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Transparency in reprocessing: A healthcare provider’s checklist

February 27, 2024
Business Affairs

Questions to ask
• Do your product codes integrate with inventory management systems like Wavemark?
• Do your products have UDI codes on the outer box?
• Can you work with our purchasing team to enter reprocessed product codes into our system?
• Does your packaging mimic OM packaging?
• How do I recognize your product as a reprocessed product in the supply room?
• When does your collection tech collect? What is their name?

Device marking and labeling
Reprocessed devices must be marked so that it is clear that they have been reprocessed and what company has reprocessed them. The reprocessor assumes ownership and liability for the device when it has been reprocessed, so this is important. If the device fails and it is not clearly marked, the hospital cannot determine where to file a complaint or where to look for responsibility. This is a key principle in reprocessing. Different reprocessors use different solutions, including serial stickers, laser etching, QR codes, pad printing, and others. There is no convention in the industry, but each reprocessor must use a clear system for marking the device.

It is important to keep in mind that the device is taken out of its packaging before use: The device itself has to be marked; the reprocessor cannot just mark the packaging.

Manufacturers invest a lot of time and money developing safe and effective products. Their brands have great value to them and to the clinicians. Legitimate reprocessors also invest great amount time and money in producing quality devices. Why would a reprocessor not be proud of their brand and clearly mark it?

Questions to ask
• How do you mark your devices?
• Can I see on a device that it has been reprocessed by your company?
• Do you mark the device itself or just the packaging?
• How do you mark your devices to keep track of number of uses?

Transparency in reporting
Hospitals use reprocessing to reduce procedure costs and environmental waste. Because of this, it is important that the hospital sees what cost savings and carbon emission reductions are driven by reprocessing. If this reporting is not transparent or frequent, the motivation for reprocessing goes away. Because environment and costs drive reprocessing behavior, this reporting needs to be done at the level where it can change or validate behaviors – the department must know, the doctor must know.

For the same reason, you should expect from your reprocessor that they do not mix bundle reprocessed product with other products sold by the same company: This hides the impact of reprocessing and usually comes out to the hospital’s disadvantage. Some forms of bundling are illegal.

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