Innovative Health received its first clearance in March of 2016. By the Spring of 2021, the company had received 38 clearances, or 5 times the number of clearances all other EP reprocessors combined received. More importantly, device clearances from Innovative Health are for very complex devices; in many cases, devices that require reprocessing technology and methodology that other reprocessors don’t possess.
These are the most difficult devices to reprocess. Many have micro-lumens that present an additional challenge to clean and inspect. Some have very intricate parts and functionalities that are challenging for the reprocessor. Innovative Health has clearances to reprocess all major mapping catheters, 4 of which only Innovative Health can reprocess. Mapping catheters are also the most expensive catheters, some costing more than $2,000 from new.
These devices have traditionally been considered impossible to reprocess. However, in the Summer of 2020, Innovative Health received clearance to reprocess both the major brands. Transseptal needles are not extremely expensive, but they are used in almost all EP procedures, so hospitals can save large amounts of money reprocessing these. No other reprocessor can reprocess transseptal needles.
Vascular imaging catheters are used most frequently in clinics and offices, but occasionally they are used in Cath labs and in EP labs. They are fairly expensive and represent a good savings opportunity for the hospital. Innovative Health, in collaboration with NorthEast Scientific, are the only reprocessors to offer these.
DIAGNOSTIC ULTRASOUND CATHETERS (ICE)
Like mapping catheters, ICE catheters are very expensive, often around $2,500. This means that if an EP lab uses a reprocessed ICE catheter and a reprocessed mapping catheter in a procedure, they reduce costs by more than $2,000. Innovative Health has clearance to reprocess all major brands of ICE catheters.
Steerable introducer sheaths can be very expensive and they are a challenge from a reprocessing perspective, since faulty sheaths can be very dangerous for the patient. To reprocess them properly, they are inspected with a borescope to determine there is no contamination inside the very tiny shaft. Innovative Health has clearance to reprocess more brands of sheaths than any other reprocessor.
DIAGNOSTIC EP CATHETERS
This is a broad category of catheters that are used for diagnostic purposes in the EP procedure. The category includes coronary sinus and specialty catheters that are expensive and require a base level of reprocessing competency – as well as a number of fixed and steerable EP catheters. All EP reprocessors have clearances to reprocess most catheters in this category.
Most EP cables are re-usable, but many hospitals decide to reprocess these with Innovative Health after each procedure, since reprocessing at the hospital involves some operational, regulatory and financial risk. Innovative Health offers more than 100 different reusable EP cables, as well as single-use cables and non-sterile cables.