Update on International Standards, Regulations at HealthPack Europe

EN ISO 11607, Packaging for Terminally Sterilized Medical Devices, continues to be the international standard for sterile medical device packaging, but proposed new medical device regulations in Europe could potentially impact packaging, reports Thierry Wagner, DuPont Medical Packaging’s regulatory affairs director. Wagner spoke at HealthPack Europe 2012, which was held in Dublin, Ireland, on December 3-4. The event marked HealthPack’s debut in Europe.

EN ISO 11607 helps medical device manufacturers “design packaging to minimize safety hazards,” explained Wagner. It clarifies that users must both “validate package design and validate packaging processes for consistent quality and control,” he said. Part 1 includes discussion of “performance and stability testing to ensure that the worst-case design withstands expected conditions, while Part 2 covers process validation,” he explained.

And EN ISO 11607 has far reach. The two-part standard can be used to show conformance with Europe’s Medical Devices Directive; FDA recognizes it as a consensus standard in the United States; and it is a national standard in Japan, Korea, Australia, and Canada to name just a few. China is working to accept the current version. The document has recently been “reaffirmed,” Wagner said, and will be republished shortly with only a few amendments in its latest revision, particularly in Annex B. “Annex B now includes a table of test methods indicating which of those standards have precision and bias statements demonstrating repeatability and/or reproducibility to support validation of test methods.” There are also a few definition changes in the standard itself in terms of defining closures, microbial barrier, and seal strength.

Annex ZA is also being redrafted to show how the standard meets the MDD’s essential requirements. “‘Usability requirements’ in particular may have a gap and may need to be improved in future revisions,” Wagner said.

Guidance on the use of EN ISO 11607-1 and EN ISO 11607-2 is currently being developed by ISO/TC 198 WG 7, which handles EN ISO 11607. The guidance, based largely on AAMI TIR 22, will be published as ISO TS 16775, as a technical specification, stated Wagner.

“Notified bodies are asking more and more about packaging these days, so guidance is needed to implement EN ISO 11607,” said Wagner. “ISO TS 16775 will be informative, not normative.”

However, proposed new medical device regulations that could one day replace the MDD are “shaking the foundation” throughout the EU, Wagner explained. Proposed Article 7, for instance, states that “if harmonized standards are not sufficient, the EC is empowered to adopt so called common technical specifications,” said Wagner. “Stakeholders are concerned that they may not have much say in such common technical specifications.”

At this point, it is unclear what impact, if any, the new regulations will have on expectations for medical device packaging. In the meantime, Wagner advised the HealthPack Europe audience to make use of ISO TS 16775 to implement EN ISO 11607, since patient safety is best guaranteed by a quality-by-design approach.

For details on HealthPack Europe 2013 and the upcoming HealthPack in March in Louisville, KY, visit healthpack.net.--Daphne Allen