HealthPack never fails to deliver a rewarding experience as leaders in packaging gather for a week of collaboration and education. Last week, PCL’s Ryan Erickson and Sarah Rosenblum attended the conference in Kansas City, Missouri. After a week of excitement, they put their heads together to share notes provide the following key highlights on upcoming changes to ISO11607 and the future of packaging validation.
Revisions to ISO 11607
The most recent breaking news in packaging are upcoming revisions to ISO 11607 that came out of the WG7 meeting the week prior to HealthPack. Two of the biggest changes are the introduction of usability verification and labeling.
- Usability Verification – packaging will not be considered “validated” unless this is built into the validation strategy and successfully passes. The usability verification is to include simulated conditions (e.g. gowns, gloves, etc) and participation from actual end-users such as operating room nurses or other clinicians who will be interacting with the packaging in the field. PCL is currently developing a program to address this, please contact us to learn more.
- Labeling – new symbols will be required on package labeling to inform end-users as to which layers of packaging are considered to be sterile barriers. While the symbol designs are still being firmed up, those shown in the table below are the leading candidates:
While labeling symbol changes do not necessarily drive changes to packaging validation in and of itself, please be aware that the act of converting labels to the new symbols may expose historical gaps in label testing during the original packaging validation. PCL is creating a remediation program to help MDM’s address these changes while also ensuring that label performance and quality meet the expectations of ISO11607.
These changes come as no surprise after watching the nursing panel that occurs annually at the conference. The nurse’s panel includes nurses from the local hospital system and exposes them to upcoming medical device packaging designs & styles. They provide feedback to the packaging industry and offer suggestions to improve packaging designs. Many of the reasons behind the changes to ISO11607 were echoed in the nursing panel feedback, which was nice to hear. These revisions aim to help medical devices be properly handled in the hospital environment.
These were hot topics of the industry, and opinion leaders are coming together to create answers. We are excited to get involved in the upcoming changes and participate in the advancement of patient safety.In the spirit of collaboration, we leave you with a question – what do you think?