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| ISSUE 19 |
ENFit ® Introduction Dates Update for introduction of ENFit Tip Syringes and Enteral Feeding Tubes with ENFit Connectors Adequate supply of ENFit tip syringes are important for the launch of the ENFit feeding system with tubes which have the ENFit connector. Feeding tubes and medication ports on feeding sets with the ENFit male connector will require ENFit tip syringes for flushing, hydration, bolus feeding and enteral administration of medication. To ensure a safe and successful transition to the ENFit system GEDSA recommends supply managers to survey their supplier base and confirm availability and supply of ENFit tip syringes.
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Low Dose ENFit tip SyringeDose accuracy has been a concern for administering low doses (<2.0mL) enterally with an ENFit tip feeding syringe. GEDSA members have identified an ENFit low dose tip design for small volume syringes.
The ENFit low dose tip connector is designed to minimize the amount of fluid in the dead space and eliminate the potential for fluid displacement. Performance testing has proven that ENFit low dose tip design delivers an accurate dose consistent with other syringes such as oral tip syringes which have been in use for years. The ENFit low dose tip syringe is anticipated to be ready for market introduction in 2016 pending regulatory clearance.
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The ISO 80369-3 standard enteral connector is part of a series of small bore connectors which will be introduced. The 80369 small bore connector series also includes standards for respiratory, limb-cuff inflation, neuraxial, and intravascular connectors. The Final Draft International Standard for 80369-6 (neuraxial) and 80369-5 (limb cuff) connectors have recently been approved with 100 percent affirmative votes. The publication of IEC 80369-5 and ISO 80369-6 were in March.
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Enteral FAQ
The connector changes will affect all components of enteral feeding systems. Our FAQ set was put together to answer your questions about the enteral connector change. View our Enteral Specific FAQ
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| Have you met? | ||||
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Pete Phillips
Director, Surgical Materials Testing Laboratory (SMTL) A pharmacist by training, Pete manages the Surgical Materials Testing Laboratory (SMTL), which is funded by the Welsh Government to test medical devices for the NHS in Wales. Pete joined his first standards committee in the 1980's and now sits on numerous national and international standards groups as well as chairing BSI CH/205/1 and CEN TC/205/WG155/PG1. He has been active on the ISO 80369 series since its inception in the late 1990s and managed the usability assessment project team for ISO 80369-6
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"The ISO 80369 series has been a long time in the making, which is not surprising given the extraordinarily difficult challenge of standardizing a range of connectors in the small dimensional space available, whilst also minimizing the operational impact on clinicians when using devices. The great pleasure has been working with technical specialists from across the world, who under normal circumstances would be competing against each other, but who have managed to work as a tight-knit team to solve some difficult problems with a good dose of pragmatism and humor. I have no doubt that patient safety will be improved due to this important piece of work"
-Pete Phillips, Director, SMTL
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Share this email and other Stay Connected tools with your nursing and clinical staff to keep them up to date on the latest small bore connector news.
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Where to find us
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The Stay Connected initiative is organized by the Global Enteral Device Supplier Association (GEDSA) in partnership with leading regulators, associations and other supporting organizations. Visit StayConnected.org If this email was forwarded to you and you would like to sign up to Stay Connected, click here. © 2015 GEDSA, all rights reserved 692 N. High St. Suite 207 GEDSA is a 501(c)(6) federal tax exempt Non-Profit Trade Association incorporated in the State of Ohio, USA. GEDSA’s mission is to promote initiatives surrounding safe and optimal delivery of enteral feeding and connectivity. It is GEDSA’s policy and the responsibility of every GEDSA member to comply in all respects with federal, state and international antitrust laws. Any discussion is strictly prohibited for the purpose of raising, lowering, or stabilizing prices; regulating production; allocating markets; encouraging boycotts; fostering unfair trade practices; or assisting monopolization at any GEDSA function. Any questions regarding the meaning or applicability of this policy, as well as any concerns regarding activities or discussions at GEDSA functions, should be promptly brought to the attention of GEDSA’s executive director, officers, and/or legal counsel. All material provided in this email is intended for informational purposes only and should not be used to replace regulatory or company-specific documents, nor should it replace the advice of a qualified professional. This information is based on the draft ISO 80369 standard; does not imply or suggest any regulatory clearance of any specific product and may not be predictive of clinical outcomes. Images provided do not imply endorsement of any specific product. All products and product designs are the responsibility of each specific legal manufacturer, distributor or supplier. Products with these design features may be pending regulatory clearance or may not be available in a specific geography. Consult your supplier representative for product-specific availability, indications, contraindications, precautions, and warnings.
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