Get ready for a pretty different ISO 11607.
Nick Fotis, global packaging director for Cardinal Health, tells PMP News that ISO 11607 Parts 1 and 2 have begun to go through the revision process. Fotis recently joined David Johnson from Halyard Health as co-chairs of AAMI Working Group 7 to succeed Jackie Daly Johnson, president of Beacon Converters. Additionally they will be on the U.S. delegation to the ISO Technical Committee (TC) 198/Working Group (WG) 7 Packaging when it meets in December.
Package testing for the DuPont Tyvek Medical Packaging Transition Project (MPTP) is progressing on schedule, and all results published to date support the functional equivalence of the transitional material to the current Tyvek. While testing continues, DuPont expects that the U.S. FDA will affirm functional equivalence by the third quarter 2015.
By Maureen Kingsley
PAC Machinery launched a high-speed medical device bagging system at Pharma Expo. Suitable for use in cleanrooms, the Rollbag Magnum HS Med can produce bags with chevron or straight seals from rollstock consisting of a polymer web and either Tyvek or paper as well as foil and metallized polyester.
More than 70,000 packages from 40 medical device manufacturers have been tested under the DuPont Medical Packaging Transition Project (MPTP), and results continue to indicate functional equivalence, reported members of the DuPont team during a Webcast on October 2.
When it comes to medical devices, packaging is sometimes an afterthought. While there are outstanding packages that win high-profile awards, some companies fail to recognize the importance of this factor until late in the game. In worst-case scenarios, this can impact the quality and safety of the device. More often, however, the result is financial, because companies neglect to take steps to reduce packaging costs.
Medical packaging converter Technipaq celebrated its 30th anniversary this summer. PMP News spoke to the company’s founder, Philip Rosenburg, and its Vice President of Sales and Marketing, Brian Rosenburg, about how the industry has changed since the company was founded.
Maintaining hand hygiene is one of the most important steps healthcare practitioners can take toward reducing healthcare associated infections (HAIs). Hand washing and other universal precautions are widely encouraged, but did you know that packaging and labeling could play roles in infection prevention, too?
Applying the predictive reliability method to medical packaging can help companies estimate a failure rate and prevent recalls
The reliability of a medical package production process depends upon maintaining a high performance level over a long time period. Predictive reliability methodology can be used to prevent defects by increasing a given production process’s time to failure and hence increasing its overall reliability. The knowledge sharing between the quality departments of those companies involved in producing medical packages can be very important to ensure the robustness of the production process and its long-term reliability.
Today, at a hospital somewhere in the United States, one patient out of 25 is likely dealing with a healthcare-associated infection. This estimate comes from the Centers for Disease Control and Prevention (CDC), which cites a healthcare-associated infection (HAI) prevalence survey.