Lessons Learned in Switching to ENFit

December 2020 - Vol.17 No. 12 - Page #18
Category: Enteral Feeding Products

Recent innovations with enteral feeding systems to eliminate tubing misconnections have elevated patient safety standards. Momentum for change is growing and may soon significantly impact pharmacy practice in the US. The following article outlines the necessity of adoption, recent progress, and lessons learned regarding ENFit-designed products in the pursuit of safe enteral connections.

Enteral feeding systems are an essential delivery mechanism for both pediatric and adult patients who are unable to ingest adequate nutrition or medications by oral intake due to illness or physiological impairments. Dependence on enteral feeding devices is increasing. In the US, over 250,000 patients admitted to hospitals and more than 400,000 patients at home or in long-term care facilities rely on tube feeding.1 Worldwide, enteral feeding systems represent a $2.4 billion market with a projected 5.8% annual growth rate, attributed to an aging population with increasing morbidity.2

Currently, most hospitals in the US utilize “legacy” enteral feeding systems with the traditional Luer connector in a male-to-female orientation. Administration devices, such as slip-tip oral syringes, have a male connector that fits into the female connector on the feeding tube (see FIGURE 13). Legacy connectors are compatible with most delivery systems, including IV ports, catheters, and non-enteral tubing. Thus, the universal Luer connector is at an inherently high risk for misconnections, which the American Society for Parenteral and Enteral Nutrition (ASPEN) defines as “an inadvertent connection between an enteral feeding system and a non-enteral system such as an intravascular line . . . ”.4 With increasing usage of enteral feeding systems, the rate of misconnections will likely grow proportionally.

Since 2006, The Joint Commission has issued two sentinel event reports that cite over 300 misconnections, 21 of which resulted in death, when using legacy syringes.5,6 Fatal cases included enteral feeds being connected to IV ports and an epidural infusion connected to a peripheral IV line. Root cause analysis of each event implicated the universal Luer connector as the major contributing factor to these errors. As is typical with medical error self-reporting, available data on misconnections inadequately represents its prevalence.5,6

Engineering a Universal Solution

In 2010, the Association for the Advancement of Medical Instrumentation (AAMI) and the International Organization for Standardization (ISO) published the first standard, ISO 80369, for designing small bore connectors for administering liquids and gases in health care.6 This was a multi-part standard to create six unique, non-compatible connections for enteral, neuraxial, blood pressure, respiratory, intravascular, and urethral devices. ISO 80369-3 specifies the dimensions, shape, and functional requirements of enteral medical devices and accessories but does not specify the orientation of the male and female connections.7 It should be noted that ISO standards are not mandated unless enforced by the government, regulatory agencies, or individual institutions.

Given this limitation, the non-profit Global Enteral Device Supplier Association (GEDSA) was formed to advance ISO standards as endorsed by over 30 member manufacturers, suppliers, and distributors of enteral feeding systems. In 2015, GEDSA endorsed ENFit as the first royalty-free, ISO-compliant enteral system. It features a non-traditional, female-to-male setup with female administration devices fitting into a male connection on the feeding tube. ENFit is a major engineering advancement that is incompatible with Luer connections, thus eliminating misconnections.6

Adoption Delays

Despite GEDSA’s solidarity, progress with a worldwide transition from legacy to ENFit enteral feeding systems has faced delays since commencing in 2015. As of 2020, the European Union, Australia, New Zealand, and Japan are nearing 100% adoption, while the US is lagging behind significantly with less than a 30% adoption rate.8 Manufacturers were initially unable to meet anticipated demand, and once this challenge had been rectified, they faced an unenthusiastic marketplace due to reported ENFit performance issues.

The original ENFit design prompted safety concerns related to syringe dosing accuracy and ability to deliver viscous nutritional formulas, such as blenderized diets, through the tubing’s small bore.6,9 GEDSA and supporting organizations responded with extensive investigations and product modifications. ENFit syringes less than 5 mL were redesigned with a low-dose tip (see FIGURE 26) and paired with new dispensing adaptors, like transfer straws, to increase dosing accuracy and avoid inadvertent overdosing due to drug accumulation in the “moat” at the syringe tip (see FIGURE 310).

