AMDR has received repeated reports that sales reps from a major cardiac catheter manufacturer have threatened to remove hospital tech support in cases where third-party reprocessed catheters are being used. The alleged reason is that the device reps are unfamiliar with reprocessed versions of their technology. Since both OEM and reprocessors must obtain the same FDA clearance (510(k)) or Notified Body certification demonstrating “equivalence”, this is obviously, in our view, not the real reason for withdrawing support.
AMDR members have seen the following examples of this behavior:
- Techs from the manufacturer advising hospitals that s/he will not cover cases in which reprocessed devices are used – unless reprocessed by the manufacturer;
- The manufacturer sending letters to hospitals advising them of support withdrawal in cases where reprocessed devices are used; and
- Manufacturer techs actually leaving the EP lab during a procedure when a reprocessed device is pulled for use.
SUCCESSFUL WORK AROUNDS:
AMDR members report that manufacturers tend to keep providing technical support when:
- Hospitals note the fact that FDA clearance or CE marking means substantial equivalence between reprocessed and new devices, rendering the above argument not credible; and
- When the hospital calculates the overall financial footprint of the manufacturer and alerts the manufacturer what is at stake for the manufacturer, should they continue to deny support.
- Alternatively, in some cases, hospitals have simply trained their own technicians to do what the manufacturer tech was doing.