Two deaths, 24 serious injuries and 32 device malfunctions. Those are the number of reports received by the U.S. Food and Drug Administration (FDA) since 2011 related to enteral device misconnections. And despite the educational and awareness efforts of many organizations, misconnections continue to occur.
Medical device misconnections, a mistaken connection among medical devices that perform very different functions, are believed to be significantly under reported and oftentimes, may not be reported at all. When a misconnection occurs, the results for some patients have been catastrophic:
- A feeding tube connected to a ventilator suction catheter causing food to get into a patient’s lungs, resulting in death
- A peripheral infusion connected to a blood pressure cuff delivering air into a patient’s bloodstream, causing death
- An intravenous infusion connected to a nasal cannula, where a patient suffered congestive heart failure, but (thankfully) survived
So, imagine an alternative which could have reduced the risk of the misconnection scenarios mentioned above; an enteral device connector that meets the International Organization for Standardization (ISO) standards for small-bore connectors for liquids and gases, as well as standards for specific design and test requirements for enteral connectors. On Sept. 7, 2018, the FDA released a statement encouraging the use of such an alternative: ENFit®.
In its letter, the FDA advises health care professionals to use enteral devices that meet new ISO design standards, reduce the use of transition adaptors and avoid changing devices from their intended, approved use. Purchasers and distributors are encouraged to purchase ISO-compliant connectors and to have adequate supplies of compliant devices in stock. You can see the entire list of the FDA’s recommendations by clicking here.
Since the introduction of the new standards for using enteral connectors, I have collaborated with several member health systems as they have made the conversion from the old enteral connectors to the new ENFit connectors. While all took a slightly different path, there were some consistent steps that stood out.
The importance of leadership support
Organizational and leadership support signals an effort to foster and improve a culture of safety and it increases awareness of the need to reduce device misconnection risk throughout the organization. It also helps to ensure the availability of dedicated resources required for success. Additionally, leadership support can help eliminate any obstacles encountered during the research and implementation phase as well as to sustain ongoing success of this very important patient safety initiative.
Designate a conversion/implementation team lead
Select an individual within your organization who can lead the charge in ensuring a proper and safe implementation of the ENFit connectors. This team lead will be responsible for managing the project timeline, identifying the necessary interdisciplinary team members, organizing team meetings and communicating with leadership, the implementation team and employees across the organization.
Develop and convene an interdisciplinary group
The impacted product scope of enteral connectors crosses many departments and care delivery areas. Therefore, it is imperative that relevant stakeholders are represented and engaged in the research, planning and implementation of ENFit connectors. Examples of disciplines include but are not limited to, supply chain (purchasing, materials), case management, nursing, dietary, pharmacy, home care and outpatient care. Consider reaching out to supplier/manufacturer and distributor partners to gain their perspective on health care facilities using ENFit. The group should meet regularly to discuss the status of the implementation plan and other pertinent information.
Identify team champions
A team champion from each stakeholder group should be identified. This person will be responsible for attending regularly scheduled meetings and communicating relevant information to the internal group and disseminating information back to their respective teams and departments. The team lead also will be responsible for updating their section of the implementation plan with status changes and updates.
Communication is key
Vizient members who made the transition to ENFit connectors all agree that frequent, ongoing communication is integral to a successful conversion. Additionally, communication is key to sustaining a focus on device connection safety after the conversion is made.
Misconnections between tubing and medical devices—whether it’s a feeding tube or a ventilator suction—has led to serious injury and loss of life. With a dedicated conversion/implementation group and a comprehensive implementation plan, converting to the ENFit connector system at your medical facility should reduce the risk of medical tubing misconnections in the enteral connector space. For more information and resources, please visit stayconnected.org, or you may email us with your questions about the new connector standards at ENFitQuestions@vizientinc.com.
