Four years ago DuPont announced plans to update its manufacturing process for Tyvek 1073B and 1059B. Mindful of the steps that medical device manufacturers must take when faced with a packaging material change, DuPont’s Medical Packaging Transition Project (MPTP) team set out to establish the functional equivalence of Tyvek 1073B and 1059B produced with the newer flash-spinning technology, now called Transition Tyvek.
In an October 6 Webcast, the MPTP team discussed “lots of good news,” as Mike Scholla, PhD, global regulatory director, explained the implications of the U.S. FDA’s recent affirmation of the functional equivalence of the Transition Tyvek as well as the recent transition guidance from Health Canada. He also provided updates on working with Notified Bodies and on Japan’s new rules.
Bruce Yost, PhD, global technical director, updated attendees on the latest test data results, while Karen Polkinghorne, packaging engineer and MDM specialist, and Meg Pyers, global marketing director, discussed DuPont’s plans for commercialization and on-going support.
Scholla urged attendees to review FDA’s letter of affirmation, which states that "absent a specific request or notice from FDA or a risk analysis to the contrary, it is not necessary for medical device manufacturers to submit a new 510(k) or PMA supplement for a change solely in packaging from the Legacy Tyvek to the Transition Tyvek manufactured using the upgraded spinning process, including both coated and uncoated styles 1073B and 1059B."
Scholla also quoted the agency’s expectations of medical device manufacturers, which he described as “nothing new—you’ve been hearing us say these three things for four years now:”
- Conduct a risk analysis to determine whether a premarket submission is needed due to a change in risk.
- Implement change control procedures in accordance with Quality System regulation.
- Document activities associated with the change and update Device Master Records with the rationale for acceptance of Transition Tyvek.
Scholla then walked attendees through the guidance from Health Canada, which provides MDMs with a form to complete by the end of the year depending upon their use of Tyvek.
Scholla also offered tips for handling submissions to Notified Bodies. Competent Authorities give Notified Bodies their rights, and each country’s Competent Authority has its own expectations and rules depending on that country, Scholla explained. Such differing expectations may result in varying requirements from Notified Bodies. “The first thing that is really important that you have to understand is that Notified Bodies are auditors; they are not regulators,” he said. FDA and Health Canada “changed the way they were going to handle regulatory submissions for the Tyvek transition because they are regulators and they have the ability and the right to do that. Auditors can only follow the rules, and their job is to assess your rationale and explanation and etc. So the first step is to have very specific discussions with your Notified Body regarding referencing reports or requirements to include reports.”
However, Scholla asked that the MDMs who participated in the MPTP studies (one of the 78 cells) “be mindful that the regulatory reports you received are confidential documents between DuPont, the converter, and device manufacturer, and to submit those to a Notified Body you need a release from DuPont and the converter or sterile packaging manufacturer. We have that mechanism in place, so we encourage you to respect that confidentiality and abide by it.”
After DuPont’s meetings with five Notified Bodies, Scholla noted that one of their major concerns was that some submissions by MDMs simply cite DuPont reports without any analysis on how they apply to specific medical devices.
Scholla also explained that recently passed guidance in Japan allows MDMs to take no action. DuPont has translated the new law and posted it to www.transition.tyvek.com.
Yost then gave an update on MPTP Industry Summary Reports, pointing out that six reports are currently available on DuPont’s Web site. These cover pre- and poststerilization test results; accelerated aging results (simulating one-, three-, and five-year conditions); one-year real-time aging; and an executive summary.
“These testing results indicate functional equivalence,” he said.
While reports for 7-year and 10-year accelerated aging are expected to be complete in 2016, Yost did share some interim test results. And additional new transition protocol material data can be found on DuPont’s Web site, he said.
“All the information on the www.areyouready.tyvek.com site as well as in the regulatory library will be remain available online at a minimum through the 5-year real-time aging industry report, which is scheduled for completion in 2019,” added Polkinghorne.
Polkinghorne then covered some steps for MDMs to take to before switching commercially available medical devices from Legacy Tyvek to Transition Tyvek.
DuPont is also extending the availability of Legacy Tyvek. “The U.S. FDA’s letter of affirmation . . . was DuPont’s requirement to begin selling Transition material commercially in the United States,” she said. “However, we do realize that due to some of these other regulatory submission requirements in other parts of the world and because of the current supply constraints, some MDMs may not be ready to transition. So to help MDMs work through these remaining hurdles from a regulatory perspective and as a result of specific customer requests, DuPont is extending the availability of Legacy Tyvek through June 2016.” She advised that MDMs contact their direct Tyvek suppliers (sterile packaging manufacturers) regarding their own inventory plans.
DuPont has not announced a specific date for the full discontinuation of Legacy Tyvek, she added. “It has not yet been determined, and it will depend on many, many factors. As we head into the middle of 2016, the exact timing and information associated with discontinuing that product will become a lot clearer.” DuPont will continue to communicate openly and often, she said.
MDMs who have developed programs supporting interchangeability among Legacy and Transition Tyvek may find some supply chain benefits, Polkinghorne noted, sooner than those who are continuing to need only Legacy products. “So we are encouraging everyone in the supply chain to work toward the goal of interchangeability,” she said.
The MPTP demonstrates DuPont’s significant commitment to the industry, Pyers noted. “Within DuPont . . . well over a hundred people across multiple functions over many years have worked on this,” she said.
The team answered several questions during the live Webcast, including several on submissions to Notified Bodies as well as on the commercialization of Transition Tyvek.
DuPont emphasized its plans for ongoing support. As Scholla explained at the beginning of the Webcast, “We’re not going away, and we’ve got stuff to do, and we’re going to be around to help you through the process.”
Please view the on-demand version of the October 6 Webcast as well as past events by visiting the Medical Packaging Community.