>   Resources  >  Toolkits  >  Single-Use Device Reprocessing

Effective reprocessing is critical to reducing the risk of transmission of healthcare associated infections when single-use devices are reused. Reprocessing of single-use devices must be performed by an FDA-approved reprocessing facility and should not be done in individual facilities.

The ASC Quality Collaboration has assembled a variety of resources and information that may be used to supplement your current processes to improve reprocessing practices.

The Single-Use Device Reprocessing Toolkit contains both essential resources and a broader array of materials, including:

• Assessment Tools
• Implementation Aids
• Training Materials
• Monitoring Tools
• Workplace Reminders
• Guidelines from Leading Authorities

Assessment Tools

• Single-Use Device Reprocessing: What CMS Surveyors Are Looking For: Perform a self-assessment using the same tool CMS surveyors use when evaluating reprocessing practices in the ASC setting.

Implementation Aids

• How to Identify FDA-Registered Reprocessors of Single-Use Devices: This guide outlines how to identify FDA-registered reprocessors of single-use devices using the online registration database available at the FDA website.
• Questions to Ask When Evaluating a Potential Third-Party Reprocessor (AMDR): The Association of Medical Device Reprocessors recommends that providers ask a series of questions before engaging a potential third-party reprocessor. Access those questions using the link above.
• Reprocessing of Single-Use Medical Devices Policy Template: This sample single-use device reprocessing policy is based on U.S. Food and Drug Administration (FDA) requirements. It should be adapted as needed for use in each facility.

Guidelines from Leading Authorities

• Guideline for Disinfection and Sterilization in Healthcare Facilities (CDC): This 2008 Centers for Disease Control and Prevention (CDC) guideline, which was updated in 2019, includes information on single-use devices. Please consult page 81 of the document for material pertinent to single-use devices.

Resources Cited

The materials presented here include publicly available resources from the following organizations:

• U.S. Food and Drug Administration (FDA)
• Centers for Disease Control and Prevention (CDC)
• Association of periOperative Registered Nurses (AORN)
• Association of Medical Device Reprocessors (AMDR)
• Johnson & Johnson/MedTech/Sterilmed

Comments and other feedback may be directed to Kathy Wilson, Executive Director, ASC Quality Collaboration.