Presentation
A Proactive Safety Approach for New Product Implementation: A Comprehensive FMEA of the ENFit™ Tube System with Human Factors Recommendations using the SEIPS Model
SessionMethods & Perspectives (PS8)
DescriptionTopic: The Human Factors, Patient Safety, Quality Improvement, and Simulation teams at the Children’s Hospital of Philadelphia (CHOP) proactively evaluated the hospital’s switch from a legacy tube connection to a new enteral tube system, known as ENFit™. Staff workflows across multiple units and entities across the hospital were assessed using the Systems Engineering Initiative for Patient Safety (SEIPS) for facilitators, barriers, and downstream impacts. Additionally, the team conducted literature reviews, focus groups, usability testing, and a Failure Mode Effects Analysis (FMEA) for a robust analysis of the current work as done. The outcome resulted in Human Factors recommendations to hospital leadership for how to proactively adopt the ENFit™ tube system.
Background: Global Enteral Device Supplier Association (GEDSA) has developed a new type of enteral tube connection, ENFit™, which will be a required International Organization for Standardization (ISO) standard. ENFit™ is a significant change from standard slip-tip (i.e., legacy) systems, and instead utilizes a ‘twist and lock’ mechanism for enteral tube connections. Although legacy connectors are being actively discontinued, CHOP has not fully switched from legacy systems to ENFit™ unlike other institutions.
Application: A literature review of over 30 articles published between 2016 and 2022 identified cleanliness, connections, dose accuracy, process and performance, equipment fatigue, gravity flow, and necessary force as the most frequent ENFit™ article topics. Identified topics informed the team’s FMEA, which evaluated and simulated front-line user (i.e., Nurses, Physicians, Advanced Practice Providers, Nutrition, Pharmacy, Radiology, Supply Chain, Home Care and Patient Care Givers) workflows. Workflow themes centered around considerations of patients care and ENFit™ system components (e.g., various feeding tubes, enteral feeding sets, medication administration syringes, gastric decompression, cleaning of enteral feeding connections and adapters).
Overview: A robust literature review and multiple usability testing sessions with front-line clinicians using ENFit™ informed a FMEA to identify the highest risks for CHOP patient care. Front-line user group discussions, questions, and hands-on experience with ENFit™ equipment created failure modes that were then scored based on their level of risk. Overall, the user groups came up with 129 failure modes of which 13 were scored over 250 (i.e., ‘high’ by improvement industry standards) and will need immediate action prior to transitioning to ENFit™. Multidisciplinary teams analyzed the 13 highest scoring failure modes to understand the broader workflow impact and barriers at each step. Finally, the team utilized SEIPS and human factors principles to illustrate barriers, predict how the impact of system elements, and inform mitigation strategies prior to the ENFit™ switch. Some concerns that could not be mitigated, such as the proximal location of the ENFit™ tube “breakaway” point, were recorded and reported to hospital leadership.
Take Away Points: An impending switch from legacy to ENFit™ enteral connections resulted in a robust, multidisciplinary approach to proactively identify patient and staff safety concerns. High risks and impacts to user workflows were identified for ENFit™ prior to a systemwide change to enteral tube by utilizing relevant literature, clinical feedback, simulations, and human factors principles. Using human factors to proactively illustrate safety concerns for new systems, such as ENFit™, provides front-line staff and leadership a comprehensive and realistic set of expectations for the ‘work as done’ for the new system.
Background: Global Enteral Device Supplier Association (GEDSA) has developed a new type of enteral tube connection, ENFit™, which will be a required International Organization for Standardization (ISO) standard. ENFit™ is a significant change from standard slip-tip (i.e., legacy) systems, and instead utilizes a ‘twist and lock’ mechanism for enteral tube connections. Although legacy connectors are being actively discontinued, CHOP has not fully switched from legacy systems to ENFit™ unlike other institutions.
Application: A literature review of over 30 articles published between 2016 and 2022 identified cleanliness, connections, dose accuracy, process and performance, equipment fatigue, gravity flow, and necessary force as the most frequent ENFit™ article topics. Identified topics informed the team’s FMEA, which evaluated and simulated front-line user (i.e., Nurses, Physicians, Advanced Practice Providers, Nutrition, Pharmacy, Radiology, Supply Chain, Home Care and Patient Care Givers) workflows. Workflow themes centered around considerations of patients care and ENFit™ system components (e.g., various feeding tubes, enteral feeding sets, medication administration syringes, gastric decompression, cleaning of enteral feeding connections and adapters).
Overview: A robust literature review and multiple usability testing sessions with front-line clinicians using ENFit™ informed a FMEA to identify the highest risks for CHOP patient care. Front-line user group discussions, questions, and hands-on experience with ENFit™ equipment created failure modes that were then scored based on their level of risk. Overall, the user groups came up with 129 failure modes of which 13 were scored over 250 (i.e., ‘high’ by improvement industry standards) and will need immediate action prior to transitioning to ENFit™. Multidisciplinary teams analyzed the 13 highest scoring failure modes to understand the broader workflow impact and barriers at each step. Finally, the team utilized SEIPS and human factors principles to illustrate barriers, predict how the impact of system elements, and inform mitigation strategies prior to the ENFit™ switch. Some concerns that could not be mitigated, such as the proximal location of the ENFit™ tube “breakaway” point, were recorded and reported to hospital leadership.
Take Away Points: An impending switch from legacy to ENFit™ enteral connections resulted in a robust, multidisciplinary approach to proactively identify patient and staff safety concerns. High risks and impacts to user workflows were identified for ENFit™ prior to a systemwide change to enteral tube by utilizing relevant literature, clinical feedback, simulations, and human factors principles. Using human factors to proactively illustrate safety concerns for new systems, such as ENFit™, provides front-line staff and leadership a comprehensive and realistic set of expectations for the ‘work as done’ for the new system.
Event Type
Oral Presentations
TimeWednesday, March 278:52am - 9:15am CDT
LocationSalon A-3
Patient Safety Research and Initiatives