The world of medical imaging servicing and manufacturing has gotten a lot of attention recently. Once a buyer of medical imaging equipment determines that a NEW piece of equipment from the OEM does not fit their budget or need, the topic of a second-hand imaging system usually starts with, "What's the difference between refurbished, reconditioned, and remanufactured?"
Though there are government and corporate entities that have formal guidelines and policies regarding these procedures, different companies use different terminology. We want to take a moment to add a bit of clarity to the discussion and dispel some of the myths about the differences when buying remanufactured, refurbished, and reconditioned imaging equipment.
The Real Question
Before we define these three R’s, let’s address the REAL question running through your mind, “How do I ensure I’m getting a great imaging system?” No matter which R-word your imaging equipment vendor uses, here are 3 ways to ensure that you ultimately get a great piece of equipment.
Work with a company:
- You trust to say what they mean and do what they say
- That has clear processes, procedures, and, in a perfect world, is ISO certified
- That has the capability to commit to providing a system that meets or exceeds OEM specifications for image quality, cosmetic appearance, and overall performance
Refurbished vs. Refurb-ish
This has been a debate going on in our industry for some time now. There are many different perspectives as to what these processes look like but, truth be told, there are no hard and fast rules concerning 2 of these 3 processes.
To be clear about what WE mean when using these terms, here is how Block Imaging defines Reconditioning vs. Refurbishment vs. Remanufacturing:
Reconditioned Imaging Equipment
There are 2 levels of reconditioning when it comes to imaging equipment:
Cosmetic Reconditioning - This level of reconditioning is sometimes requested by customers for “as is” equipment. The equipment is decontaminated including cables and accessories. When decontamination is complete, the equipment is painted, and ready for shipment or pickup.
Full Reconditioning - This level includes the above cosmetic process with the addition of testing the full functionality of the system.
Refurbished Imaging Equipment
The refurbishment process is intended to restore the equipment to OEM standards of performance. This means the optimum condition a system would function at under OEM service. The equipment will undergo decontamination, repair, replacement of worn parts, full cosmetic rehabilitation, calibration, and other procedures necessary to return the system to OEM standards.
Remanufactured Imaging Equipment
Consider a remanufactured system a "new beast" all together. The system has been significantly altered in such a way as to no longer fit it's prior use or design. In the words of the FDA:
Remanufacturer, as defined in 21 CFR 820.3, means any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use. Remanufacturers are considered manufacturers. As such, these manufacturers are subject to inspection by FDA and shall meet the applicable requirements of the medical device QS regulation.
Remanufacturers are also required to comply with the labeling requirements of 21 CFR 801.1(c)
How Have You Seen These Terms?
If you have questions, comments, or see any of these three terms being used differently on the secondary market, please share your thoughts below. We’d love everyone’s help to bring clarity to the conversation.