In addition to hospital and other health care settings, medical devices are often used in the home setting, most frequently for enteral feeding, urinary, respiratory and intravenous uses. Patients, families, caregivers and home health care professionals need to be aware of any changes to connectors and other components of their devices.
Changes to connectors for medical devices used in the home setting
In order to make their medical devices safer, manufacturers are producing devices with new connectors that conform to international standards. The first of these are connectors used with enteral devices. As enteral manufacturers change to new products, they are producing interim transition connectors to facilitate the continuity of care.
While the FDA encourages manufacturers to incorporate the new connector design standards for enteral devices and other future device types, the Agency is not requiring manufacturers to switch to the new standard design, or to remove products currently in use from the market. Devices with older designs (legacy devices) may still be available on the market for patients who rely on them for their care.
Many of the devices identified on the Reducing Risks through Standards Development for Medical Device Connectors page can be used in the home setting. As standards are developed and recognized for connectors for these devices, the FDA will update information on this website.
Who to contact for more information
It is essential for patients to speak with their health care provider to ensure they have the right devices for their nutritional, therapeutic and lifestyle needs. Patients should work with their doctor, device suppliers and manufacturers to make sure all options are understood and where to get training if products in use change. Specifically for enteral devices, patients can:
- Become involved in international standards work related to enteral device standards. The Association for the Advancement of Medical Instrumentation (AAMI) has offered patients opportunities for involvement.
- Engage with patient advocacy organizations, such as the Oley Foundation, ASPEN, and the Feeding Tube Awareness Foundation about enteral device concerns.