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Pharmaceutical & Medical Packaging News, November/December 2015

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News pmpnews.com • Pharmaceutical & Medical Packaging News November/December 2015 8 UPS Now Supports Processing, Replenishment, Distribution of Loaner Surgical Kits M anaging inventory in the field can be a time-consuming chal- lenge for medical device manu- facturers and their sales representatives. "OEMs work to ensure that surgical sets are ready for surgery, and their reps, who will be in surgery with the surgeons, need to ensure that they sup- ply the right set, at the right time, with the right quantity of supplies," explains Josh Cannon, UPS's global healthcare strategy director. After every surgery, the unused portions of these loaner sets go through hospitals' central ster- ilization departments and then back to the sales representatives to arrange replenishment. "About 30–40% of sales reps' time is spent on inventory. Why should they be worrying about replenishing parts?" asks Cannon. UPS is working to "bring simplicity and added value to a complex system," says Cannon. The global logistics company is building upon its medical device capabilities strategy, established last year with a network of field stock- ing locations (FSLs), to include a new distribution and warehousing facility that ofers services such as autoclave capabilities, instrument inspection, and surgical set replenishment, among others. The 208,000-sq-ft facility is located in Swedesboro, NJ, near UPS's air hub at Philadelphia International Airport. The facility can process loaner surgi- cal kits so that OEMs and distribu- tors can reach more than 80 percent of U.S. hospitals within four hours of shipment. "We autoclave and inspect incoming surgical sets, validate the number of parts used by the hospital, replenish from stock, and send the sets out using UPS's same-day or other best-in-class delivery options," says Cannon. UPS tracks all items throughout the process and can provide a level of visibility that is often lacking with what Cannon calls "trunk stock" to DuPont MPTP Team Shares Long-Awaited Regulatory News During Webcast, Explains Plans for Commercialization of Transition Tyvek F our years ago DuPont announced plans to update its manufacturing process for Tyvek 1073B and 1059B. Mindful of the steps that medi- cal 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 equiva- lence of Tyvek 1073B and 1059B pro- duced 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, glob- al regulatory director, explained the implications of the U.S. FDA's recent afrmation of the functional equiva- lence 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 analy- sis to the contrary, it is not necessary for medical device manufacturers to submit a new 510(k) or PMA supple- ment for a change solely in packaging from the Legacy Tyvek to the Transi- tion Tyvek manufactured using the upgraded spinning process, includ- ing both coated and uncoated styles 1073B and 1059B." Scholla also quoted the agency's expectations of medical device man- ufacturers, 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 proce- dures in accordance with Quality System regulation. • Document activities associated with the change and update Device

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