Originally Published MDDI December 2002
Originally Published MDDI December 2002
NEWS & ANALYSIS
After several years of dormancy, the Medical Device Packaging Committee has been revived by The Institute of Packaging Professionals (IoPP; Naper-ville, IL). It plans to begin work on at least four initiatives.
The first meeting of the revived committee took place at the Pack Expo trade show in Chicago on November 5. It drew a large crowd of medical device manufacturers, packaging material suppliers, packaging machinery suppliers, testing laboratory representatives, academic institutions, and consulting firms. Participation of FDA representatives will be sought in the future.
Organizers said they would like the committee to provide a forum for packaging professionals in the medical device industry. This would enable them to exchange, discuss, develop, and disseminate information on technical, regulatory, organizational, and other important packaging-related issues.
"We may be in a position to actually develop information," said John Spitzley, associate fellow, packaging, for Medtronic Inc. (Minneapolis) and one of the committee's co-chairs. "No other trade organization does. We may even decide to fund research or studies."
The meeting produced the formation of four subcommittees, each of which will tackle an issue that participants believe has been underaddressed in recent years.
One subcommittee will look into conducting an industry-sponsored research project to determine the appropriate level of sensitivity needed to test medical device package integrity, and perhaps to pinpoint the size at which holes begin to compromise integrity. Debate has raged for years within the industry as to how sensitive an integrity test should be; those that are not sensitive enough may fail to detect leaks and jeopardize the sterility of a package, but those that are too sensitive may produce false positives and result in the waste of good packages. If a project were to get off the ground, it might be conducted at the Michigan State University School of Packaging.
"Previous work on this issue was done with too little information," said Hugh Lockhart, PhD, a packaging professor at Michigan State. "But with the level of expertise we now have, I think it is doable. However, FDA involvement would be critical, because of the differences between what we'd like and what we think they want."
Another subcommittee will examine the sharing of information about materials commonly used for primary packaging of sterile medical devices, with the hope of being able to justify reduced testing of the most frequently used materials.
"Most of us use similar materials and similar processes," said Curtis Larsen, packaging consultant for DuPont Medical Packaging (Wilmington, DE) and the committee's other co-chair. "How many companies have done shelf-life tests on uncoated Tyvek 1073B with a polyesterpolyethylene clear film? Probably everyone. Can we collect all the data, give it to FDA, and say, 'Why do we have to do this over and over again? Why not accept this as a certified packaging system?'"
The catch, Spitzley said, will be getting industry members to share such information, and that might be more likely to happen under the auspices of the IoPP than it would otherwise. "There are a lot of potential hurdles out there," he said. "This is not going to happen overnight."
A third subcommittee will address the issue of standardizing the format of technical data sheets for medical device packaging materials.
Finally, the fourth is charged with providing education and guidance for those new to medical device packaging. "We'd like to get rid of the concept that says, 'I got stuck with packaging,'" Larsen said. "We would like to be a resource for those who have come into the field without any prior experience."
The next meeting of the committee is scheduled during the HealthPack 2003 conference, March 27, 2003, in Scottsdale, AZ. Those interested in joining the committee may contact Spitzley at John.Spitzley@medtronic.com or Larsen at Curtis.L.Larsen@usa.dupont.com.
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