SafetyShare® newsletter brought to you by the Premier Safety Institute®
March 1, 2015
U.S. moves forward, FDA releases guidance for enteral standards for medical tubing connectors
In recognition of Patient Safety Awareness Week,
SafetyShare is focusing on an important safety issue for patients,
families, care providers, pharmacists, and supply chain professionals –
preventing serious and sometimes fatal consequences from tubing misconnections. A new design standard for enteral nutrition products is on its way. The ENFit connector has been designed just for enteral nutrition products and will not fit into any other ports, such as IV ports, reducing the risk of misconnections between devices that have different intended uses.
Patient Safety Awareness Week March 8 – 14.
Visit NPSF website for more information
The use of common connector designs, such as Luer connectors, has led to unintended misconnections between devices that have different intended uses and
has resulted in serious and sometimes fatal consequences to patients.
The U.S. has moved forward with an AAMI1 / ANSI2 provisional standard for small bore connectors for enteral applications without
waiting for final approval of the international standard from ISO3. These new standards are designed to reduce the risk of unintended
connections between enteral and non-enteral devices. The FDA4 has also recognized the newly published provisional standard so that manufacturers
can begin production and distribution of products that contain the new enteral ENFit connectors, in time to meet the California deadline requiring these
products by January 1, 2016. FDA has released final guidance for industry:
Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications
New enteral products available in 2015
The new enteral products with ENFit connectors are expected to be released throughout 2015 and include transition feeding administration sets,
enteral-specific syringes, and new enteral feeding tubes. A complete timeline is available
at www.stayconnected2015.org. The enteral connector standard is one of the first in a series of new global
design standards being developed for medical tubing connectors or small bore connectors to prevent misconnections.
What does this mean for hospitals and other providers?
As ISO works to finalize the entire series of standards, healthcare providers need to prepare for the implementation of new connectors, first for enteral
and then for neuraxial and respiratory devices. Transitions will begin early this year with enteral feeding and the new ENFit connector. The purpose of the
new design standards is to ensure that connectors do not fit into ports other than the type for which they are intended, reducing the risk of serious or
often fatal consequences of misconnections. These standards and new connectors have broad implications across the entire supply chain and continuum of
patient care settings.
Prepare for the transition
The first key component to prepare for the transition is to develop a cross-functional, multidisciplinary team charged with creating an organization
specific plan. This team will need to assess processes and protocols that may need to change as a result of the new connectors; inventory current products
and prepare for the transition to new products; train clinicians and materials management staff; and work with suppliers to ensure a smooth transition to
new enteral products that include the ENFit connector. Help is available. Transition checklists developed by GEDSA5 are included in this
newsletter, as well as links to additional resources.
- Transition checklists from GEDSA5
- Premier Safety Institute
- Additional resources and timelines from GEDSA
1. Association for the Advancement of Medical Instrumentation (AAMI)
2. American National Standards Institute (ANSI)
3. International Standards Organization (ISO)
4. U.S. Food and Drug Administration (FDA)
5. Global Enteral Device Supplier Association (GEDSA)