Ask Your Device Rep About the Purpose of Chips that Block Reprocessing

The ability to re-use “single-use” labeled devices in the EP lab is becoming critically important for hospitals – and for patients. The high price of devices used in AF ablation procedures and other electrophysiology procedures has already dampened growth in procedures: Although CMS reimbursement has been going up the last years (about $17,000 in 2017), the cost of running an EP lab for often 4-5 hours combined with device costs is prohibitively high for hospitals with an unfavorable payer mix. Medical device costs in a typical AF ablation procedure can be as high as $10,000, with key devices such as mapping catheters, diagnostic ultrasound catheters, and flexible sheaths individually costing approximately $1,000, $2,500 and 1,100, respectively. Each of these, fortunately, can be reprocessed, and in total, device costs in an AF ablation case can be reduced by as much as 30% or approximately $3,000 through reprocessing.

Medical device costs in a typical AF ablation procedure can be as high as $10,000, with key devices such as mapping catheters, diagnostic ultrasound catheters, and flexible sheaths individually costing approximately $1,000, $2,500 and $1,100, respectively. Each of these, fortunately, can be reprocessed, and in total, device costs in an AF ablation case can be reduced by as much as 30% or approximately $3,000 through reprocessing.

Hospitals’ ability to reduce device costs by 30% through reprocessing may be what makes it possible for them to offer AF ablation to more patients. Therefore, reprocessing in the EP lab is not just a “nice to have”, but literally the key to making AF ablation accessible to a population with increasing need for the procedure. Similarly, reprocessing catheters has the potential to speed up technology adoption, making device manufacturers more successful. Sound like a win-win.

In the light of this, it is surprising that many device manufacturers react adversely to hospitals’ attempts to reprocess devices in the EP lab. And the array of methods to block reprocessing is baffling.

The Association of Medical Device Reprocessors (AMDR) recently published their inventory of anti-reprocessing techniques, where these are listed: Bundling, eliminating or restricting utilization of reprocessed devices, replacing devices with devices that cannot be reprocessed, removal of technical support, software add-ons that block reprocessing, replacing cables so only certain (not reprocessable) devices can be used, physical removal of used devices from the lab.

However, one such technique is particularly difficult to overcome: The placement of device “locks” in devices – chips or mechanical design aspects that make it impossible to use the device more than once. Innovative Health’s engineers have become experts in understanding these locks – and in removing them so hospitals can continue to save through reprocessing.

...one such technique is particularly difficult to overcome: The placement of device “locks” in devices – chips or mechanical design aspects that make it impossible to use the device more than once. Innovative Health’s engineers have become experts in understanding these locks – and in removing them so hospitals can continue to save through reprocessing.

Our June whitepaper places these locks under a microscope and goes into detail about not only the locks themselves, but also the escalation of lock complexity over time, in response to reprocessors making reprocessed devices available for the hospital.

Innovative Health encourages hospital professionals to ask the device manufacturers why these chips and other locks are placed in their devices: If it is not for clinical reasons, then why? Patient safety reasons? Impossible: FDA oversight means that reprocessed devices are substantially equivalent to new ones. Then why? Hospitals have a right to know. For they are paying for the locks in terms of lost reprocessing savings.