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NeoMed Supports FDA Letter Encouraging Use of Enteral Connectors that Reduce Risk of Misconnection

On September 7, 2018, the FDA issued a letter titled “The FDA Encourages Use of Enteral Device Connectors that Reduce Risk of Misconnection and Patient Injury.” The letter was addressed to all manu­fac­turers of enteral feeding tubes, health care profes­sionals, hospital purchasing depart­ments, and distrib­u­tors. Within the letter, the FDA refer­ences many inci­dences of enteral device miscon­nec­tions and expresses the need for hospi­tals and clin­i­cians to tran­si­tion to safer enteral device connec­tors, including ENFit®, which is a signif­i­cant step forward to help improve patient safety.

In the letter the FDA states, “The U.S. Food and Drug Administration (FDA) is concerned by continued reports of miscon­nec­tions with enteral devices. To reduce the risk of miscon­nec­tions and patient injury, the FDA recom­mends hospi­tals and clin­i­cians use enteral devices with connec­tors that meet the International Organization for Standardization ISO 80369-1 or ISO 80369-3 stan­dard, or that are other­wise designed to reduce the risk of miscon­nec­tions. There are currently marketed enteral connec­tors that meet the 80369-3 stan­dards, many of which are iden­ti­fied by the trade­name ENFit®.”

As health­care facil­i­ties and profes­sionals imple­ment FDA recom­men­da­tions, it is essen­tial to under­stand the distinc­tion between ISO 80369-1 and ISO 80369-3 (commonly iden­ti­fied as ENFit). Below are frequently asked ques­tions to help you recog­nize the differ­ences between ISO 80369-1 and 80369-3, and to empha­size the impor­tance of timely adop­tion of ISO 80369-3 as supported by GEDSA, the Institute for Safe Medication Practices (ISMP), ASPEN, and ECRI.

  1. What is the difference between ISO 80369-3 and ISO 80369-1?

ISO 80369-3 is the specific stan­dard for small-bore enteral connec­tors. It defines the dimen­sions and require­ments for the design and func­tional perfor­mance of connec­tors used on enteral delivery and access devices.  ISO 80369-3 is the only stan­dard that is asso­ci­ated with the term ENFit.

 ISO 80369-1, first published in 2010, discusses general require­ments for small-bore connec­tors for liquids and gases across multiple routes of admin­is­tra­tion. It estab­lishes method­ology to assess non-interconnectable             char­ac­ter­is­tics, but it does not provide dimen­sional spec­i­fi­ca­tions for any connector.  Enteral devices that claim compli­ance to ISO 80369-1 may not connect with other enteral devices. This stan­dard allows for                    propri­etary connec­tors that do not satisfy the require­ments of ISO 80369-3.

 ISO 80369-1 is NOT asso­ci­ated with the term ENFit.

 

  1. What is ENFit®?

ENFit is a regis­tered trade­mark commonly used to iden­tify ISO 80369-3 compliant connec­tors. All ENFit devices (syringes, admin­is­tra­tion sets, exten­sion sets, NG tubes, G-tubes, PEG, J-tubes, and acces­sories) are              connectable across manu­fac­turers because they have a stan­dard­ized direc­tion of flow. ENFit is a unique enteral-specific design that:

  • Mandates a specific direc­tion of fluid flow (female to male)
  • Supports patient safety initia­tives
  • Mitigates the risk of miscon­nec­tion with non-enteral devices
  • Provides a secure, locking connec­tion, mini­mizing inad­ver­tent discon­nec­tions

 

  1. Why is ENFit® the best choice for my hospital?

ENFit is the best choice for your hospital because it provides a simple way to reduce the risk of enteral tube feeding miscon­nec­tions and improve patient safety. ENFit device adop­tion and stan­dard­iza­tion is crit­ical for several reasons:

