Friends and Foes in the EP Lab - Desperation Tactics and the Burden of Proof

Posted by Rick Ferreira on Mar 19, 2019 11:07:30 AM

Last month I wrote about how Biosense Webster, the dominant manufacturer of Electrophysiology (EP) devices, threatens hospitals to withdraw technical support (mapping) from EP cases where reprocessed devices are used – or to shut down support for labs that use reprocessed devices altogether. The threat is based on the faulty premises that device calibration, specifications, etc. of reprocessed devices are different from those of new devices. FDA has, in the process of clearing devices to be reprocessed, determined that reprocessed devices are functionally equivalent to new ones. Should Biosense Webster (or anyone else) have data to back up these horrendous claims, they should contact FDA immediately, not send letters to the EP lab.

 

FDA has, in the process of clearing devices to be reprocessed, determined that reprocessed devices are functionally equivalent to new ones.

 

While it amazes me that a device technology leader such as Biosense Webster actually publishes this nonsense on their letterhead, it amazes me less that more and more labs are calling the Biosense Webster rep out and continue to reprocess regardless (see our most recent video case study here: It simply makes no sense that EP labs and hospitals, who we call on to save lives and cure us from diseases, should allow multinational companies with large profit margins and growing stock value to rob them of the savings the hospital can achieve by legally and safely reusing devices they already own.

Meanwhile, Biosense Webster sales reps seem to be feeling the pinch from EP lab managers who “say no” to Biosense Webster. From our EP lab partners, we hear about more and more desperate statements and actions that reflect the inability of Biosense Webster corporate messaging to protect them from the “dangers” of reprocessing and responsible EP lab management:

  • “Reprocessed devices are not functionally equivalent to new devices; they fail more often”. I recommend you go to FDA’s Manufacturer and User Facility Device Experience (MAUDE) database which contains reports of device malfunction as well as injury and death occurring in connection with device usage, and you’ll see that reprocessed devices are barely even there, in spite of the growing use of reprocessed devices in the EP lab. As hard as it may be to accept, new devices simply fail more frequently than reprocessed ones. Even better: ask the Biosense Webster rep to show you the data.
  • Over the last few weeks, some Biosense Webster reps have threatened EP labs that they “will void the lab’s insurance policy if they use reprocessed devices, because otherwise the Biosense Webster technician will be liable in court if something goes wrong." While there is no such “insurance policy” (there is, of course, a warranty on the Biosense Webster mapping system, Carto), it sounds scary… But think about it: there are lots of different devices from different manufacturers used in the same cases in the EP lab. While they don’t all plug into the Carto system, they all contribute to the overall success of the procedure. If one manufacturer can simply wash it's hands and abandon responsibility if other devices are used, it has effectively granted itself the right to decide what devices the hospital must use. That’s not right. Clinicians and hospital administrators need to be able to decide what technology is best for the patient. Suggestion: ask the Biosense Webster rep to prove how the use of reprocessed devices makes the Carto system fail.
  • We have also recently heard that “we [Biosense Webster] will not replace Biosense Webster devices that fail if reprocessed devices are also used in the same case." I am not quite sure how this is logical, but if the idea is that “it’s the reprocessed device’s fault”, I suggest Biosense Webster reps provide the evidence that that is the case. Besides, FDA doesn’t care what other devices were involved – and I highly doubt that Biosense Webster would get away with this policy in any EP lab in the country.
  • The bigger picture is that in some labs, Biosense Webster reps have succeeded in creating an atmosphere of tension and anxiety around the use of their equipment and their support of EP cases that some EP lab managers simply don’t have the courage to stray from the device utilization direction dictated by an outside commercial entity. I heard one EP lab manager say that he can’t do reprocessing, because the Biosense Webster technician at the beginning of the case has to enter into the Carto system whether the device is reprocessed or new – and that the Carto system “flags” the use of reprocessed catheters. The reality is that Carto does NOT have this requirement, and reprocessed devices are NOT recognized by Carto as such (otherwise, the Carto system would no doubt have been programmed to shut down…).

I am tempted to celebrate these acts of desperation, because when the opponent starts lying and cheating, it is typically a pretty good sign that you are winning. BUT this is no game: many EP labs depend on reprocessing savings to remain profitable; more EP labs are having to limit their reprocessing program to only the least expensive devices; and most EP labs can triple or quadruple their savings by adding imaging and sensor-enabled devices to their reprocessing program (that is, a small EP lab that saves $100K from reprocessing can typically save $400K+ if they insisted on reprocessing diagnostic ultrasound catheters and mapping catheters).

 

...a small EP lab that saves $100K from reprocessing can typically save $400K+ if they insisted on reprocessing diagnostic ultrasound catheters and mapping catheters.

 

We have, in the past (I have been in this industry for 20 years), tried to arrange meetings where EP lab management can sit down across the table from Biosense Webster and Innovative Health representatives to discuss and determine issues around safety, liability, and functionality. At no time has Biosense Webster been willing to show up. I am HAPPY to take these meetings, and I would like to extend an invitation to all EP lab managers out there: arrange the meeting. I’ll be there. But know one thing: as long as reprocessed EP devices are cleared by FDA, as long as data doesn’t show added risk of malfunction or safety, and as long as the reprocessor is liable for their own devices, the burden of proof is with Biosense Webster.

 

Rick Ferreira
CEO
Innovative Health

 

Topics: innovation, reprocessor, electrophysiology, reprocessing, savings, FDA, 510(k)

Making a Difference in Healthcare

Innovative Health introduces a targeted, high-impact Cardiology program to realize the largest possible savings from using reprocessed single-use devices. The Innovative Health team consists of the reprocessing pioneers who founded the industry. Innovative Health is the next generation in reprocessing, realizing optimal savings while reducing complexity: New technologies, more savings, better service.

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