Taking A Thoughtful Approach To Medical Device Sterilization

January 2020

HIDA Government Affairs Update

By Linda Rouse O'Neill
Vice President, Government Affairs, HIDA
Critical To Effective Healthcare

It’s well known across our industry that sterilized medical products are critical to healthcare. Poor or incomplete sterilization can lead to transmission of infectious diseases, compromised patient health, or even death.

While there are a handful of sterilizing agents to choose from when it comes to medical devices, the most common is via ethylene oxide. The Food & Drug Administration recognizes that there are no viable alternatives currently available to replace EtO sterilization for certain medical products. EtO is used to sterilize 50% of all medical devices sold in the United States. That’s a total of more than 20 billion devices annually. EtO is often a device manufacturer’s top choice for sterilization because it’s toxic to microorganisms but non-corrosive to common materials used to make medical devices such as plastic, metal, glass, and rubber.

EtO sterilizes many life-saving items commonly used to treat patients across all care settings. It can effectively sterilize materials as diverse as polyurethane and gels for hydrocolloid wound care dressings, stents for heart surgery, and custom procedure packs for emergency Caesarean sections. It’s often the most effective sterilizing agent for devices that have many packaging layers or hard-to-reach areas such as with catheters. For example, the damaging effects of steam and radiation on anti-microbial coatings on single-use plastic devices make them unacceptable alternatives.

FDA Studying Public Health Factors

An FDA committee held a hearing on the matter to gather input from stakeholders so it could better understand the impact and importance of environmental, public health, and other factors related to the use of EtO. HIDA Government Affairs Director Josh Babb spoke at the meeting in Maryland, relaying to the panel that “HIDA recommends a thoughtful approach that considers the impact on the delivery of healthcare nationwide. Any changes to EtO policies must include a realistic and feasible plan to anticipate and address any potential product disruptions.”

A Magnified Impact

Disruption at a single sterilization facility can have a magnified impact across the country and across all healthcare settings. Devices sterilized in one facility often support healthcare providers and patients in all 50 states. It’s important that policymakers understand the complexities of device sterilization to protect patients, circumvent unintentional supply chain disruptions, and avoid product shortages.

HIDA has created a resource page outlining the issue, HIDA’s related activity, news updates, and links to government resources, including educational information from the FDA and Environmental Protection Agency on the use of EtO for medical device sterilization.

Visit our information and resource page: HIDA.org/EtO►
(Members log in to see all the member-only resources.)

To learn more about HIDA Government Affairs efforts on this and other issues, please contact us: HIDAGovtAffairs@HIDA.org►