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BEGIN:VEVENT
DTSTAMP:20240325T185837Z
LOCATION:Salon A-3
DTSTART;TZID=America/Chicago:20240327T085200
DTEND;TZID=America/Chicago:20240327T091500
UID:HFESHCS_2024 International Symposium on Human Factors and Ergonomics i
 n Health Care_sess149_INDLEC147@linklings.com
SUMMARY:A Proactive Safety Approach for New Product Implementation:  A Com
 prehensive FMEA of the ENFit™ Tube System with Human Factors Recommendatio
 ns using the SEIPS Model
DESCRIPTION:Oral Presentations\n\nErin Pohl Donohue, Ryan Donnelly, Lauren
  Brennan, Heather Giardino, and Kim Perry (Children's Hospital of Philadel
 phia)\n\nTopic: The Human Factors, Patient Safety, Quality Improvement, an
 d Simulation teams at the Children’s Hospital of Philadelphia (CHOP) proac
 tively 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 Eng
 ineering Initiative for Patient Safety (SEIPS) for facilitators, barriers,
  and downstream impacts. Additionally, the team conducted literature revie
 ws, focus groups, usability testing, and a Failure Mode Effects Analysis (
 FMEA) for a robust analysis of the current work as done. The outcome resul
 ted in Human Factors recommendations to hospital leadership for how to pro
 actively adopt the ENFit™ tube system. \n\nBackground: Global Enteral Devi
 ce Supplier Association (GEDSA) has developed a new type of enteral tube c
 onnection, ENFit™, which will be a required International Organization for
  Standardization (ISO) standard. ENFit™ is a significant change from stand
 ard slip-tip (i.e., legacy) systems, and instead utilizes a ‘twist and loc
 k’ mechanism for enteral tube connections. Although legacy connectors are 
 being actively discontinued, CHOP has not fully switched from legacy syste
 ms to ENFit™ unlike other institutions.\n\nApplication: A literature revie
 w of over 30 articles published between 2016 and 2022 identified cleanline
 ss, connections, dose accuracy, process and performance, equipment fatigue
 , gravity flow, and necessary force as the most frequent ENFit™ article to
 pics. Identified topics informed the team’s FMEA, which evaluated and simu
 lated front-line user (i.e., Nurses, Physicians, Advanced Practice Provide
 rs, Nutrition, Pharmacy, Radiology, Supply Chain, Home Care and Patient Ca
 re Givers) workflows. Workflow themes centered around considerations of pa
 tients care and ENFit™ system components (e.g., various feeding tubes, ent
 eral feeding sets, medication administration syringes, gastric decompressi
 on, cleaning of enteral feeding connections and adapters). \n\nOverview: A
  robust literature review and multiple usability testing sessions with fro
 nt-line clinicians using ENFit™ informed a FMEA to identify the highest ri
 sks for CHOP patient care. Front-line user group discussions, questions, a
 nd hands-on experience with ENFit™ equipment created failure modes that we
 re 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 barrie
 rs at each step. Finally, the team utilized SEIPS and human factors princi
 ples to illustrate barriers, predict how the impact of system elements, an
 d inform mitigation strategies prior to the ENFit™ switch. Some concerns t
 hat could not be mitigated, such as the proximal location of the ENFit™ tu
 be “breakaway” point, were recorded and reported to hospital leadership.\n
 \nTake Away Points: An impending switch from legacy to ENFit™ enteral conn
 ections resulted in a robust, multidisciplinary approach to proactively id
 entify patient and staff safety concerns. High risks and impacts to user w
 orkflows were identified for ENFit™ prior to a systemwide change to entera
 l tube by utilizing relevant literature, clinical feedback, simulations, a
 nd human factors principles. Using human factors to proactively illustrate
  safety concerns for new systems, such as ENFit™, provides front-line staf
 f and leadership a comprehensive and realistic set of expectations for the
  ‘work as done’ for the new system.\n\nTrack: Patient Safety Research and 
 Initiatives\n\nSession Chair: Yuval Bitan (Ben-Gurion University of the Ne
 gev)
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