By: Suzanne B. Schwartz, M.D., M.B.A., Deputy Director of the Office of Strategic Partnerships and Technology Innovation and Acting Office Director, Center for Devices and Radiological Health (CDRH), and CAPT Elizabeth F. Claverie-Williams, M.S., Microbiologist and Branch Chief, Infection Control Devices Branch, CDRH
Medical device shortages are a serious public health issue and can be particularly detrimental if they occur with life-saving, life-sustaining, or critical devices. As the federal agency that regulates medical devices, among other products, the U.S. Food and Drug Administration (FDA) is particularly attuned to this issue and works to monitor potential problems.
Medical devices that are sterilized to remove potentially harmful germs and other microorganisms are critical to the American health care system. The FDA is particularly aware of issues relating to sterilization during manufacturing—and the potential device shortages that can occur if there are problems during this process. So, the FDA is working to help ensure this process is carried out in a safe and effective manner.
The Importance of Sterilization and Oversight
Before they can be marketed as “sterile,” many medical devices are sterilized by the device manufacturer or contract sterilizer using ethylene oxide before they are delivered to healthcare facilities. Ethylene oxide is a flammable, colorless gas used for equipment and plastic devices that cannot be sterilized by steam. In fact, ethylene oxide sterilization accounts for approximately 50 percent of medical devices that require sterilization before devices get to patients. And a single sterilization facility can be responsible for sterilizing dozens—or hundreds—of types of medical devices.
Effective sterilization processes are critical to ensuring device safety, and manufacturers depend on this process. For instance, medical devices made from certain polymers (such as plastic or resin), metals, or glass—or devices that have multiple layers of packaging or hard-to-reach crevices (such as catheters)—are likely to be sterilized with ethylene oxide to avoid product damage during the process. And frequently there are no readily available processes today that can serve as alternatives to those that use ethylene oxide.
Even before most sterile medical devices are on the market, the FDA reviews premarket submissions to assess whether sterility information is in accordance with FDA statutes and regulations, in addition to internationally agreed upon voluntary consensus standards that the FDA also recognizes. For ethylene oxide sterilization, two voluntary consensus standards (ANSI AAMI ISO 11135:2014 and ANSI AAMI ISO 10993-7:2008(R)2012) describe how to develop, validate, and control ethylene oxide sterilization processes for medical devices and the acceptable levels of residuals left on a device after it has undergone ethylene oxide sterilization. These standards help ensure levels of ethylene oxide on medical devices are within safe limits.
While ethylene oxide sterilization is a necessary part of the manufacturing process for many medical devices, there have been concerns recently about its effects on people who are exposed (or overexposed) to it—and there are concerns about environmental emissions. The Environmental Protection Agency (EPA) is the entity responsible for reviewing and enforcing Clean Air Act regulations for sterilization facilities that emit ethylene oxide to ensure that facilities protect the public from significant risks. And, based on the results of the latest National Air Toxics Assessment, the EPA has identified this chemical as a potential concern in several areas across the country. For example, long-term exposure to ethylene oxide can irritate the eyes, skin, nose, throat, and lungs, and harm the brain and nervous system, causing side effects such as headaches, memory loss, and numbness. Long-term and occupational exposure to ethylene oxide also has been linked to cancer.
Earlier this year, the FDA was made aware of the closure of a large device sterilization facility—which sterilized 594 types of medical devices—because of concerns about the level of ethylene oxide emissions. The agency immediately began monitoring the situation closely and working with device manufacturers affected by the closure, with the goal to minimize impact to patients who needed device access. Today, the FDA continues to work with manufacturers on site changes and engage with manufacturers about potential solutions to shortage concerns. The FDA also continues to collaborate with the EPA and provide the EPA with updates on FDA activities in this area.
Taking Action to Promote Innovation and Help Ensure Safety
The issues around medical device sterilization with ethylene oxide will continue to require a delicate combination of oversight and innovation because these issues require an ongoing commitment to safety and to keeping needed medical devices on the market and available for use. Understanding the importance of ethylene oxide in sterilizing medical devices, the FDA has been developing solutions to avoid potential device shortages and encouraging new, innovative ways to sterilize medical devices while reducing the potential impact on the environment and on the public health.
As part of this work, the FDA continues to monitor the supply of devices sterilized in facilities that have closed or that may close and is paying special attention to life-saving, life-sustaining, and critical devices. For instance, in the case of Smiths Medical’s Bivona tracheostomy tubes, used in health care facilities or homes to help adult and pediatric patients breathe, the agency helped mitigate a device shortage by helping the manufacturer get a timely site change to keep supply interruptions at a minimum.
Along with monitoring the supply of devices, planning for and preventing potential device supply shortages are other key activities the FDA performs to help ensure public safety. For example, the FDA continues to engage with device manufacturers and health care providers and encourages them to voluntarily provide the agency with information on potential product supply issues.
In addition, the FDA engages with the infection control community on this topic through the Healthcare Infection Control Practices Advisory Committee (HICPAC), a federal advisory committee created to provide guidance to the U.S. Department of Health and Human Services and the Centers for Disease Control and Prevention on the practice of infection control and other issues.
Furthermore, today—as part of these timely, collaborative, and preventive efforts—the FDA also is announcing two new innovation challenges. From July 15, 2019, through October 15, 2019, the FDA is encouraging ideas from stakeholders, academics, industry, and others about sterilization process solutions.
The first challenge is to identify new or alternative sterilization methods and technologies that are alternatives to those that use ethylene oxide. With existing sterilization methods including moist heat (steam), dry heat, radiation, vaporized hydrogen peroxide, and other sterilization methods (e.g., chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide) in addition to ethylene oxide sterilization, this challenge encourages novel and forward-looking solutions. For instance, new sterilization methods might include new devices or new modalities. The new modality or medical device 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), and it should be scalable.
The second challenge focuses on reducing ethylene oxide emissions. Specifically, it encourages the development of strategies to reduce ethylene oxide emissions to as close to zero as possible when ethylene oxide must be used to sterilize medical products. Innovative strategies might include changing current sterilization processes or workflow or procedures in the sterilization site. You can learn more about both challenges on the FDA’s website.
These innovation challenges are two more ways the FDA is acting to encourage solutions—and the challenges will supplement the communications and oversight that the FDA has carried out, and will continue to provide, on the issue of medical device sterilization.
Moving forward, the FDA will continue to communicate with the public, stakeholders, federal and state partners, and Congress on what it knows about these matters as well as on potential solutions. The agency also continues to work with developers, other agencies, and stakeholders to protect public health by ensuring safe and effective sterilization methods are available. To this end, the FDA also is announcing a forthcoming Advisory Committee Meeting on this topic to be held November 6 and 7, 2019.
The issue of ethylene oxide emissions and potential medical device shortages is a serious one. As the FDA works with industry and stakeholders, the hope is that challenging them to present effective, efficient, and innovative solutions will help the agency prevent medical device shortages due to sterilization issues in the future.