REVOX Advantage: How REVOX Sterilization Outperforms Ethylene Oxide
It’s been over two decades since the FDA approved a new novel method for industrial sterilization. Beginning in the early 1990s—when the last method was given the green light—the agency has become much more stringent in its standards for granting approval. In May, Cantel Medical Corp.’s REVOX Sterilization Solutions process ended that long innovation drought when OsteoSymbionics announced FDA 510(k) clearance of ClearShield™, its Class II cranial implant, which uses REVOX’s groundbreaking sterilization technology.
This FDA approval is important, says REVOX co-inventor Mason Schwartz. It demonstrates that this innovative new sterilization process can provide several distinct cost and time-savings advantages to manufacturers who are still using legacy sterilization products, like Ethylene Oxide (ETO).
No Residual or Safety Concerns
Over the past decade, a number of industry concerns have been raised about ETO sterilization. During this time, an increasing number of hospitals across the U.S. have chosen not to perform ETO sterilization in-house because the method may produce residual levels of carcinogens that can be harmful to the patient and the operators involved with the sterilization process, notes Schwartz. As recently as four or five years ago, ISO standards for ETO residual levels were at 20ppm. Today that standard is 4ppm. OsteoSymbionics CEO Dorothy Burnback says her company chose REVOX sterilization precisely because it was having difficulty finding hospitals that would still do ETO sterilization.
The results speak for themselves. “The Osteosymbionics 510(k) submission process revealed the superior performance of REVOX,” Schwartz points out. “The residual levels found in the Clearshield product processed with REVOX sterilization were 36 times lower than the minimum no-observed-effect-level for devices in direct contact with blood.”
Shorter Turnaround Time
For manufacturers who have resorted to off-site ETO sterilization, the resulting cost to their production schedules can be significant. Turnaround time for remote ETO sterilization can vary anywhere from 3 days to several weeks. But REVOX technology enables an on-site, in-line, just-in-time sterilizationSM solution and offers a contract service that can turn around products in as little as one day.
Lower Sterilization Temperature
Compared to the elevated temperature necessary for ETO sterilization (40˚ C), the REVOX room temperature process (18˚–30˚C) offers a much less harsh environment. This lower temperature translates into less chance of compromising the integrity of product components during the sterilization process.
More Packaging Choices
While ETO technology mandates a permeable barrier be used, such packaging is only one of several options for REVOX’s room temperature sterilization process. More packaging flexibility can be crucial to providing better per-unit cost savings as well as end-user convenience.