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Clinical Education and Support

ENFit Training Modules for NeoConnect

This curriculum was devel­oped as an essen­tial resource to assist clin­i­cians during tran­si­tion to ENFit, and to help enhance patient outcome by addressing essen­tial topics such as:

  • Compliance with GEDSA Guidelines to admin­ister low volume doses using the Low Dose Tip Syringe
  • Impact of the moat during small volume doses to preserve dose accu­racy
  • Identifying protocol changes
  • Maintaining current processes
  • Enhancing produc­tivity
  • Maximizing ease of use
  • Feeding tube hub cleaning proce­dures that support ASPEN recom­men­da­tions

Click here to sign up for access to our ENFit Training Modules for NeoConnect and other resources.

ENFit Resources

ENFit Connector Conversion Schedule Released

The Global Enteral Device Supplier Association (GEDSA) announced that member manu­fac­turers will phase out legacy feeding devices and tran­si­tion adap­tors starting July 1st, 2020 in order to comply with guid­ance from the U.S. Food and Drug Administration (FDA), Joint Commission and Centers for Medicare & Medicaid Services (CMS) to reduce medical tubing miscon­nec­tions and improve patient safety.


GEDSA Position Statement on the FDA's Letter to Healthcare Providers

  • GEDSA fully supports the recent letter on "The Use of Enteral Device Connectors that Reduce Risk of Misconnection and Patient Injury" issued by the FDA on September 7, 2018.
  • GEDSA expects this letter to serve as a cata­lyst for accel­er­ated U.S. market adop­tion of safer, compliant connec­tors, as defined by the International Standards Organization (ISO) 80369-3, commonly known as ENFit.
  • GEDSA and its supporting orga­ni­za­tions urge manu­fac­turers, distributors/suppliers and health­care providers to actively partic­i­pate in the adop­tion of new ENFit connec­tors as called for in the FDA's letter.
  • GEDSA plans to imme­di­ately estab­lish a task force with health­care providers and patient orga­ni­za­tions to develop a coor­di­nated phase out plan for connec­tors that do not meet ISO 80369-3, to accel­erate adop­tion.
  • All hospi­tals and clin­i­cians are encour­aged to work with their supplier repre­sen­ta­tives to align on a tran­si­tion date, provide training and secure supply of ENFit feeding devices.

Click Here for Full GEDSA Position Statement

Click Here for FDA Letter

GEDSA Releases November 2017 Guidance Document Supporting ISO 80369-3 ENFit

GEDSA’s latest guid­ance docu­ment intro­duces several new clin­ical recom­men­da­tions that are key to successful ENFit tran­si­tions, including:

  • “For accu­rate enteral dosing of small doses, syringe sizes of 5 mL or smaller require an ENFit Low Dose Tip (LDT) Syringe design.”
  • “Transition connec­tors were only intended to be tempo­rary. To ensure compat­i­bility without the long-term use of adapters, GEDSA does not support the use of propri­etary connec­tors or any current or proposed male to female connec­tors.”
  • “Male ENFit connec­tors by design have a moat outside of the fluid path where fluid can build up. ENFit feeding tubes may be hard to keep clean. As with any feeding tube, proper tube main­te­nance is essen­tial.”

NeoMed’s line of ENFit solu­tions complies with all three recom­men­da­tions above by offering ENFit LDT syringes from 0.5 mL to 6 mL, an adapter-free system, and a cleaning tool used with our ENFit open floor hub feeding tube.

