Upcoming Changes Affect Parenteral Consumers, Too
The Oley Foundation was founded over thirty years ago to serve both home enteral and parenteral nutrition (HEN and HPN) consumers. The safety and well-being of all nutrition support consumers is in the forefront of all that we do. Today, changes seen in the enteral market—specifically, the introduction of International Organization for Standardization (ISO) standard 80369-3 and new enteral tubing connectors known as ENFit™—have the potential to affect both HEN and HPN consumers. And while HEN consumers are having a mixed reaction to the change, both HEN and HPN consumers may benefit as the risk of tubing misconnections will be reduced and patient safety increased.
Oley is aware of several issues and concerns surrounding ISO 80369-3 and ENFit, and remains committed to facilitating an open dialogue between consumers, members of industry, the Food and Drug Administration (FDA) and the clinical community, and working towards seeing these issues resolved. We also applaud the effort to reduce tubing misconnections, which is the stated goal behind this initiative.
Reducing Tubing Misconnections
On its website, the FDA notes, “Patients in health care settings receive food, medication and other therapies through a variety of tubes and catheters.” We know that this happens in the home setting as well. FDA continues, “These delivery systems are often connected to one another by small-bore connectors (e.g. Luer connectors). Because these connectors are compatible between different delivery systems, patient injuries and deaths have occurred when medicines, liquid feeding formulas, or air were accidentally delivered through the wrong tubing.” This is a “tubing misconnection.”
All of our members should be ever alert to the fact that misconnections can and do happen. The FDA website lists several examples: a feeding tube connected to a tracheostomy tube; an epidural tube connected to an IV line; an IV line connected to a tracheostomy cuff; and oxygen tubing connected to a needleless IV port. Each of these cases resulted in patient death.
Closer to home, an HEN/HPN consumer—and nurse—told us how she had mistakenly administered an enteral medication into her central venous (IV) catheter at home. The lighting was low and she had picked up the wrong syringe. She was taken by ambulance to the hospital and given IV antibiotics. To her relief, there were no long-term consequences. But she was keenly aware that this could have been a fatal mistake.
The proposed changes to enteral connectors are in response to calls from the World Health Organization, the Joint Commission, and other organizations to reduce the risks by making connectors used in different systems incompatible with one another. ISO 80369 sets the international standard for these “small bore connectors.”
Listening to Consumer Concerns
Reactions toward ENFit among HEN consumers are varied. Some are loudly opposing the new system, some are (perhaps more quietly) supporting the change, and some are anxious to be through the transition period and to give the new system a try. Last fall, we invited consumers, caregivers, and clinicians to fill out a survey about their current experiences with the connectors and transition adaptors, and to answer questions about how they anticipated ENFit might affect them in the future. (Thank you to all who provided feedback!)
The questions and comments that came out of the survey, along with questions that came to us by phone, social media and e-mail, have helped guide discussions about how the new connectors will be used by consumers/caregivers in the home setting, and whether they will meet all of their needs. Several of these questions were addressed at a one-day ENFit summit Oley coordinated in December in Atlanta, Georgia.
HEN consumers, caregivers, clinicians, enteral tubing manufacturers, the home care industry, the Global Enteral Device Supplier Association (GEDSA), and the FDA—all of the various stakeholders—were represented at the summit. In the morning, consumers and caregivers shared their tube feeding experiences and routines while clinicians and manufacturers watched and asked questions. Consumers and caregivers provided examples of how they blenderized enteral formulas from whole foods and table foods and how they administered these diets; explained how and why they vent through their G-tubes; and discussed concerns, such as keeping the connectors clean and whether those with limited dexterity could manage them. This allowed manufacturers to witness some of the ways their products are used in the home, so they could use that information in their design considerations.
In the afternoon, we met as a group to learn more about ENFit and to discuss some of the questions raised via the survey and during the event. This session was broadcast live and recorded (available on YouTube.com/OleyFoundation; watch for an edited transcript of the meeting). We ended the day with wrap-ups sessions where we brainstormed ideas for moving forward. We agreed that further discussion was necessary, and suggested a meeting in January.
Responding to Concerns
At a meeting in Austin, Texas, in January, we reviewed what we’d learned and discussed the future. Some ideas generated in Austin were to create basic fact sheets about ENFit and to answer the questions that had been posed in a way that stakeholders could easily understand.
