SILVER SPRING, Md., March 26, 2019 /PRNewswire/ -- A
critical focus for the FDA is preventing and mitigating potential
medical product shortages. As part of these efforts, we're taking
steps to address potential medical device shortages due to the
recent closure of a large sterilization facility in Illinois. We're
working to ensure that safe and effective sterilization of medical
devices continues and hospitals, health care providers and patients
have access to critical devices.
Earlier this year, the FDA became aware that the Illinois
Environmental Protection Agency (EPA) issued a state EPA Order to
stop a contract sterilizer, Sterigenics, from sterilizing medical
products and other products with gas called ethylene oxide at their
Willowbrook, Illinois facility. The state EPA order was due to the
presence of levels of ethylene oxide higher than the EPA found to
be acceptable in air around the facility.
As the agency responsible for ensuring the safety and efficacy
of all medical devices, the FDA has been closely monitoring the
situation and working with device manufacturers affected by the
closure to minimize any impact to patients who need access to these
medical devices.
Certain medical devices need to be sterilized to reduce the risk
of those devices causing infections in patients from living
microorganisms. Sterilization of medical devices is a
well-established and scientifically-proven method of preventing
harmful microorganisms from reproducing and transmitting
infections. It's critical to our health care system. And
ethylene oxide is a commonly used method of medical device
sterilization. It's considered a safe and effective method that
helps ensure the safety of medical devices and helps deliver
quality patient care. Devices sterilized with ethylene oxide range
from wound dressings to more specialized devices, like stents, as
well as kits used in routine hospital procedures or surgeries that
include multiple components made of different materials. However,
the FDA recognizes the environmental considerations that are
currently impacting manufacturers' ability to use this process.
To that end, and in light of the recent state EPA order, the FDA
has been working to quickly and proactively secure alternative
locations and methods for the sterilization of devices that were
previously processed at the Willowbrook facility in order to
mitigate potential product supply issues. We're taking steps to
prevent patient harm from potential device shortages that could
delay or disrupt critical care. At the same time, we're
undertaking new efforts to encourage innovative and improved
sterilization options.
Steps to Prevent Potential Shortages
First, the FDA is actively working to prevent potential medical
device shortages that may arise from the closing of the Willowbrook
facility. Upon learning that the facility was ordered to stop
sterilizing hundreds of various types of medical devices, we
immediately reached out to the medical device manufacturers that
relied on Sterigenics' services to better understand which devices
were affected by the facility ceasing operations and to assess the
potential impact to patients. We are working directly with
manufacturers, as needed, to help them transition to another
sterilization site or sterilization method.
According to the FDA's Establishment Registration & Device
Listing database, Sterigenics listed a total of 594 types of
devices that undergo an ethylene oxide sterilization process at the
Willowbrook facility and therefore could be affected by
the closure. These include products such as sutures, clamps,
knives, stents and needles. At this time, the FDA isn't aware of
any device shortages attributable to the Willowbrook facility
closure. We're closely monitoring the situation and will continue
to provide updates. There's a risk that for some sterile
packaged products that are already in distribution, existing supply
may be diminished—or even depleted—as health care facilities use
their inventory before alternative arrangements can be made
accommodate the sterilization of new products coming off
manufacturing lines. This could lead to temporary or "spot"
shortages of some products until sterilization can be
restored.
In addition, the FDA is aware that Viant, another contract
sterilizer, recently made public that their Grand Rapids
ethylene oxide sterilization facility is scheduled to close later
this year after receiving attention from the Michigan
Department of Environmental Quality for air quality issues.
According to the FDA's Establishment Registration & Device
Listing database, Viant listed a total of 46 types of devices that
undergo an ethylene oxide process at the Grand Rapids
facility which, in the future, could be
affected by the closure of the facility. These include devices
such as catheters and surgical mesh.
Because of the shutdown of the Sterigenics Willowbrook facility
and the planned closing of the Viant Grand Rapids facility, the FDA
is urging medical device manufacturers that use these facilities to
begin assessing any potential downstream impacts of the closures on
device distribution through their supply chain to end users (such
as health care facilities), and ultimately on patient care. We're
also encouraging medical device manufacturers to consider
alternative contract sterilizers that can process their devices.
We've already communicated the steps manufacturers need to take to
make changes to their contract sterilizers and maintain
availability of their devices. We're committed to working closely
with manufacturers to expedite our review of any site change
submissions to ensure they can efficiently switch to other contract
sterilizer facilities while still ensuring safe and effective
sterilization of their devices.
Second, while every effort is being taken to prevent a potential
shortage, we're monitoring the situation closely and stand ready to
act quickly with strategies intended to limit the impact of device
supply interruptions on patients. These include looking at making
devices available from other sources if needed.
Early awareness of a potential shortage enables us to be
proactive and develop a plan to mitigate its effects on patient
care. We're taking steps to proactively identify potential
shortages. Among other steps, we've established a device shortages
mailbox so that any user, patient or organization within the supply
chain that's aware of a delay in distribution of new product,
and/or anticipates a shortage, can notify us.
Third, as we continue to monitor any shortages associated with
facility closings, we're also working with stakeholders—including
sterilization experts, medical device manufacturers and other
government agencies—to identify innovative ways to sterilize
medical devices that don't raise the same concerns as those
identified at the Willowbrook facility. About half of all
sterilized medical devices undergo sterilization using ethylene
oxide. In view of the concerns about the environmental impact of
this method, we recognize the importance of identifying new and
improved ways of sterilizing medical devices.
We've already started exploring ways we can continue to ensure
sterilization processes are safe and effective, and evolving with
the current science. This includes considering validation of
methods that would support using lower levels of currently-used
agents like ethylene oxide gas, thereby reducing environmental
exposure risks, while still ensuring effective device
sterilization. There may also be ways to employ—and eventually
validate—new sterilization agents or processes that don't come with
the same environmental risks but still enable the safe and
effective sterilization of devices.
To advance these efforts, we plan to discuss this issue with the
infection control community at the May 2019 Healthcare
Infection Control Practices Advisory Committee (HICPAC). We will
also host a public advisory committee meeting that will be
announced later this year dedicated to discussing how best to
encourage innovation in medical device sterilization. In addition,
later in 2019, we will announce a public innovation challenge to
encourage development of novel sterilization methods, which could
include new devices or new modalities that are safe and effective
for sterilizing medical devices.
Finally, we recognize that new challenges may arise from the
current situation. To help ensure transparency and communication
about the use of ethylene oxide in medical device sterilization,
today we launched a new FDA web page to act as a resource on
this sterilization method as well as any future actions we take
regarding shortages or other activities associated with this
issue. We'll update this site as new information becomes
available. We'll continue to act to help ensure patient access to
safe and effective medical devices. And we'll work directly with
manufacturers, contract sterilizers, government agencies and other
public health stakeholders to evaluate potential impacts and take
additional steps as needed to avert device shortages. We're seeking
to not only limit the immediate impact of these facility closures,
but also to identify new and improved methods for medical device
sterilization.
Media Inquiries: Alison Hunt, 240-402-0764
Consumer Inquiries: 888-INFO-FDA
View original content to download
multimedia:http://www.prnewswire.com/news-releases/statement-from-fda-commissioner-scott-gottlieb-md-on-steps-the-agency-is-taking-to-prevent-potential-medical-device-shortages-and-ensure-safe-and-effective-sterilization-amid-shutdown-of-a-large-contract-sterilization-facility-300818818.html
SOURCE U.S. Food and Drug Administration