Problem: Tubing misconnections, or inappropriate connections between devices with different intended uses, have resulted in serious harm or death.1,2 In Part I, published in our October 31, 2024 newsletter, we shared results from a recent survey by a group of clinical advisors working in coordination with the Global Engineered Device Supplier Association (GEDSA). The survey revealed that misconnections are common and likely underreported externally. The best solution to prevent misconnections is to eliminate the potential for interconnectivity between various types of medical tubing. Currently, a series of standards developed by the International Organization for Standardization (ISO), known as the ISO 80369 series (Figure 1), address misconnections among the different systems. These standards create unique connectors for each system, making them mechanically incompatible with one another. This reduces the risk of harmful and even fatal misconnections between these systems, in which medical tubing, syringes, or other medical devices have inadvertently connected to one another. The recognized standards have been evaluated by the US Food and Drug Administration (FDA), and manufacturers are encouraged to apply these standards to medical devices, as appropriate.
Figure 1. The ISO 80369 series has unique tubing connectors for each system that are incompatible with one another. Photo courtesy of GEDSA (www.stayconnected.org).
Safe Practice Recommendations: The survey data showed that tubing misconnections are not uncommon and continue to present a risk to patient safety, so assume this may be a risk within your organization and do not wait until an event occurs to take action. Consider the following recommendations:
Promote a culture of safety and learning. Promote and implement a fair and Just Culture (www.justculture.com), where safety is a primary value in the organization and staff continually look for risks that pose a threat to patient safety. Incorporate policies about error reporting that align with a Just Culture. Routinely meet with practitioners to discuss concerns related to tubing misconnections and foster increased communication and feedback. Regularly ask staff about safety issues and exhibit appreciative listening. Maintain confidentiality of those involved in misconnection events while sharing event details and lessons learned. For additional information, see our July 11, 2024, newsletter article, Cultivate discussions in a psychologically safe workplace—Part I.
Plan for device conversion. The ISMP Targeted Medication Safety Best Practices for Hospitals, Best Practice #4, calls for organizations to ensure that all oral liquid medications that are not commercially available in unit dose packaging are dispensed by the pharmacy in an oral/enteral syringe that meets the ISO 80369 standard. If not already done, leaders should make it an organizational priority to convert to ENFit devices as soon as practical. In addition, as we expect NRFit devices to become more readily available in the near future, leaders should begin evaluating the feasibility of converting to NRFit devices. As mentioned in Part I, GEDSA will be hosting an NRFit webinar with practitioners from Gillette Children’s on November 20, 2024 (NRFit - Improving Patient Safety - presented with the first US clinicians to adopt NRFit: register here). We encourage practitioners to attend the webinar and learn from Gillette Children’s about how to overcome challenges when planning the transition to NRFit devices within your organization.
Identify key stakeholders. Organizations should understand the scope of transitioning to new devices (e.g., ENFit, NRFit). This is not just a single department (e.g., pharmacy, nursing, anesthesia) initiative but requires stakeholders from across the organization. Gather a multidisciplinary transition team composed of prescribers and specialists (e.g., surgery, anesthesiology, emergency department, gastrointestinal, oncology), pharmacists and pharmacy technicians (inpatient and outpatient), nurses, dietitians, respiratory therapists, risk management, educators, case management, materials management, and outpatient clinic staff.
Complete an FMEA. Prior to transitioning to ENFit and NRFit devices within your organization, the team should complete a failure mode and effects analysis (FMEA) to identify and address potential failure modes. Assess the potential for tubing misconnections with medical devices, connectors, and tubing used in your facility, including those reported in the literature, and determine mitigation strategies.
Partner with device vendors. It is important to partner with device vendors to understand what products your organization will need based on your patient population. Create a list of current products (i.e., legacy products) and complete a crosswalk to understand what new products (e.g., ENFit, NRFit) will be needed. Organizations should plan for one device system (e.g., ENFit) conversion prior to transitioning to the next (e.g., NRFit).
Evaluate products. Once you have a list of the needed products, bring in samples including all syringe sizes and product variations such as ENFit bottle adaptors in different diameters. Have practitioners test the products so any issues and concerns can be addressed prior to going live. GEDSA has tool kits for ENFit and NRFit devices which are available for a nominal fee. Also work directly with device vendors to understand potential problems that other organizations have reported to prevent them within your organization.
