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SILVER SPRING, Md., March 26, 2019 / PRNewswire / – A key objective of the FDA is to prevent and mitigate potential shortages of medical products. As part of these efforts, we are taking action to address potential shortages 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 providers and patients have access to critical devices.
Earlier this year, the FDA learned that the Environmental Protection Agency (EPA) of Illinois had issued an EPA order to prohibit a contract sterilizer, Sterigenics, from sterilizing medical products and other products. containing gas called ethylene oxide in their Willowbrook, Illinois plant. The control of the state EPA was due to the presence of higher ethylene oxide levels than the EPA found to be acceptable in the air around the facility.
As the body responsible for the safety and efficiency of all medical devices, the FDA has been closely following the evolution of the situation and collaborating with the device manufacturers concerned with the closure in order to to minimize any impact on patients requiring access to these devices.
Some medical devices need to be sterilized to reduce the risk of these devices causing infections with live microorganisms in patients. Sterilization of medical devices is a well established and scientifically proven method to prevent harmful microorganisms from reproducing and transmitting infections. It is essential to our health system. And ethylene oxide is a commonly used method of sterilizing medical devices. It is considered a safe and effective method that helps to ensure the safety of medical devices and provide quality patient care. Ethylene oxide sterilized devices range from wound dressings to more specialized devices, such as stents, as well as kits used in routine hospital procedures or surgeries comprising multiple components made from of different materials. However, the FDA recognizes the environmental considerations that are currently affecting the ability of manufacturers to use this process.
To this end, and in light of the recent EPA order, the FDA is working to proactively secure alternative locations and methods for the sterilization of devices previously processed at the Willowbrook plant in order to reduce potential problems with product supply. We are taking steps to ensure that equipment shortages that can delay or disrupt critical care do not hurt patients. At the same time, we are undertaking new efforts to encourage innovative and improved sterilization options.
Steps to prevent potential shortages
First, the FDA is actively working to prevent potential shortages of medical devices that may result from the closure of Willowbrook's facility. After learning that the facility had been ordered to stop sterilizing hundreds of different types of medical devices, we immediately contacted the medical device manufacturers that relied on Sterigenics to better understand what devices were available. affected by the cessation of operations of the facility and badess their potential. impact on patients. We work directly with manufacturers, as needed, to help them transition to another sterilization site or sterilization method.
According to the FDA's database of facility registration and device listing, Sterigenics has listed a total of 594 types of devices undergoing an oxide sterilization process. ethylene at Willowbrook facilities. and could therefore be affected by the closure. These include products such as sutures, forceps, knives, stents and needles. At present, the FDA is not aware of any shortage of devices attributable to the closure of Willowbrook's facility. We are monitoring the situation closely and will continue to provide updates. There is a risk that for some sterile packaged products already distributed, the existing supply may be reduced or even exhausted because health facilities use their inventory before other solutions can be sterilization of new products leaving the production lines. This could result in a temporary or "punctual" shortage of some products until sterilization can be restored.
In addition, the FDA knows that Viant, another contracted sterilizer, has recently announced that its Grand Rapids ethylene oxide sterilization facility is expected to close later this year after being reviewed by the Michigan Environmental Quality Department for air quality problems. According to the FDA's database of facility registration and device listing, Viant has listed a total of 46 types of devices subject to ethylene oxide treatment in Grand Rapids facilities. which, in the future, could be affected by the closure of the facility. These include devices such as catheters and surgical meshes.
Due to the closing of the Sterigenics Willowbrook facility and the planned closure of the Viant Grand Rapids facility, the FDA urges medical device manufacturers that use these facilities to begin badessing the possible downstream effects of Closures on the distribution of devices throughout their supply chain. users (such as health care facilities), and ultimately on patient care. We also encourage medical device manufacturers to consider alternative contract sterilizers that can treat their devices. We have already outlined the steps that manufacturers must take to make changes to their contract sterilizers and maintain the availability of their devices. We are committed to working closely with manufacturers to expedite our review of any proposed site modification to enable them to effectively transition to other contract sterilization facilities while ensuring safe and effective sterilization of the site. their devices.
Secondly, while everything is being done to avoid a possible shortage, we are monitoring the situation closely and are ready to act quickly with strategies to limit the impact of power interruptions on devices on the market. patients. These include the provision of devices 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 potential shortages. Among other steps, we have set up a device shortage mailbox so that any user, patient or supply chain organization warned of a delay in the distribution of the new product and / or anticipating a shortage can inform us.
Third, while continuing to monitor shortages related to facility closures, we are also working with stakeholders, including sterilization experts, medical device manufacturers and other government agencies, to find innovative ways. to sterilize medical devices that do not raise the same concerns. like those identified at the Willowbrook facility. About half of all sterilized medical devices are sterilized with ethylene oxide. Given the concerns about the impact of this method on the environment, we recognize the importance of identifying new and improved ways to sterilize medical devices.
We have already begun to explore ways to continue to ensure that sterilization processes are safe and effective and evolve with current scientific knowledge. This includes considering the validation of methods that would make it possible to use fewer currently used agents, such as ethylene oxide, which would reduce the risk of environmental exposure, while ensuring effective sterilization of the device. There may also be ways to employ – and possibly to validate – new sterilizing agents or processes that do not pose the same environmental risks, but still allow safe and effective sterilization.
To advance these efforts, we plan to discuss this issue with the Infection Control Community at the Health Infection Prevention Practices Advisory Committee (HICPAC) in May 2019. We will also be hosting a meeting. Public Advisory Committee to be announced later this year and devoted to the best way to encourage innovation in the sterilization of medical devices. In addition, later in 2019, we will announce a public innovation challenge to encourage the development of new sterilization methods, which could include new devices or new safe and effective methods for the sterilization of medical devices.
Finally, we recognize that new challenges may arise from the current situation. In order to ensure transparency and communication on the use of ethylene oxide in the sterilization of medical devices, we today launched a new FDA web page, aimed at serve as a resource for this method of sterilization, as well as for the actions we undertake in the future problem. We will update this site as soon as new information becomes available. We will continue to work to help patients access safe and effective medical devices. And we will work directly with manufacturers, contract sterilizers, government agencies and other public health stakeholders to badess potential impacts and take the additional steps needed to avoid device shortages. We are not only trying to limit the immediate impact of these closures, but also to identify new and improved methods of sterilizing medical devices.
Media requests: Alison Hunt, 240-402-0764
Consumer Inquiries: 888-INFO-FDA
SOURCE US Food and Drug Administration
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