards in the U.S. had originally been set for November 2015 and then postponed to January 2016. California has already adopted ENFit as the standard for enteral feeding devices and supplies. Due to ENFit product availability, delays in FDA approval, and concerns expressed by industry, clinicians and consumers, the implementation of these standards nationally has been further delayed.
It is imperative that those of us who are caring for patients with enteral feeding devices take an active role in this process in order to avoid creating a new problem by solving another. That being said clinicians will need to partner with industry in the re-design of these devices with ENFit connections and negotiate with vendors and third party payers who may not see the need for this transition. APSNA members may contact me for additional info at email@example.com or through the Legislative Special Interest Group listserve. Additional details about ENFit and regarding the implementation of this initiative may also be found at the following websites:
Guenter, P., Hicks, R.W., & Simmons, D., et al., (2008). Enteral Feeding Misconnections: A Consortium Position Statement. Joint Commission Journal of Quality and Patient Safety. 34, 285-292.
Enteral Nutrition Task Force (2009). Enteral Nutrition Practice Recommendations. JPEN. 20 (10), 1-45.
The Joint Commission (2014). Sentinel Event Alert53: Managing Risk During Transition to New ISO Tubing Connector Standards.www.jointcommission.org.