• The number of times a device has been used. A unique mark-ing process can be employed to identify the usage cycles of
each customer's shipment so there is a record of every device
received and the details of its reprocessing.
• The unique specifications of each device so each can be properly reprocessed.
• The original manufacturer number of each device to ensure
customers receive back their own devices.
What type of expertise does the reprocessor
have on staff?
• Are experienced engineers involved in the process?
• Understand the type of training and certifications their reprocessing technicians receive
Can the quality control approach of the reprocess-
ing program be described step-by-step?
Every company should be able to walk through their reprocessing steps, ideally making their facility available for an in-person or virtual tour.
Are the reprocessed devices guaranteed?
After a device has been reprocessed, the company should
guarantee that it will meet all FDA requirements and be fit
for their intended purpose. The reprocessor must be willing
to serve as the manufacturer of record once they have repro-
cessed a product.
Are there field personnel who can help the
customer maximize their savings?
The reprocessor should have resources available to
help analyze a customer’s item file/case mix in order to
identify all the potential savings opportunities. Field
personnel can be vital in conducting periodic account
reviews and gap analysis intended to maximize the program’s financial benefits and address any questions or
How does the reprocessor educate the cus-
tomer about device rejections and ways to
avoid issues in this area?
If a customer is interested in understanding the reasons
their devices have been rejected, the reprocessor should
be in a position to articulate what happened to result in
the rejections and to offer suggestions relative to improving device acceptance levels.