Support choice of feeding tube connectors to meet the needs of a diverse population

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We the undersigned:

1. Support choice of enteral feeding products in the marketplace.

2. Support safe enteral feeding products.

3. Support enhancing tube feeder independence by allowing choice of feeding products.

4. Oppose a mandated single connector option, namely ENFit®.

Enteral tube feeding is administered in individuals who do not receive adequate nutrition via the mouth.

It is estimated that there are 500,000 feeding tube users in the United States. Some industry experts believe there may be as many as one million tube feeders in the U.S.

Each user is unique in terms of age, level of independence, method of feeding, and nutrition of choice. Tube feeders are considered disabled according to the Americans with Disability Act.

Users range from very young to very old. They reside at home, rehabilitation facilities, nursing homes, or in hospitals. They are fed via pump, gravity, or syringe. Their nutrition is commercial formula, commercial blenderized nutrition, or homemade blenderized type. Approximately 60% of feeders live independently at home. About 40% of all users use blenderized feeding.

Over the last 30 years, progressively larger enteral feeding tubes with correspondingly larger connectors which press-fit mate with large bore catheter tip syringes have been introduced. Catheter tip syringes and funnel connectors received necessary FDA clearance decades ago and are recognized to be safe devices.

The Global Enteral Device Supplier Association (GEDSA) was formed to help establish and promote a new connector known as ENFit. Toward that end, the Final Draft International Standard ISO 80369-3 (commonly known as ENFit) was approved and published on July 1, 2016. ENFit is smaller in inner diameter, has a deep moat area, a screw thread design, and gravely misconnects with adult tracheostomy tubes. Manufacturers within GEDSA have spent millions of dollars in production tooling and inventory of ENFit. However, since its commercial launch, ENFit has failed to find much acceptance in the U.S. market. Numerous users have expressed that ENFit does not provide substantial benefits, does not enhance the feeding process, or improve the delivery of nutrition. ENFit actually introduces new safety concerns and user challenges for disabled Americans and caregivers.

Astonishingly, GEDSA recently announced its petition to seek a U.S. governmental mandate for ENFit wherein ENFit will be the only connector on the market and the only connector reimbursed by Medicare/Medicaid. While the product is unsuccessful in the market on its own merits, GEDSA seeks governmental interventional to eliminate product competition and choice.

GEDSA seeks to eliminate all choice for the diverse feeding tube community. To deny choice, however, is to deny many feeders their independence and to complicate the lives of caregivers who seek product options and simplicity of the feeding process.

The ENFit screw thread poses difficulty for those of any age with arthritic hands or poor motor skills. The smaller inner diameter poses difficulty for those who wish to blenderize feed and may increase feed times for many users on formula. The deep moat area presents bacterial growth concerns and must be cleaned often with special brushes recently introduced, thereby making the lives of tube feeders more complex. Recent Mayo Clinic studies call for further testing of ENFit. A recent Nelson Labs Study concludes the moat area has a bioburden of “too many to count” even after cleaning with a commercially available specially designed ENFit cleaning brush.

The undersigned request that choice of enteral feeding connectors be preserved so as to meet the varying needs of each tube feeder.

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