- FDA Monday launched a voluntary pilot to allow companies sterilizing single-use Class III devices in a fixed chamber to submit a master file when making changes to reduce ethylene oxide concentrations or changing sterilization sites. The goal is to allow manufacturers affected by these changes to reference the sterilizer's master file in a post approval report instead of submitting a premarket approval application supplement. The pilot is intended to speed adoption of new methods to sterilize devices with less ethylene oxide by several months.
- The agency also announced the winners for its two innovation challenges aimed at speeding development and review of new sterilization methods and ways to reduce ethylene oxide emissions. Out of 46 applications, FDA selected 12 from companies including Sterigenics, Steris, Medtronic and BD.
- Device manufacturers should also reduce the amount of paper in device packaging "as soon as possible" to cut down on the amount of ethylene oxide required for effective sterilization, according to FDA. The agency said it is working with industry to encourage a switch to "electronic materials" instead of paper packaging when feasible and safe.
The newest steps to reduce reliance on ethylene oxide come weeks after FDA convened a two-day advisory committee to discuss ways to transition from the carcinogenic gas used to sterilize more than half of medical devices amid concern about the health affects on local populations.
Generally, if a medical device manufacturer changes the method, process or facility it uses to sterilize devices, it needs to submit a PMA supplement to FDA before the changes can occur.
"However, considering the recent sterilization facility closures and concerns about their impact on medical device availability, we recognize the need to facilitate timely process and site changes that may reduce the amount of ethylene oxide used and minimize the impact of supply interruptions," Centers for Devices and Radiological Health Director Jeff Shuren said in a statement.
By speeding how manufacturers can adopt new sterilization methods for certain devices, the voluntary pilot program may result in months of saved time.
"We believe this pilot program will allow more nimble response to sterilization site closures by more quickly approving sterilization site relocations and speeding up the implementation of sterilization methods that reduce the amount of ethylene oxide needed to sterilize PMA-approved medical devices," Shuren said.
While FDA's expert panel warned there are no adequate alternative sterilization methods that can achieve the material compatibility and scale of ethylene oxide, the agency hopes its innovation challenge will help accelerate the development of new sterilant technologies. Shuren said FDA would directly work with the selected winners to accelerate review of the new methods.
The winners of its challenge to develop new sterilization methods and technology are:
Innovation Challenge 1 Winners: Finding New Sterilization Tech
|Company||Reduction Technology or Strategy Category|
|NovaSterilis||Supercritical Carbon Dioxide Sterilization|
|Noxilizer, Inc.||Nitrogen Dioxide Sterilization|
|STERIS||Accelerator-Based Radiation Sterilization|
|STERIS||Vaporized Hydrogen Peroxide Sterilization|
|TSO3, now a part of Stryker||Vaporized Hydrogen Peroxide-Ozone Sterilization|
SOURCE: Food and Drug Administration
In August, Stryker announced a deal to acquire TSO3, a maker of a low-temperature sterilizer for heat-sensitive medical devices, for $51.7 million.
In tandem with the pilot and recommendation on paper packaging, FDA also announced the winners of its innovation challenge aimed at reducing ethylene oxide emissions:
Innovation Challenge 2 Winners: Reducing EtO Emissions
|Company||Alternative Technology Category|
|Abbott||Enhanced EtO Cycle Design and Processes|
|Andersen Scientific, Inc.||Use of EtO-Flexible Chamber Technology|
|Becton, Dickinson and Company (BD)||Enhanced EtO Cycle Design and Processes|
|DMB Apparatebau GmbH||Reduced Sterilant Concentration|
|Medtronic plc||Enhanced EtO Cycle Design and Processes|
|Sterigenics U.S., LLC||Enhanced EtO Cycle Design and Processes|
|STERIS||Enhanced EtO Cycle Design and Processes|
|Taiwan Advanced Sterilization Technologies Inc.||Abatement Strategy|
SOURCE: Food and Drug Administration
The Environmental Protection Agency is set to release its advanced notice of proposed rulemaking on commercial ethylene oxide sterilizers before the end of November, according to the White House's recently announced fall regulatory schedule. The agency expects to issue a proposed rule in February 2020, but has yet to set a timeline to finalize the regulations that could boost the required abatement of ethylene oxide emissions and directly impact medical device manufacturers.