Billed as “innovation,” some medical device manufacturers introduce new models of existing technology that are designed to make it impossible to reprocesses and reuse them. When such generational innovation disallows reprocessing, the hospital loses the savings they used to have on the last generation of the device – as well as projected future savings lost due to the OEM’s locking out reprocessing.
While many technology innovations come with clinical and technological advantages to prior models, the launch of devices with reprocessing “kill switches” or “locks” – and without scientifically backed clinical advantages – is becoming more and more common.
Examples of these tactics include:
- Placing chips in single-use devices so that they cannot be reused after reprocessing. These chips have become more and more complex with time;
- Covering critical pieces of the device in glue or materials that cannot be removed to clean parts of the device;
- Degrading the material used for the device so that it breaks more easily; and
- Designing devices with unnecessary holes or creases that make it difficult or impossible to clean the device
AMDR urges hospitals to fully understand all aspects of these device “improvements” before adopting new models being rolled out by manufacturers.
For example, AMDR understands the newest version of a popular electrophysiologic catheter contains a chip in the handle of the device that prevents electrophysiology (EP) labs from reprocessing the device – and hospitals from reusing the device. The introduction of this new version of the product is justified by “technological improvements,” but the clinical literature has not produced solid evidence of outcome advantages. AMDR members can “break” the chip code or otherwise work around this; however, this takes time. Since the new device is very expensive, hospitals lose critical financial resources. For example, hospitals that use 240 such catheters per year could lose about $25,000 per month as a consequence.
SUCCESSFUL WORK AROUNDS:
AMDR members have reported that hospitals who directly confront the medical device manufacturer rep about this, successfully manage to preserve their savings:
- AMDR urges hospitals to carefully evaluate the overall impact of new devices before adopting them. This includes determining clinical evidence of device superiority as well as determining loss of cost savings and overall impact on healthcare delivery;
- Hospitals should insist that sales reps are transparent about the impact of adopting new devices;
- As an example, some hospitals have successfully stopped the adoption of the latest model and continue to use prior generation devices, protecting their savings without compromising patient care