Biosense Positioning Letter About Electrophysiology Case Support
Dear Hospital Partners,
In a February 4th position statement (see the letter here), Biosense Webster makes several observations about reprocessed Electrophysiology (EP) devices, technical support for Electrophysiology (EP) labs, and Biosense Webster’s role in EP cases.
While most of these observations are factual, the positioning statement threatens hospitals that Biosense Webster will stop providing mapping support in EP cases where reprocessed single-use catheters are used. Biosense Webster bases this on a false and misleading claim that somehow reprocessed devices have different specifications and calibration and therefore cannot be handled by the technician. However, the threat is NOT rooted in clinical concern, but purely in an attempt to maximize revenue from hospitals.
...the threat is NOT rooted in clinical concern, but purely in an attempt to maximize revenue from hospitals.
I agree that the Tech (the “Clinical Account Specialist”) needs to be trained on the “capabilities, limitations, and proper functioning of all our devices and equipment”. However, this has nothing to do with supporting cases with reprocessed devices, as the Tech’s training works just as well on reprocessed devices as on new ones – they are deemed by FDA to be functionally the same.
I also agree that the vendor contribution at the hospital is important (although the Biosense Webster Tech’s contribution is and should be limited to technical support, not treatment participation). Hospitals, in general, appreciate the support Biosense Webster provides in EP cases, and I recognize the important role that the representatives of leading technology companies like Biosense Webster play at the facility and in the EP lab.
The positioning statement also notes that “once Biosense Webster's single use devices are subjected to the reprocessing process of another company, those devices are no longer our products”. This is correct, but has nothing to do with supporting cases with reprocessed devices; again, since the reprocessed devices are deemed by FDA to be functionally the same and do not present any additional risk to the patient. Innovative Health takes full legal responsibility for its reprocessed Biosense Webster devices.
Innovative Health takes full legal responsibility for its reprocessed Biosense Webster devices.
It is a big “win” for hospitals across the country that Biosense Webster’s positioning statement clearly endorses reprocessing performed by companies that have the competency to appropriately calibrate and test devices to the needed specifications. Our hospital partners depend on reprocessing savings in the EP lab. There should be nothing stopping the hospital from continuing to reprocess with a reprocessing partner that follows FDA regulations and provides the best savings and supply chain control.
However, the positioning statement continues to state that Biosense Webster’s lack of “knowledge of the manufacturing operations or specifications of reprocessed devices manufactured by third parties with which we are not affiliated” means Biosense Webster Techs cannot support EP cases with reprocessed devices. This is a faulty premise, unless Biosense Webster questions the methods and results of FDA’s device clearance process.
This is a faulty premise, unless Biosense Webster questions the methods and results of FDA’s device clearance process.
Information about calibration and specifications is not necessary to safely reprocess Biosense Webster devices and make them functionally the same as new devices. When reprocessing companies obtain 510(k) clearance to reprocess devices, they have to develop and use calibration methodologies and specifications that satisfy FDA’s requirement that the device in the end functions the same as the new device. While “Biosense Webster cannot attest to the safety, effectiveness, and accuracy of these devices”, Innovative Health does, and the accuracy of the device is tested to be the same as the new device.
The fact that FDA clears the reprocessed devices by determining that they are similar to new devices in terms of accuracy, specifications, calibration, etc. means there is no reason why Biosense Webster “Clinical Account Specialists can only provide product technical support in cases that use diagnostic mapping and ultrasound catheters distributed by Biosense Webster”.
I suggest you ask your Biosense Webster representative for any data that reveals that reprocessed devices are problematic from a calibration or specification point of view. They should make this available to you, as well as the FDA.
If such data does not exist - and, since Biosense Webster hasn’t advised FDA to this fact, I assume so -, I encourage you to tell Biosense Webster to stop issuing warnings about reprocessed devices and threats to cancel technical mapping support, as you shouldn’t have to accept interruption to your operations and finances based on empty threats. In several of our partner hospitals, Biosense Webster techs continue supporting EP cases – including those where reprocessed devices are used – while the hospital continues to save hundreds of thousands of dollars per year from reprocessing in the EP lab.
Please let me know if I can do anything to help support this.