Xeridiem® Designs ISO Compliant Connectors for G-tubes
Xeridiem has designed connectors for replacement G-tubes to offer various options for the International Standards Organization (ISO) 80369-1:2010; Small-bore connectors for liquids and gases in healthcare applications. The connectors designed provide a variety of features intended to improve patient care, comfort and performance. In addition, the early designs will assist with the rollout or introduction of the connections standard requirement scheduled for January 1, 2015.
The new designs incorporate the ISO 80369-1:2010 dimensions for the male and female connection and mating surfaces. Also, a cap has been added to the standard device to prevent dust, dirt or foreign material from entering the device, improving cleanliness of the connection area and reducing clogging. In addition, different design revisions have incorporated a connection external to the device with another option placing the connection housing inside the enteral feeding tube.
The potential for enteral feeding misconnections has been persistently growing over the past 10 years. More individuals, particularly ageing baby boomers, require supplemental nutrition to cope with autoimmune diseases, metabolic disorders, chronic conditions like celiac disease, or recovery from cancer treatment. Connection mishaps are tracked by the U.S. Food and Drug Administration; however, the extent of the misconnections is difficult to determine due to inconsistent reporting standards from one organization to the next.
Human error is the root cause of many misconnection errors. Caregivers can be overwhelmed with the volume or urgency of their work. In 2010, the decision was made to establish an ISO working group to develop a connector standard recommendation. The standard is being reviewed by national standards groups and is expected to be effective in January 1, 2015. Xeridiem will continue early collaboration and continue planning efforts designed to improve patient care.
Xeridiem designs, develops, and manufactures single-use medical devices focused in gastroenterology, cardiology, and urology for established healthcare companies and venture- backed entrepreneurs. Services comprise full design and development including risk management, design history files, technical files, verification/validation testing, regulatory and supply chain management. Since 1986, as a silent partner, Xeridiem has enabled major medical device companies and venture-backed entrepreneurs to deliver over 22 million medical devices used worldwide and intended to reduce cost of patient care.
In recognition of design and development capabilities, Xeridiem was awarded the Medical Device Excellence Award in General Surgical Equipment and the R&D 100 for Life Sciences in 2011. ISO 13485:2003 certified, FDA registered and compliant to Code of Federal Regulations 21 Part 820.