PURPOSE: To ensure appropriate reprocessing of single-use medical devices; single-use medical devices shall not be reprocessed within the facility
DEFINITIONS:
Original Device:A new, unused single-use device
Single-use Device (SUD): A SUDis a device that is intended for one use or on a single patient during a single procedure
Reprocessed Single-use Device: A reprocessed SUD is an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient
POLICY:
Selection of Single-use Devices for Reprocessing
- Single-use devices identified for reprocessing must be approved by the Food and Drug Administration (FDA) for reprocessing
- Single-use devices identified for reprocessing must be further approved in writing by the designated multi-disciplinary committee responsible for overseeing the Infection Prevention Program and/or the Governing Board. Note: designate who has oversight in your ASC.
Selection of Third-party Reprocessor
- Any potential third-party reprocessing vendor must be registered with the FDA as a reprocessor of single-use devices
- Any potential third-party reprocessing vendors must be approved by the multi-disciplinary committee responsible for overseeing the Infection Prevention Program and/or the Governing Board. Note: designate who has oversight in your ASC
- The committee should review documentation provided by the third party reprocessor regarding policies, procedures, and practices;they should include the following information:
- How items will be repackaged
- How containers for used and unused products will be provided and labeled
- How they shall track how many times a product has been reprocessed
- Who shall be responsible to provide written directions and educational materials for users
- How they plan to comply with all state and federal regulatory requirements and standards
- How they plan to package and ship biohazardous equipment according to federal and state regulations
- How they will contact appropriate ASC representatives in writing for any product recalls
REFERENCES
U.S. Food and Drug Administration. (2002).Selecting a Third-Party Reprocessor for Single-Use Devices.Silver Spring, Maryland.
U.S. Food and Drug Administration.(2001). Changes in Enforcement of FDA’s Requirements on Reprocessing of Single-Use Devices. Silver Spring, Maryland.
DISCLAIMER: All data and information provided by the Oregon Patient Safety Commission is for informational purposes only. The Oregon Patient Safety Commission makes no representations that the patient safety recommendations will protect you from litigation or regulatory action if the recommendations are followed.The Oregon Patient Safety Commission is not liable for any errors, omissions, losses, injuries, or damages arising from the use of these recommendations.
3.09 SINGLE-USE DEVICES POLICY 1