Andersen Sterilizers Awarded First 510(k) Master File for EtO Sterility Change

In a major win for companies hoping to minimize the amount of ethylene oxide (EtO) needed to sterilize medical devices without the risk of 510(k) resubmission, Andersen Sterilizers and its contract sterilization specialist sister company, Andersen Scientific, announced it’s been awarded the very first master file in the FDA’s 510(k) EtO Sterility Change Master File Program.

The pilot program, which was born out of EPA and FDA’s mission to reduce EtO emissions, aims to remove regulatory hurdles when changing sterilization methods. Previously when changing methods, there would be a risk that companies would have to re-submit a 510(k) for a device. Now, 510(k) class I or class II device holders labeled as sterile can reference the Andersen Sterilizers master file rather than submitting a new 510(k) for the sterilization change.

“In 2019 we were very proud to be selected as a winner of FDA’s Innovation Challenge 2, which was an initiative by FDA to identify ways of using [EtO] more efficiently,” A.E. May, president and CEO of Andersen Scientific, told MD+DI. “For the winners of this initiative, the FDA agreed to help remove regulatory hurdles to the adoption of gas-efficient technologies. In our case the request was simple. When a medical device manufacturer changes sterilization methods, there is the risk that they will be asked by FDA to re-submit a 510(k) for their device. With the FDA’s Medical Device Master File program, the transition to an Andersen sterilization system just became a lot easier.”

Andersen Sterilizers sterilization systems, including the EOGas 4 or EOGas 3 in-house systems as well as Andersen Scientific's contract sterilization services, use proprietary flexible chambers in tabletop and refrigerator-sized versions, which require 85-90% less EtO gas compared to current systems. The company specializes in small to medium lot sterilization, custom cycles, and fast turnaround for the manufacturing, research, medical, and veterinary markets.

“There is a reason that ethylene oxide is used to sterilize the majority of this country’s new medical devices,” May said. “It is incredibly effective against even the most dangerous pathogens, and it is compatible with a wide variety of materials. The beauty of the Andersen process is that it uses this very effective sterilant much more efficiently than any other method. Andersen sterilizers employ a flexible chamber system that uses 85-90% less gas than traditional EO sterilizers.”

Andersen is the only company, so far, that has been awarded FDA EtO pilot program master file for 510(k) holders. The program is open to all current 510(k) holders and is intended to help with changes to a cleared medical device’s sterilization method.

“We are very proud of this award and the completion of the FDA Master File,” he told MD+DI. “It is the next step in our history of relentless innovation. [EtO] sterilization has been around since the 1960’s, and many people are not aware of how this technology has advanced. Andersen has obtained 18 510(k) clearances since 2015, including the first terminal sterilization clearance for duodenoscopes. This is a state-of-the-art system that delivers the proven reliability of [EtO] in a modern, ultra-efficient process.”

For PMA holders, a specific EtO sterilization master file pilot program has been created to accomplish the same as its 510(k) counterpart. Under the program, PMA holders of Class III medical devices would be able to reference the master file submitted by their sterilization provider in a post-approval report instead of submitting a PMA supplement.

Currently, the PMA pilot program includes Boston Scientific, Becton, Dickinson & Company (BD), Steris, Oscor, and Medtronic.