Medical device packaging updates focus on standards

Economic factors, testing for ‘real-world’ distribution, and evolving standards dominate the discussion at the Medical Packaging Update conference, held Feb. 8 at MD&M West 2010 in Anaheim.

iStock_medical
iStock_medical

Cost pressures continue to influence the healthcare packaging sector, and medical devices are no exception. And while delivering a safe, effective medical device package to a hospital or other end user will always be the top priority of medical device manufacturers, MDMs must also consider economic factors.

Costs come into play in designing medical device packaging, where there’s an occasional tendency by some MDMs to “over-package” to meet worst-case scenarios. MDMs might over-package to meet extreme distribution damage or temperature fluctuations that their packages may never see, noted Scott Levy, packaging engineer at DDL during his presentation, “Distribution Testing—What is the industry doing?”

In his speech, “ISO11607,” Mike Scholla, senior consultant with DuPont Protection Technologies, recommended that MDMs follow that standard. Scholla, calling in remotely after plowing “33 inches of snow from my driveway,” said he hoped a revision to 11607 would be in the works by the end of the year.

Much of that challenge he attributed to global language barriers, particularly in China. He said the Chinese prefer to translate from the Japanese translation of technical documents written originally in English. Language is also a key reason why international standards, drafts, and balloting processes can take years.

Over-packaging is not only a potential economic disadvantage, but it can also cause problems when sterilizing packaged medical devices. “We’ve seen instances where a company trying to do a good thing may add extra layers of stretch-wrap film or extra-strong corrugated to protect their devices, and that can be a nightmare,” related Lisa Foster, vp, SteriPro Services at Sterigenics. The problem: The devices may not have been validated for that extra material, and as a result, the sterilization may not be sufficient.

ESD, IoPP, and the MDPTC

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