Protect Your Reprocessing Program

Medical devices in Electrophysiology are very expensive and many facilities rely on reprocessing savings to provide quality care. However, instead of gradually accepting that reprocessing is necessary, medical device makers have recently launched the perhaps most damaging attack on reprocessing since the regulation around 2000:

The largest medical devicecompanies in the OR and in the Electrophysiology lab have systematically begun to “lock” their devices – only new devices can be used. This happens in a variety of different ways, and the impact on reprocessing programs is not the same everywhere. In several cases, a device company provided hospitals with a software upgrade that effectively shut down the hospital’s reprocessing program. The upgrade was installed without consulting the hospital, and a new device that communicated with the software was introduced. The rep removed the cables and replaced them with new ones, ensuring that the hospital couldn’t keep using the old devices that could be reprocessed.

While the software upgrade provided certain clinical improvements to the system, these clinical improvements are unrelated to the functionality of a reprocessed device. The fact that the software also removes the ability of the hospital to save money through reprocessing should be considered: If the hospital starts using the new device and the new software, they cannot achieve savings by reprocessing the devices.

The reason this anti-reprocessing campaign is so damaging, is that it targets the most expensive devices (=the devices that the hospital can save most on when reprocessing). In some reprocessing programs, locking only three devices from reprocessing can reduce savings by 65-80%. In fact, some hospitals are currently looking at losing more than $1/2M per year due to the inability to reprocess three devices.

In other cases, the device makers refuse to support cases where 3rd party reprocessed devices are used. This happens both centrally in the form of letters written from the manufacturer to hospitals, and locally, where service reps refuse case support.

The alleged reason is the need for support techs to be intimately familiar with the devices – so they can only support cases where devices are used that they “have been trained to support”. By definition, a reprocessed device is no longer the original manufacturer’s product, but the reprocessor’s product.

However, the 510(k) process ensures that the devices are functionally the same, so unless FDAs process is being put in question, there is no difference in “training needs” – unless, of course, FDA’s process for clearing devices is being called into question.

Here are eight things that you can do, that have worked for hospitals to get to a more equitable arrangement with medical device manufacturers:

  1. Ask about upgrades
  2. Evaluate total value
  3. Understand the overall spend
  4. Talk with the Doctors
  5. Leverage your hospital system
  6. Insist on accountability from the rep/manufacturer
  7. Get help from your reprocessing partner
  8. Confront the Rep


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