Below you’ll find some of these questions, with answers provided by GEDSA and, in some cases, with additional comments from Oley. The GEDSA answers are taken from a more comprehensive list of frequently asked questions (FAQs) available on their website (see “Home Enteral Nutrition FAQs on Blenderized Diets and Other Concerns” at stayconnected.org). These answers were provided in late February 2016.
Plans moving forward include further testing of blenderized diets and flow rates, better understanding how patients vent via their tubes, and testing of low-dose syringes (under way). We expect GEDSA will update the FAQs as the additional testing is done and manufacturers release products. Oley is working on providing answers to additional, manufacturer-specific, questions.
In a position statement issued in early March, GEDSA states, “The input provided by those patients and caregivers at home who are concerned with the option of using ENFit has been valuable to manufacturers. Work is under way to evaluate the requirements of this population. Some GEDSA member manufacturers have committed to keep existing product on the market until additional testing identifies if a more optimal approach is needed.”
What is ENFit™?
GEDSA: ENFit is the trademarked name commonly used for ISO 80369-3 connectors that specify a reverse connector orientation when compared with legacy (current or existing) products. To help consumers easily identify compatibility, some manufacturers have adopted the ENFit name to use on devices that are made with the ENFit connector system.
OLEY: Industry uses the terms “female” and “male” and to refer to the connectors on the “patient access end” (your tube, currently female) and the “delivery end” (a syringe or administration set, currently male). ENFit reverses this female-male orientation
What is the purpose of GEDSA?
GEDSA: The Global Enteral Device Supplier Association (GEDSA) is a nonprofit trade association formed to introduce new international standards for health-care tubing connectors. Comprised of manufacturers, distributors, and suppliers worldwide, GEDSA facilitates information flow regarding the ISO 80369 small bore connector initiative.
OLEY: Not all enteral device manufacturers are GEDSA members. See www.stayconnected.org for a list of members.
Why should home users convert to using ENFit™ connectors? Aren’t misconnections more likely to happen in hospitals and nursing homes than at home?
GEDSA: Some consumers use both HPN and HEN systems at home. This creates situations where formula, solutions, and medications that are intended for the enteral feeding tube could potentially be inadvertently administered into a central venous catheter.
In addition, if a home user is using a feeding tube that does not have an ENFit connector and he or she is hospitalized in a facility that only has tubing and syringes with ENFit connectors available, he or she may experience a disruption in their enteral therapy or may potentially have to undergo a tube replacement procedure.
It is recommended that HEN consumers speak with their health-care providers to determine if transitioning to an ENFit connector enteral system would be optimal for their current practice.
OLEY: Additionally, if an enteral consumer is hospitalized and gets an IV, they will be at risk of a misconnection.
Will all GEDSA members produce devices with the ENFit connectors?
GEDSA: Companies that are members of GEDSA are committed to rolling out enteral devices that comply with the ISO 80369-3 reverse orientation standard.
It has been asked if large syringe manufacturers, Medtronic in particular, have decided to not produce ENFit tip syringes. As a founding member of GEDSA, Medtronic will be launching ENFit feeding tubes and syringes. Their launch of ENFit is to coincide with the ability to provide the low-dose ENFit tip syringe to the market and satisfaction that there will be sufficient syringe supply in the marketplace to support an ENFit transition.
Will manufacturers benefit from changing their products to ENFit?
GEDSA: A positive benefit for the manufacturers will be introducing devices that reduce the risk of dangerous tubing misconnections to better serve all patient populations using small bore tubing, which includes enteral feeding.
The development work for ISO 80369-3 began several years ago as nursing and other clinical associations asked for a device that would not connect with devices it was not intended to connect with. The work has been supported by clinical, technical, regulatory, and commercial experts volunteering their time and committing significant company resources. In addition to the resources committed to the collaborative effort, each manufacturer in the enteral delivery market is making significant capital investment in the production equipment needed to produce ENFit compatible products. These manufacturers are doing so because they believe the gains in patient safety merit this investment of resources.
Will ENFit misconnect with a tracheostomy tube?
