Unless you’ve been asleep for a long time, you know that big changes are taking place in the medical device compliance standard, ISO 11607. We’ve been tracking the details since the discussions began and have an exciting response to what we see that we know will be helpful to many of our medical device friends.
About the ISO 11607 Update, Section 7
The ISO 11607 usability update is found in Section 7. The purpose of the update is to ensure usability of packaging at its point of use. Not only is usability important to efficiency and protecting the sterility of the product, how it is accessed and handled prior to use directly affects many aspects of patient safety. ISO 11607 Section 7 identifies three steps for compliance with usability standards:
Step 1: Identify a specific entry location on the packaging
Step 2: The ability to clearly recognize how to open without damaging or contaminating the contents
Step 3: The ability to present the content for use aseptically
Packaging engineers are skilled at studying the dimensional reality of an object and what it takes to package it for a perfect, sterile delivery to the end user. What’s historically been missing from all of that brilliance, however, is that nobody has asked the nurses, doctors or surgeons how it worked, what they thought. Our team has really been on board with the importance of this update. Usability is something in which we’ve always taken a keen interest. We’ve frequently discussed ways to integrate the end user experience into our work. It is highlighted each year at the nurse panel discussions we attend during HealthPack, a healthcare focused packaging conference.
The Human Factor Usability MicroProgram
It’s rewarding to be putting all of that inspiration to work. Packaging Compliance Labs has officially kicked off our Human Factor Usability MicroProgram.
With the ISO 11607 update, a client need and our internal interest in usability, the time was right. We went to work formalizing a program that would support the Section 7 update, serve the client and set the stage for industry access to the new usability compliance standards.
Bringing the Hands into the Plans
Our pilot study begins with engineering packaging for a medical device that requires specific nurses and surgical technicians. During its patient use, a nurse or team must assemble the components of the device prior to use. We engineered the packaging following all ISO 11607 standards, including the new Section 7. How easy will it be for the surgical team to understand our medical device packaging, unpacking and assembly instructions? Using the partnerships designated in our Human Factor Usability Microprogram, we enlist the medical professionals who will use the device from store room to patient to simulate the experience and demonstrate its ease of use—and effectiveness. The teams score each step and answer a series of questions to rate their experience. These become design inputs for our engineers. Our program incorporates scientific quantitative data to calculate the ease of use factor for each interactor in the use of a medical device.
It is an exciting time to be in medical packaging. And it’s time to welcome ISO 11607 Section 7: uniting the precision of engineering, the science of medicine and the power of gifted hands.