FDA Sterilization Requirements

Food and Drug Administration requirements for sterilization in hospitals and third-party facilities deal predominantly with the research and regulation of processing of SUDs (single-use devices). SUDs include but are not limited to pacemakers, single-use biopsy forceps, and/or laparoscopic devices. The FDA recognizes traditional and non-traditional sterilization. The FDA also requires that if a sterilization device is dysfunctional, the devices that were sterilized improperly must be recalled and the incident reported to the FDA by following specific requirements.

Traditional

• Devices must be washed before they are sterilized.

  The FDA recognizes traditional sterilization methods, which include ethylene oxinide with a fixed chamber; dry heat; gas; moist heat; radiation, or gamma ray; and chemical. The FDA requires that traditional sterilization be in compliance with the original manufacturer's design; if any changes are made that could affect the efficiency of the sterilization process, the manufacturer must report the changes to the FDA. According to the Center for Disease Control (CDC), "In August 2000, FDA released a guidance document on single-use devices reprocessed by third parties or hospitals. In this guidance document, FDA states that hospitals or third-party reprocessors will be considered "manufacturers" and regulated in the same manner."

Non-traditional

• Sterilization ensures a patient's safety in a hospital.

  Generally, any type of sterilization method not meeting specific requirements by the Center for Devices and Radiological Health is considered non-traditional. These methods include but are not limited to ethylene oxide without a fixed chamber, high-intensity light, and microwave radiation. Every year hospitals or third-party reprocessors are required by the FDA to report all sterilization devices and their compliance with premarket requirements. Premarket requirements state that the sterilization device must be as effective as it was when first manufactured.

Recalls

• Sterilization areas must prohibit cross contamination with non-sterile items

  Guidelines have been developed by the FDA regarding concerns about recalls within hospitals and third-party reprocessors. The FDA requires recalls of devices that are not correctly sterilized because of improper function of sterilization devices. A biological test indicator must be processed with all devices to identify if the sterilization process is successful. If the test indicator fails, all items that were being sterilized within the unit must be quarantined and recalled. A report must be filed with the facility, and the items must be reprocessed successfully before reuse.