Exchange on the Horizon

How would you like to have a forum where you could discuss any industry issue you wanted, as long as it did not raise antitrust concerns? Medical device packaging professionals have been without such a forum for years. It has been difficult for medical packagers and their vendors to all share common, nonproprietary information. Equally challenging has been finding the chance to voice opinions to FDA and other regulatory bodies without fear of consequences.

These challenges may soon be addressed by the recent revival of the Medical Device Packaging Committee of the Institute of Packaging Professionals (IoPP; Naperville, IL).

After being inactive for several years, the committee was revived at the Pack Expo International trade show in Chicago on November 5, 2002. The group's mission is to provide a forum for "discussion, exchange, and development of information" on issues that affect medical packaging professionals.

The meeting drew a large crowd of representatives from medical device manufacturers, packaging material suppliers, packaging machinery suppliers, testing labs, academia, and consultants. It produced commitments to work on at least four initiatives. And if the group fulfills its goal of getting FDA involved, it could become a very productive outlet.

"We may be in a position to actually develop information," says John Spitzley, associate fellow–packaging for Medtronic Inc. and one of the committee's cochairs. "No other trade organization does. We may even decide to fund research or studies."

The potential reach of the new committee was evident at the first meeting, which resulted in the formation of four subcommittees. One would look into conducting an industry-sponsored research project to determine the appropriate level of sensitivity needed to test medical device package integrity. It may even pinpoint the size at which holes begin to compromise integrity, which has been under debate for years. If a project were to get started, it might be conducted at Michigan State University's School of Packaging.

Another would examine the sharing of information about commonly used materials for primary packaging in the hope to justify reduced testing on the most frequently used materials. "Most of us use similar materials and processes," says Curtis Larsen, packaging consultant for DuPont Medical Packaging and the committee's other cochair. "How many have done shelf-life tests on uncoated Tyvek 1073B with a polyester/polyethylene clear film? Probably everyone. Can we collect the data, give it to FDA, and say 'why do we have to do this over and over? Why not accept this as a certified packaging system?'"

A third subcommittee would recommend ways to standardize the format of technical data sheets for packaging materials.

The fourth would be charged with educating and guiding people new to medical device packaging. "We'd like to get rid of the concept that 'I got stuck with packaging,'" Larsen says. "We would like to be a resource for those without any prior experience."

We welcome the advent of any forum willing to take on issues that haven't been ad-dressed elsewhere. We encourage you to participate and help keep up the momentum generated at the first meeting. IoPP's Drug and Pharmaceutical Committee has been a success for more than a generation; there's no reason to believe that the Medical Device Packaging Committee can't also be successful.

Interested parties may contact Spitzley at John.Spitzley@medtronic.com or Larsen at Curtis.L.Larsen@usa.dupont.com. The committee's next meeting will be held March 27 during HealthPack 2003 in Scottsdale, AZ.

Erik Swain, Senior Editor

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