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.