- For Immediate Release:
- Statement From:
Jeffrey E. Shuren, MD, JD
Director - CDRH Offices: Office of the Center Director
As part of the agency’s ongoing efforts to minimize impacts of medical product shortages, last month, the FDA alerted the public of the potential for medical device shortages to arise from the closure of a large ethylene oxide sterilization facility in Willowbrook, Illinois, and the future planned closure of a similar facility in Michigan. Since the closure was announced, we have been taking steps to prevent patient harm from potential device shortages that could delay or disrupt critical care, including working to quickly and proactively secure alternative locations and methods for the sterilization of devices that were previously processed at the Willowbrook facility. We also committed to sharing updates on potential impacts to medical devices once sterilized at these facilities.
Despite best efforts to minimize the impact of the closures wherever possible, we have identified a medical device that is now in temporary shortage. Today, we are alerting health care professionals, parents and caregivers that there is a temporary shortage of a type of a tracheostomy tube manufactured by Smiths Medical. I want to assure you that the FDA is working closely with the company to quickly resolve their sterilization challenges and bring these critical devices to the patients who need them as quickly as possible, which we anticipate will be made available again beginning the week of April 22.
Smiths Medical’s Bivona tracheostomy tubes are used in health care facilities, such as hospitals, or at home to help adult and pediatric patients breathe. A tracheostomy is a surgical procedure that creates a small opening that goes through the skin and tissue of the neck directly into the windpipe (trachea). The tracheostomy tube is placed through this opening, called a stoma, into the trachea to allow a patient to breathe through the tube instead of through their mouth or nose. Prior to initial use, Bivona tracheostomy tubes are sterilized with ethylene oxide before they are marketed in the U.S. After initial use, patients may reuse the tubes by reprocessing them as described in Bivona’s Instructions for Use. Hospitals also may clean the tubes and sterilize them so they can be reused on the same patient.
Although the Bivona tubes are indicated for use in both adult and pediatric patients, the temporary shortage is more likely to impact pediatric patients because supply of alternative tubes with similar functionality is limited. The Bivona tube is made from a flexible silicone material which makes them easier to insert in the stoma of pediatric patients. While there are other FDA-cleared silicone tracheostomy tubes for pediatric patients, there may not be enough available to adequately cover the shortage. We recognize the challenges this shortage imposes for these pediatric patients who need access to new tubes now, and are working to limit the impact to patients as much as possible by helping the company quickly move their sterilization to another facility.
During the temporary shortage, health care professionals who have patients urgently in need of a new Bivona tube should contact Smiths Medical directly to inquire about current inventory. Parents and caregivers who need new Bivona tubes (e.g., due to damage or leaking of current tubes) should work with their health care professionals to find an appropriate alternative until the Bivona tracheostomy tube is back on the market. Adult patients experiencing problems obtaining Bivona tubes should talk with their health care professional about using other FDA-cleared tracheostomy tubes, including those made from different materials.
The closure of the Willowbrook facility does not impact tubes already in use by patients at home or in health care settings. The company is communicating with patients about the tubes and how patients and caregivers can mitigate any potential impact, including re-using and cleaning tubes in accordance with the manufacturer’s instructions for use.
The company is continuing to manufacture tracheostomy tubes per their normal schedule. The company has already started to use an alternative facility to sterilize their devices and estimates that approximately 28,000 new Bivona tracheostomy tubes are currently awaiting sterilization. We are working closely with Smiths Medical to expedite release of sterilized tubes that still meet the FDA’s standards for safety and effectiveness and expect new tubes to be available within the next few weeks.
At this time, we are not aware of any other shortages due to these closures. As with the case of Smiths Medical, early awareness and engagement enables us to be proactive and develop a plan to mitigate effects on patient care. We continue to monitor the situation closely, including any submissions to the FDA device shortages mailbox and stand ready to act quickly with strategies intended to limit the impact of device supply interruptions on patients. We are continuing to update our ethylene oxide in medical device sterilization web page to ensure patients, health care professionals and industry have the most up-to-date information. As we previously noted, 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 for which we will make additional announcements in the coming weeks.
We recognize the very real consequences that medical device shortages have on patients, and we’ll continue to work directly with manufacturers, contract sterilizers, government agencies and other public health stakeholders to do all we can to avert new device shortages.
- Alison Hunt