For tube feeds, patients expressed concerns that viscous formulas are difficult, if not impossible, to pass through ENFit’s small bore. However, studies by the Mayo Clinic and the FDA found that, overall, ENFit’s “flow rates may be slightly slower” than legacy systems, “but this does not pose a safety concern.”11 While challenges and solutions evolve, transition efforts continue as health systems view reduction or elimination of misconnections as the ideal state.

Incremental Momentum in the US

In 2018, the FDA formally recommended that health care systems use ISO 80369-3 compliant enteral feeding systems to reduce misconnections.11 GEDSA leveraged this position to expedite 100% ENFit adoption in the US by proposing a 2-year plan (2019 to 2021) to phase out legacy feeding devices.8 However, because no governmental or regulatory mandate is in place, select GEDSA manufacturer members have opted out of this timeline due to differing business needs. In addition, note that a health system’s decision to convert may be further complicated by recent financial stresses caused by the COVID-19 pandemic.

See the CASE STUDY6,12,13 below.

Final Thoughts

Adopting ISO-compliant enteral feeding systems is best practice.14 Although conversion can seem daunting, it is manageable. A proactive approach in engaging key decision makers, addressing known limitations, eliciting frontline feedback, and learning from your professional network makes converting more efficient. At UIHC, we are deeply grateful for the enthusiastic support from our teams and ENFit colleagues.


Felix Lam, PharmD, MBA, BCPS, is the pediatric pharmacy operations manager for University of Iowa Health Care (UIHC) in Iowa City, Iowa.

Alyce Steig, CPhT, is the pediatric pharmacy technician manager for UIHC.

Emily Spellman, MSN, RNC-NIC, is the associate director of neonatal services for UIHC.

 
Alisa Schantz, RN, is the supply chain specialist for procurement services for UIHC.

 
 

References

  1. Mundi MS, Pattinson A, McMahon MT, et al. Prevalence of home parenteral and enteral nutrition in the United States. Nutr Clin Pract. 2017;32(6):799-805.
  2. Enteral Feeding Devices Market Size, Share & Trends Analysis Report By Product (Giving Set, Enteral Feeding Pump, Gastrostomy Tube, Nasogastric Tube), By Region, And Segment Forecasts, 2019 – 2025. Grand View Research. Published April 2019. Accessed June 1, 2020. www.grandviewresearch.com/industry-analysis/enteral-feeding-devices-industry. Accessed June 10, 2020.
  3. Boston Scientific. ENFit Connector Transition Guide. www.bostonscientific.com/content/dam/bostonscientific/endo/general/gastro-specialty/BSCI_ENFit_Connector_Transition_Guide_Spreads.pdf. Accessed June 10, 2020.
  4. Enteral Nutrition Connectors and Misconnections. American Society for Parenteral and Enteral Nutrition website. www.nutritioncare.org/Guidelines_and_Clinical_Resources/Toolkits/Enteral_Nutrition_Toolkit/Enteral_Nutrition_Connectors_and_Misconnections/. Accessed May 29, 2020.
  5. The Joint Commission. Managing risk during transition to new ISO tubing connector standards. Sentinel Event Alert. 2014;20:1-6.
  6. Safe Enteral Connectors: Years of Effort that Support the Need for a U.S. Regulatory Mandate. GEDSA. Published April 3, 2019. http://stayconnected.org/wp-content/uploads/2019/03/GEDSA-White-Paper-2019-2.pdf. Accessed May 29, 2020.
  7. ISO 80369-3. Small-bore connectors for liquids and gases in healthcare applications– Part 3: Connectors for enteral applications. International Organization for Standardization. Published July 2017. https://www.iso.org/obp/ui/#iso:std:50731:en. Accessed May 29, 2020.
  8. ENFit connector conversion schedule for the US GEDSA. Published July 18, 2019. http://stayconnected.org/wp-content/uploads/2019/07/ENFit-Connector-Conversion-Schedule-for-US.pdf. Accessed June 10, 2020.
  9. ENFit enteral devices are on their way . . . Important safety considerations for hospitals. Institute for Safe Medication Practices. Published April 9, 2015. www.ismp.org/resources/ENFit-enteral-devices-are-their-wayimportant-\safety-considerations-hospitals. Accessed May 28, 2020
  10. NeoMed Inc. NeoConnect. NeoMed Oral/Enteral Syringes with ENFit Connector for Pharmacy Use; Instructions for Use. www.neomedinc.com/product/enteral-syringes-neoconnect/. Accessed June 10, 2020.
  11. The FDA Encourages Use of Enteral Device Connectors that Reduce Risk of Misconnection and Patient Injury. US Food and Drug Administration. Published September 7, 2018. www.fda.gov/media/127990/download. Accessed May 22, 2020.
  12. ENFit Transition Tip Sheet, 4th ed. GEDSA. Published April 23, 2020. Accessed June 1, 2020. https://indd.adobe.com/view/c9fe4bd3-8571-45a3-84c4-01da652e90cf. Accessed June 10, 2020.
  13. Procedure for Inpatient Settings: Preparing and Administering Medications Using ENFit. GEDSA. Published November 7, 2016. Accessed May 25, 2020. http://stayconnected.org/wp-content/uploads/2016/11/11-07-16_InfoGraphic_-Inpatients_-FINAL.pdf. Accessed May 22, 2020.
  14. Institute for Safe Medication Practices (ISMP). ISMP Targeted Medication Safety Best Practices for Hospitals; 2020. www.ismp.org/guidelines/best-practices-hospitals. Accessed June 10, 2020.