Use simulation. Before implementing ENFit and NRFit devices, use simulation to evaluate the system. Simulate the workflow to test what does and does not work, gain crucial feedback from frontline staff, and identify any potential safety gaps. Consider holding “a day in the life” with a diverse group of end users to run real-life simulations to see how the devices work in your clinical settings. Evaluate all devices practitioners may use and ask end users to identify vulnerabilities. Discuss concerns with the team so they can correct any issues before implementation.
Designate resources. Leaders should provide support for staff before, during, and after the conversion. Routinely meet with end users to discuss the rollout, enhance communication, and gather feedback. Have the device vendors available for question and answer sessions.
Maintain an adequate supply of devices. Purchase, store, and maintain an adequate supply of devices (e.g., ENFit syringes) in all patient care areas where oral/enteral medications may be prepared or administered. Pharmacy should verify the syringes are in stock and readily available during monthly unit inspections. In our experience, even in hospitals that are committed to stocking ENFit syringes, they are not consistently used because they are not always available.
Educate practitioners. During orientation and annual competency assessments, educate staff to verify the access point and trace the line toward the insertion site/cuff before any connection is made. Review tubing connections during bedside handoff, at the change of shift, and during patient rounds. Take every opportunity (e.g., huddles, newsletters) to communicate the rationale behind using ENFit and NRFit devices as a forcing function to prevent wrong-route misconnections. During orientation stress that parenteral syringes should never be used to prepare or administer oral liquid medications and reinforce this practice on a regular basis. This information is not routinely included as part of the academic curricula for healthcare practitioners, nor does this safety issue appear in fundamental textbooks used by many academic settings. Hospital orientation may be the first time a new practitioner hears about this risk.
Plan for discharge and outpatient care. Assess all steps in the continuum of care to determine patient supply needs. If your organization is sending prescriptions to outpatient pharmacies for dispensing, learn what products the pharmacies will supply so that you know how to support patients. If your organization's outpatient pharmacy carries both legacy oral syringes and ENFit syringes, and pharmacists can access the electronic health record (EHR), use the EHR to confirm the route of administration and the device that should be used.
Educate patients. Educate patients about the type of devices they will need so they understand how to safely administer their medications. Prior to hospital discharge, and when patients are picking up medications at outpatient pharmacies, staff should confirm the route of administration (e.g., oral, enteral) to ensure patients have access to the correct products. If planning for ENFit device transition, notify patients (e.g., through the patient portal) well in advance of conversion.
Report and learn from errors. Encourage staff to report close calls and errors involving tubing misconnections internally. Share reports with device manufacturers, ISMP, and the FDA. Educate staff that the goal is to increase reporting, so actions can be taken to improve system reliability. Review internally reported errors as well as published external events. During safety huddles, share impactful stories and recognize staff for good catches, including those prevented through use of ENFit or NRFit devices. Communicate the meaningful impact of implemented changes that resulted from error reporting.
Additional Resources
- Global Engineered Device Supplier Association’s (GEDSA’s) website and ENFit Pharmacy Resource Guide
- Call to Action: Experience in Adopting the ENFit System to Guard Against Accidental Tubing Misconnections
- FDA "Examples of Medical Device Misconnections"
- Ethington S. Five tips for smooth adoption of safer enteral connectors. Nebraska Medicine’s ENFit conversion designed to improve patient safety. PSQH website. Published April 26, 2021. Accessed August 30, 2024.
- Larimer C, Reddick C. Making connections: practical transition techniques from legacy to ENFit enteral feeding tubes [White paper]. Salt Lake City, UT: Moog Medical. 2023. Accessed August 30, 2024.
- Institute for Safe Medication Practices (ISMP). NRFit: A global “fit” for neuraxial medication safety. ISMP Medication Safety Alert! Acute Care. 2020;25(14):1-4.
References
- Simmons D, Symes L, Guenter P, Graves K. Tubing misconnections: normalization of deviance. Nutr Clin Pract. 2011;26(3):286-93.
- Ethington S, Volpe A, Guenter P, Simmons D. The lingering safety menace: a 10-year review of enteral misconnection adverse events and narrative review. Nutr Clin Pract. 2024;39(5):1251-58.
Suggested citation:
Institute for Safe Medication Practices (ISMP). Take action to prevent tubing misconnections – Part II. ISMP Medication Safety Alert! Acute Care. 2024;29(23):1-4.
