For years, single-use device reprocessing has been about identifying low-complexity, single-use labeled devices and obtain FDA clearance to reprocess these and sell them back to the hospital at half the price. The “low-complexity” limitation has meant that savings have been limited to a small number of devices used during procedures. Other devices could not be reprocessed, due to the challenge of cleaning and/or inspecting the devices. In the EP lab, EP-focused reprocessors have been able to reduce device costs in a common A-Fib case by 20-30%, which significantly improves the economics of these high-cost cases, where device costs can be as much s $10,000 per case.
Innovative Health was founded with the explicit goal of challenging this “low-complexity” limitation. Lately, the focus has been on evolving the industry from “cleaning and inspecting” to a point where a specific set of competencies and methodologies – we call it “reprocessing technology” – can take even very complex devices and make them available for another use. This has meant the development of very advanced medical technology competencies arguably unmatched in the medical device industry.
FDA recently cleared Innovative Health to reprocess and sell Biosense Webster’s PENTARAY® eco Catheter. This device represents exactly the evolution from “cleaning and testing” to “reprocessing technology”: Unlike any device previously cleared for reprocessing, the PENTARAY® has a microlumen and a very complex tip geometry. The FDA’s requirements for cleaning and testing the device have included standards and measures never previously associated with single-use device reprocessing. In fact, Innovative Health has filed for protection of a number of intellectual property rights associated with micro-occlusion cleaning and inspection.
So now, the door is open for reprocessors to leverage these new methodologies and seek clearance to reprocess a number of other advanced devices that were previously considered “un-reprocessable”. However, with the evolution of reprocessing technology, the bar for getting FDA reprocessing clearances is now higher than ever before – and the demand to the engineering teams involved with reprocessing electrophysiology devices is clear: Get ready to meet standards that nobody else in the medical device industry have met before.
...the bar for getting FDA reprocessing clearances is now higher than ever before...
The higher demands from FDA to get clearance for more complex devices are a GOOD thing for reprocessing. The FDA’s role is to protect the patient, and when single-use device reprocessing sets it's eyes on complex devices, FDA must raise the standards. At Innovative Health, we welcome this development, and we appreciate that new competencies and processes must be developed in order to be cleared to reprocess these devices. Let’s keep in mind that single-use device reprocessing is governed by two goals: Reduce the cost of devices, AND protect the safety of the patient. Reprocessing PENTARAY® eco can increase savings per case by almost $1,000 and other micro-lumened devices represent similar savings potential. Adding PENTARAY® to Innovative Health’s portfolio of reprocessable devices will have a significant cost reduction impact for EP labs – and thanks to advanced reprocessing technology, this can be achieved without adding risk to the patient.