As with all historic journeys of human healthcare equipment and supplies, the development of orthopedic devices was constrained by the level of anatomical and physiological understanding. Treatment of physical conditions and risks at any given time also played a significant role.
The earliest orthopedic devices were created in response (as were most early medical discoveries) to dire circumstances. The battlefields of war were there from the beginning, with shattered and crushed bones keeping orthopedic trauma at the forefront. Splints, slings and casting were perpetually hot topics, yet the historic record of ortho devices is at best sparse, even non-existent in many ways. It is no surprise then, that even less is known about early containment or packaging of orthopedic equipment. At that point, “packaging” did not exist.
MILE MARKERS
1880-1895 What is known is that blacksmiths and saddlers, adept at working with metal and leather, served as makers of orthopedic devices until the machine age arrived. In the late-19th century, surgeon Joseph Lister’s statement, “The best medicine is prevention,” introduced the concept of aseptic presentation, as he learned more about Louis Pasteur’s sterilization and disinfection procedures. Lister’s subsequent research about infection prevention would also lead to the first sterile packaging practice: wrapping cleaned medical and surgical tools and medical devices in sterilized cloth.
1895-1900 Lister’s turn-of-the-century science expanded the understanding of sterilization. Mass manufacturing expanded product availability, with the debut of DePuy splints. No mention is found as to whether the splints were enclosed in any sort of packaging. The splints were made from sterilized bronze and nickel—sterilized by boiling or steam—and intended for frequent re-use. By now, awareness of the need for safe, hygienic protection, storage and handling was clear, yet the lack of any mention seems to support that packaging was not yet associated with the delivery of orthopedic care.
1950s-1960s Packaging of medical devices, including orthopedics did not exist for another half century. Finally, the light dawned as three breakthroughs aligned:
- 1. Plastic packaging and heat-sealing capabilities made sterile barrier packaging a practical reality.
- 2. Orthopedic surgeon John Charnley pioneered and furthered the science of internally implanted joint replacements.
- 3. The world’s first bachelor’s degree program in packaging engineering was offered by Michigan State University.
1970s-2000s From there, the acceleration of packaging science advanced at warp speed. Even as films, bags, boxes and pouches, cartons and overwraps proliferated, orthopedic specialty lagged. While ortho goods required sterile barrier integrity as much as any medical device, the materials and sterilization processes for unusual shapes, protruding or sharp angles, textured features and comparatively heavy components didn’t make for easy solutions.
TODAY AND TOMORROW
Materials science is a key to watch for trends in orthopedic device packaging. The highly customized packaging required for ortho is also finding new options in 3-D printing and other technologies. Foams are another example of versatile materials ideal for orthopedic packaging design. Cross-linked poly foams are lightweight, conducive to compression molding, die cutting and offer low particulate concerns. How materials used in the orthopedic devices (i.e., titanium) interact with packaging materials and sterilization is another crucial aspect of the packaging design process.
Understanding how sterilization will be ensured when blind holes or other tricky features are enclosed in packaging is an ongoing issue, completely aside from the global and regulatory push for new sterilization methods.
Ongoing emphasis on cost cutting and reducing packaging while maintaining the highest degree of performance, manufacturability and sterile barrier protection remains a constraint slowing the pace of accepting new packaging materials. Finding the balance between trying something new and meeting regulatory demands is a high priority across industry disciplines.
In summary, the history of orthopedic devices and their packaging may have seen an excruciatingly slow beginning, but it has reached warp speed and shows no signs of slowing down. Investing time in trend watching and scientific research may feel like a luxury; in reality, it could be our secret to success.