GEDSA: All connectors within the ISO 80369 series are designed to reduce the risk of tubing misconnections. Tracheostomy connectors today do not specify dimensional requirements for the inside tube and as a result every connector or device smaller than a tracheostomy connector, including the connectors defined within the 80369 standard, have the potential to misconnect with tracheostomy tubes. This potential is also inherent to existing or legacy devices. Until tracheostomy connectors are better defined, misconnection risks may still exist with these types of devices and many others, including almost all enteral proprietary connectors.
ISO 80369-3 is the first enteral design that addresses this problem. As a result of a careful survey of the tracheostomy tube market dimensional changes have been made to reduce the risk of misconnections with a tracheostomy tube.
OLEY: Note that the ISO 80369 series covers other small-bore connectors used in health care, such as IV, respiratory, neuraxial and more, in addition to enteral. The goal is to create connectors for each application that are not compatible with connectors used in another application.
Will gastrostomy tube (G-tube) low-profile devices be changed?
GEDSA: Connectors on low-profile feeding devices are not covered by the ISO 80369-3 standards, so the connectors on those specific devices should not change. Extension sets that attach to these devices will likely have the same (non-ENFit) connection at the point that inserts into the device. However, the other end of the extension set that connects to administration sets and syringes will have the ENFit connector(s).
Will ENFit connectors allow for venting?
GEDSA: With smaller French size tubes, venting should function the same as it does with current connectors. Additional testing is planned to better understand venting in larger French size tubes.
Venting a feeding tube with the ENFit connector will require an ENFit tip syringe or a venting bag with an ENFit connector. Some companies may offer venting bags and tubing connectors that are ENFit compatible.
OLEY: There is concern that, with the ENFit connector, some people will not be able to vent as they currently do (because the size of the hole, or bore, in the connector may limit what can pass through it). Additional discussion and testing is planned to see if another solution is needed for this population and what that solution might look like.
Will blenderized diets flow through the ENFit connector?
GEDSA: Currently there are no published professional standards for the use of blenderized foods for tube feeding, and there is great variability in viscosity and density of each individual blend being used. According to the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Standards for Nutrition Support: Home and Alternate Site Care, published in 2014, “EN formulas shall be prepared to prevent contamination. Commercially available EN formulations shall be used whenever possible,” and the use of home blenderized formulas “requires additional attention to safe food handling and storage practices.”
The ISO 80369-3 enteral connector design standard was developed with these A.S.P.E.N. guidelines in mind and specific requirements were established that would meet those needs in order to avoid any disruption of therapy for patients. The bore size (or size of the opening) in the ENFit connector was designed to be consistent with the current connector (commonly called “Christmas tree” or “stepped adapter”).
If you are currently using a blenderized diet with a pump set that has an ENFit connector and an ENFit transition connector, the flow rate will be consistent with what you will experience with the complete system using the ENFit connector. [See next question re: blenderized diet and larger French size tubes.]
Flow rates may vary by manufacturer, type of tube, and blenderized diet.
Has testing been done on ENFit performance for blenderized diets?
GEDSA: Initial laboratory testing has been completed to show consistent flow rates between ENFit and legacy connectors using low-profile devices with extension sets and 20 Fr and smaller tubes.
Additional performance testing with larger French size tubes and a variety of blenderized foods is planned for the future.
Will individuals with limited dexterity be able to manage ENFit connectors?
GEDSA: Limited dexterity is something each company factors into its designs. In preparation for FDA submission, human factors and usability testing were completed using nurses and home caregivers and the ENFit connection has been found to be suitable. Many users found it easier to connect than current friction fitments. Twist lock systems, similar to the ENFit connector have been in use effectively for enteral feeding systems in the United Kingdom and around the world for more than ten years.
In addition, while ISO 80369-3 defines certain parts of the connector (principally those which will affect the connector’s compatibility with other devices), individual manufacturers are able to incorporate features into their devices to address dexterity issues, as they see necessary.
OLEY: We will continue to discuss this concern and the possible need for innovation.
Will it be possible to hydrate with an ENFit tip syringe?
GEDSA: Yes. Hydration through a feeding tube with an ENFit connector will require the use of a syringe with an ENFit connector. Enteral-specific syringes with the ENFit connector must be widely available before feeding tubes with ENFit connectors can be placed.