  • To support patient safety initia­tives
  • To ensure compat­i­bility across multiple ENFit manu­fac­turers that cover the entire enteral device ecos­phere
  • To provide common­ality and connectability for enteral devices across all patient popu­la­tions (no need for propri­etary connec­tors that are )
  • To help ensure adequate and robust supply chain through multiple vendor partic­i­pa­tion
  • To reduce the risk of back­o­rders that might arise from single source propri­etary connec­tors
  • To allow for patient porta­bility, no matter if the patient came from a facility across the street or across the world

 

  1. How can a manufacturer supply a proprietary enteral connector that meets only ISO 80369-1?

Unlike ISO 80369-3, ISO 80369-1 does not define a stan­dard­ized enteral specific connector design, and allows for a variety of propri­etary connector designs under specific condi­tions. Manufacturers must ensure their propri­etary enteral connector design is not connectable with devices intended for admin­is­tra­tion routes other than enteral as outlined in the stan­dard. This requires exten­sive risk assess­ments, engi­neering assess­ments, compat­i­bility assess­ments, human factors testing and regu­la­tory agency approval/clearance (where applic­able) prior to commer­cial distri­b­u­tion. Specifically, it requires the following shall be met:

  • Not connectable with connec­tors intended for admin­is­tra­tion routes other than enteral
  • Does not create an unac­cept­able risk for the medical device or its acces­sories
  • Is exten­sively eval­u­ated per require­ments in ISO 80369-1 to mechan­i­cally verify non-interconnectable char­ac­ter­is­tics
  • Connector must be made of rigid or semi-rigid mate­rial

Prior to using such a device, clin­i­cians should verify compli­ance by confirming that docu­mented objec­tive evidence demon­strates that risks have been reduced to accept­able levels for the accept­ability criteria spec­i­fied ISO 80369-1 and other accept­ability criteria estab­lished by the manu­fac­turer for non-interconnectable char­ac­ter­is­tics for the medical device or acces­sory. (See Section 5.8 of ISO-80369-1:2010 Part 1 General Requirements).

Manufacturers promoting ISO 80369-1 prod­ucts should be compelled to provide docu­men­ta­tion that demon­strates ISO 80369-1 compli­ance.

 

  1. Why should my hospital select NeoMed’s NeoConnect® portfolio of ENFit products?

NeoConnect is NeoMed’s branded family of ENFit prod­ucts and is the ideal ENFit product port­folio for use in all care envi­ron­ments. NeoConnect should be selected as your hospital’s ENFit vendor of choice because:

  • NeoConnect delivery and patient access devices with the ISO 80369-3 Standard
  • NeoMed has designed a compre­hen­sive port­folio of ENFit prod­ucts, including the ENFit Low Dose Tip (LDT) Syringe, open hub feeding tubes, and many inno­v­a­tive filling and dosing acces­sories for the phar­macy
  • NeoMed is an ENFit solu­tion leader with over 250 successful ENFit tran­si­tions repre­senting over 21 million admin­is­tered feed and medica­tion doses
  • The NeoConnect with ENFit Connectors product port­folio follows guide­lines and recom­men­da­tions estab­lished by The Joint Commission, GEDSA, ECRI, ISMP and ASPEN
  • NeoMed offers your facility ENFit tran­si­tion support and assis­tance programs
  • NeoMed’s secure supply chain ensures that your NeoConnect products/orders are committed to your facility and will not be diverted to another customer

In summary, NeoMed supports the FDA’s guid­ance encour­aging the use of enteral device connec­tors that reduce the risk of miscon­nec­tion and patient injury. ENFit enhances improved patient outcomes, mini­mizes the risk of miscon­nec­tion, and provides the benefit of stan­dard­iza­tion that propri­etary systems cannot offer. NeoMed encour­ages adop­tion of safer ISO 80369-3 compliant connec­tors and is dedi­cated to helping our customers with a smooth ENFit tran­si­tion using the NeoConnect port­folio. Selecting NeoMed as your ENFit tran­si­tion partner will ensure a secure supply chain, demand plan­ning, and GO LIVE manage­ment.