CASE STUDY

UIHC’s ENFit Implementation Journey

On a macro-level, the goal of transitioning to ENFit has gained significant support among key stakeholders that span the medical device industry, health care industry, government agencies, and patient advocacy groups. However, on the micro-level, there are logistical and operational hurdles that health systems must overcome to implement ENFit successfully.

Recently, the ENFit enteral feeding system was successfully implemented at the University of Iowa Health Care (UIHC). UIHC is a non-profit, academic medical system that includes 811 beds within two tertiary care hospitals: UI Hospital and Clinics and UI Stead Family Children’s Hospital. Initial ENFit implementation discussions began in 2014 but were paused to allow for the resolution of design challenges and disruptions within the ENFit supply chain. In 2019, UIHC determined that the market had matured enough to confidently convert. A phased-in transition ultimately occurred in January 2020 for pediatrics and February 2020 for adult patients.

In the acute care setting, ENFit products are utilized for both enteral and oral administration with the exception of 1 mL syringes remaining as a legacy product due to air bubble concerns (this issue is discussed later under Lessons Learned). Ambulatory settings utilize ENFit supplies only for patients with enteral feeding tubes and legacy products for all other patients.

Despite the challenges and disruptions to implementing this technology, UIHC remains steadfast in advancing safety for patients, caretakers, and clinicians by utilizing ENFit. While each transition journey is unique, UIHC’s lessons learned are presented to assist other institutions in the mutual mission of advancing patient care.



Forming an interprofessional steering committee comprising ambulatory and acute care physicians, nurses, supply chain personnel, dieticians, pharmacists, pharmacy technicians, and quality and safety representatives is essential for a cohesive and inclusive transition. It is also critical to engage with home care agencies within the health system and externally, if possible. Aligning ENFit practices throughout the patient care continuum will ensure consistency and a higher level of safety in all settings.

Ideally, inpatient and outpatient practice settings should transition concurrently to ensure patient care continuity. Due to unanticipated legacy supply disruptions, UIHC’s home care group converted to ENFit before the hospital, which was converting in the following months. Fortunately, there were sufficient quantities of ENFit-to-legacy adaptors in the warehouse, and inpatient clinicians were already familiar with the product. Nevertheless, this misaligned conversion had the potential to cause unnecessary stress on patient care coordination given the need to quickly source ENFit products and educate clinicians. There was the additional challenge of converting homecare patients with ENFit feeding tubes back to legacy products upon hospital admission until the hospital also converted.

It is important to determine any possible effects from external stakeholders involved with nutritional or medication management. For example, medication repackaging companies may require adequate lead time to service requests for ENFit syringes. If they do not utilize ENFit, alternate plans, such as insourced repackaging, must be considered.

