We ask ISO voting members to vote against the proposed 80369-3 ENFit connector standard. We believe ENFit will cause more problems than it solves.

Dangerous Misconnection:

The ENFit female delivery set side dangerously and snugly fits inside an adult Shiley tracheostomy tube. This can be catastrophic if enteral formula is inadvertently delivered into a patient's airway. This is very concerning as many patients (some at home where care may not be highly skilled) have both a tracheostomy tube and an enteral feeding tube, lending to the possibility of this misconnection.

Comparison of Dimensions (ENFit patient side vs. Existing patient side connector)

ENFit Patient Side Connector: 2.95 mm inner diameter over a minimum 11 mm length.

Existing Patient Side 24fr Bolus Connector: 4.65 mm inner diameter. Many at-home patients use a bolus connector when syringe feeding.

Existing Patient Side Y-port Connector: 3.94 mm inner diameter.

The ENFit connector has an 84% lower flow volume versus the existing 24fr bolus connector.

The ENFit connector has a 68.5% lower flow volume vs. the existing 24fr universal y-port connector.

ENFit reduction in flow volume over a minimum 11 mm length will:

1. Negatively impact formula delivery time, especially with gravity and syringe feeding.

2. Increase clogging occurrences in the connector.

ENFit connector will increase costs. Specifically:

1. Nursing time to unclog the ENFit patient side male connector.

2. Nursing time to clean the moat area on the ENFit patient side male connector (must routinely clean to keep from becoming encrusted and to reduce contamination).

3. More frequent replacement of the ENFit patient side male connector. Connectors are not Medicare reimbursable. ENFit patient side male connectors will clog frequently thereby leading to frequent replacement.

Clinical performance testing:

We are unaware of any non-bench, clinical patient performance testing demonstrating that the ENFit male patient side connector is essentially equivalent in flow to the existing connector.

We urge ISO voting members to reject the 80369-3 ENFit standard.