It Isn’t.

For freeloading bacteria, terminal sterilization is actually quite sinister. But for the rest of us, it is the last step in preparing a medical device or piece of medical equipment for use with patients in the operating room.

Terminal sterilization makes things sterile.

Continuum of Clean

“Sterile” is precisely the quality you want in the pacemaker or heart valve or suture you are scheduled to get. “Sterile” is clean to a very specific standard: 1 in 1,000,000. The general sterility assurance level (SAL) is the probability that the presence of a single viable microorganism on a product after sterilization is less than or equal to one in a million. It’s a benchmark number: 10^-6. You may be surprised to know there is a lot of science behind that number.

It turns out that “clean” and “dirty” are not the binaries our mothers warned us about when we learned to wash our hands. In the terminal sterilization industry, there is a continuum of clean—this is one of the things we learned in doing an analysis of the terminal sterilization industry.

Terminal Sterilization Community of Practice

An extensive and talented community of practice studies, defines, and makes “sterile” happen, day after day, silently (for most of us, anyway), and far from any operating room drama. Without the efforts of this community, modern medicine would come to a standstill. Because “sterile” is an expected starting point for most of the sutures, needles, swabs, pacemakers, heart valves, or anything else that has contact with—or goes inside—the human body.

For the last year, our team had the opportunity to discuss and document the significant shifts in this terminal sterilization community of practice. These shifts are the result of deepening restrictions on the amount of ethylene oxide (EtO) that can be used for sterilization. EtO has been in use for 40+ years because it is effective: it can kill bacteria by the truckload. But EtO has been shown to be carcinogenic, and regulatory bodies in the US and around the world are trying to locate new methods for sterilization. We discussed four alternative sterilization modalities:

• Chlorine dioxide
• Low-energy radiation
• Nitrogen dioxide

Vaporized hydrogen peroxide

Our team wrote a 36-page analysis of the state of terminal sterilization based on the opinions, disagreements, and questions voiced by the experts in this field. Much about sterilization is still unknown. For example, one question the community continues to ask is how each sterilization modality impacts different materials over time.

Collaborating with Experts

What we loved about this project was the chance to dive deep into a topic and learn from a variety of sterilization industry experts. Interacting with passionate experts helps propel our work. As copywriters, we are intent on accurately translating the community’s science and questions into resources for anyone considering changing their terminal sterilization process.

Contact us and we’ll send you a copy for free.

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