A new ASTM International standard provides a much needed methodology for determining the shelf life of various attributes of endovascular devices.
F2914, Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices, was developed by Subcommittee F04.30 on Cardiovascular Standards, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices.
According to Benjamin Gundale, manager, research and development, Boston Scientific, lack of standardization has complicated the process of shelf life testing.
“Different companies do this process differently and different regulatory agencies treat the topic differently,” says Gundale, an F04.30 member. “This makes the process of getting products approved unpredictable and more expensive than necessary. Standardizing the process for determining which attributes are tested in shelf life will enable manufacturers to have a more direct path to get approved and yet provides flexibility for companies to do what makes sense.”Gundale notes that the new standard will enable companies to use engineering testing or fundamental engineering principles to justify whether certain attributes are unaffected by age and whether they need to be tested after aging.
“The application of F2914 can drive the cost of validation down and enable our medical devices to be more affordable to patients and our society,” says Gundale. “This is especially important given our healthcare environment with the drive medical costs down while maintaining patient care quality. Finally, F2914 can help give regulatory reviewers a road map for how to review a company’s justification.”
Interested parties are welcome to join in the activities of F04.30. The subcommittee plans on expanding the focus of F2914 in future revisions and would like the input of people who do shelf life studies and who may have knowledge about aspects that have not been well defined in recent publications.
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CONTACT Technical Information: Benjamin Gundale, Boston Scientific • Maple Grove, Minn. • Phone: 763-494-2771 | ASTM Staff: Pat Picariello • Phone: 610-832-9720 | Upcoming Meeting: Nov. 13-16 • November Committee Week • Atlanta, Ga.
This article appears in the issue of Standardization News.