Date: 5/30/2024
Medical devices undergo sterilization through various methods, such as steam (moist heat), dry heat, radiation, ethylene oxide (EtO) gas, vaporized hydrogen peroxide, and other techniques like chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide.
The FDA is organizing the upcoming session of its medical device sterilization town hall series on June 12, 2024.
Ethylene Oxide
Ethylene oxide (EtO) sterilization is widely used by manufacturers to ensure medical device safety. It's valued for its effectiveness without causing damage, making it suitable for various materials and complex devices like catheters. About half of all sterile medical devices in the U.S. undergo EtO sterilization, from wound dressings to stents.
The FDA reviews submissions to ensure EtO sterilization methods meet standards before devices hit the market, validating processes and controlling residual EtO levels. The EPA oversees regulations for EtO sterilization facilities under the Clean Air Act to protect the public from potential risks.
FDA's Actions to Improve Medical Device Sterilization
The FDA is collaborating with experts and manufacturers to find safer, more effective ways to sterilize medical devices. They've launched Sterilization Master File Pilot Programs to encourage innovation in sterilization methods, reducing the impact of agents like ethylene oxide (EtO) on the environment and public health.
Sterilization Master File Pilot Programs
The FDA created the Sterilization Master File Pilot Programs to make sure patients can get safe medical devices. These programs also encourage finding new, innovative ways to sterilize medical devices. The goal is to reduce the impact of ethylene oxide (EtO) on the environment and public health.
Radiation Sterilization Master File Program for PMA Holders
Introduced on April 11, 2023, this program assists companies sterilizing single-use PMA-approved devices with radiation. It facilitates changes or exploration of new methods like switching radiation sources, simplifying regulatory procedures.
510(k) EtO Sterility Change Master File Pilot Program
Launched in May 2022, it targets sterilization providers altering sterilization methods for 510(k) cleared medical devices. Open to current 510(k) holders, it aids in transitioning from fixed chamber EtO sterilization to the method outlined in the Master File, reducing the need for new 510(k) submissions.
EtO Sterilization Master File Pilot Program for PMA holders
Announced on November 25, 2019, this voluntary program permits PMA holders of Class III medical devices to submit a Master File for certain sterilization process changes. It enables referencing the Master File in a post-approval report instead of submitting a PMA supplement.
FDA innovation challenges
in July 2019 to develop novel sterilization methods.
Challenge 1: Encourages new approaches to device sterilization without ethylene oxide.
Challenge 2: Aims to reduce emissions from ethylene oxide sterilization.
46 applications received, 12 participants selected.
Advisory Committee Meetings
On November 6-7, 2019, the FDA held a meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee to discuss advancements in medical device sterilization.
One recommendation from the meeting was for device manufacturers to reduce the amount of paper in sterile device packages to improve ethylene oxide penetration.
FDA Standards Recognition
FDA determines appropriate standards for medical devices.
Recognized Consensus Standards updated to include standards related to medical device sterilization, including ISO 22441:2022 for vaporized hydrogen peroxide sterilization.
FDA Guidance Update
January 2024: FDA updated final guidance on sterilization information in premarket notifications.
Vaporized hydrogen peroxide (VHP) recognized as Established Category A sterilization process, reducing regulatory burden for manufacturers.
Medical Device Sterilization Town Hall Series
The FDA organizes virtual town halls to explore avenues for innovation in medical device sterilization.
Virtual town halls to discuss the current landscape of medical device sterilization and explore innovation opportunities.
Topics include past and present FDA activities, premarket considerations, reducing ethylene oxide use, and sterilization standards.
This series aims to provide an interactive platform for sharing information, posing questions, and offering comments.
Date | Event |
08/07/2024 | Sterilization Open Q&A (2:00-3:00 PM ET) |
07/10/2024 | Mock Pre-Submission on Implementing a Change in Sterilization Method (1:00-2:30 PM ET) |
06/12/2024 | Sterilization Open Q&A (2:00-3:00 PM ET) |
Report Sterilization Site Changes to the FDA
If your products are affected by a sterilization facility shutdown and you plan to switch to an alternative facility for sterilization:
Premarket Approval (PMA) Holders: Submit a 180-day site change supplement. The FDA aims to review these supplements within 30 days. Refer to the FDA's final guidance, "Manufacturing Site Change Supplements: Content and Submission," for detailed information on site change supplements
For 510(k) Holders: Typically, you don't need to submit a new 510(k) for this change. However, document the qualification activities supporting this change internally. The FDA recommends consulting their guidance, "Deciding When to Submit a 510(k) for a Change to an Existing Device: Guidance for Industry and Food and Drug Administration Staff," to determine if a new 510(k) submission is necessary.
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