When researching options, we recommend the steering committee test products from every ENFit supplier (a list of ENFit suppliers is available at: http://stayconnected.org/enteral-enfit/product-resources/). While the ENFit connector design is universal across all brands, there may be nuances in the design of accessories (eg, medication bottle adaptors, syringe caps), labeling (eg, volume markings, unit of measure), and product diversity (eg, syringe and plunger color) that may affect stakeholder safety and usability expectations. For example, UIHC pharmacy only uses amber-tinted oral syringes as a medication safety strategy to distinguish from clear IV syringes, but these syringes are not universally available. Moreover, UIHC utilizes both pop-on and screw-on syringe caps, but not all suppliers provided both options. Nurses favor the screw-on caps as they are perceived to be more secure, whereas the pharmacy team prefers the pop-on caps to minimize repetitive use injuries from preparing approximately 1500 oral syringes per day.

When possible, have frontline staff test products. This can provide practice-specific insight that may influence the conversion strategy. Initially, the UIHC steering committee only tested a handful of syringes and caps prior to selecting suppliers and a go-live date. After bulk repackaging oral medications into one hundred 1 mL ENFit syringes, UIHC pharmacists reported concerns with varying air volume introduced into the barrel after capping syringes, which creates the perception that the dose is inaccurate. The air bubbles are less significant for larger size syringes. To avoid confusion, both nursing and pharmacy agreed to exclude 1 mL ENFit syringes from conversion, concluding that both ENFit and legacy oral syringes could be safely supported. A full transition to ENFit syringes is anticipated by 2021 once a solution addressing this concern is introduced.

Per GEDSA, “ENFit caps are interchangeable with different ENFit brand syringes.”12 Based on our experience and feedback from other institutions, while caps may fit, certain combinations may work better than others. Manufacturers have and are continuing to redesign caps to address the possibility of caps coming off in the pneumatic tube system and introducing air bubbles into the syringe.12 As new caps are introduced and if multiple ENFit brands are utilized, multiple generations and types of caps may be circulating throughout the hospital. Ideally, caps and syringes of the same brand should be paired together, as mismatches may have varying performance, such as the quality of the seal with the syringe tip. Moreover, frontline teams may become confused when presented with multiple options. If your institution sources multiple brands, we recommend testing compatibility and communicating with frontline staff as to appropriate mix-and-match combinations.

According to GEDSA, European and other US hospitals have successfully adopted the full array of ENFit products, including low volume syringes, with no adverse safety events reported.6 When developing a conversion strategy, we recommend performing an internal risk-benefit analysis based on hands-on experience with ENFit products, feedback from other institutions, and assessment of current practices. Ultimately, patient and clinician safety must be at the forefront of all decisions.

To minimize frustrations due to supply disruptions, it is essential to secure at minimum a primary and secondary supplier for ENFit products. UIHC’s conversion strategy included contracting with two suppliers and storing 2 to 3 months’ worth of supplies in an offsite warehouse. When backorders occur, the strategic stockpile mitigates acute changes in product offerings to frontline clinicians and affords adequate time for communicating changes to stakeholders. As described previously, each ENFit brand product design has nuances (eg, different accessories, syringe caps, colors, labeling). Proactive education reduces confusion and increases clinician confidence in the product.

While the ENFit design eliminates misconnections, it has limitations that frontline personnel must understand and make adjustments for in order to provide the highest level of care. Select insights for using ENFit syringes include the following12,13:

ENFit syringes are available by prescription only, although over-the-counter variations are anticipated. Ambulatory clinics and pharmacies will need to modify workflows for dispensing supplies. The following should be considered:

UIHC ambulatory pharmacies carry both legacy and ENFit supplies to accommodate each patient’s unique needs, as not all community providers have or will convert to the ENFit system. When reviewing prescriptions, pharmacists confirm the appropriate supplies to dispense based on the ordered administration route, reviewing the patient’s EMR, calling the prescriber, or verifying with the patient or caregiver. Patients requiring ENFit supplies are dispensed one bottle adaptor and one syringe at no charge for each prescription. For mail orders, if administration route cannot be confirmed, patients are sent both types of supplies. A collaborative practice agreement is currently being evaluated at UIHC that would allow pharmacists to modify and add prescriptions for the correct administration route and administration supplies.

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