Will bolus syringes be available with ENFit connectors?
GEDSA: Yes. The diameter in the outlet of the syringe will be the same size or larger than the patient access end of most feeding tubes 20 Fr or smaller, or the opening on most low-profile devices. As long as the inner diameter of the connector on the patient end of the extension set remains the smallest opening in the system, the flow rate properties will not change from the existing (legacy) configuration.
For larger French size feeding tubes (> 22 Fr), the industry is currently evaluating the impact of ENFit on overall performance. Until more is understood regarding performance with common blenderized diets, several existing larger French size feeding tubes (> 20 Fr) will remain available from some manufacturers. This will allow consumers to continue using catheter tip syringes to deliver blenderized diets.
Will there be adapters for different kinds of syringes?
GEDSA: It is not anticipated that there will be an adapter for catheter or oral tip syringes, as this would create the risk for a tubing misconnection. Once an ENFit compatible feeding tube is used, only ENFit compatible syringes can be used for feeding, flushing, and medication delivery.
Once syringes are specifically enteral, will the cost of syringes increase? Will pharmacies stock enteral syringes?
GEDSA: We cannot comment on pricing, insurance coverage, or reimbursement. Pricing is at the discretion of the manufacturer. Consumers should check with their insurance provider about their policy. Distributors and pharmacies will be alerted of the potential need for ENFit compatible syringes, but it is up to the pharmacy to decide whether to carry them. Consumers should check with their pharmacy or their home-care supplier for the availability of ENFit tip syringes.
How do I ensure I have the products I need to use an ENFit tube?
OLEY: Consumers should check (with their health-care provider or home-care company) that ENFit compatible syringes, as well as syringe caps, bottle adapters and any other necessary supplies, will be available to them before they get an ENFit G- or J-tube placed. Also, the Oley Foundation is joining with home care companies and other organizations to explore insurance coverage and reimbursement issues related to syringes.
What is recommended to keep ENFit connectors clean?
GEDSA: A reverse Luer system with a similar design has been in place in the United Kingdom and initially this was a concern. This issue was resolved quickly, however, as consumers became familiar with the system. When connecting or disconnecting the tubing, the ENFit connector portion of the tubing and syringe should be kept free of fluid. Some have suggested using a [clean] toothbrush and warm water to clean the ENFit connector daily. Additionally, there are products on the market being promoted for the cleaning of ENFit connectors.
OLEY: We are aware of one product designed to clean these connectors, called ENClean™. (See encleantube.com or call 215-407-5227.)
Will there be more clogging with ENFit connectors?
GEDSA: It is not anticipated that clogging incidences will increase for feeding tubes with inner diameters smaller than the inner diameter of the ENFit connector (20 Fr and smaller). Additional performance testing with larger French sizes is planned for the future.
Individual flow rates may vary depending on the device and the patient’s feeding and medication regimen. The adoption of correct clinical practice with proper flushing has shown to prevent clogging in tubes smaller than the ENFit inner diameter and is recommended.
OLEY: For flushing, please follow the protocol provided by your health-care provider. In general, you should (a) flush well with warm water before and after putting formula, medication, or anything else in your tube; ask your doctor how much water you should use; (b) flush tube every four to six hours if on continuous feedings; and (c) flush tube at least once a day if not in use (from our “Tube Feeding Troubleshooting Guide”).
Will tubes need to be replaced more often, due to clogs or being accidentally dislodged?
GEDSA: For most feeding tubes, it is anticipated that performance will be consistent with current performance. This is a subject you should address with your health-care provider, home care supplier or the manufacturer. Manufacturers have considered this as they have designed their new devices and will be able to answer this question in regard to your specific device.
| Steps You Can Take
☛ So they can better “identify and understand the risks associated with medical devices,” the FDA encourages consumers and health-care providers to report all tubing misconnections, including “near misses” and “device use errors.” Visit www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TubingandLuerMisconnections/ucm313323.htm.
☛ Concerns, questions, complaints? Direct anything in reference to a specific product to the manufacturer. Direct general comments to GEDSA, www.stayconnected.org. Report product failures to your home care company and/or the FDA www.fda.gov/safety/medwatch/default. Contact Oley anytime; we will do our best to answer questions.
LifelineLetter, January/February 2016