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Pharmaceutical & Medical Packaging News, November/December 2015

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9 November/December 2015 Pharmaceutical & Medical Packaging News • pmpnews.com describe the inventory that sales reps frequently carry. It can also facilitate billing. "For the majority of products on consignment, billing doesn't take place until after surgery. Our systems will help provide the necessary vis- ibility." UPS uses software from Baxter Planning to track components and kits. "We can plan the number of sets need- ed based on usage," says Cannon. "It gives us a better means to plan inven- tory and actually reduce inventory. We can take 25–30% of the inventory out of the field." All that sales reps need to do "is feed information from surgeons to UPS 24 to 48 hours prior to surgery," he says. "We can help make a sales rep more productive so they can assist more sur- geons and help their companies grow more revenue." UPS maintains product and data quality throughout the process through extending its Quality System and SOPs to the new facility as well as its FSLs. It also maintains strict temper- ature control if needed and is eval- uating how it can assist with device identification. "We are in deep consultation with OEMs to understand their needs. Pres- sures are high on OEMs for turnaround and cost," Cannon says. "So we are developing cost-effective, compliant programs that ofer quick turnaround time and can help reduce costs." T h e m e d i c a l d e v i c e d i s t r i b u - tion strategy is part of UPS's overall healthcare logistics plan. "UPS contin- ues to strengthen our integrated net- work globally to help manufacturers lower costs, streamline inventory, and meet increasing demands," says John Menna, UPS vice president of global healthcare strategy, in a news release. "In the U.S., building out a best-in- class, comprehensive service that inte- grates a loaner hub with our vast FSL and global transportation network rais- es the bar and further demonstrates our commitment to the healthcare industry." —Daphne Allen A UPS employee inspects a surgical kit for Alphatec Spine, a medical device manufacturer specializing in spinal fusion technologies, at UPS's new healthcare facility in New Jersey. 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 han- dling submissions to Notified Bodies. Competent Authorities give Notified Bodies their rights, and each coun- try'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 under- stand is that Notified Bodies are audi- tors; 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 docu- ments between DuPont, the convert- er, and device manufacturer, and to submit those to a Notified Body you need a release from DuPont and the converter or sterile packaging manu- facturer. 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 sim- ply cite DuPont reports without any analysis on how they apply to specific medical devices. Scholla also explained that recent- ly 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 cur- rently 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 func- tional equivalence," he said. Photo Credit: UPS Continued on page 12

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