A new standard, developed by ASTM International Committee F04 on Medical and Surgical Materials and Devices, establishes performance requirements for single-use, enteral feeding devices with retention balloons. These devices are used by medical professionals to provide nutrition or administer medication to patients through a natural orifice (nasal, oral, transluminal) or through a surgically created stoma. Enteral devices can be made in a variety of sizes out of silicone, urethane and various polymers. The new standard, F 2528, Test Methods for Enteral Feeding Devices with a Retention Balloon, is under the jurisdiction of Subcommittee F04.35 on GI Applications.
 
Lisette Rice, president, Leading Medical Research, says that the origin for F 2528 was a market demand for a ballooned enteral feeding device that could withstand the harsh acidic conditions of the stomach. “If a feeding device cannot remain properly positioned in the established stoma via the retention balloon due to its failure, then often additional medical procedures have to be performed to extract the device and replace it with a new device,” says Rice. “This results in the patient having to undergo additional procedures that may be preventable.”
 
Leading Medical Research developed a balloon that can withstand conditions inside the stomach for at least 90 days. During the R&D phase of the balloon development, LMR discovered that there was not an ASTM standard to cover the new device and began working with Subcommittee F04.35 to develop F 2528 to ensure the highest level of quality for end users of enteral feeding devices with retention balloons.
 
“Producers of enteral feeding devices that contain a retention balloon will be able to use F 2528 to provide them with quality assurance assessment and release criteria, as well as with a comparative testing baseline,” says James Bardwell, manager, product development, Medi-Flex, Inc. Bardwell says that the ASTM standard meets the goal of Subcommittee F04.35, which was to develop a “best practice” standardized set of enteral feeding devices that employ retention balloons. “In particular, a standardized method was needed to assess the performance of the balloons in a gastric fluid environment because of cost pressures and always changing reimbursement laws from state to state,” says Bardwell.
 
Interested parties are invited to participate in future revisions to Test Method F 2528. “More participation is always encouraged and very helpful when seeking varied perspectives throughout the industry,” says Bardwell. The subcommittee is particularly seeking the perspectives of different producers as well as potential end users of the feeding devices, such as clinicians.
 
ASTM International standards are available for purchase from Customer Service (phone: 610/832-9585; https://www.astm.org/contact/) or at www.astm.org.

For further technical information on Test Method F 2528, contact Lisette Rice, Leading Medical Research, Tucson, Ariz. (phone: 520/275-0806; Lisette@LeadingMedicalResearch.com). Committee F04 will meet Nov. 14-17, at the November Committee Week in Atlanta, Ga. For membership or meeting details, contact Daniel Schultz (phone: 610/832-9716; dschultz@astm.org).

Release #7430