Through collaborations with industry, the standards community, patients and other stakeholders, the FDA continues to promote the development of connectors that reduce the risk of device misconnections.
Standards and Guidance Development
Unique international standard designs have been developed for device connectors for high-risk medical applications. These standards promote patient safety by assuring connectors for unrelated systems are incompatible, so the devices cannot be accidentally linked or forced to fit. In 2011, the FDA recognized The International Organization for Standardization (ISO) consensus standard series for small-bore connectors for liquids and gases in health care applications, which was formally published in July 2016. ISO is continuing to develop the 80369 standards for other product areas. Recognized standards have been evaluated by the FDA and manufacturers are encouraged to apply these standards to medical devices, as appropriate.
Through guidance, the Agency provides recommendations to manufacturers, FDA reviewers and other stakeholders. On February 11, 2015, the FDA published final guidance for small-bore connectors used in enteral applications. This guidance is important because it offers recommendations to reduce the potential for misconnections with connectors that are part of, or form connections to, enteral devices intended to administer liquid nutrients or medicine to patients.
With the new enteral connector design entering the marketplace, several patients who rely on tube-feeding in the home environment have made the FDA aware that the new enteral connector design change creates unforeseen challenges. These challenges include reduced ability for some home-blenderized foods to pass through smaller bore sizes, cleaning difficulties, and challenges with operating the new twist-and-lock mechanism. FDA is considering these patients’ feedback as we work toward ensuring that ISO 80369-3:2016 and future standards meet the many different needs of patients who use these devices.
The Agency, in collaboration with multiple stakeholder groups, is assessing this information to ensure patients’ health care needs are met. Some of the organizations FDA is collaborating with to address these issues include:
- Health Care Advocacy organizations e.g. California Hospital Association (CHA)
- Other government agencies, e.g. Veterans Administration (VA)
- International organizations e.g. National Health Service (NHS), Great Britain, World Health Organization (WHO)
- Hospitals, e.g. Children’s Hospital of Philadelphia (CHOP)
- Accrediting bodies, e.g. The Joint Commission
- Organizations focused on patient safety, e.g. The Institute for Safe Medication Practices (ISMP), Premier Safety Institute
- Patient advocacy organizations, e.g. the Oley Foundation, American Society of Parenteral and Enteral Nutrition (ASPEN), Feeding Tube Awareness Foundation
- Device manufacturers and associations e.g. Global Enteral Device Supplier Association (GEDSA)
- Standards organizations, e.g. International Organization for Standardization (ISO), Association for the Advancement of Medical Instrumentation (AAMI)
As manufacturers shift to devices with new enteral connectors, the FDA is working with a number of professional and health care organizations as well as device suppliers to increase clinical awareness to support a seamless transition. The Information for Health Care Facilities page provides specific recommendations for health care facilities to consider during the transition.
Testing and Research
Due to the concerns brought forward by patients, the FDA and others are conducting testing to assess the new enteral connector design with commercial or home-prepared blenderized food.
On April 27, 2018, the FDA published an article on “In Vitro Performance Testing of Legacy and ENFit Gastrostomy Tube Devices Under Gravity Flow Conditions” in the Journal of Parenteral & Enteral Nutrition about our lab-based research on the use of commercial canned formula diets with 80369-3 compliant connector-based enteral feeding tubes. The FDA has also engaged with patients and advocacy groups to understand how patients currently use their enteral feeding tube devices at home, with commercial enteral feeding diets or blenderized foods. This information will be used to help us better understand the needs of patients who will use feeding tubes with 80369-3 connectors. The information will also be used to inform future efforts and standards development that will take into account the needs of all patients. The FDA will provide additional information to the public when it becomes available.