CDRH Unveils Pilot Project for Sterilization Changes

Regulatory NewsRegulatory News | 25 November 2019 |  By 

As medical device ethylene oxide (EtO) sterilization facilities continue to close across the country, the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) on Monday unveiled a new pilot project to expedite certain changes to EtO sterilization processes and facilities.

The voluntary pilot will allow manufacturers of Class III devices to reference a Master File submitted by up to nine sterilization providers in lieu of submitting a premarket approval application (PMA) supplement.

“Under this pilot program, sterilization providers that sterilize single-use medical devices using fixed chamber EtO would submit a Master File when making certain changes between sterilization sites or when making certain changes to sterilization processes that utilize reduced EtO concentrations. Under this voluntary program, PMA holders of Class III devices affected by such changes may, upon FDA's permission, reference the Master File submitted by their sterilization provider in a postapproval report,” the agency said.

FDA notes that the postapproval report does not remove or replace the requirement for manufacturers to submit annual reports identifying changes made to PMAs. And FDA said it intends to evaluate the pilot’s progress in six months and provide any updates in the meantime.

“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 implemention of sterilization methods that reduce the amount of ethylene oxide needed to sterilize PMA-approved medical devices,” CDRH Director Jeff Shuren said in a statement.

EtO Innovation Challenge Winners

In addition to the pilot, CDRH on Monday also announced the selection of 12 applications (out of 46 total applicants) as winners of its two innovation challenges related to EtO.

One challenge was to identify alternatives to the use of EtO, while the other one was set up to find ways to significantly reduce the amount of EtO used to sterilize devices.

Abbott, Andersen Scientific, Becton Dickinson, DMB Apparatebau GmbH, Medtronic, NovaSterilis, Noxilizer, Sterigenics, Steris and Taiwan Advanced Sterilization Technologies were selected to participate in the challenges.

“These applications run the gamut of innovative ideas and novel methods, including nitrogen dioxide sterilization, vaporized hydrogen peroxide sterilization, reduced sterilant concentration and use of ethylene oxide-flexible chamber technology to name a few examples,” Shuren said.

He also said FDA is moving forward with several recommendations made at an advisory committee meeting earlier this month on device sterilization.

For instance, FDA is encouraging device manufacturers to reduce the amount of paper, “such as the labeling and instructions for use manuals,” included in a sterile device package because such large amounts of paper can hinder the EtO from getting to the device and generally means that more EtO is required for effective sterilization.

The announcements of the pilot and challenge winners come as high levels of EtO emissions have caused two device sterilization facilities in Illinois and Georgia to close earlier this year, and a large Becton Dickinson sterilization facility in Georgia may also close.

Statement on new steps to advance innovation in medical device sterilization with ethylene oxide

Federal Register


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