August 2016 GEDSA Position Statement

As a summary of previous Position Statements, GEDSA re-emphasizes recom­men­da­tions saying, “Performance testing conducted by an accred­ited third party lab and usability studies conducted throughout the world confirm the ENFit LDT syringe when used as instructed:

  • Delivers an accu­rate dose substan­tially equiv­a­lent with current male orien­tated enteral/oral syringes.
  • Outperforms existing female (reverse) orien­tated syringes.
  • Fits into current prac­tice and main­tains compat­i­bility with other ENFit devices

Furthermore, the August GEDSA Position Statement recom­mends: “GEDSA and its supporting orga­ni­za­tions including the Joint Commission, ISMP, ASHP, ASPEN, NHS, and EPSG encourage manu­fac­turers to intro­duce enteral devices with ENFit connec­tors, and health­care facil­i­ties to:

  • Adopt feeding systems with ENFit connec­tors as soon as possible.
  • Use ENFit LDT syringes to ensure accu­rate dose delivery of small volumes.
  • Work with your supplier repre­sen­ta­tive and distrib­utor network to under­stand their specific timing and product avail­ability for tran­si­tion.
  • Confirm syringe suppliers have adequate supplies of stan­dard and LDT ENFit syringes before converting to ENFit feeding tubes”

A new and signif­i­cant recom­men­da­tion is included by GEDSA:

“In order to obtain the requi­site dose accu­racy, manu­fac­turers of ENFit LDT syringes should specify in their instruc­tions for use and labeling that the syringe user should remove fluid that lies outside of the fluid path. The area between the male lumen and the outer ring (the “moat”) is not part of the fluid path and should be free of fluid. For settings that require highly accu­rate low volume doses, an ENFit LDT Syringe is recom­mended. The ENFit LDT syringe tip design satis­fies the perfor­mance expec­ta­tions for dose accu­racy, dead space, and toler­ance on grad­u­ated capacity."

July 2016 GEDSA Position Statement

According to GEDSA, “to ensure small volume dosing accu­racy, syringe sizes of 5 mL or smaller may require an ENFit Low Dose Tip Syringe design.” NeoMed is the only ENFit vendor offering a compre­hen­sive line of ENFit Low Dose Tip syringes from 0.5 mL to 6 mL neces­sary to comply with GEDSA’s guid­ance docu­ment recom­men­da­tions. Choosing a vendor that does not offer a wide range of ENFit Low Dose Tip syringe sizes (including amber and clear) risks system­atic dosing inac­cu­ra­cies beyond the accept­able range for medica­tion delivery.

April 2016 ENFit Low Dose Tip Syringe Review

ECRI Top 10 Health Technology Hazards for 2018

1. Ransomware and Other Cybersecurity Threats to Healthcare Delivery Can Endanger Patients

2. Endoscope Reprocessing Failures Continue to Expose Patients to Infection Risk

3. Mattresses and Covers May Be Infected by Body Fluids and Microbiological Contaminants

4. Missed Alarms May Result from Inappropriately Configured Secondary Notification Devices and Systems

5. Improper Cleaning May Cause Device Malfunctions, Equipment Failures, and Potential for Patient Injury

6. Unholstered Electrosurgical Active Electrodes Can Lead to Patient Burns

7. Inadequate Use of Digital Imaging Tools May Lead to Unnecessary Radiation Exposure

8. Workarounds Can Negate the Safety Advantages of Bar-Coded Medication Administration Systems

9. Flaws in Medical Device Networking Can Lead to Delayed or Inappropriate Care

10. Slow Adoption of Safer Enteral Feeding Connectors Leaves Patients at Risk

March 2017 ECRI ENFit Alert and Guidance

ECRI Institute, an inde­pen­dent nonprofit orga­ni­za­tion that researches the best approaches to improving patient care, released an Alert and Guidance on preventing enteral tubing miscon­nec­tions Critical Notice–Avoid Fatal Misconnections with ENFit-compliant Feeding Tube Connectors. Included in the exec­u­tive summary, ECRI states “ECRI Institute believes that facil­i­ties should move to the new connec­tors as soon as practicable—ideally, by the end of 2017.” As an orga­ni­za­tion committed to patient safety initia­tives, this time­line will have substan­tial influ­ence in all hospital tran­si­tion time­lines. ECRI also states:
"There are many different styles, sizes, and config­u­ra­tions of enteral feeding devices produced by multiple manu­fac­turers. The use of ENFit connec­tors will stan­dardize the connec­tion between all enteral devices, helping to ensure that enteral connec­tors will fit only with each other, and not with other connector types."

