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Navigate Evolving Medical Device Packaging & Sterilization Regulations

Background image courtesy of Canva; graphic created in Canva SPMC Alip pullquote.png
Leaders from the Sterilization Packaging Manufacturers Council will explore the latest in package testing, materials, and more at MD&M Minneapolis.

Regulations surrounding medical device packaging and sterilization constantly evolve, and making matters more challenging, they vary according to the type of sterilization process the device undergoes. The complexity of these ever-changing sterile packaging requirements challenge engineers' ability to design and manufacture medical devices that meet the FDA and EU MDR's requirements safely and efficiently. And because packaging is considered an accessory to the device itself, sterile packaging is often an afterthought during the manufacturing process rather than a practice that should be integrated into the design stages.

Addressing these challenges, the Sterilization Packaging Manufacturers Council, 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, providing unparalleled patient care.

Three leaders from SPMC are set to take the stage at MD&M Minneapolis, the Midwest’s largest advanced manufacturing and medtech event, held at the Minneapolis Convention Center from November 3 through 4. The conference and exhibition is strategically held in one of the nation’s largest healthcare hubs, designed to bring together the visionaries who are changing the digital health technology landscape, refining the art of surgical robotics, and transforming the critical field of medical device packaging sterilization.

With the event on the near horizon, I had the opportunity to speak with Don Alip, marketing committee chairman at the SPMC, about the council’s upcoming panel discussion. 

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

Alip: I think the SPMC mission provides an excellent overview of who we are and what we do:

SPMC is a consortium of like-minded companies committed to patient protection by providing sterilization packaging for life-saving medical devices and pharmaceuticals. The SPMC collaborates with our supply chain partners and regulators to provide packaging requirement guidance, test methodology clarity, standards development, and user education. SPMC members use their wealth of experience for the betterment of all.

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

I understand that a group of peers from SPMC are speaking on a panel at the upcoming event. What can attendees look forward to learning in the session?

Alip: Yes. Three leaders from SPMC are bringing their 60+ combined years' experience to MD&M Minneapolis and "Unpacking the Science of Medical Packaging Requirements." In their session, attendees can look forward to learning 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 initiatives and continued advances in materials underway that are helping supply chain partners and packaging engineers for medical devices overcome sterilization challenges. Still, there remains a critical need for education surrounding medical packaging requirements and considerations related to gels, package integrity, and standard specifications for rollstock and pouches. Additionally, our session will include ways to engage with Sterile Packaging Day 2022, to be celebrated on April 13, 2022.

Our high-caliber speaker lineup includes:

What excites you about reconnecting in person with your community?

Alip: If the pandemic has taught us one thing, it's that we are better together. As an industry, we leveraged technology through Zoom meetings and webinars to keep projects going and find new outlets to engage our customers. But there is no substitute for face-to-face collaboration. From raw material suppliers, the packaging engineers, packaging converters, device designers, equipment manufacturers, sterilization companies, to the OR nurses, physicians, and down to each patient, this industry is focused on people. We are excited to see many new and familiar faces at MD&M Minneapolis next week.

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

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