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.
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.
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
- On April 13, 2016, GEDSA made available a summary of the performance testing for the low dose syringe tip design.
- The summary of independent data validates that the NeoMed syringe design meets or exceeds the delivery accuracy of existing oral syringes in the marketplace.
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.
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."