ISO 11607 Usability and Labeling Revisions
The breaking news? Looming revisions to ISO 11607 that originated from the WG7 meeting prior to HealthPack. It’s a fact: introduction of usability verification and labeling is on the horizon.
- 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. We are staying ahead of what’s need to ensure that labeling performance and quality meet the expectations of ISO 11607.
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 and styles. They provide feedback to the packaging industry and offer suggestions to improve packaging designs. Many of the reasons behind the changes to ISO 11607 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.