Statement by FDA Commissioner Scott Gottlieb, MD, on the steps the Agency is taking to prevent the potential shortage of medical devices and to ensure safe and effective sterilization amid the shutdown of a large contract sterilization facility



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SILVER SPRING, Maryland, March 26, 2019 / PRNewswire / – A critical focus for the FDA is to prevent and mitigate the potential shortage of medical products. As part of these efforts, we are taking action to address the potential shortage of medical devices due to the recent closure of a large sterilization facility in Illinois. We are working to ensure that safe and effective sterilization of medical devices continues and that hospitals, healthcare professionals and patients have access to critical devices.

Earlier this year, the FDA noted that the Illinois Environmental Protection Agency (EPA) issued an EPA order to prevent a contract sterilizer, Sterigenics, from sterilizing medical products and other gas products called ethylene oxide at its facility. Willowbrook, Illinois. The state EPA order was due to the presence of EPA levels higher than EPA considered acceptable in the air around the facility.

As the agency responsible for ensuring the safety and effectiveness of all medical devices, the FDA has closely monitored the situation and worked with manufacturers of devices affected by closure to minimize any impact on patients who need access to these medical devices.

Certain medical devices need to be sterilized to reduce the risk that these devices cause infections in patients with living microorganisms. Sterilization of medical devices is a well-established and scientifically proven method of preventing harmful microorganisms from reproducing and transmitting infections. It is critical to our health care system. And ethylene oxide is a commonly used method of medical device sterilization. It is considered a safe and effective method that helps to ensure the safety of medical devices and helps to provide quality patient care. Devices sterilized with ethylene oxide range from dressings to more specialized devices, such as stents, as well as kits used in routine hospital procedures or surgeries that include multiple components made from different materials. However, the FDA recognizes environmental considerations that are currently affecting manufacturers' ability to use this process.

To this end, and in light of the recent EPA request, the FDA has been working to proactively and quickly protect locations and alternative methods for sterilizing devices that have been pre-processed at the Willowbrook facility to mitigate possible problems of product supply. We are taking steps to avoid harm to patients due to the potential shortage of devices that can delay or disrupt critical care. At the same time, we are undertaking new efforts to encourage innovative and improved sterilization options.

Steps to avoid potential shortage

First, the FDA is actively working to avoid the potential shortage of medical devices that may arise from the closure of the Willowbrook facility. Upon learning that the facility was ordered to discontinue the sterilization of hundreds of various types of medical devices, we immediately contacted the medical device manufacturers who relied on Sterigenics services to better understand which devices were affected by the installation and to assess the potential impact to patients. We are working directly with manufacturers as needed to help them make the transition to another sterilization site or sterilization method.

According to the FDA registration and device registration 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 closure. These include products like sutures, staples, knives, stents and needles. At this time, the FDA is not aware of any shortages of devices attributable to the closure of the Willowbrook facility. We are closely monitoring the situation and will continue to provide updates. There is a risk that for some sterile packaged products already in distribution the existing supply may be reduced – or even exhausted – as health facilities use their inventory before alternative arrangements accommodate the sterilization of new products leaving the manufacturing lines. This may lead to temporary or "timely" shortages of some products until the sterilization can be restored.

In addition, the FDA is aware that Viant, another contract sterilization company, recently announced that the Grand Rapids ethylene oxide sterilization facility is scheduled to close this year after receiving attention from the Michigan Department of Environmental Quality . According to the FDA registration and device registration 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.

Due to the closure of the Sterigenics Willowbrook facility and the planned closure of the Viant Grand Rapids plant, the FDA is urging medical device manufacturers to use these facilities to begin evaluating the possible subsequent impacts of closures on device distribution through its chain supply. users (such as health services) and, ultimately, patient care. We are also encouraging medical device manufacturers to consider alternative contract sterilizers that can process their devices. We have already communicated the steps manufacturers need to take to change their contract sterilizers and maintain the availability of their devices. We are committed to working closely with manufacturers to expedite our analysis of shipments of changes to the site to ensure that they can effectively switch to other contract sterilizer facilities while ensuring safe and effective sterilization of their devices.

Second, while every effort is being made to avoid potential shortages, we are monitoring the situation closely and are ready to act quickly with strategies designed to limit the impact of disruptions in the delivery of devices to patients. This includes the availability of making devices available from other sources, if necessary.

Early awareness of a potential shortage allows us to be proactive and develop a plan to mitigate its effects on patient care. We are taking steps to proactively identify possible shortcomings. Among other steps, we have established a device shortage mailbox so that any user, patient, or organization within the supply chain who is aware of a delay in distributing a new product and / or anticipating a shortage may notify us.

Third, as we continue to monitor any shortages associated with facility closures, we are also working with stakeholders – including sterilization specialists, medical device manufacturers and other government agencies – to identify innovative ways of sterilizing medical devices that do not raise the same concerns . such as those identified at the Willowbrook facility. About half of all sterile medical devices are sterilized with ethylene oxide. In view of concerns about the environmental impact of this method, we recognize the importance of identifying new and improved ways to sterilize medical devices.

We have begun to explore ways to continue to ensure that sterilization processes are safe and effective and evolve with current science. This includes considering the validation of methods that would support the use of lower levels of currently used agents such as ethylene oxide gas, thereby reducing the risks of environmental exposure, while ensuring effective sterilization of the devices. There may also be ways to employ – and eventually validate – new sterilizing agents or processes that do not present the same environmental risks but which still allow safe and effective sterilization of devices.

To advance these efforts, we plan to discuss this issue with the infection control community on the May 2019 Health 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 the development of new sterilization methods that 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, we have today launched a new FDA page to act as a resource on this method of sterilization, as well as any future actions we take in relation to shortage or other activities associated with this type of sterilization. question. We will update this site as new information becomes available. We will continue to work to help ensure patient access to safe and effective medical devices. And we will work directly with manufacturers, contract sterilizers, government agencies and other public health stakeholders to assess potential impacts and take additional action as needed to avoid device shortages. We are looking not only to limit the immediate impact of closing such facilities, but also to identify new and improved methods of medical device sterilization.

Media Inquiries: Alison Hunt, 240-402-0764
Consumer Consultation: 888-INFO-FDA

SOURCE US Food and Drug Administration

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