Ecouen, France, April 25, 2017 – Vygon, the single-use medical devices group, today announces the launch of www.safe-enteral.com, a website dedicated to the therapeutic implications of enteral tubing and connectors. The site provides information for medical staff and raises awareness about the therapeutic benefits and risks associated with the new connection standards for enteral feeding devices. The site has a special focus on premature neonates and newborns; considered to be high-risk populations.
Vygon Group has been involved for several years in the creation of the ISO 80369-3 standard, which defines the new safety connector for enteral feeding. Released in July 2016 and known as ENFit™, the connector has a distinctive geometric shape that prevents the risk of connection errors between enteral feeding systems and other administration systems (oxygen, intravenous solutions and drugs, anesthesia, etc). It prevents the danger of milk being injected into the veins or the airways, or intravenous drugs being administered into the stomach, which can have serious or even fatal consequences for patients.
Since September 2015, Vygon has offered a full range of ENFit™ products, for adult and children, including administration sets for enteral feeding pumps, syringes and feeding tubes.
However, for some high-risk patient populations, such as premature neonates and newborns, the ENFit™ connector can involve a risk of drug overdose, which was identified by Vygon thanks to its 10 years expertise in accurate safety feeding systems for neonatology. Accurate dosing is crucial for these tiny patients who, in some cases, have to be given very low doses of powerful drugs (such as morphine, digoxin or methadone) several times a day. As part of the ISO working group, Vygon interviewed nearly 120 neonatologists in 11 countries. These specialists cited high-accuracy dosing amongst their main concerns.
In addressing this issue, a new syringe, known as the ‘ENFit™ Low-Dose Tip’ was designed to meet the need for accurate dosing in neonatology. There is a stringent accompanying protocol for the system, to achieve an accurate dose for neonatology. This complex protocol adds further stages to current procedures; this can lead to dosing errors (as a result of inadequate or outdated training, distraction, forgetfulness or a member of staff operating on ‘autopilot’).
Reacting to these concerns, Vygon has now launched the new site, www.safe-enteral.com. The company’s aim is twofold: to provide information on the significant progress that the new ENFit™ safety enteral connector represents for the majority of patients and to raise awareness amongst physicians and hospital staff of the risks of overdose for premature neonates. The site contains a number of information resources (FAQs, studies, brochures, etc.) on the new ISO standard and the Vygon product range.
“As a specialist in medical devices for enteral feeding, Vygon felt it should offer a full range of safety products for patients from neonates to adults, in accordance with the new standard,” said Stéphane Regnault, chairman of Vygon’s management board. “Our teams have regular interaction with hospital staff and were alerted to the need for accurate dosing for enteral feeding for the very smallest patients, who weigh between 750 g and 2 kg (1.1 to 4.6 lb.). This is why we are launching www.safe-enteral.com, to answer the questions raised by medical staff and to increase awareness about the risks of potential overdose via enteral tube therapy.”
Vygon designs, manufactures and markets high-tech single-use medical devices for healthcare professionals in hospital and for private and independent practitioners. Vygon is a world leader within this industry, offering a wide range of products in a number of clinical specialties: neonatology, adult and pediatric critical care, anesthesia, long-term vascular access, oncology, emergency, cardiovascular and surgery, and home care. With expertise right along the value chain, from product design to the delivery of training for medical personnel, Vygon provides health care professionals with effective and innovative products tailored to their needs and those of their patients, for optimum use and safety. The company distributes over 205 million products a year in more than 120 countries through its network of 27 subsidiaries and 331 distributors. Vygon products display the CE and/or FDA mark and are manufactured in the group’s eight factories in Europe, the USA and Colombia. A family company founded in 1962, Vygon is based in Ecouen, in France’s Greater Paris region. It is a mid-sized business employing 2,150 staff worldwide. The turnover in 2016 was €316 million ($344M), with 81% of this derived from Vygon’s international business.
 Analysis of Report GEDSA Low Dose Syringe Accuracy Test, dated 31 January 2016, by SELECT June 2016