Questions to ask
• How many devices will be available for me to purchase from you? How do you determine this?
• Do you provide access to real-time data about what has been collected?
• Do you provide access to real-time data about what is available to buy back?

• How do you identify devices and facilities from which the device originates?
• How is this information stored and utilized?

Product development and safety
Some reprocessors have very old FDA clearances and have stopped getting new ones. This is problematic for two reasons:

1. Product lifecycles in electrophysiology are very short, so old clearances rarely have any value to the hospital – because the products simply are not used anymore.
2. FDA has increased its standards over the years, so a recently cleared product will often be subject to stricter requirements than the same product cleared 10 years ago.

The original idea behind the reprocessing industry was implied constant pursuit of new areas for reprocessing. You should expect that your reprocessor brings new products to you every year so that you can add to your savings or “replace” savings lost on obsolescent devices.

Questions to ask
• Can I see your list of recently cleared devices?
• Can I see your pipeline and your planned pathway to obtain new clearances?
• Can I expect my reprocessing program to grow year over year?
• How old are your clearances?

These are all principles that have guided the reprocessing industry for 25 years. Observing these principles protects the reprocessing industry (and the associated cost savings) because it enables hospitals and clinicians to trust reprocessing. 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.

Back to HCB News

Business Affairs Homepage