Jim Kasic, President and CEO, Boulder iQ11.14.23
When you think of orthopedic devices, you may envision devices made out of stainless steel or titanium. While manufacturers certainly still use these materials, they are moving rapidly toward more widespread use of novel composite materials.
The development of these materials presents opportunities to improve performance, flexibility and functionality. It also creates specific and unique considerations orthopedic device manufacturers must take into account when choosing a sterilization method.
In particular, manufacturers need to be aware of characteristics that biodegradable materials bring to the sterilization decision. Used often in implant devices, these materials degrade and absorb into the surrounding tissue after implantation. In the sterilization process, they are very sensitive to temperature and can have issues with residuals. In some cases, it’s also possible to find interactions between the sterilization medium and device itself.
The sterilization choices for orthopedic devices include electronic beam (e-beam), gamma irradiation, ethylene oxide (EO) and chlorine dioxide (CD). Key considerations to discuss with a sterilization vendor include the following:
In contrast, the CD molecule is a very unstable molecule that wants to degrade into chlorates, chlorites, chlorides and water. CD will quickly aerate, as it will not condense on surfaces or absorb readily into many materials. This has two important benefits: a reduction in the cycle time of the sterilization process; and the elimination of any time-consuming post-sterilization aeration process. Residues on products and packaging are far below detectable levels. It’s possible to handle sterilized products and packaging immediately after the sterilization cycle.
The ability to accurately measure and monitor it in real time with photometric devices enables greater safety through close management during sterilization. In most situations, it can be exhausted directly to the environment; no scrubbing with hazardous chemicals needed. It is a registered sterilant with the EPA.
Jim Kasic is the president, CEO and founder Boulder iQ. With more than 30 years of experience in the Class I, II, and III medical device industry, he holds more than 40 U.S. and international patents. His career includes experience with companies ranging from large multinational corporations to startups with a national and international scope. Kasic has served as president and CEO of Sophono, Inc., a multinational manufacturer and distributor of implantable hearing devices, which was acquired by Medtronic. He also was the president of OrthoWin, acquired by Zimmer-BioMed. He received a Bachelor of Science degree in physics and a Master of Science degree in chemical/biological engineering from the University of Colorado, and a Master of Business Administration degree from the University of Phoenix. He can be reached at jim.kasic@boulderiq.com or on LinkedIn.
The development of these materials presents opportunities to improve performance, flexibility and functionality. It also creates specific and unique considerations orthopedic device manufacturers must take into account when choosing a sterilization method.
In particular, manufacturers need to be aware of characteristics that biodegradable materials bring to the sterilization decision. Used often in implant devices, these materials degrade and absorb into the surrounding tissue after implantation. In the sterilization process, they are very sensitive to temperature and can have issues with residuals. In some cases, it’s also possible to find interactions between the sterilization medium and device itself.
The sterilization choices for orthopedic devices include electronic beam (e-beam), gamma irradiation, ethylene oxide (EO) and chlorine dioxide (CD). Key considerations to discuss with a sterilization vendor include the following:
Energy Type
E-beam and gamma irradiation methods of sterilization use ionizing energy. They work well for metallic implants, but generally are not the best choices for today’s cutting-edge biodegradable and high-tech materials, because they tend to change the material properties.Temperature
Some orthopedic devices are extremely sensitive to temperature. So, while EO runs at a relatively low temperature (60°C), it still could affect some fragile materials. On the other hand, CD, working at room temperature, is compatible with nearly all materials, including plastic components and electronics.Residuals
The EO molecule is a stable molecule that wants to linger and absorb into materials – a problem for the new bio-absorbable materials. As a result, incorporation of aeration time into the development process is critical. Some orthopedic devices can require more than 48 hours to aerate when sterilized with EO. This becomes expensive for both the manufacturer and the EO sterilization vendor.In contrast, the CD molecule is a very unstable molecule that wants to degrade into chlorates, chlorites, chlorides and water. CD will quickly aerate, as it will not condense on surfaces or absorb readily into many materials. This has two important benefits: a reduction in the cycle time of the sterilization process; and the elimination of any time-consuming post-sterilization aeration process. Residues on products and packaging are far below detectable levels. It’s possible to handle sterilized products and packaging immediately after the sterilization cycle.
Surface
For traditional orthopedic devices, the surface finish for metallic devices must be able to withstand the sterilization method being considered. With biomedical alloys and bio-absorbable devices, it’s possible that EO or CD could cause some undesirable chemical characteristic changes on the surface. Since every product and situation will be different, orthopedic device manufacturers would be wise to work with a sterilization vendor that offers both EO and CD options, and who has the knowledge and experience to determine the best choice for each device.Environmental Factors
While half of all medical devices today use EO sterilization, the tide is turning toward alternatives – such as CD. Considered an environmentally friendly method of sterilization, CD is low-impact, non-cancerogenic, and nonflammable.The ability to accurately measure and monitor it in real time with photometric devices enables greater safety through close management during sterilization. In most situations, it can be exhausted directly to the environment; no scrubbing with hazardous chemicals needed. It is a registered sterilant with the EPA.
Conclusion
All orthopedic devices are becoming more novel. We are seeing the integration of biologics, designs that are more functional and longer-lasting, and features to help the body heal faster, along with novel materials. As the industry continues to advance, the choice of sterilization method – and vendor – will become more important.Jim Kasic is the president, CEO and founder Boulder iQ. With more than 30 years of experience in the Class I, II, and III medical device industry, he holds more than 40 U.S. and international patents. His career includes experience with companies ranging from large multinational corporations to startups with a national and international scope. Kasic has served as president and CEO of Sophono, Inc., a multinational manufacturer and distributor of implantable hearing devices, which was acquired by Medtronic. He also was the president of OrthoWin, acquired by Zimmer-BioMed. He received a Bachelor of Science degree in physics and a Master of Science degree in chemical/biological engineering from the University of Colorado, and a Master of Business Administration degree from the University of Phoenix. He can be reached at jim.kasic@boulderiq.com or on LinkedIn.