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Since its founding in 1949, Medtronic has been at the forefront of designing and developing innovative medical technology that are relied on by millions of patients worldwide. As we deliver on the Medtronic Mission to alleviate pain, restore health, and extend life, protecting the health and well-being of all people — including the patients who rely on our devices and individuals who work in or live near our facilities — is our top priority.
Central to this Mission is limiting the infection risk associated with medical care.
Effective sterilization of medical devices and instruments is essential to minimize the risk of healthcare associated infections.
Healthcare associated infections are a major public health concern in the United States (U.S.) and worldwide. In the U.S. alone, it is estimated that more than one million patients experience healthcare associated infections each year. If not properly sterilized, life-saving medical devices can place patients at even higher risk for infection and associated complications, including the need for prolonged hospitalization, IV antibiotics, and surgical removal of the device. Effective sterilization of medical devices and instruments is essential to minimize the risk of healthcare associated infections.
Medtronic uses a range of methods to sterilize medical devices, including steam, radiation, ethylene oxide (EtO), and hydrogen peroxide. We make every effort to select the most effective and safe method for each device. Unfortunately, no sterilization technique exists that can be effectively used on all medical devices. The U.S. Food and Drug Administration (FDA) requires Medtronic and other manufacturers to validate sterilization methods for all sterile devices before they are approved (or cleared) for marketing in the U.S.
EtO has been used for more than 90 years and is one of only a handful of sterilization agents that has been recognized by the FDA as having a long history of safe and effective use. EtO is currently used to sterilize the majority of all medical devices that help treat patients with cardiac arrhythmias, heart failure, coronary artery disease, diabetes, chronic pain, and Parkinson’s disease, as well as instruments routinely used in surgical suites, intensive care units, and emergency rooms of hospitals across the United States.
In recent months, sterilization processes have fallen under increasing scrutiny due to state regulatory actions and legislation that would put additional regulations on the use and emissions of the most common sterilization compound: EtO. Medtronic takes recent concerns regarding EtO emissions very seriously. Medtronic believes that, when used responsibly, EtO is a safe and effective sterilization method. We have processes and controls in place to minimize risks associated with EtO use for patients, sterilization workers, and the general public.
Medtronic believes that, when used responsibly, EtO is a safe and effective sterilization method.
Medtronic continues to research and assess the benefits and risks of new sterilization techniques and methods. We are working cooperatively with industry and regulatory partners to improve existing techniques and develop new processes. However, time is needed to thoroughly evaluate the safety, efficacy, and viability of potential alternatives.
Responsible changes to established sterilization practices will take years, as new techniques must be carefully tested and validated to ensure that they are appropriate, effective, and safe for patients, life-sustaining medical devices, and the environment. While that scientific and regulatory process is ongoing, Medtronic believes EtO must continue to be available to ensure the sterility and safety of the many EtO-dependent medical devices and instruments relied on every day by millions of patients and physicians.