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INSIGHTS

August 7, 2023 FDA Updates
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EO STERILIZATION; EPA MANDATE; ALTERNATES FROM FDA

In April, the U.S. Environmental Protection Agency proposed limiting EtO
emissions from sterilization facilities by 80% to minimize the risk of people
developing cancer from exposure to the gas. To support manufacturers transition
to other, FDA is doing it’s part by suggesting alternate methods

Ethylene oxide sterilization is an important sterilization method that
manufacturers widely use to keep medical devices safe. For many medical devices,
sterilization with ethylene oxide may be the only method that effectively
sterilizes and does not damage the device during the sterilization process.
Medical devices made from certain polymers (plastic or resin), metals, or glass,
or that have multiple layers of packaging or hard-to-reach places (for example,
catheters) are likely to be sterilized with ethylene oxide.

There are two voluntary consensus standards for ethylene oxide sterilization…

 * ANSI AAMI ISO 11135:2014 and
 * ANSI AAMI ISO 10993-7:2008(R)2012)

These standards help ensure levels of ethylene oxide on medical devices are
within safe limits since long-term and occupational exposure to ethylene oxide
has been linked to cancer.

The U.S. Environmental Protection Agency proposed limiting EtO emissions from
sterilization facilities by 80% to minimize the risk of people developing cancer
from exposure to the gas.

The FDA announced two public innovation challenges to encourage the development
of new approaches to medical device sterilization:

Challenge 1: Identifying Sterilization Alternatives:

The goal of this challenge is to identify safe and effective sterilization
methods or technologies for medical devices that do not rely on ethylene oxide
and that meet these criteria:

   

   
 * Compatibility: The method or technology should be compatible with a large
   cross -section of materials used to manufacture or fabricate medical devices
   as well as packaging materials or sterile barriers. The materials, devices
   and barriers of particular interest are those that are compatible with
   ethylene oxide sterilization.

   

   
 * Scalability and High Throughput: The method or technology should have the
   potential to be scalable and allow for the effective sterilization of large
   volumes of devices.

The challenge submissions were expected to succinctly describe:

 * Anticipated benefit of the technology or method
 * Impact of the method or technology on public health as compared to other
   available alternatives
 * Compatibility of the method or technology with medical device materials
 * Capability of the method or technology to ensure scalability and high
   throughput for safe and effective sterilization of large volumes of devices

The FDA also considered factors such as:

 * Feasibility of the strategy or technology
 * Impact of the FDA’s involvement

Elements that would have been considered within this challenge scope:

 * Methods that can sterilize a wide range of polymeric materials without
   changing the chemical and physical properties of the polymers by degrading
   them (e.g., through oxidization, chain scission, or other unfavorable
   reactions) or by generating unacceptable levels of toxic by-products such as
   leachables.
 * Materials or medical devices that are typically sterilized by ethylene oxide.
 * Methods that can or have potential to sterilize bulk volumes/large loads of
   products
 * Methods that employ the use of technologies and infrastructure that is
   readily accessible or rapidly developed to medical device manufacturers and
   sterilization providers in the United States.

The FDA updated the Recognized Consensus Standards database to include the
complete recognition of one sterilization standard and two Technical Information
Reports (TIRs) intended to advance innovation in medical device sterilization
processes, support manufacturers’ use of “low temperature vaporized hydrogen
peroxide”, and streamline the premarket review process:

 * ISO 22441:2022 Sterilization of health care products Low temperature
   vaporized hydrogen peroxideRequirements for the development, validation and
   routine control of a sterilization process for medical devices
 * AAMI TIR104:2022 Guidance on transferring health care products between
   radiation sterilization sources
 * AAMI TIR17:2017/(R)2020 Compatibility of materials subjected to sterilization

Low Temperature Vaporized Hydrogen Peroxide: This method uses hydrogen peroxide
vapour under vacuum to sterilize medical devices. VHP technology demonstrates
low toxicity and rapidly decomposes into non-toxic by-products of water vapour
and oxygen. Once the vapour has been removed from the sterilization chamber by a
series of vacuum/air pulses, unlike other processes such as ethylene oxide, no
further aeration is required.

Challenge 2: Reduce the EtO Emission:

The goal of this challenge is to develop strategies or technologies to reduce
emissions to as close to zero as possible from the ethylene oxide sterilization
process.

The strategies or technologies may allow for the:

 * Use of lower levels of ethylene oxide while maintaining assurance that
   devices are safely and effectively sterilized.
 * Capture of ethylene oxide emissions and/or transformation to harmless by
   products.
 * Detection, measurement, tracking, and containment of fugitive emissions to
   prevent or minimize emissions into the sterilization facility or environment.
 * Safe use of ethylene oxide while minimizing harmful exposure (such as
   toxicity and carcinogenicity) to sterilization workers and nearby
   communities.

The challenge submissions were expected to succinctly describe:

 * Anticipated benefit of the strategy or technology
 * Impact of the strategy or technology on public health as compared to other
   available alternatives
 * Compatibility of the strategy or technology with medical device materials
 * Capability of the strategy or technology to ensure scalability and high
   throughput for safe and effective sterilization of large volumes of devices

The FDA also considered factors such as:

 * Feasibility of the strategy or technology
 * Impact of the FDA’s involvement

Elements that would have been considered within this challenge scope:

 * Methods that can or have potential to sterilize bulk volumes/large loads of
   products
 * Methods that employ the use of technologies and infrastructure that is
   readily accessible or rapidly developed to medical device manufacturers and
   sterilization providers in the United States
 * Strategies to control or reduce bioburden prior to sterilization
 * Incorporation of processes that use lower levels of ethylene oxide while
   assuring that requisite sterility assurance/sterilization is attained
 * Capture of ethylene oxide emissions and transformation to harmless byproducts
 * Detection, measurement, tracking, and containment of ethylene oxide emissions
   or byproducts to minimize or prevent dissemination into the sterilization
   facility and environment
 * Allowing for the safe use of ethylene oxide while minimizing exposure to
   sterilization workers or nearby communities

Tags:

EthyleneoxideFDAFDA UpdatesHealthcareInnovationMedical
DevicesRegulationsSterilization

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