August 2016 ISMP Medication Safety Alert: Low Dose Enteral Syringe Tip Gets FDA Clearance

"NeoMed devel­oped the low dose tip to address an earlier industry-wide problem concerning ENFit syringe dead­space and the asso­ci­ated concerns with dose accu­racy when admin­is­tering small volumes of medica­tions. NeoMed has offered all syringe manu­fac­turers royalty-free access to the design. Thus, other compa­nies are now adopting this low dose tip design…The NeoMed 510(k) clear­ance includes enteral and oral use of its syringes. The ability to utilize a low dose or stan­dard ENFit syringe for both oral and enteral delivery of liquid medica­tions means that a facility may not neces­sarily have to main­tain a sepa­rate inven­tory of oral syringes once they tran­si­tion to ENFit."

April 2016 ISMP Medication Safety Alert: Another twist in the ENFit imple­men­ta­tion process

  • An April ISMP Medication Safety Alert expressed concerns about BD's exit from the ENFit initia­tive.
  • "The BD action is counter to what we had hoped would happen—a single, new enteral system to prevent catheter mix-ups with vascular lines. While either of the new devices will accom­plish this, it is also predictable that there will be compat­i­bility prob­lems when patients transfer from one health­care provider to another, or when they are admitted to a hospital with an existing enteral feeding system different than that used by the hospital.”

August 2014 Joint Commission Sentinel Event Alert: Managing risk during tran­si­tion to the new ISO tubing connector stan­dards

The Joint Commission’s recom­men­da­tion targets tempo­rary adapters for the purpose of miti­gating the risk of poten­tial miscon­nec­tions from use of adapters, addi­tional priming volume, handling, and costs all linked to the use of adapters.

Some ENFit suppliers that do not offer a complete ENFit solu­tion are advo­cating the use of adapters to mask gaps in ENFit product offer­ings. Healthcare facil­i­ties should seek out ENFit vendors that can offer a complete ENFit solu­tion without the use of any adapters in accor­dance with Joint Commission recom­men­da­tions.

  • Eliminate the use of tempo­rary adapters as soon as possible.
  • Don’t force connec­tions, and avoid workarounds. Forced connec­tions or workarounds could indi­cate that the connec­tion should not be made.

NeoConnect with ENFit Connector port­folio of prod­ucts are designed to miti­gate the need for any adapter.

Other suppliers (off-brand) provide adapters to enable legacy syringe use with ENFit feeding tubes.  This increases the risk for dosing inac­cu­ra­cies, choking hazards, and workarounds.  Also, adapters add up to 0.3 mL priming volume to the system, poten­tially impacting the dosing accu­racy beyond what is clin­i­cally accepted.

Pharmacy Resources

2016-2017 ISMP Targeted Medication Safety Best Practices for Hospitals

  • In Best Practice 5 (page 4), the ISMP recom­mends only using the metric scale to avoid dosing mix-ups. NeoMed Pharmacy syringes only display mLs to comply with this impor­tant safety prac­tice.

“ISMP has received more than 50 reports of mix-ups between milli­liter (mL) and house­hold measures such as drops and teaspoon­fuls, some leading to injuries requiring hospi­tal­iza­tion. Oral syringes, dosing cups, drop­pers, and other measuring devices have been involved. Use of the apothe­cary system has also caused confu­sion with mix-ups between drams and mL and other non-metric measure­ments such as ounces and table­spoons.”

2009 Hospital Pharmacy Special Feature Light Sensitive Oral Prescription Drugs

NeoMed offers a full line of amber oral/enteral syringes from 0.5 mL to 60 mL, including Low Dose Tip designs in 0.5, 1, 3, and 6 mL to help protect light-sensitive medica­tions and main­tain current poli­cies and proce­dures. Sterile amber syringes are avail­able for in-house sterile compounding.

