Description

The ENFit Feeding Tube is an essential medical device engineered for the safe administration of enteral nutrition and medication. Its design features the standardized ENFit connector system, adhering to ISO 80369-3, which plays a crucial role in enhancing patient safety by minimizing the risk of misconnections with non-enteral medical tubing.

Key Features

• Secure Connections: The ENFit connector includes a rigid, threaded, male design that ensures secure, leak-resistant connections. Its "lock and key" mechanism is intentionally incompatible with Luer and other non-enteral connectors, significantly reducing the risk of accidental misconnections.

• Easy Identification: The connector is color-coded in purple, providing easy identification as an enteral device. This internationally standardized design ensures compatibility with other ENFit devices, streamlining the enteral feeding process.

• Material and Variants: Constructed from medical-grade, sterile polyurethane, the tube is available in various sizes suitable for both pediatric and adult patients. It offers options for gastric and intestinal placements, including specialized variants like nasogastric and Y-Port tubes.

Compatibility

The ENFit Feeding Tube is designed for seamless integration with ENFit-compatible syringes, extension sets, and administration sets. It supports both gravity and pump feeding methods, and transition adapters are available to aid compatibility with legacy systems during phased implementation.

Safety and Compliance

This device meets ISO 80369-3 standards and complies with relevant FDA regulations, effectively reducing the risk of wrong-route medication errors. Its design includes clear measurement markings and "Prepared for ENFit" labeling on packaging, further enhancing safety and usability.

Intended Use

The tube is intended for delivering nutrition, fluids, and medications directly into the gastrointestinal tract, bypassing the oral cavity. It is suitable for use in hospitals, long-term care facilities, and homecare settings, serving neonatal, pediatric, and adult patients.

Maintenance and Care

Proper use requires ENFit syringes for tube position checks, flushing, and medication administration. Users are advised to clean the proximal end with warm water and a brush, inspect regularly, and maintain patency by flushing with water according to clinical guidelines.

Installation and Training

Secure connection setup and tube placement verification should be conducted using clinical methods such as pH testing or imaging. Adhering to sterility protocols during installation and maintenance is crucial. Regular replacement and staff training are recommended to ensure safe handling and care.

Benefits

The ENFit Feeding Tube enhances patient safety, improves dosing accuracy, and standardizes enteral feeding systems. Its adoption as the industry standard in regions like the US and Canada marks a significant step towards reducing device-related safety events globally. Transition adapters facilitate a smooth conversion process for legacy devices, supporting a comprehensive implementation of the ENFit system worldwide.