Innovative Health reprocesses J&J MedTech’s intracardiac imaging and mapping catheters under strict FDA oversight. The FDA requires Innovative Health to validate device safety and functionality, including the accuracy of sensor-enabled catheters. And yet, the original manufacturer’s staff had made wrongful or confusing claims about the reprocessed sensor-enabled catheters.
Original manufacturer reps have claimed that they do not know what Innovative Health does to test catheter sensors. In fact, Innovative Health has developed proprietary testing processes, approved by the FDA, to ensure that the location sensors in every device work just as they would in an originally manufactured device. Location sensors, which are copper coils embedded in the catheter tip, are not directly exposed to chemicals, water, or heat during reprocessing and therefore remain unaffected by the process. Following reprocessing, the FDA has reviewed and cleared Innovative Health’s sensor-testing methods. FDA has mandated that Innovative Health test these sensors under worst-case conditions as part of the clearance process. Devices that fail to meet acceptance criteria are rejected.
Original manufacturer reps have also stated that they cannot make accuracy claims regarding reprocessed devices. This is correct, as original manufacturers do not test or validate reprocessed devices. However, the FDA requires Innovative Health to test and validate sensor accuracy as a condition of clearance. FDA clearances confirm that reprocessed catheters such as the PENTARAY® NAV ECO and SOUNDSTAR® are substantially equivalent in design, materials, and function to their original counterparts. Location sensors are verified as intact and functional, providing the same performance as the original device.
Sensor-enabled mapping catheters from J&J MedTech are not only sensor-enabled, they also have microlumens. It is often claimed that micro-lumened catheters cannot be cleaned and inspected. These catheters represent some of the most technically challenging devices to reprocess due to their small internal diameters and delicate structures. These lumens are often continuously flushed during procedures, which limits contamination but makes effective cleaning and validation critical. The FDA requires that reprocessing companies demonstrate validated methodologies for cleaning, disinfecting, and verifying the integrity of these lumens. Innovative Health has met those rigorous standards for every micro-lumened device it reprocesses.
In fact, Innovative Health has developed a proprietary multi-step methodology to address FDA requirements for micro lumen devices:
Through this rigorous process, Innovative Health meets and exceeds FDA requirements for micro lumen catheter reprocessing. This ensures that micro lumen devices return to clinical use with performance equivalent to original manufacturer devices, while safeguarding both patient safety and physician confidence.
In short, Innovative Health follows rigorous FDA-mandated processes that test and validate catheter sensor accuracy, ensuring that reprocessed devices perform equivalently to original manufacturer devices.
What are the implications of the injunction for how much money an EP lab can save through reprocessing single-use medical devices? A typical EP ablation procedure consumes about $10,500 in medical devices. These are costs to the hospital. CMS reimburses Medicare procedures with ~$24,500, so medical device costs are roughly 43% of reimbursement, which leaves few dollars for other costs incurred in the procedure – not to mention hospital profits.
Under the case coverage policy, EP labs could not take advantage of using reprocessed sensor-enabled catheters from Biosense Webster. The EP lab could still use reprocessed diagnostic catheters, introducer sheaths (in some cases), transseptal needles, and coronary sinus catheters. Savings per procedure from using these reprocessed devices are approximately $920 or less than 9% of device costs. If the procedure was done with Biosense Webster devices, reprocessed mapping catheters and intracardiac echocardiography (ICE) catheters (plus in some cases introducer sheaths) could NOT be used, and savings from these could not be realized.
EP labs can typically save around $1,300 by using a reprocessed ICE catheter and about $800 by using a reprocessed mapping catheter. This means that a typical EP lab can more than triple its savings now that the case coverage policy has been removed by the court. $920 in procedure savings become $3000+ in procedure savings or almost 30% of procedure costs, versus less than 9%.
It may sound unrealistic that the EP lab can triple their savings just by adding the now reprocessable ICE and mapping catheters, but these two catheters also happen to be the most expensive (by far) devices used in an EP ablation procedure (not counting the ablation catheter itself).
The best news for the physician is that while procedure device costs can be reduced by 30%, the physician can still decide to use whatever ablation catheter s/he wants – including ablation catheters that may otherwise be prohibitively expensive (savings from reprocessing can often pay for more expensive technology).