Tyvek® Rx: November 2014
This year, DuPont Medical and Pharmaceutical Protection has conducted three global webinars to help the industry stay up to date on the DuPont™ Tyvek® Medical Packaging Transition Project (MPTP). The first webinar in 2014 was held on May 7 and featured in the August issue of Tyvek® Rx. The most recent events were held on October 2 and November 13.
During the October webinar, titled “The Results Are In—First Industry Summary Report,” Bruce A. Yost, Ph.D., Global Technical Director, presented the first complete summary of pre- and post-sterilization package data. This summary represents test results across more than 70,000 packages from 40 medical device manufacturers (MDMs). It is the first of five summaries that will be published. Yost also shared the latest 1-year accelerated aging package data and 3-year accelerated aging material data.
Also during the October webinar, Michael H. Scholla, Ph.D., Global Regulatory Director, provided a brief regulatory update and shared a guidance letter from DQS Medizinprodukte GmbH, a European Notified Body. Leslie Love, North America MDM Specialist, discussed what MDMs can do to be ready for the transition and gave webinar attendees a sneak peek at a new App for mobile devices and a new tool designed to help with their risk assessments—the MPTP Package Test Results Selector Tool. The new App—“myTyvekMobile”—is available from iTunes and Google Play. The Results Selector Tool will be available later this month.
The November webinar, titled “The Results Are In…But What Can I Do With Them?” was designed to help MDMs learn what functional equivalence really means and to understand how it can facilitate their risk assessments. Jennifer H. Van Mullekom, Ph.D., Senior Consulting Statistician, used a common everyday example to explain the difference between functional equivalence and statistical significance. Scholla discussed how functional equivalence supports interchangeability; shared a quick-reference chart to help MDMs see what supporting documentation is available at www.areyouready.tyvek.com to help them address specific risk assessment topics; and then addressed questions commonly asked about regulatory guidance. Love discussed tools that are available to help MDMs be prepared for the transition, such as the First Industry Summary Report for Pre- and Post-Sterilization, which will be available this month.