Around the World with Just One Standard

If you package medical devices that are shipped around the world, you’ve got to be pretty happy right now. Global standards for sterile medical device packaging are almost a reality. AAMI/ANSI/ISO 11607-1 and AAMI/ANSI/ISO 11607-2 have been accepted by AAMI, ANSI, ISO, and CEN after the final draft international standard balloting, report John Spitzley and Curt Larsen. Spitzley is an industry consultant with Spartan Design Group, and Larsen is with DuPont Medical and Industrial Packaging. The two are cochairs of IoPP’s medical device packaging technical committee.

Spitzley and Nick Fotis of Cardinal Health had told conference attendees at MD&M West 2006 this was likely. Mike Scholla (also from DuPont) confirmed it at Health Pack.

The two-part document will replace ISO 11607 and EN 868, Part 1. (For details on the revision, please see the March 2006 PMP News Regulatory Focus, “Delivering One Globally Harmonized Document.” Scholla’s article in PMP News’ sister publication, MD&DI, “Medical Packaging: Achieving a Single Global Standard,” January 2004, may also be of interest.)

While the document was largely developed by U.S. and European authorities and experts, other regulatory authorities outside of Europe and the United States are interested in the revision. Such acceptance could ease work for the U.S. manufacturer.

But some of you seem a bit overwhelmed. “When do we stop paying attention to the old standards and start following the new ones?” asked an attendee at Health Pack.

“Why continue along the old road?” asks Larsen. “Start implementing it now.” Chances are, he says, “if you complied with the old standards, you will pretty much be in compliance with the new one.”

But how much of the standard do you need to worry about? an attendee asked me at MD&M West. Scholla points out that the standards are mandatory in Europe. But in the United States, “ISO 11607 is voluntary,” says Fotis. “It is, however, the consensus of thought about how terminally sterilized medical device packages should be engineered and tested. FDA included ISO 11607 among its recognized consensus standards.” Spitzley adds that the new document will have to be resubmitted to FDA for recognition as a consensus standard. FDA did participate in developing the documents, so recognition is likely.

If you do decide to follow the new standards, “Highlight all the ‘shall’ statements in the new document,” advises Larsen. For instance, manufacturers of preformed sterile barrier systems, such as preformed header bags and pouches, are now responsible for validating their processes. And medical device packagers are responsible for collecting documentation of such validations.

It’s a fair change, says Larsen. “Why should device manufacturers have to validate their processes when component suppliers don’t?” Spitzley adds that most of the suppliers have been receptive to this new requirement.

Finally, says Fotis, ISO 11607-1 and ISO 11607-2 are “just plain good engineering. An engineer can use the improved, harmonized documents as a checklist to ensure proper materials qualification, design, and testing.”

Stay tuned for the revised technical information report (TIR) 22 currently under way at AAMI. Since the new standard is much more comprehensive and uses key industry terms consistently, reports Spitzley, the upcoming TIR 22 revision should make a palatable document even easier to digest.

Daphne Allen

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