Navigate the evolution of regulations on packaging and sterilization of medical devices


Regulations regarding the packaging and sterilization of medical devices are constantly evolving and, making matters more difficult, vary depending on the type of sterilization process to which the device is subjected. The complexity of these ever-changing sterile packaging requirements calls into question the ability of engineers to design and manufacture medical devices that meet FDA and EU MDR requirements in a safe and efficient manner. And because packaging is seen as an accessory to the device itself, sterile packaging is often an afterthought during the manufacturing process rather than a practice that should be built into the design stages.

Faced with these challenges, the Council of sterilization packaging manufacturers, or SPMC, consists of a group of industry leaders who work collaboratively to educate professionals on packaging and sterilization practices and how to deliver medical devices in a safe and sterile manner, ultimately account, providing unprecedented patient care.

Three SPMC executives are about to take the stage at MD&M Minneapolis, the Midwest’s largest advanced manufacturing and medical technology event, held at the Minneapolis Convention Center from November 3-4. technological landscape, refining the art of surgical robotics and transforming the critical field of sterilization of medical device packaging.

With the event on the horizon, I had the opportunity to speak with Don Alip, Chairman of the SPMC Marketing Committee, about the upcoming Board Roundtable.

Can you tell us about the Sterilization Packaging Manufacturers Council (SPMC)?

Ali: I think the SPMC mission gives a great overview of who we are and what we do:

SPMC is a consortium of like-minded companies committed to protecting patients by providing sterilization packaging for life-saving medical devices and pharmaceuticals. The SPMC works with our supply chain partners and regulators to provide advice on packaging requirements, clarity of testing methodology, standards development and user training. The members of the SPMC put their rich experience at the service of the good of all.

For more information, the About SPMC section provides additional information about the group: https://www.sterilizationpackaging.org/about

I understand that an SPMC peer group is speaking at a panel at the upcoming event. What can participants expect to learn during the session?

Ali: Yes. Three SPMC executives bring their combined experience of over 60 years to MD&M Minneapolis and “Unpack the science of medical packaging requirements. ”During their session, participants can expect to learn about the long-standing relationship with AAMI and ASTM and the group’s mission as a technical thought leader on testing standards. There are many ongoing initiatives and advances in materials underway that help provide chain partners and packaging engineers for medical devices overcome the challenges of sterilization. Yet there remains a critical need for education regarding medical packaging requirements and considerations for gels, package integrity and standard specifications for rolls and pouches.In addition, our session will include ways to participate in Sterile Packaging Day 2022 , which will be celebrated on April 13, 2022.

Our range of high caliber speakers includes:

What motivates you to reconnect in person with your community?

Ali: If the pandemic has taught us anything, it’s that we’re better together. As an industry, we have leveraged technology through Zoom meetings and webinars to pursue projects and find new opportunities to engage our customers. But nothing can replace face-to-face collaboration. From raw material suppliers, packaging engineers, packaging converters, device designers, equipment manufacturers, sterilization companies, operating room nurses, doctors and down to every patient, this industry is people driven. We’re excited to see many new and familiar faces at MD&M Minneapolis next week.

To attend the session, purchase an Expo or Conference pass for MD&M Minneapolis here.


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