An op-ed by MarkAnthony Manganello

As an Electrophysiology Specialist about to leave a long career at US hospitals, I have served as an Electrophysiology (EP) coordinator and technologist. We have always tried to live with the high device costs and demands from Electrophysiology vendors that run counter to our objectives, because we depend on the technical support for 3D mapping and the good device quality of leading manufacturers. As an example, Biosense Webster, the leading provider of EP technology in the US – and the supplier our doctors prefer – has consistently denied providing technical support in procedures where we use reprocessed sensor-enabled catheters, unless they are from Biosense Webster’s own reprocessing division, SterilMed.

Reprocessed EP devices have been used successfully in the US for decades, with no impact on patient safety or procedures outcome. This practice has been adopted by all leading US hospitals, and a sophisticated industry of regulated reprocessors follow strict regulatory guidelines and device-by-device review requirements to be able to offer reprocessed devices. Financially, using reprocessed devices not only makes sense; it is an economic necessity for many EP labs. Using reprocessed devices in an AFib procedure (one of the most common, fastest growing, and most expensive EP procedures) can reduce device costs in a procedure by around $3,000. This can make the difference between whether the EP lab is profitable or not – or sometimes between whether an EP procedure is offered to a complicated patient, or not.

The position of companies like Biosense Webster to not support procedures where reprocessed sensor-enabled catheters from other providers are used effectively costs hospitals approximately $2,000 per procedure. This is because SterilMed usually doesn’t offer the reprocessed sensor-enabled devices, so we have to forfeit the savings and unpack new sensor-enabled devices every time. Between the diagnostic ultrasound catheter (sensor-enabled) and the mapping catheter (sensor-enabled), lost savings amount to $2,000. Biosense Webster has not provided evidence that reprocessed catheters from other vendors are unsafe or perform differently. We have accepted this, because Biosense Webster is a strong partner of ours and because our doctors depend on their support during a procedure.

In fact, the reasons provided by Biosense Webster for not offering procedure support in these cases have never made sense, and the rationale is a bit of a fairy tale designed to create confusion and uncertainty. The rationale has usually been that location sensor precision is lost with reprocessing, that independent reprocessors cannot document performance levels similar to original manufacturers, and that Biosense Webster cannot guarantee device performance. I have been around reprocessed devices – with a critical mind – enough to know that location sensors are not impacted by reprocessing and tested every time before re-use, that independent reprocessors have to document to FDA that reprocessed devices function the same as new, and that the reprocessor assumes liability when providing a reprocessed device. So a rationale to walk out and not provide support is provided, but the rationale just doesn’t make sense. And since SterilMed really doesn’t provide the devices, we are out $2,000 in every procedure for no good reason at all, other than to maximize Biosense Webster profits.


It's getting worse. Last Monday, our Biosense Webster rep informed us that the company would not be able to support a Ventricular Tachycardia ablation procedure, because we were planning on using a reprocessed DecaNav catheter, which is used for mapping and usually without fully utilizing its navigational functionality. In other words: This is not a sensor-enabled catheter, neither is it a catheter that could in any way be compromised by reprocessing and re-use. I have heard from colleagues that Biosense Webster reps in other areas have upped the ante as well and simply shut down support if ANY reprocessed catheter is used.

As mentioned, fully utilizing reprocessed catheters in an electrophysiology procedure could reduce our costs by as much as $3,000. We are blocked from realizing $2,000 of these savings, due to a non-sensical rationale about sensor-enabled catheters. Now, it appears that we will be losing the $1,000 in savings from non-sensor-enabled catheters as well – with absolutely NO rationale. Other than, “we said so – and your doctors depend on us.”

There are two reasons why this is just not going to work. One has to do with EP procedure economics, and one comes down to the resilience of the supply chain.

Firstly, every few years we take price increases from Biosense Webster on “new generation” technologies and software solutions. We do this because Biosense Webster is a leader in EP technology and truly provide fantastic options for our doctors. However, as device costs go up, procedure profits go down and threaten the economic feasibility of our EP labs. Thankfully, safe re-use solutions are available to remedy this while utilizing Biosense Webster’s new technology, but if we cannot access them, in the end we cannot offer the best technologies to our doctors.

The math just doesn’t work, and I am actually baffled that Biosense Webster doesn’t understand that our utilization of their best technology, their leadership in the area, DEPENDS on our re-use of their devices. Using reprocessed devices in our procedures is safe and responsible. It allows us to address modern-day economic realities as well as the need for healthcare to become more environmentally sustainable. I would like to see Biosense Webster become more of a partner in this, but up to this point, they have fought it rather than becoming the partner I think they should be.

Secondly, the post-pandemic reality of the EP lab means supply chain shortages are a real thing that effectively restrict our ability to do procedures. There have been many situations lately where we haven’t been able to get new devices for our procedures. Thankfully we have reprocessed devices that we can rely on to actually get through our cases. Reprocessing does help to make our supplies more reliable; the practice helps us stay in business. This is something that is not discussed enough: When we can re-use devices through an FDA regulated process, this becomes a life-saver in our day-to-day operations – like my situation this Monday. How am I supposed to go to my doctor and say, “you can’t do your procedure because I am lacking a device,” when I have five reprocessed devices on the shelf that will do the job just fine? Biosense Webster, your policy here is not doing your honor, and your position is not going to be successful. We need reprocessed devices.

I fully expect my colleagues across the nation to say “enough is enough” if Biosense Webster continues to reduce meaningful savings. Eventually labs like mine will seek partnerships with other suppliers to be able to access the benefits of resilience, cost savings and environmental benefits offered by safe, FDA controlled reprocessing.

About the author: MarkAnthony Manganello is a former registered cardiovascular invasive specialist at Bon Secours Health System.