Category: Professional Posters
Purpose: The International Organization for Standardization (ISO) has approved design standards to prevent misconnections between medical devices that have different intended uses. In September 2018, the U.S. Food and Drug Administration (FDA) released recommendations for hospitals and clinicians to start utilizing enteral devices with connectors that meet the standards of ISO 80369-3. A large, Catholic health system evaluated the ENFit enteral connection system to determine the feasibility of implementing the enteral connector changes within each of its hospitals in a safe and efficient manner.
Methods: A multidisciplinary decision team was formed to evaluate the ENFit enteral connection system. The team included representatives from nursing, pharmacy, supply chain, dietary, quality/safety, case management, and the operating room. Team members with pediatric experience were also present on the decision team. Once established, the committee developed a charter and mission. The objective of the team was to evaluate the ENFit enteral connection system and develop a plan to safely implement the ENFit connector changes throughout the system's hospitals, including the overall care of patients after discharge. To accomplish these goals, the team set out to determine the desired attributes of the ENFit products. The group also created and reviewed current state and future state process maps to evaluate potential risks in the new workflow and identify corresponding mitigation strategies. The team determined the resources it would generate as part of its charter, which would include an SBAR (Situation, Background, Assessment, Recommendation) document, frequently asked questions (FAQ) resource, and executive summary slides. The supply chain members of the team created a supplier matrix, displaying which ENFit products were available from vendors contracted with the organization. The committee was also tasked with determining a measurement of compliance with the conversion to ISO 80369-3. The team’s recommendations and resources were subsequently advanced through the health system's formal clinical initiative approval process.
Results: The desired attributes and supplies agreed upon by the team included characteristics of the ENFit syringes: display metric units only, range in size from 0.5mL to 60mL, and availability in an amber color. To minimize workflow changes, the group recommended that ENFit syringes replace oral syringes for oral administration of liquid medications. Based on the expectation that patients would still be admitted with “legacy” feeding tubes after implementation of the ENFit system, the team agreed that availability of adapters would be necessary to allow use of ENFit syringes with legacy feeding tubes. To assist with safely discharging patients with a newly inserted ENFit feeding tube, the team created a patient discharge instruction sheet. This document contained information for the patient’s tube feeding supplies and included recommendations for patient communication with outpatient services. The group also identified resource documents on appropriate cleaning of feeding tubes and on the preparation/administration of liquid medications. The committee established a goal of implementing the ENFit enteral connection system in 50% of all the organization's hospitals by the end of June 2020 and 100% of sites by the end of June 2021, with implementation priority given to pediatric facilities and those needing to meet state/regional mandates.
Conclusion: The creation of a multidisciplinary decision team was essential in evaluating implementation of the ENFit enteral connection system. The various disciplines represented were able to help determine important product attributes to be considered when making the transition and to identify potential risks in workflow that would need to be addressed. The team also identified resources that would be helpful in adequately educating the health system's associates prior to implementation of the ENFit connector changes.