Comments of the Healthcare Supply Chain Association (HSCA) on FDA Request for Comments on Ethylene Oxide Sterilization of Medical Devices

On behalf of the Healthcare Supply Chain Association (HSCA), we appreciate the opportunity to provide comments to the U.S. Food and Drug Administration (FDA) regarding the use of Ethylene Oxide (EtO) to sterilize medical devices.

HSCA represents the nation’s leading healthcare group purchasing organizations (GPOs), the sourcing and purchasing partners to virtually all of America’s 7,000+ hospitals, as well as the vast majority of the 68,000+ long-term care facilities, surgery centers, clinics, and other healthcare providers. GPOs work with healthcare providers to support a safe and reliable supply of healthcare products. We help ensure quality medical products at the best value for patients, hospitals, payers, Medicare and Medicaid, and taxpayers. The value that GPOs deliver allows healthcare providers and physicians to focus on their core mission: providing first-class patient care.

HSCA and its member GPOs have a unique line of sight over the entire healthcare supply chain – from raw materials to the manufacturing process for drugs and medical devices to their delivery to patients. Even seemingly minor disruptions to the healthcare supply chain could have significant consequences for patients. In that vein, we appreciate the Agency’s efforts to seek feedback and input on this critical matter.

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