• How many uses did you test your latest cleared device for? How do you determine how many uses to test for?
• How do you test for material degradation between uses?
• How do you test for the impact of transportation and storage of used devices?
• How do you determine what tests to conduct on a device that is being reprocessed?
• What tests did you go through to obtain your latest clearance?

• What are your last line extensions and which clearances were referenced?
• Did the line extensions have the same indication as the predicate device?
• What are the design differences? Functional differences?

Double-reprocessing concerns
A reprocessor cannot reprocess a device previously reprocessed by another reprocessor. There are two reasons for this:

1. When an FDA clearance is granted to a reprocessor, that clearance is granted to reprocess the device a certain number of times. Reprocessing and reusing beyond this is against regulations. Since there is no convention in the industry for how devices are marked, you are only able to “read” your own devices and discover their history in terms of number of uses. It follows that you risk going against regulation if you reprocess another reprocessor’s device.
2. Different reprocessors with clearance to reprocess the same device may use different methods for cleaning devices. For example, different chemicals may be used in the cleaning process. Using different chemicals may result in reactions in the material that make the device unsafe. For similar reasons, reprocessing open and unused devices is not a safe process unless FDA cleared.

Please note that although clearance-exempt devices and reusable devices do not have an FDA clearance, the same principle applies here, as the number of uses is controlled by other agencies.

Reusable EP cables are an excellent example of this: Although there is no 510(k) clearance, getting ready to reprocess one of the more complex cables takes a lot of time and a lot of money. Material characterization is necessary, as is understanding the potential degradation from reprocessing and sterilization. In many cases, custom fixtures have to be designed and built. Beware of cable reprocessing sold at very low rates: The safety and quality of the reprocessed cable may not be as you should expect.

Questions to ask
• When you receive a device, how do you determine how many times a device has been used?
• What do you do with devices that have been used the maximum number of times?
• What do you do if a device has been reprocessed by another reprocessor?
• If you reprocess these, how do you know how many times they have been used in the past?

By ensuring your partners are committed to best practices in the above areas, you can ensure your organization is maximizing the sustainability, efficiency, safety and overall value of its single-use device reprocessing program.

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