2016 AAP Policy Statement on Metric Units

  • “Orally admin­is­tered liquid medica­tions should be dosed exclu­sively by using metric-based dosing with milli­liters (ie, mL) to avoid confu­sion and dosing errors asso­ci­ated with common kitchen spoons…”
  • “Pharmacies, hospi­tals, and health centers should distribute appropriate-volume milli­liter based dosing devices with all orally admin­is­tered liquid medica­tions…”
  • “Syringes…are the preferred dosing device for admin­is­tering oral liquid medica­tions.”
  • “Dosing devices should not bear extra­neous or unnec­es­sary liquid measure mark­ings that may be confusing to care­givers.”
  • “Manufacturers should elim­i­nate labeling, instruc­tions, and dosing devices that contain units other than metric units.”

Neonatal, Pediatric, and Adult Best Practices and Recommendations

ADA Guidelines for Preparation of Human Milk and Formula in Health Care Facilities

  • "When avail­able, closed system admin­is­tra­tion sets should be used."
  • "Human milk and formulas should be prepared using aseptic tech­nique."
  • "To prevent cont­a­m­i­na­tion of milk during prepa­ra­tion, aseptic tech­nique in handling milk should be used."

2016-2017 ASPEN Safe Practices for Enteral Nutrition Therapy

  • Given the imma­ture immune system of NICU infants, an impor­tant ques­tion is whether an indwelling feeding tube increases the risk of infec­tion in these infants and if the frequency of feeding tube change can alter this risk. Indwelling feeding tubes in infants in the NICU have been shown to be a reser­voir for patho­logic, even antibiotic-resistant bacteria."
  • “In one study, 5-researchers cultured 125 feeding tubes from 50 preterm infants and demon­strated that only 8 of the 125 feeding tubes had cultures that were completely nega­tive. Thus, 94% of the feeding tubes were colo­nized with bacteria, and 57% of them were colo­nized with greater than 1000 colony forming units per tube."
  • "Most impor­tantly in this study, preterm infants who had cont­a­m­i­nated feeding tubes were more likely to exhibit episodes of feeding intol­er­ance, have inad­e­quate weight gain and develop necro­tizing ente­ro­col­itis (NEC)…Studies have demon­strated that some tubes had organ­isms isolated from them as early as six hours after place­ment."

Summer 2017 Neonatal Intensive Care Prolacta Case Study

  • This case study docu­ments obser­va­tions of a 100 bed NICU before and after converting to the NeoMed Enteral Safety System after imple­menting Prolacta
  • The case study explores key issues such as priming volume, syringe tip dead space, and secu­rity of connec­tions

How Syringe Choice Can Reduce Fat Loss in Human Breast Milk

  • In late 2013, NeoMed spon­sored a limited inde­pen­dent compar­ison of HBM fat loss in three syringes.  The results of this compar­ison demon­strated a statis­ti­cally lower fat loss in off-center tip syringes with solid plunger/piston design.
  • The white paper inves­ti­gates the impact of syringe design on lipid loss, and thus on NEC and BPD. The study contrasts syringes designed with concen­tric (centered) tips and conical rubber plunger heads against syringes designed with eccen­tric (off-center) tips and solid polypropy­lene plunger heads.
  • Syringes with an off-center tip and solid polypropy­lene plunger heads have the lowest fat loss, aver­aging only 6% compared to syringes with centered tips and black elas­tometer piston/plunger assem­blies, which had up to 22% lipid loss.

2015 Microbial Biofilm on Neonatal Feeding Tubes

"The risk of the increased and repeated expo­sure to bacte­rial cells from the colo­nized enteral feeding tube is not only due to the state of the neonates immune system and the lack of a compet­i­tive intestinal microflora,  but also due to the ability to resist host defenses and antibi­otics."