Modern medical technology saves more lives each day. From imaging systems to surgical tools, there is a vast spectrum of solutions pushing the medical field forward thanks to the tireless work and innovation of healthcare vendors.
Transporting these assets can be half the battle. Doctors and specialists rely on these investments to not only arrive on time and undamaged, but also 100-percent sterile. The slightest intrusion of bacteria can put patients at risk of infection, illness, and other severe complications. This is in addition to the risks of tools that are broken in any way, or those that malfunction when a doctor needs them most.
Fortunately, packaging materials and practices have evolved in tandem with these medical assets. Medical device packaging is its own field entirely, with global spending projected to reach more than $50 billion by 2024. Constant improvements and advancements in the space have been paramount to the booming global healthcare sector, the valuation of which will cross $10 trillion by 2022.
The history of medical device packaging is long and storied, with a number of significant milestones. Various governments and committees have been involved at one time or another in both device and packaging review. For instance, the U.S. Food and Drug Administration released a set of Medical Device Amendments in 1976 that called for intensive premarket review of medical devices based on their respective “risk classification,” or the potential degree of associated risks.
The packaging itself did not receive this sort of attention until years later. Medical packaging materials were gradually improved, as were methods in package testing. Then, in 1993, there was a substantial leap forward with regard to sterility as awareness as the topic gained traction around the globe. And not a minute too soon.
That year, the International Organization for Standardization (ISO) released process documents titled “Packaging for Terminally Sterilized Medical Devices,” also known as ISO 11607. Within the document, ISO spelled out new requirements for device manufacturers that involve “forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.” In June of the same year, the European Commission released a legal framework called the Medical Device Directive (MDD), which contained its own set of packaging requirements in addition to unified principles around devices themselves.
Sterile barrier systems (SBS) and rigorous testing of packages are two core components of this widespread movement. These initiatives have had an immeasurable impact on the healthcare field in the years since, and remain major priorities across the medical supply chain.
The Sterile Barrier Association (SBA), a European trade association that includes more than 75% of regional manufacturers of SBS products, was founded around the same time as these watershed regulations. SBA members convene twice a year to discuss the latest process updates and ensure continued compliance in their respective operations.
As defined by ISO, a sterile barrier system is “the minimum packaging configuration that provides a microbial barrier and allows aseptic presentation of the product unit at the point of use.” There are various materials and designs involved, based on the type of device being packaged and certain other factors. That said, any form of SBS needs to pass a thorough inspection to be approved for use.
There are a few other key terms related to ISO-approved medical packaging laid out in the documentation:
- Preformed sterile barrier system: A partially assembled sterile barrier system prior to filling and final closure and sealing.
- Protective packaging: Packaging configuration designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use.
- Packaging system: The combination of the sterile barrier system and protective packaging (could include the transit packaging).
Coinciding with these base components are the package testing and validation procedures. You can read more about testing requirements, along with sterilization options, in the article “Medical Packaging 101” by Packaging Digest.
In the years since these major regulations, sterile and secure packaging for medical devices has grown into the formidable industry it is today. Players in the space include Fortune 500 companies DuPont and 3M, alongside upstarts and other well-established manufacturers alike. In June 2019, the Australia-based Amcor completed an acquisition of Bemis Manufacturing, forming a real heavyweight in the medical device packaging space.
This massive acquisition is paired with the company’s recent pledge for more sustainable packaging by 2025. As green initiatives are brought increasingly to the forefront, it will be interesting to see how vendors meld sustainability with the regulatory standards of medical packaging design.
These challenges will go hand-in-hand with the continuing push for packaging automation, as well as intelligent asset tracking, which will help prevent counterfeiting and theft in the medical device sector. As with any industry, there’s always new hurdles waiting around the corner. That said, the prodigious funding and creative resources being pooled into the space bodes well for the next decade of medical device packaging.
Standards in medical packaging are oft-revisited and revised, based on new factory technologies, materials, and studies. Sterility and patient safety remain the number-one priority for the growing portfolio of companies involved, which are helping healthcare professionals improve patient outcomes and operational integrity with each device they receive.
All in all, it’s safe to say that healthcare could not be what it is today without the recent and ongoing contributions of the packaging industry.
For the latest on medical packaging regulations and related news — whether you’re a device manufacturer, a healthcare professional, or a member of the general public — we encourage you to visit the Sterile Business Association website.
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