Don’t Pass on Poststerilization Testing
March 10, 2010 – 2:17 pm
FDA’s Quality System Regulation states that as part of “final acceptance activities. . . each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria.”
Why the regulation lesson? I just read today that Guidewire Technologies Inc. (Salem, NH) received a warning letter from FDA stating that “testing is not conducted after each sterilization process for your sterile packed guidewires. Your 510(k) submission states that finished Teflon coated guidewires will be free unless packaging is opened or damaged.”
I am not aware of the specific details, but poststerilization testing seems absolutely necessary. Of course, you must decide what tests to perform based on your processes and the risks presented to your products. Seal strength and package integrity seem givens, but there may be some gray areas. Common sense should prevail.
For instance, at HealthPack last week, emergency room nurses stated that they had some trouble reading package labels. So when Dave Olson, vice president of sales and marketing for Advanced Web, stated that a survey his firm conducted found that 73% of those label users surveyed evaluated label integrity poststerilization, I wondered whether any label troubles snuck past the remaining 27%.
I am not equating package integrity and label integrity. But as FDA’s regulation states, “each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria.”
Don’t let the rigors of sterilization escape your scrutiny.
Growth in bio-engineered products more susceptible to variations in temperature and humidity. Emerging global markets that require packaging that will stand up to the handoffs, complexities, and climate variations of extended supply chains. The proliferation of guidelines and regulations from countries around the world promoting best practices for handling sensitive freight.