The U.S. Food and
Drug Administration (FDA) is providing information on recent actions responding
to ongoing concerns about ethylene oxide in commercial operations and
encouraging innovative approaches to medical device sterilization.
FDA innovation Challenges
On June 15, 2019,
the FDA announced two Innovation Challenges to identify sterilization
alternatives and reduce ethylene oxide emissions.
Ethylene Oxide Sterilization Master File Pilot Program
On Novembr 25,
2019, the FDA announced its Ethylene Oxide Sterilization Master File Pilot
Program (EtO Pilot Program).
This voluntary
program is intended to streamline the submission process, so that sterilization
providers that sterilize single-use medical devices using fixed chamber
sterilization processes may submit a Master File to the FDA when making certain
changes between sterilization sites, or when making certain changes to
sterilization processes that utilize reduced ethylene oxide concentrations, and
PMA holders can reference such a Master File in a postapproval report instead
of submitting a traditional PMA supplement.
General Hospital and Personal Use Devices Panel
Advisory Committee Meeting
On November 6 and
7, 2019, the FDA held an advisory committee meeting to discuss ethylene oxide
sterilization of medical devices and its role in maintaining public health.
Based on panel discussions, the FDA is encouraging device manufacturers to move
to electronic labeling and instructions for use in the near term and is committed
to working with industry to make this change.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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