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Frontiers in Medical Device Reprocessing


Q1 2019 Innovative Health Newsletter


In Q4 of 2018, Innovative Health could celebrate a year of substantial growth, and we would like to thank our growing number of hospital and Electrophysiology (EP) lab partners that have enjoyed savings growth in their relationship with Innovative Health.


510(k) submissions under review with FDA

Innovative Health continues to seek and achieve new clearances from FDA to reprocess additional devices. We are focused on devices that are expensive for the lab, early in their product lifecycle, and in high demand – so that we can continue to grow reprocessing savings in the EP lab. Innovative Health currently has 6 submissions under review.


4 new product clearances

In Q4 of 2018, Innovative Health was able to receive 3 more 510(k) clearances to reprocess the Torqr diagnostic EP catheter from Medtronic, Advisor FL sensor-enabled circular mapping catheter from St. Jude/Abbott, and the Marinr diagnostic EP catheter from Medtronic. In January of 2019, we ventured into a new product category with a clearance to reprocess Visions Digital IVUS Catheter from Philips. This expensive device is popular in the office setting and also sees some utilization in the EP and Cath lab.


ValidatedMore and more labs start reprocessing SoundStar

At Innovative Health, we are focused on helping EP labs with minimal EP reprocessing programs take these programs to the next level, which is really about starting to reprocess sensor-enabled and imaging catheters. Adding these devices onto a minimal reprocessing program usually triples or quadruples savings, but EP labs have had a hard time reprocessing especially SoundStar from Biosense Webster. However, in recent months, we have seen more and more EP labs standing their ground and starting to reprocess this $2,500 device. One customer simply wrote to us, “we used the two re-processed soundstar catheters on Friday with Dr. Shultz. There was no difference from those and new catheters so we would like to order our replacement catheters as the re-processed catheters.” The conversation the Lab will have to have with the Biosense Webster rep is well worth the savings this lab will receive.


Complaint rates

At Innovative Health, we take pride in returning devices to our partner facilities that are as safe and effective as new devices. This is why we have been able to consistently keep complaint rates below 1%. Given that new devices in some cases have been shown to fail 5 times more frequently1 than reprocessed devices, the reprocessed device may be the safer choice?



To help EP labs optimize their EP reprocessing program, Innovative Health has developed a detailed roadmap that guides the lab through the creation of an equitable marketplace in the EP lab, where Lab management controls vendor relations, trains their own techs and ultimately get the full value from their EP reprocessing program. Several EP labs have gone through this process and have seen substantial increases to their savings. Innovative Health even helps the lab with competency assessment for training their own techs.


Heart Rhythm Society

Heart Rhythm Society May 8-11, 2019 is in San Francisco. Innovative Health will be present and we would like to invite customers and everybody interested to come join our engineers and program managers in discussions about how to take EP reprocessing to the next level from a scientific and an EP lab management perspective. We will have experts here that can discuss every aspect of this, including training in mapping and how to reprocess SoundStars and other more advanced devices.


ViewFlex tips

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It is always important to use caution when handling EP devices – both new, used and reprocessed. Devices are expensive, and it can be easy to damage a new/reprocessed device before use – or to damage used devices so they cannot be reprocessed. Towards the end of 2018, we were notified that a few of the tips of the Viewflex device were being damaged prior to clinical use. Upon investigation, it was found that the damage was done when the device was pulled out of its packaging. This video demonstrates how this can happen and the proper handling of the Viewflex device.


Reprocessing and program management videos

Innovative Health has now made several informational videos available on our website: Videos that demonstrate every step in the reprocessing process as well as videos that show how to manage an EP reprocessing program. This is a result of our commitment to openness and education to optimize savings for EP labs. Please follow this link to browse the video catalog.


Innovative Health in the press

Innovative Health has appeared in the press several times in Q4 of 2018 and again in early 2019. Planned Obsolescence and Single-Use Reprocessing in Healthcare appeared in Medtech Intelligence in October, 2018. Later the same month, Breaking point: should we be reusing more medical devices? was published by Medical Technology. In January, Tom Finn wrote in SpendMatters about the need for hospital supply chain to start controlling vendor relations and utilize initiatives like reprocessing: A 2019 Wish: U.S. Healthcare Supply Chain Leadership Will Learn to ‘Just Say No’.


1 Terrence J. Loftus (2015): A Comparison of the Defect Rate Between Original Equipment Manufacturer and Reprocessed Single-Use Bipolar and Ultrasound Diathermy Devices; Journal of Medical Devices | Volume 9 | Issue 4 | Technical Brief