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| November 2015 - ISSUE 18 |
ENFit™ Tip Syringes for Low Medication Dosing ENFit Syringe Design for Low Doses ENFit syringes are vital to the launch of a complete ENFit enteral feeding system. Because ENFit syringes have tips which are female small-bore connectors, concerns have been raised regarding possible risks of delivering inaccurate doses when dosing low volumes of medication that require high accuracy (0.2mL within ± 10%). GEDSA members have been collaborating to develop a solution which delivers a highly accurate dose with minimal impact to current practices. Through this collaboration a design has been developed that incorporates an internal feature within the female connector that effectively allows the ENFit syringe to function similarly to male tipped syringes currently on the market today while maintaining compliance to ISO 80369-3 female connector requirements. We are currently terming this design a low dose ENFIt syringe.
Initial proof of concept testing has demonstrated that the low dose ENFit syringe delivers an accurate dose while meeting the requirements of ISO 7886-1 for dead space and tolerance on graduated capacity. The low dose ENFit syringe will be introduced into the market after successful completion of validation, verification and usability studies.
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Low Dose ENFit Tip Syringe Usability Testing GEDSA will be conducting a usability study for the new low dose ENFit tip syringe at the ASHP MidYear Conference. The study will be focus on individual 20 minute sessions allowing clinicians to try and provide feedback on the low dose ENFit tip syringe. The study will be held throughout the day Sunday December 6th 9:00am-6:00pm and Monday December 7th 7:00am-8:20am. Pharmacists and pharmacy technicians attending the conference interested in participating please contact GEDSA to set up an appointment.
Request a usability study session
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GEDSA and members have recently participated in a public forum at the Association for the Advancement of Medical Instrumentation (AAMI) headquarters. GEDSA member representatives demonstrated a positive effective flow rate testing and consistency in current systems and the future ENFit system. While actual ENFit tip syringes and feeding tubes with ENFit males are not yet available, some patients continued to express concern on the perceived reduction in flow rates. Further collaboration between GEDSA, the Oley Foundation, ASPEN, Feeding Tube Awareness Foundation, and the FDA is underway to further consider challenges faced today by users of blenderized diets and potential solutions.
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Stay Connected Video
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Colleen Elliott
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“The creation of the ISO 80369 series of small-bore connector standards has been an extraordinary standards development effort. Clinicians, regulators and manufacturers have come together, devoting thousands of hours of technical expertise, to develop global consensus on designs and requirements to reduce tubing misconnections and increase patient safety. This project exemplifies AAMI’s mission - supporting the healthcare community in the development, implementation, management, and use of safe and effective healthcare technology.”
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Share this email and other Stay Connected tools with patient safety directors, managers, and risk management personnel to help them keep up to date on the ENFit connector transition
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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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