THE ISSUE:
AMDR is aware that OEM contracts may include provisions voiding warranties on equipment used in conjunction with third-party reprocessed single-use devices.  We are also aware of OEM sales representatives threatening that warranties will be voided for the same reason. 
AMDR members have seen the following examples of this behavior:
  • A sales representative instructs a hospital that a warranty on a generator may be voided if it is used with a reprocessed catheter.
  • An OEM contracts that void a warranty for a robotics system that is used in conjunction with a third-party reprocessed scope or other accessory. 
An OEMs purported basis to void such warranties is that the reprocessed device somehow affects the performance of the connected OEM device. In our view this is not the real reason to void such warranties because OEMs and reprocessors must obtain the same FDA clearance (510(k)) or Notified Body certification demonstrating “equivalence” that would include validating the reprocessed device works in conjunction with other necessary OEM equipment.  Therefore, OEM equipment should operate and function in the same way, whether it is used in conjunction with an OEM device or a reprocessed device.
SUCCESSFUL WORK AROUNDS:
AMDR members have successfully supported hospitals battling this tactic by demanding more transparency from the OEM:
  • Hospitals and surgical centers should make clear to OEMs that there is no rationale to void warranties on equipment that is used with reprocessed devices because FDA clearance or CE marking means the device has been validated to work with other necessary OEM equipment.
  • Hospitals and surgical centers should request any evidence to support assertions that OEM equipment fails more frequently when used in combination with reprocessed devices and forward that information to AMDR. We know of no evidence to support this assertion.
  • Hospitals and surgical centers are advised to tell OEM sales reps that being threatened is not well received and the institution is always looking for alternative suppliers willing to support the institutions clinical, cost and environmental goals.
  • Hospitals and surgical centers successfully counter these threats by advising all staff of the reasons the institution is committed to reprocessing the zero tolerance for undermining reprocessing programs by competing vendors will not be tolerated.