(KENTWOOD, MI, October 1, 2021) – Packaging Compliance Labs (PCL) has built a simulated surgical facility to offer Usability Evaluations for sterile medical device packaging for the medical and pharmaceutical industries. A Usability Evaluation establishes design requirements with end-user inputs so medical device packaging is more effective in the healthcare environment.
“We invested in this state-of-the-art facility to give healthcare professionals the best environment to provide feedback on our clients’ sterile packaging, in accordance with the 2019 revision to ISO 11607:1,” said Matthew Lapham, President at PCL. “As a medical device packaging pioneer, we know it’s critical to engineer device packaging so it meets user needs and sterile requirements.”
ISO 11607:1, the International Standard for Packaging for Terminally Sterilized Medical Devices, was revised in 2019 to include Section 7: Usability Evaluation for Aseptic Presentation. PCL’s addition of Usability Evaluation and the simulated surgical facility allows medical device manufacturers (MDM’s) to request usability testing for their sterile medical device packaging.
“Prior to the 2019 revision, it was not mentioned in ISO 11607:1 that MDM’s should provide a documented packaging usability evaluation,” says Ryan Erickson, Vice President and Packaging Engineer at PCL. “The addition of usability evaluation for sterile medical device packaging is important because of the potential risk of infection in patients receiving medical care.”
PCL offers two solutions for usability evaluations. The Panel Usability Evaluation process brings at least one clinical user and PCL’s medical device packaging engineers together to discuss observations and provide feedback on device packaging. The Clinical Usability Evaluation involves activities in the simulated surgical environment that include gowning, surgical suite set up, aseptic presentation, and transfer of sterile contents into a sterile field, followed by questionnaires, formal discussion notes, and recommendations to improve client packaging.
Both the Panel and Clinical Usability Evaluations meet and even exceed the three assessments stated in 7.2 of ISO 11607:1 that address where the user begins opening the package, how to open the sterile barrier system without damaging the contents, and the subsequent display of contents aseptically.
For more information, visit www.pkgcompliance.com or call 616.227.4540 to speak with an experienced packaging expert.
About PCL
Packaging Compliance Labs is an ISO 17025:2017 accredited packaging engineering, development, and validation firm for the medical and pharmaceutical industries. They partner with medical device manufacturers, development firms, startups, and contract manufacturers to eliminate packaging barriers that can put product launches at risk. PCL’s testing lab and engineering team are located in Kentwood, MI, and their sales office is in Denver, CO. Visit www.pkgcompliance.com for more information about services and resources.