Center for Disease Control and Prevention (CDC):

Center for Disease Control and Prevention (CDC):

Reuse of Single-Use Medical Devices, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)

“… In August 2000, FDA released a guidance document on single-use devices reprocessed by third parties or hospitals.995 In this guidance document, FDA states that hospitals or third-party reprocessors will be considered “manufacturers” and regulated in the same manner. A reused single-use device will have to comply with the same regulatory requirements of the device when it was originally manufactured.”

https://www.cdc.gov/infectioncontrol/guidelines/disinfection/reuse-of-devices.html

By |2019-09-12T18:06:21+00:00September 18th, 2016|Regulatory Resources|0 Comments